ORIGINAL ARTICLE
Intraoperative Crede Maneuver for Tape Adjustment During Transobturator Sling Placement: Does It Improve Continence? George Lazarou, MD, FACOG, FACS, Corrie Miller, DO, Neetu Gupta, MD, Shahidul Islam, MPH, CPH, and Peter Vetere, MD, FACOG, FACS Objective: This study evaluated the efficacy of intraoperative extrinsic manual compression on the bladder, or Crede maneuver (CM) for tape adjustment during transobturator tape (TOT) sling procedure versus the traditional method where tension-free tape is adjusted the same for all patients. Methods: All patients undergoing TOT sling procedure for stress urinary incontinence (SUI) between May 2008 and June 2011 by the first author were assessed. Tape adjustment was either performed in a traditional manner, leaving a tonsil clampYsize space between the sling and posterior urethra, or by using CM after filling the bladder to 300 ml capacity. Patients were considered cured at postoperative visits if they had no SUI symptoms and negative Cough Stress Test (CST) result, improved if they had some SUI symptoms and negative CST result, and failed if symptomatic and had positive CST result. The Fisher exact test and the Wilcoxon rank sum test were used to evaluate the baseline differences between the 2 groups, along with multiple logistic regression to evaluate independent predictors of cure. Results: The continence rate was 77.67% in the traditional group (87/112) and 79.65% (137/172) in the CM group (P = 0.76). Older patients and smokers were less likely to be continent (odds ratio, 0.95; P = 0.015; and odds ratio, 0.22; P = 0.003, respectively). Five (4.5%) of the 112 patients in the traditional group and 12 (6.9%) of the 172 patients in the CM group had adverse outcomes including transient urinary retention, mesh erosion, or dysuria (P = 0.45). Conclusion: Using CM for intraoperative tape adjustment does not improve continence rates compared to the traditional method of TOT sling placement. Key Words: crede maneuver, tape adjustment, transobturator tape
these procedures is the most effective treatment for SUI.4,5 Transobturator tape has become a popular choice for its decreased operative time and lower complication rate.6,7 To date, few studies have investigated the impact of adjusting midurethral slings according to the patient’s leaking symptoms intraoperatively.8Y10 Ulmsten and Petros11 originally intended TVT placement to be performed under local anesthesia with intraoperative adjustment via Cough Stress Test (CST). However, CST is not a possible option for patients undergoing surgery with general anesthesia. Therefore, some surgeons report placing manual suprapubic pressure, or the Crede maneuver (CM), intraoperatively with a full bladder to simulate CST and a rise in intra-abdominal pressure.12Y16 The tension on the sling is then adjusted until the patient does not leak any urine. Yet, whereas CM has been anecdotally described for TVT adjustment, there are few data to support whether this technique effectively recreates CST. Furthermore, use of CM reported in the literature has only been for TVT, and no studies of tension adjustment exist for TOT slings. The initial description of the TOT sling procedure did not include intraoperative tape adjustment by CST or CM but instead was left tension-free by leaving a space the size of a scissor breadth between the posterior urethra and sling.17,18 Currently, it is unclear whether the tension should be adjusted on TOT for improved continence without causing voiding dysfunction. We hypothesize that intraoperative adjustment of TOT improves continence rates. Therefore, the purpose of this study was to investigate the effect of tape tension adjustment for TOT using CM to provide superior continence rates postoperatively.
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MATERIALS AND METHODS
S
tress urinary incontinence (SUI) is a prevalent condition that is estimated to affect as many as 1 in 4 women around the world annually.1 Whereas often underreported, SUI has a significantly negative impact on the quality of life for those afflicted.2 Midurethral slings have been used for the treatment of SUI with increasing frequency over the past decade.3 The types of midurethral slings vary from pubovaginal slings, retropubic tension-free vaginal tape (TVT) to transobturator tape (TOT). There is controversy in the literature about which of
From the Department of Obstetrics and Gynecology, Winthrop University Hospital, Mineola, NY. Reprints: George Lazarou, MD, FACOG, FACS, Urogynecology and Reconstructive Pelvic Surgery, Winthrop-University Hospital; and Department of Obstetrics, Gynecology and Women’s Health, Stony Brook University Hospital, 259 First St, Mineola, NY 11501. E-mail: [email protected]. The authors have declared they have no conflicts of interest. The authors have no relevant financial disclosures. Copyright * 2013 by Lippincott Williams & Wilkins DOI: 10.1097/SPV.0000000000000034
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After obtaining approval through the Winthrop University Hospital Institutional Review Board, medical records of all patients with SUI who underwent a TOT midurethral sling procedure between May 2008 and June 2011 by the first author were retrospectively assessed. All patients had been evaluated preoperatively to validate the presence of SUI by history and physical examination, CST, Q-tip test for urethral hypermobility, and multichannel urodynamic studies. Transobturator tape had not performed on any patient with a fixed, immobile urethra. All slings used were made of woven macroporous polypropylene tape and placed using the ‘‘outside-in’’ technique by one surgeon. The procedures were performed under general anesthesia and with cystoscopy after sling placement. For those undergoing concomitant abdominal procedures for pelvic organ prolapse (POP), such as supracervical hysterectomy with sacrocolpopexy, the abdominal procedure was performed first. Then, after closure of the abdomen, attention was directed to the vagina for the TOT, as the patient was positioned in Allen stirrups in modified lithotomy. If the patient underwent concomitant vaginal colporrhaphy, the tape was placed initially and only adjusted after completion of the prolapse repair.
