IJG-08351; No of Pages 4 International Journal of Gynecology and Obstetrics xxx (2015) xxx–xxx

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International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo

CLINICAL ARTICLE

Treatment of stress urinary incontinence with a generic transobturator tape Amgad Abougamrah, Moustafa Ibrahim, Haitham Elsabaa, Mohamed Ellaithy ⁎, Mohamed Sweed Obstetrics and Gynecology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt

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Article history: Received 19 October 2014 Received in revised form 16 March 2015 Accepted 13 May 2015 Keywords: Generic tape Low-income countries Stress urinary incontinence Transobturator tape Type 1 monofilamentous macroporous polypropylene mesh

a b s t r a c t Objective: To evaluate the efficacy and safety of using a generic tape tailored from type 1 monofilamentous, macroporous polypropylene mesh during transobturator tape (TOT) surgery. Methods: A prospective study was performed in a tertiary center in Cairo, Egypt, between July 2004 and December 2013. Women with stress urinary incontinence scheduled for TOT surgery using the outside-in technique were recruited. Monarc tape was used in all patients until November 2005, after which it was used for patients who could afford it only; generic tape was used in the other patients. The primary outcome measures were the objective and subjective cure rates. Results: Overall, 431 women were included in analyses. After 5 years of follow-up, objective cure was achieved in 143 (94.1%) of 152 women who received Monarc tape and 249 (89.2%) of 279 who received the generic tape (P = 0.135). Subjective cure was achieved in 121 (79.6%) women who received the Monarc tape and 236 (84.6%) women who received the generic tape (P = 0.229). There were no significant betweengroup differences in postoperative urgency, de novo urgency, urge incontinence, voiding dysfunction, urinary retention, vaginal erosion, or the frequency of TOT-related reoperation or repeat anti-incontinence procedures. Conclusion: The TOT outside-in procedure can be easily, safely, and effectively performed in low-resource settings using a generic polypropylene tape. © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

1. Introduction

2. Materials and methods

Stress urinary incontinence (SUI) refers to the involuntary leakage of urine during physical exertion, or on coughing or sneezing [1]. Transobturator tape (TOT) insertion is a simple, effective, and safe procedure that can be reliably used in the treatment of SUI [2]. It is now the most common procedure performed to treat SUI in women [3]. Urinary incontinence is a significant problem in low-income countries: its prevalence in low- and lower-middle-income countries is estimated to be 28.7% (range 5.2%–70.8%) [4,5]. Unfortunately, in these countries, TOT insertion is not affordable for many women because of the relatively high cost of the tapes [2]. Some women receive no treatment and live with the condition for many years [4,6]. The aim of the present study was to evaluate the efficacy and the short- and long-term safety of using a generic tape tailored from type 1 macroporous polypropylene mesh to perform TOT surgery according to the outside-in technique described by Delorme [7].

The present prospective interventional study was conducted in the Urogynecology Unit of Ain Shams University Maternity Hospital in Cairo, Egypt—one of the largest tertiary referral centers in the country—between July 8, 2004, and December 23, 2013 (the date at which the last patient completed 5 years of follow-up). Women with SUI who were scheduled for treatment by TOT surgery using the outside-in technique were recruited. Pregnancy, genital prolapse greater than stage 1 (according to the Pelvic Organ Prolapse Quantification system [8]), urge incontinence, intrinsic sphincter deficiency, neurogenic bladder, urinary retention, and/or anticoagulant or antipsychotic therapy were exclusion criteria. The local institutional ethics and research committee approved the study. All participants gave written informed consent. All women underwent a thorough assessment for pelvic support defects and urinary incontinence. The assessment included history taking, general and pelvic examination, cough stress testing, cotton swab testing, urine analysis, urine culture, and urodynamic testing. Urodynamic testing was performed using the Dantec 5500 urodynamic machine (Dantec Medical, Bristol, UK) with a multichannel system; it included cystometry, uroflowmetry, urethral pressure profilometry, and measurement of the Valsalva leak point pressure (VLPP). The

⁎ Corresponding author at: Building 14, Block 14, Alwaha District, Nasr City, Cairo 11528, Egypt. Tel.: +20 1006873417. E-mail address: [email protected] (M. Ellaithy).

http://dx.doi.org/10.1016/j.ijgo.2015.03.038 0020-7292/© 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Please cite this article as: Abougamrah A, et al, Treatment of stress urinary incontinence with a generic transobturator tape, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2015.03.038

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A. Abougamrah et al. / International Journal of Gynecology and Obstetrics xxx (2015) xxx–xxx