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In the study design, the only inclusion criteria were for the patient to have had TOT performed during the designated study dates. There were no exclusion criteria. The first part of the cohort (group A) had no intraoperative tape adjustment using CM, and the tape was placed via the traditional method of leaving a 2-mm space, the size of a tonsil clamp, between the sling and posterior urethra. The tape was first placed against the posterior urethra and then pulled gently away, leaving it tension-free. This method was performed for all patients in group A by the first author, using the same technique and the same tonsil clamp. During the chosen retrospective study period, the primary author had made a change in his surgical technique from the traditional method of TOT placement to adjustment by CM. Thus, all patients undergoing the procedure after April of 2010 underwent intraoperative TOT adjustment with CM (group B). There was no overlap in time between the 2 groups. Crede maneuver was performed in the following manner: After retrograde filling of the bladder to 300 ml with isotonic sodium chloride solution, the hypothenar eminence of the nondominant hand of the primary surgeon was used to perform gentle CM in all patients, pushing inferiorly and posteriorly over the patients’ bladder. A conscious effort was made to apply the same amount of pressure for all patients. The tape was then adjusted until no leakage of urine occurred. Postoperatively, the subjective and objective outcomes were assessed by evaluating urinary continence at follow-up visits. Subjectively, the primary author interviewed all patients at regular postoperative visits, the first being 2 weeks after surgery. They were asked if they continued to leak urine when coughing, laughing, or sneezing, as well as if they experienced any leakage of urine with urgency compared to their preoperative symptoms. Objectively, patients were asked to come to the office with a full bladder, and CST was performed in the standing position. After CST, voided volume was measured along with postvoid residual volume by bladder scan. Based on the results, the patients were categorized as ‘‘completely continent’’, ‘‘improved’’, or ‘‘failed’’ by the following criteria: Patients were considered to be continent if they reported no SUI symptoms at their postoperative assessments and had a negative CST result with a full bladder. Patients were considered improved if still reporting some SUI symptoms but the CST result was negative. These patients were grouped with the ‘‘failure’’ group and not considered completely continent. Patients were categorized as ‘‘failed’’ if they were symptomatic for SUI with positive CST result.
Statistical Analysis To test the null hypothesis of equivalent cure rates in the traditional (group A) and Crede group (group B), we assumed that a 13% difference in cure rate is clinically meaningful (77% cure in the traditional group vs 90% cure in the Crede group; odds ratio [OR], 2.69; and RR, 1.17). We incorporated these assumptions to Power and Precision software version 4.1. This program reported that a total sample size of 284 (40% in the classic group vs 60% in the Crede group) was needed to achieve 80% power (exact number, 82%) at 5% level of significance (2-tailed test). Continence rate was specified as the main outcome variable. We compared continence rates between the traditional group (group A) and the CM group (group B) using the Fisher exact test and the simple logistic regression univariately. After univariate comparison, we then constructed a simultaneous multiple logistic regression model to understand if other factors influence continence rate. This analysis was performed on the
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cohort as a whole, with adjustment type used as a variable. The model was also used to analyze each group separately. A stepwise multiple logistic regression model was used to confirm significant variables that proved to affect continence rate. Continuous variables were presented as meanTSD and categorical variables as proportions. We used the Fisher exact test (for categorical variables) and the Wilcoxon rank sum test (for continuous variables) to compare baseline characteristics between groups. All calculations were performed using SAS version 9.3 (SAS Institute, Cary, NC), and results were considered significant if P G 0.05.
RESULTS Two hundred ninety-three patients underwent the TOT procedure. Of these, 115 patients underwent tape adjustment using the traditional method of leaving space the size of a tonsil clamp between the sling and posterior urethra (group A). One hundred seventy-eight patients had the TOT adjusted using CM (group B). Three patients were lost to follow-up in group A, leaving a remainder of 112 patients. Six patients were lost to follow-up in group B, with a remaining 172 patients who underwent adjustment. The 2 groups were similar with respect to age, parity, menopausal status, concomitant surgery for POP, prior surgery for SUI, smoking, asthma, chronic obstructive pulmonary disease, constipation, use of hormone replacement therapy, and heavy lifting (P = 0.19Y0.92; Table 1). Mean Valsalva leak point pressure (VLPP) was higher in group B. However, the number of patients with intrinsic sphincter deficiency (ISD) defined as a VLPP of less than 60 cmH2O was equivalent in both groups. Additionally, patients in group B had a minimally higher body mass index (BMI) and more patients reported symptoms of urge incontinence at initial presentation before surgery. The
TABLE 1. Preoperative Characteristics Traditional Crede Group (B) Group (A) (n=112) (n=172)
Age, mean (SD) Parity, mean (SD) BMI, mean (SD) Menopause HRT Smoking COPD Asthma Constipation Urge incontinence Concomitant surgery Prior surgery VLPP Presence of ISD
Mean (SD) or Proportion %
Mean (SD) or Proportion %
P*
56 (13) 3 (1) 27 (3) 63% 4% 10% 7% 4% 23% 42%
54 (12) 3 (1) 28 (5) 53% 5% 8% 3% 7% 20% 56%
0.532 0.915 0.045 0.141 0.770 0.519 0.174 0.451 0.552 0.029
41%
44%
0.714
8% 94 (79) 14%
4% 123 (93) 13.9%
0.191 0.019 0.719
*P values are from Wilcoxon rank sum test for continuous variables and the Fisher exact test for categorical variables. COPD, chronic obstructive pulmonary disease; HRT, hormone replacement therapy.
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TABLE 2. Independent Predictors of Cure Based on Multiple Logistic Regression Analysis Variable Crede maneuver group vs traditional group Age† Parity BMI Menopause Hormone replacement therapy Smoking COPD Asthma Constipation Urge incontinence Concomitant surgery for POP Prior surgery for SUI VLPP
Unadjusted OR (95% CI)
Adjusted OR (95% CI)
P*
1.13 (0.63Y2.01) 0.98 (0.96Y1.00) 0.92 (0.74Y1.15) 1.06 (0.98Y1.14) 0.71 (0.40Y1.28) 0.36 (0.11Y1.17) 0.23 (0.10Y0.54) 0.46 (0.15Y1.43) 1.27 (0.35Y4.56) 1.44 (0.68Y3.04) 0.94 (0.53Y1.65) 1.25 (0.70Y2.24) 0.79 (0.25Y2.55) 1.00 (0.99Y1.005)
0.98 (0.52Y1.85) 0.95 (0.92Y0.99) 0.95 (0.75Y1.21) 1.06 (0.98Y1.14) 1.38 (0.53Y3.57) 0.49 (0.13Y1.84) 0.22 (0.08Y0.60) 0.70 (0.19Y2.58) 1.52 (0.308Y7.51) 1.55 (0.69Y3.47) 1.10 (0.58Y2.09) 1.36 (0.69Y2.69) 0.99 (0.27Y3.60) 1.00 (0.99Y1.004)
0.941 0.015 0.691 0.146 0.512 0.290 0.003 0.588 0.606 0.291 0.775 0.377 0.985 0.895
*Reported P values are from the multiple logistic regression model. †Per 1-year increase from the mean of study sample (55 years).
types and number of concomitant pelvic surgeries performed included supracervical hysterectomy (69), vaginal hysterectomy (25), anterior and posterior colporrhaphy (75), abdominal sacrocolpopexy (40), uterosacral ligament fixation (4), Lefort colpocleisis (6), and anal sphincteroplasty (2). The cure rate was 77.67% (87/112) versus 79.65% (137/172) (P = 0.76) in groups A and B, respectively. The median follow-up time was 12 weeks for both groups (group A interquartile range, 20; group B interquartile range, 6). Nine of the 112 patients in group A and 16 of the 172 patients in group B (P = 0.67) improved according to the criteria of a negative CST result with some remaining SUI symptoms. These patients were not categorized as completely continent. Multiple logistic regression showed no difference in continence rates between either adjustment types (Table 2). The analysis did demonstrate that patients who smoked were 78% less likely to be cured compared to nonsmokers (OR, 0.22; P = 0.003 [95% confidence interval, 0.08Y0.60]). Increased age also proved to be a risk factor for continued SUI postoperatively; each 1-year increase in age from the mean decreased chance for cure by 5% (OR, 0.95, P = 0.015, [95% confidence interval, 0.92Y0.99]). Multiple logistic regression analysis was also performed separately on each adjustment group and identified hormone replacement therapy (P = 0.0366), smoking (P = 0.0012), and age (P = 0.0194) as independently significant risk factors in the traditional group but not in the Crede group. Patients with ISD as defined by preoperative urodynamic testing were found to have equivalent continence rates in both the adjustment group (18/22 or 85%) and traditional method group (18/21 or 81.8%) (P = 1.0). Although there was a higher mean BMI and more patients with symptoms of urge incontinence in group B, there was no association with BMI (OR, 1.06; P = 0.15) or urge incontinence (OR, 1.10; P = 0.78) and prognosis of cure in the adjusted analysis. Postoperatively, 4.5% (5/112) of the patients in group A and 6.9% (12/172) of the patients in group B had complications such as vaginal spotting, urinary tract infection, and dysuria (P = 0.45). No patients in the traditional group had voiding difficulty, elevated postvoid residual volumes, or prolonged urinary retention, whereas 5 patients in the CM group encountered transient complications of voiding difficulty * 2013 Lippincott Williams & Wilkins
postoperatively (P = 0.16). These few patients were discharged home with a transurethral catheter, and all had successful voiding trials within 5 to 7 days in the office postoperatively. Lastly, no patient required a sling release for voiding difficulties.
DISCUSSION Our study examined the use of CM to improve continence rates for the TOT procedure. Crede maneuver is a method that is at times used by physicians for tape adjustment during sling procedures but has not formally been investigated as a prognostic factor of midurethral sling success. The results from this study show that intraoperative TOT adjustment via CM does not have a statistically significant impact on cure rates of SUI compared to the traditional method of tape placement. Additionally, patients with SUI due to ISD experienced no greater benefit from the tape adjustment. Midurethral slings are frequently adjusted in the operating room via CST if the patient has local anesthesia for the procedure and is able to cough. Cough Stress Test has been studied and shown to be an effective method for tape adjustment specifically in TVT procedures. Murphy et al9 compared patients undergoing TVT procedure under local anesthesia and tape adjustment using CST, versus patients under general anesthesia unable to perform CST. Their results demonstrated a 16-point higher score of improvement for those performing CST and subsequent tape adjustment under local anesthesia on the Urinary Distress Inventory Stress Symptoms subscale (P = 0.02).9 Whereas local anesthesia and CST may be advantageous for intraoperative tape adjustment, often, patient’s preference or concurrent surgery for correction of POP necessitates the use of general anesthesia. Some studies anecdotally report trying to mimic CST under general anesthesia by using CM after retrograde filling of the bladder and adjusting tension of the midurethral slings until the patient does not leak.12Y16 However, it is not well documented whether CM accurately recreates CST. To date, no studies have compared the 2 methods of tape adjustment nor compared solely CM versus no CM. In evaluating the results of our study, we postulate that CM may not generate the same increase in intra-abdominal pressure over a midurethral sling that CST does. It is possible that the www.fpmrs.net
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patient may leak less with manual suprapubic pressure directly over a full bladder versus an increase in total intra-abdominal pressure when coughing. Crede maneuver may lead the physician to put less tension on the sling than when adjusting via CST. A limitation of our study is that quantification of the intraabdominal pressure as a result of CM applied was not performed. With this in mind, it may be worthwhile to compare these 2 methods and measure the amount of tension needed to prevent leakage with both methods in a prospective study. The literature reports several reasons for TOT failure. In a case series of TOT sling revisions, Moore et al19 suggest that one of these is insufficient adjustment when the sling is placed. We aimed to specifically evaluate this variable and suggest further studies. Another commonly suggested reason for TOT failure is low VLPP or ISD. O’Connor found that patients with a VLPP of less than 60 cmH2O were 12 times more likely to fail TOT treatment compared with patients with a VLPP of more than 60 cmH2O.20 Guerette et al21 also cautioned the use of TOT in ISD after noting that median VLPP in successful cases was 71 cmH2O versus 32 cmH2O in failures (P = 0.001). Conversely, Haliloglu et al22 and Karateke et al23 found no difference in cure rates with low and high VLPP but did report a significant difference in those who had a fixed, immobile urethra. Anast et al24 performed TOT on 124 patients under local anesthesia and adjusted the tape with CST. After stratifying patients with low VLPP and high VLPP, no difference in cure rates was found between the 2 groups. Our study also found no statistical difference in cure rates for patients with a VLPP of less than 60 cmH2O in either traditional or CM groups. Yet the numbers of our patients with ISD were small and thus are not necessarily powered to contribute to the general fund of knowledge regarding this topic. The results of our study did identify prognostic risk factors for TOT failure previously reported in the literature.25 Patients who smoked were 78% less likely to have persistence of their SUI symptoms. Increasing age above the mean was also a risk factor for TOT failure (OR, 0.95). These findings corroborate with Barber et al,26 showing an OR of 1.3 of anti-incontinence surgery failure per decade. The study suggested that the contributing mechanism for continued incontinence is decreased muscle tone and connective tissue strength.27 The same study also reported a lower OR for failure in smokers, but the number of smokers was small in the study. Based on these findings, it is recommended that patients be counseled on their risk profile for success in treatment of SUI. We acknowledge the limitations of this study. This retrospective study had a rather short follow-up period. Ideally, patients would be followed past a median of 3 months in a future prospective study. Additionally, subjective outcomes could be measured by validated questionnaires such as the Urinary Distress Inventory 6 or Quality of Life Assessment Tools. Objective outcomes could be evaluated intraoperatively with urodynamic testing during CM to measure the amount of pressure generated with CM. Postoperative objective measures also could be taken at follow-up visits along with standing CST, such as urodynamic testing or pad test. Finally, the patients in our retrospective study were not randomized into traditional or CM groups. However, having a single experienced pelvic surgeon operate on all the patients in this study minimized variability. Although the 2 groups differed preoperatively with regard to BMI and symptoms of urgency, these differences did not influence continence rates after the procedure. Lastly, future prospective studies with larger sample size and longer follow-up are needed to further evaluate the efficacy of intraoperative tape fadjustment.
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REFERENCES 1. Minassian VA, Drutz HP, Al-Badr A. Urinary incontinence as a worldwide problem. Int J Gynecol Obstet 2003;82:327Y338. 2. Harding CK, Thorpe AC. Surgical treatment for stress urinary incontinence. Int J Urol 2008;15:27Y34. 3. Magon N, Chopra SV. Transobturator tape in treatment of stress urinary incontinence: it is time for a new gold standard. N Am J Med Sci 2012;4(5):226Y230. 4. Jeon, MJ, Jung HJ, Chung SM, et al. Comparison of the treatment outcome of pubovaginal sling, tension free vaginal tape, and transobturator tape for stress urinary incontinence with intrinsic sphincter deficiency. Am J Obstet Gynecol 2008;199(1):76.e1Y76.e4. 5. Yang X, Jiang M, Chen X, et al. TVT-O vs. TVT for the treatment of SUI: a non-inferiority study Int Urogynecol J Pelvic Floor Dysfunct J 2012;23:99Y104. 6. Fischer A, Fink T, Zachmann S, et al. Comparison of retropubic and outside-in transobturator sling systems for the cure of female genuine stress urinary incontinence. Eur Urol 2005;48:799Y804. 7. Karram MM, Segal JL, Vassallo BJ, et al. Complications and untoward effects of the tension-free vaginal tape procedure. Obstet Gynecol 2003;101:929Y932. 8. Murphy M, Heit MH, Fouts L, et al. Effect of anesthesia on voiding function after tension-free vaginal tape procedure. Obstet Gynecol 2003;101(4):666Y670. 9. Murphy M, Culligan PJ, Arce CM, et al. Is the cough-stress test necessary when placing the tension-free vaginal tape? Obstet Gynecol 2005;105(2):319Y324. 10. Low JS, Smith KM, Holt EM. Tension free vaginal tape: is the intraoperative cough test necessary? Int Urogynecol J Pelvic Floor Dysfunct J 2004;15:328Y330. 11. Ulmsten U, Petros P. Intravaginal slingplasty (IVS): an ambulatory surgical procedure for the treatment of female urinary incontinence. Scand J Urol Nephrol 1995;29:75Y82. 12. Liang HM, Huang KH, Kung FT, et al. Combination of a tension-free vaginal tape procedure and laparoscopic-assisted vaginal hysterectomy for the treatment of benign uterine disease associated with stress urinary incontinence. Chang Gung Med J 2005;28(3):166Y173. 13. Lo TS. Tension free vaginal tape procedures in women with stress urinary incontinence with and without co-existing genital prolapse. Curr Opin Obstet Gynecol 2004;16:399Y404. 14. Paraiso MFR, Mark WD, Karram MM, et al. Laparoscopic Burch colposuspension versus tension-free vaginal tape: a randomized trial. Obstet Gynecol 2004;104:1249Y1258. 15. Partoll LM. Efficacy of tension-free vaginal tape with other pelvic reconstructive surgery. Am J Obstet Gynecol 2002;186:1292Y1295. 16. Huang KH, Kung FT, Liang HM, et al. Concomitant surgery with tension-free vaginal tape. Acta Obstet Gynecol 2003;82:948Y953. 17. Delorme E. Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women. Prog Urol 2001;11:1306Y1313. 18. de Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol 2003;44(6):724Y730. 19. Moore RD, Gamble K, Miklos JR. Tension-free vaginal tape sling for recurrent stress incontinence after transobturator tape sling failure. Int Urogynecol J Pelvic Floor Dysfunct J 2007;18:309Y313. 20. O’Connor RC, Nanigian DK, Lyon MB, et al. Early outcomes of mid-urethral slings for female stress urinary incontinence stratified by Valsalva leak point pressure. Neurourol Urodyn 2006;25:685Y688.
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21. Guerette NL, Bena JF, Davilla GW. Transobturator slings for stress incontinence: using urodynamic parameters to predict outcomes. Int Urogynecol J Pelvic Floor Dysfunct 2008;19:97Y102.
24. Anast JW, Skolarus TA, Yan Y, et al. Transobturator sling with intraoperative cough test is effective for patients with low Valsalva leak point pressure. Can J Urol 2008;15:4153Y4157.
22. Haliloglu B, Karateke A, Coksuer H, et al. The role of urethral hypermobility and intrinsic sphincteric deficiency on the outcome of transobturator tape procedure: a prospective study with 2-year follow-up. Int Urogynecol J Pelvic Floor Dysfunct J 2010;21:173Y178.
25. Chen HY, Yeh LS, Chang WC, et al. Analysis of risk factors associated with surgical failure of inside-out transobturator vaginal tape for treating urodynamic stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2007;18:443Y447.
23. Karateke A, Haliloglu B, Cam C, et al. Comparison of TVT and TVT-O in patients with stress urinary incontinence: short-term cure rates and factors influencing the outcome. A prospective randomised study. Aust N Z J Obstet Gynaecol 2009;49(1):99Y105.
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26. Barber MD, Kleeman S, Karram MM, et al. Risk factors associated with failure 1 year after retropubic or transobturator midurethral slings. Am J Obstet Gynecol 2008;199:666Y670.
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Intraoperative Crede Maneuver for Tape Adjustment During Transobturator Sling Placement: Does It Improve Continence? George Lazarou, MD, FACOG, FACS, Corrie Miller, DO, Neetu Gupta, MD, Shahidul Islam, MPH, CPH, and Peter Vetere, MD, FACOG, FACS Objective: This study evaluated the efficacy of intraoperative extrinsic manual compression on the bladder, or Crede maneuver (CM) for tape adjustment during transobturator tape (TOT) sling procedure versus the traditional method where tension-free tape is adjusted the same for all patients. Methods: All patients undergoing TOT sling procedure for stress urinary incontinence (SUI) between May 2008 and June 2011 by the first author were assessed. Tape adjustment was either performed in a traditional manner, leaving a tonsil clampYsize space between the sling and posterior urethra, or by using CM after filling the bladder to 300 ml capacity. Patients were considered cured at postoperative visits if they had no SUI symptoms and negative Cough Stress Test (CST) result, improved if they had some SUI symptoms and negative CST result, and failed if symptomatic and had positive CST result. The Fisher exact test and the Wilcoxon rank sum test were used to evaluate the baseline differences between the 2 groups, along with multiple logistic regression to evaluate independent predictors of cure. Results: The continence rate was 77.67% in the traditional group (87/112) and 79.65% (137/172) in the CM group (P = 0.76). Older patients and smokers were less likely to be continent (odds ratio, 0.95; P = 0.015; and odds ratio, 0.22; P = 0.003, respectively). Five (4.5%) of the 112 patients in the traditional group and 12 (6.9%) of the 172 patients in the CM group had adverse outcomes including transient urinary retention, mesh erosion, or dysuria (P = 0.45). Conclusion: Using CM for intraoperative tape adjustment does not improve continence rates compared to the traditional method of TOT sling placement. Key Words: crede maneuver, tape adjustment, transobturator tape
these procedures is the most effective treatment for SUI.4,5 Transobturator tape has become a popular choice for its decreased operative time and lower complication rate.6,7 To date, few studies have investigated the impact of adjusting midurethral slings according to the patient’s leaking symptoms intraoperatively.8Y10 Ulmsten and Petros11 originally intended TVT placement to be performed under local anesthesia with intraoperative adjustment via Cough Stress Test (CST). However, CST is not a possible option for patients undergoing surgery with general anesthesia. Therefore, some surgeons report placing manual suprapubic pressure, or the Crede maneuver (CM), intraoperatively with a full bladder to simulate CST and a rise in intra-abdominal pressure.12Y16 The tension on the sling is then adjusted until the patient does not leak any urine. Yet, whereas CM has been anecdotally described for TVT adjustment, there are few data to support whether this technique effectively recreates CST. Furthermore, use of CM reported in the literature has only been for TVT, and no studies of tension adjustment exist for TOT slings. The initial description of the TOT sling procedure did not include intraoperative tape adjustment by CST or CM but instead was left tension-free by leaving a space the size of a scissor breadth between the posterior urethra and sling.17,18 Currently, it is unclear whether the tension should be adjusted on TOT for improved continence without causing voiding dysfunction. We hypothesize that intraoperative adjustment of TOT improves continence rates. Therefore, the purpose of this study was to investigate the effect of tape tension adjustment for TOT using CM to provide superior continence rates postoperatively.
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MATERIALS AND METHODS
S
tress urinary incontinence (SUI) is a prevalent condition that is estimated to affect as many as 1 in 4 women around the world annually.1 Whereas often underreported, SUI has a significantly negative impact on the quality of life for those afflicted.2 Midurethral slings have been used for the treatment of SUI with increasing frequency over the past decade.3 The types of midurethral slings vary from pubovaginal slings, retropubic tension-free vaginal tape (TVT) to transobturator tape (TOT). There is controversy in the literature about which of
From the Department of Obstetrics and Gynecology, Winthrop University Hospital, Mineola, NY. Reprints: George Lazarou, MD, FACOG, FACS, Urogynecology and Reconstructive Pelvic Surgery, Winthrop-University Hospital; and Department of Obstetrics, Gynecology and Women’s Health, Stony Brook University Hospital, 259 First St, Mineola, NY 11501. E-mail: [email protected]. The authors have declared they have no conflicts of interest. The authors have no relevant financial disclosures. Copyright * 2013 by Lippincott Williams & Wilkins DOI: 10.1097/SPV.0000000000000034
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After obtaining approval through the Winthrop University Hospital Institutional Review Board, medical records of all patients with SUI who underwent a TOT midurethral sling procedure between May 2008 and June 2011 by the first author were retrospectively assessed. All patients had been evaluated preoperatively to validate the presence of SUI by history and physical examination, CST, Q-tip test for urethral hypermobility, and multichannel urodynamic studies. Transobturator tape had not performed on any patient with a fixed, immobile urethra. All slings used were made of woven macroporous polypropylene tape and placed using the ‘‘outside-in’’ technique by one surgeon. The procedures were performed under general anesthesia and with cystoscopy after sling placement. For those undergoing concomitant abdominal procedures for pelvic organ prolapse (POP), such as supracervical hysterectomy with sacrocolpopexy, the abdominal procedure was performed first. Then, after closure of the abdomen, attention was directed to the vagina for the TOT, as the patient was positioned in Allen stirrups in modified lithotomy. If the patient underwent concomitant vaginal colporrhaphy, the tape was placed initially and only adjusted after completion of the prolapse repair.
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In the study design, the only inclusion criteria were for the patient to have had TOT performed during the designated study dates. There were no exclusion criteria. The first part of the cohort (group A) had no intraoperative tape adjustment using CM, and the tape was placed via the traditional method of leaving a 2-mm space, the size of a tonsil clamp, between the sling and posterior urethra. The tape was first placed against the posterior urethra and then pulled gently away, leaving it tension-free. This method was performed for all patients in group A by the first author, using the same technique and the same tonsil clamp. During the chosen retrospective study period, the primary author had made a change in his surgical technique from the traditional method of TOT placement to adjustment by CM. Thus, all patients undergoing the procedure after April of 2010 underwent intraoperative TOT adjustment with CM (group B). There was no overlap in time between the 2 groups. Crede maneuver was performed in the following manner: After retrograde filling of the bladder to 300 ml with isotonic sodium chloride solution, the hypothenar eminence of the nondominant hand of the primary surgeon was used to perform gentle CM in all patients, pushing inferiorly and posteriorly over the patients’ bladder. A conscious effort was made to apply the same amount of pressure for all patients. The tape was then adjusted until no leakage of urine occurred. Postoperatively, the subjective and objective outcomes were assessed by evaluating urinary continence at follow-up visits. Subjectively, the primary author interviewed all patients at regular postoperative visits, the first being 2 weeks after surgery. They were asked if they continued to leak urine when coughing, laughing, or sneezing, as well as if they experienced any leakage of urine with urgency compared to their preoperative symptoms. Objectively, patients were asked to come to the office with a full bladder, and CST was performed in the standing position. After CST, voided volume was measured along with postvoid residual volume by bladder scan. Based on the results, the patients were categorized as ‘‘completely continent’’, ‘‘improved’’, or ‘‘failed’’ by the following criteria: Patients were considered to be continent if they reported no SUI symptoms at their postoperative assessments and had a negative CST result with a full bladder. Patients were considered improved if still reporting some SUI symptoms but the CST result was negative. These patients were grouped with the ‘‘failure’’ group and not considered completely continent. Patients were categorized as ‘‘failed’’ if they were symptomatic for SUI with positive CST result.
Statistical Analysis To test the null hypothesis of equivalent cure rates in the traditional (group A) and Crede group (group B), we assumed that a 13% difference in cure rate is clinically meaningful (77% cure in the traditional group vs 90% cure in the Crede group; odds ratio [OR], 2.69; and RR, 1.17). We incorporated these assumptions to Power and Precision software version 4.1. This program reported that a total sample size of 284 (40% in the classic group vs 60% in the Crede group) was needed to achieve 80% power (exact number, 82%) at 5% level of significance (2-tailed test). Continence rate was specified as the main outcome variable. We compared continence rates between the traditional group (group A) and the CM group (group B) using the Fisher exact test and the simple logistic regression univariately. After univariate comparison, we then constructed a simultaneous multiple logistic regression model to understand if other factors influence continence rate. This analysis was performed on the
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cohort as a whole, with adjustment type used as a variable. The model was also used to analyze each group separately. A stepwise multiple logistic regression model was used to confirm significant variables that proved to affect continence rate. Continuous variables were presented as meanTSD and categorical variables as proportions. We used the Fisher exact test (for categorical variables) and the Wilcoxon rank sum test (for continuous variables) to compare baseline characteristics between groups. All calculations were performed using SAS version 9.3 (SAS Institute, Cary, NC), and results were considered significant if P G 0.05.
RESULTS Two hundred ninety-three patients underwent the TOT procedure. Of these, 115 patients underwent tape adjustment using the traditional method of leaving space the size of a tonsil clamp between the sling and posterior urethra (group A). One hundred seventy-eight patients had the TOT adjusted using CM (group B). Three patients were lost to follow-up in group A, leaving a remainder of 112 patients. Six patients were lost to follow-up in group B, with a remaining 172 patients who underwent adjustment. The 2 groups were similar with respect to age, parity, menopausal status, concomitant surgery for POP, prior surgery for SUI, smoking, asthma, chronic obstructive pulmonary disease, constipation, use of hormone replacement therapy, and heavy lifting (P = 0.19Y0.92; Table 1). Mean Valsalva leak point pressure (VLPP) was higher in group B. However, the number of patients with intrinsic sphincter deficiency (ISD) defined as a VLPP of less than 60 cmH2O was equivalent in both groups. Additionally, patients in group B had a minimally higher body mass index (BMI) and more patients reported symptoms of urge incontinence at initial presentation before surgery. The
TABLE 1. Preoperative Characteristics Traditional Crede Group (B) Group (A) (n=112) (n=172)
Age, mean (SD) Parity, mean (SD) BMI, mean (SD) Menopause HRT Smoking COPD Asthma Constipation Urge incontinence Concomitant surgery Prior surgery VLPP Presence of ISD
Mean (SD) or Proportion %
Mean (SD) or Proportion %
P*
56 (13) 3 (1) 27 (3) 63% 4% 10% 7% 4% 23% 42%
54 (12) 3 (1) 28 (5) 53% 5% 8% 3% 7% 20% 56%
0.532 0.915 0.045 0.141 0.770 0.519 0.174 0.451 0.552 0.029
41%
44%
0.714
8% 94 (79) 14%
4% 123 (93) 13.9%
0.191 0.019 0.719
*P values are from Wilcoxon rank sum test for continuous variables and the Fisher exact test for categorical variables. COPD, chronic obstructive pulmonary disease; HRT, hormone replacement therapy.
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TABLE 2. Independent Predictors of Cure Based on Multiple Logistic Regression Analysis Variable Crede maneuver group vs traditional group Age† Parity BMI Menopause Hormone replacement therapy Smoking COPD Asthma Constipation Urge incontinence Concomitant surgery for POP Prior surgery for SUI VLPP
Unadjusted OR (95% CI)
Adjusted OR (95% CI)
P*
1.13 (0.63Y2.01) 0.98 (0.96Y1.00) 0.92 (0.74Y1.15) 1.06 (0.98Y1.14) 0.71 (0.40Y1.28) 0.36 (0.11Y1.17) 0.23 (0.10Y0.54) 0.46 (0.15Y1.43) 1.27 (0.35Y4.56) 1.44 (0.68Y3.04) 0.94 (0.53Y1.65) 1.25 (0.70Y2.24) 0.79 (0.25Y2.55) 1.00 (0.99Y1.005)
0.98 (0.52Y1.85) 0.95 (0.92Y0.99) 0.95 (0.75Y1.21) 1.06 (0.98Y1.14) 1.38 (0.53Y3.57) 0.49 (0.13Y1.84) 0.22 (0.08Y0.60) 0.70 (0.19Y2.58) 1.52 (0.308Y7.51) 1.55 (0.69Y3.47) 1.10 (0.58Y2.09) 1.36 (0.69Y2.69) 0.99 (0.27Y3.60) 1.00 (0.99Y1.004)
0.941 0.015 0.691 0.146 0.512 0.290 0.003 0.588 0.606 0.291 0.775 0.377 0.985 0.895
*Reported P values are from the multiple logistic regression model. †Per 1-year increase from the mean of study sample (55 years).
types and number of concomitant pelvic surgeries performed included supracervical hysterectomy (69), vaginal hysterectomy (25), anterior and posterior colporrhaphy (75), abdominal sacrocolpopexy (40), uterosacral ligament fixation (4), Lefort colpocleisis (6), and anal sphincteroplasty (2). The cure rate was 77.67% (87/112) versus 79.65% (137/172) (P = 0.76) in groups A and B, respectively. The median follow-up time was 12 weeks for both groups (group A interquartile range, 20; group B interquartile range, 6). Nine of the 112 patients in group A and 16 of the 172 patients in group B (P = 0.67) improved according to the criteria of a negative CST result with some remaining SUI symptoms. These patients were not categorized as completely continent. Multiple logistic regression showed no difference in continence rates between either adjustment types (Table 2). The analysis did demonstrate that patients who smoked were 78% less likely to be cured compared to nonsmokers (OR, 0.22; P = 0.003 [95% confidence interval, 0.08Y0.60]). Increased age also proved to be a risk factor for continued SUI postoperatively; each 1-year increase in age from the mean decreased chance for cure by 5% (OR, 0.95, P = 0.015, [95% confidence interval, 0.92Y0.99]). Multiple logistic regression analysis was also performed separately on each adjustment group and identified hormone replacement therapy (P = 0.0366), smoking (P = 0.0012), and age (P = 0.0194) as independently significant risk factors in the traditional group but not in the Crede group. Patients with ISD as defined by preoperative urodynamic testing were found to have equivalent continence rates in both the adjustment group (18/22 or 85%) and traditional method group (18/21 or 81.8%) (P = 1.0). Although there was a higher mean BMI and more patients with symptoms of urge incontinence in group B, there was no association with BMI (OR, 1.06; P = 0.15) or urge incontinence (OR, 1.10; P = 0.78) and prognosis of cure in the adjusted analysis. Postoperatively, 4.5% (5/112) of the patients in group A and 6.9% (12/172) of the patients in group B had complications such as vaginal spotting, urinary tract infection, and dysuria (P = 0.45). No patients in the traditional group had voiding difficulty, elevated postvoid residual volumes, or prolonged urinary retention, whereas 5 patients in the CM group encountered transient complications of voiding difficulty * 2013 Lippincott Williams & Wilkins
postoperatively (P = 0.16). These few patients were discharged home with a transurethral catheter, and all had successful voiding trials within 5 to 7 days in the office postoperatively. Lastly, no patient required a sling release for voiding difficulties.
DISCUSSION Our study examined the use of CM to improve continence rates for the TOT procedure. Crede maneuver is a method that is at times used by physicians for tape adjustment during sling procedures but has not formally been investigated as a prognostic factor of midurethral sling success. The results from this study show that intraoperative TOT adjustment via CM does not have a statistically significant impact on cure rates of SUI compared to the traditional method of tape placement. Additionally, patients with SUI due to ISD experienced no greater benefit from the tape adjustment. Midurethral slings are frequently adjusted in the operating room via CST if the patient has local anesthesia for the procedure and is able to cough. Cough Stress Test has been studied and shown to be an effective method for tape adjustment specifically in TVT procedures. Murphy et al9 compared patients undergoing TVT procedure under local anesthesia and tape adjustment using CST, versus patients under general anesthesia unable to perform CST. Their results demonstrated a 16-point higher score of improvement for those performing CST and subsequent tape adjustment under local anesthesia on the Urinary Distress Inventory Stress Symptoms subscale (P = 0.02).9 Whereas local anesthesia and CST may be advantageous for intraoperative tape adjustment, often, patient’s preference or concurrent surgery for correction of POP necessitates the use of general anesthesia. Some studies anecdotally report trying to mimic CST under general anesthesia by using CM after retrograde filling of the bladder and adjusting tension of the midurethral slings until the patient does not leak.12Y16 However, it is not well documented whether CM accurately recreates CST. To date, no studies have compared the 2 methods of tape adjustment nor compared solely CM versus no CM. In evaluating the results of our study, we postulate that CM may not generate the same increase in intra-abdominal pressure over a midurethral sling that CST does. It is possible that the www.fpmrs.net
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patient may leak less with manual suprapubic pressure directly over a full bladder versus an increase in total intra-abdominal pressure when coughing. Crede maneuver may lead the physician to put less tension on the sling than when adjusting via CST. A limitation of our study is that quantification of the intraabdominal pressure as a result of CM applied was not performed. With this in mind, it may be worthwhile to compare these 2 methods and measure the amount of tension needed to prevent leakage with both methods in a prospective study. The literature reports several reasons for TOT failure. In a case series of TOT sling revisions, Moore et al19 suggest that one of these is insufficient adjustment when the sling is placed. We aimed to specifically evaluate this variable and suggest further studies. Another commonly suggested reason for TOT failure is low VLPP or ISD. O’Connor found that patients with a VLPP of less than 60 cmH2O were 12 times more likely to fail TOT treatment compared with patients with a VLPP of more than 60 cmH2O.20 Guerette et al21 also cautioned the use of TOT in ISD after noting that median VLPP in successful cases was 71 cmH2O versus 32 cmH2O in failures (P = 0.001). Conversely, Haliloglu et al22 and Karateke et al23 found no difference in cure rates with low and high VLPP but did report a significant difference in those who had a fixed, immobile urethra. Anast et al24 performed TOT on 124 patients under local anesthesia and adjusted the tape with CST. After stratifying patients with low VLPP and high VLPP, no difference in cure rates was found between the 2 groups. Our study also found no statistical difference in cure rates for patients with a VLPP of less than 60 cmH2O in either traditional or CM groups. Yet the numbers of our patients with ISD were small and thus are not necessarily powered to contribute to the general fund of knowledge regarding this topic. The results of our study did identify prognostic risk factors for TOT failure previously reported in the literature.25 Patients who smoked were 78% less likely to have persistence of their SUI symptoms. Increasing age above the mean was also a risk factor for TOT failure (OR, 0.95). These findings corroborate with Barber et al,26 showing an OR of 1.3 of anti-incontinence surgery failure per decade. The study suggested that the contributing mechanism for continued incontinence is decreased muscle tone and connective tissue strength.27 The same study also reported a lower OR for failure in smokers, but the number of smokers was small in the study. Based on these findings, it is recommended that patients be counseled on their risk profile for success in treatment of SUI. We acknowledge the limitations of this study. This retrospective study had a rather short follow-up period. Ideally, patients would be followed past a median of 3 months in a future prospective study. Additionally, subjective outcomes could be measured by validated questionnaires such as the Urinary Distress Inventory 6 or Quality of Life Assessment Tools. Objective outcomes could be evaluated intraoperatively with urodynamic testing during CM to measure the amount of pressure generated with CM. Postoperative objective measures also could be taken at follow-up visits along with standing CST, such as urodynamic testing or pad test. Finally, the patients in our retrospective study were not randomized into traditional or CM groups. However, having a single experienced pelvic surgeon operate on all the patients in this study minimized variability. Although the 2 groups differed preoperatively with regard to BMI and symptoms of urgency, these differences did not influence continence rates after the procedure. Lastly, future prospective studies with larger sample size and longer follow-up are needed to further evaluate the efficacy of intraoperative tape fadjustment.
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REFERENCES 1. Minassian VA, Drutz HP, Al-Badr A. Urinary incontinence as a worldwide problem. Int J Gynecol Obstet 2003;82:327Y338. 2. Harding CK, Thorpe AC. Surgical treatment for stress urinary incontinence. Int J Urol 2008;15:27Y34. 3. Magon N, Chopra SV. Transobturator tape in treatment of stress urinary incontinence: it is time for a new gold standard. N Am J Med Sci 2012;4(5):226Y230. 4. Jeon, MJ, Jung HJ, Chung SM, et al. Comparison of the treatment outcome of pubovaginal sling, tension free vaginal tape, and transobturator tape for stress urinary incontinence with intrinsic sphincter deficiency. Am J Obstet Gynecol 2008;199(1):76.e1Y76.e4. 5. Yang X, Jiang M, Chen X, et al. TVT-O vs. TVT for the treatment of SUI: a non-inferiority study Int Urogynecol J Pelvic Floor Dysfunct J 2012;23:99Y104. 6. Fischer A, Fink T, Zachmann S, et al. Comparison of retropubic and outside-in transobturator sling systems for the cure of female genuine stress urinary incontinence. Eur Urol 2005;48:799Y804. 7. Karram MM, Segal JL, Vassallo BJ, et al. Complications and untoward effects of the tension-free vaginal tape procedure. Obstet Gynecol 2003;101:929Y932. 8. Murphy M, Heit MH, Fouts L, et al. Effect of anesthesia on voiding function after tension-free vaginal tape procedure. Obstet Gynecol 2003;101(4):666Y670. 9. Murphy M, Culligan PJ, Arce CM, et al. Is the cough-stress test necessary when placing the tension-free vaginal tape? Obstet Gynecol 2005;105(2):319Y324. 10. Low JS, Smith KM, Holt EM. Tension free vaginal tape: is the intraoperative cough test necessary? Int Urogynecol J Pelvic Floor Dysfunct J 2004;15:328Y330. 11. Ulmsten U, Petros P. Intravaginal slingplasty (IVS): an ambulatory surgical procedure for the treatment of female urinary incontinence. Scand J Urol Nephrol 1995;29:75Y82. 12. Liang HM, Huang KH, Kung FT, et al. Combination of a tension-free vaginal tape procedure and laparoscopic-assisted vaginal hysterectomy for the treatment of benign uterine disease associated with stress urinary incontinence. Chang Gung Med J 2005;28(3):166Y173. 13. Lo TS. Tension free vaginal tape procedures in women with stress urinary incontinence with and without co-existing genital prolapse. Curr Opin Obstet Gynecol 2004;16:399Y404. 14. Paraiso MFR, Mark WD, Karram MM, et al. Laparoscopic Burch colposuspension versus tension-free vaginal tape: a randomized trial. Obstet Gynecol 2004;104:1249Y1258. 15. Partoll LM. Efficacy of tension-free vaginal tape with other pelvic reconstructive surgery. Am J Obstet Gynecol 2002;186:1292Y1295. 16. Huang KH, Kung FT, Liang HM, et al. Concomitant surgery with tension-free vaginal tape. Acta Obstet Gynecol 2003;82:948Y953. 17. Delorme E. Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women. Prog Urol 2001;11:1306Y1313. 18. de Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol 2003;44(6):724Y730. 19. Moore RD, Gamble K, Miklos JR. Tension-free vaginal tape sling for recurrent stress incontinence after transobturator tape sling failure. Int Urogynecol J Pelvic Floor Dysfunct J 2007;18:309Y313. 20. O’Connor RC, Nanigian DK, Lyon MB, et al. Early outcomes of mid-urethral slings for female stress urinary incontinence stratified by Valsalva leak point pressure. Neurourol Urodyn 2006;25:685Y688.
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21. Guerette NL, Bena JF, Davilla GW. Transobturator slings for stress incontinence: using urodynamic parameters to predict outcomes. Int Urogynecol J Pelvic Floor Dysfunct 2008;19:97Y102.
24. Anast JW, Skolarus TA, Yan Y, et al. Transobturator sling with intraoperative cough test is effective for patients with low Valsalva leak point pressure. Can J Urol 2008;15:4153Y4157.
22. Haliloglu B, Karateke A, Coksuer H, et al. The role of urethral hypermobility and intrinsic sphincteric deficiency on the outcome of transobturator tape procedure: a prospective study with 2-year follow-up. Int Urogynecol J Pelvic Floor Dysfunct J 2010;21:173Y178.
25. Chen HY, Yeh LS, Chang WC, et al. Analysis of risk factors associated with surgical failure of inside-out transobturator vaginal tape for treating urodynamic stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2007;18:443Y447.
23. Karateke A, Haliloglu B, Cam C, et al. Comparison of TVT and TVT-O in patients with stress urinary incontinence: short-term cure rates and factors influencing the outcome. A prospective randomised study. Aust N Z J Obstet Gynaecol 2009;49(1):99Y105.
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26. Barber MD, Kleeman S, Karram MM, et al. Risk factors associated with failure 1 year after retropubic or transobturator midurethral slings. Am J Obstet Gynecol 2008;199:666Y670.
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