VLPP was recorded in the 45° semi-sitting position, using an 8-French catheter and starting at a bladder volume of 250 mL with subsequent increments of 50 mL until SUI was demonstrated; both Valsalva maneuver and coughing were used to provoke SUI. Urethral pressure profilometry was performed using an 8-French catheter fitted with a transducer. Urodynamic SUI was diagnosed on the basis of the presence of involuntary urine leakage with increased intra-abdominal pressure—without the presence of detrusor contractions—during filling cystometry. Detrusor overactivity was diagnosed by the presence of spontaneous or provoked involuntary detrusor contractions during filling cystometry. Mixed urinary incontinence refers to involuntary urine loss associated with urgency and also with physical exertion, sneezing, and/or coughing [9]. Intrinsic sphincter deficiency was indicated by a VLPP of less than 60 cm H2O or a maximum urethral closure pressure of less than 20 cm H2O. All tape insertions were performed in an outside-in manner as described by Delorme [7] by the same team of experienced surgeons, who were all familiar with the procedure. TOT procedures were performed between July 8, 2004, and December 18, 2008. Initially, Monarc tape (American Medical Systems, Minnetonka, MN, USA) was used, with good results. However, the increasing cost of the tape was an obstacle to implementation of the procedure for all patients; hence, a generic tape adapted from a monofilamentous, macroporous polypropylene mesh (Gynecare Gynemesh PS, Johnson and Johnson, New Brunswick, NJ, USA) was used from November 17, 2005, to decrease the cost of surgery. The generic tape was tailored to be 25 cm long and 1 cm wide. The edges of the tape were then attached to number 1 polyglactin suture by a surgical knot, and the other side of the thread was left to be attached to the eye of an adapted wide outside-in centered helical needle pair during the procedure. The same steps were repeated on the contralateral side of the tape. Women who had undergone TOT surgery before introduction of the generic tape and those who refused use of the generic tape and could afford the price Monarc tape formed the control group. If urinary bladder injury was suspected, the integrity of the bladder was checked by the methylene blue test (250 mL). Cystoscopy was performed only if needed. All participants received preoperative chemoprophylaxis (1 g of a first-generation cephalosporin). All procedures were conducted under general or regional anesthesia. The procedure time was calculated from the start of the vaginal incision until the completion of vaginal wound closure. The procedureassociated blood loss was measured by calculating the difference in the weight of used gauze before and after the procedure and adding the volume of the blood in the suction device. The type and extent of any procedure-associated complications (bladder injury, urethral injury, wound infection, vaginal erosion, and/or need for blood transfusion) were recorded. In the absence of complications, the Foley catheter was removed after 24 hours and patients were discharged after 48 hours. Women with complications were managed individually. Following catheter removal, the postvoid residual urine volume was measured; patients with a residual urine volume of more than 100 mL received an indwelling catheter and made return visits every 2 days. Postoperative follow-up visits were scheduled weekly for 2 weeks, every 3 months for 1 year, and then annually. The participants were also instructed to come at any time if there was a procedure-related problem. All participants were required to have a minimum follow-up of 5 years. Those who did not attend the follow-up visits were excluded from the analysis. During the follow-up visits, the participants were assessed both subjectively (pad count and quality-of-life questionnaire) and objectively (cough stress test, pelvic examination, and urodynamic testing). The clinical pelvic assessment involved sling palpation and a check for vaginal erosion. A postoperative urodynamic evaluation was performed when failure of the procedure was suspected. The primary outcome measures were the objective and subjective cure rates. The secondary outcome measures were perioperative/

long-term complications and some functional outcomes (de novo urgency, urge incontinence, recurrent urinary tract infection, and shortand/or long-term voiding dysfunction). A negative cough stress test after surgery indicated an objective cure. A patient-perceived improvement in urinary incontinence and the absence of distressing urinary manifestations (urgency, urge incontinence, and/or prolonged voiding dysfunction) after surgery indicated a subjective cure. Urinary urgency was defined as a sudden compelling desire to pass urine immediately, and urge incontinence was defined as involuntary urine leakage accompanied by, or immediately preceded by, urinary urgency [9]. Urinary retention was defined as a peak flow rate of less than 5 mL/s and a postvoid volume of more than 100 mL. Short-term voiding dysfunction (transient voiding difficulty) was defined as incomplete bladder emptying during the first 6 weeks after surgery, whereas prolonged voiding dysfunction was diagnosed if there was a need to perform intermittent self-catheterization after the first 6 weeks. The statistical analysis was performed using SPSS version 17 (SPSS Inc, Chicago, IL, USA). The Shapiro–Wilk test was used to examine the normality of numerical variables. Numerical variables are presented as mean and SD (if normally distributed) or as median and interquartile range (if skewed). Categorical variables are presented as number (percentage) or as ratio. For intergroup comparisons, the unpaired t test was used to compare normally distributed numerical variables. The Mann–Whitney U test was used to compare skewed data. The Pearson χ2 test (or Fisher exact test if appropriate) was used to compare nominal data. Ordinal data were compared with linear-by-linear association. The Wilcoxon signed-rank test was used to compare paired numerical data. P b 0.05 was considered statistically significant. 3. Results Among 503 participants, 72 (14.3%) did not complete follow-up and so were excluded from analyses. The final statistical analysis included 431 women: 152 (35.3%) women received the Monarc tape and 279 (64.7%) received the generic tape. There was no statistically significant difference between the two groups in terms of baseline demographic data, medical comorbidities, prior gynecologic interventions, associated genitourinary problems, urodynamic parameters, and the other clinical characteristics investigated (Table 1). The median operative time was 26 minutes (interquartile range [IQR] 20–31). General anesthesia was used for 148 (34.3%) procedures; the remaining 283 (65.7%) procedures were performed under regional anesthesia. The median blood loss was 50 mL (IQR 55–95); 26 (6.0%) women had blood loss of at least 200 mL. Overall, 120 (27.8%) women had concomitant surgery (34 had an abdominal hysterectomy, 4 had a myomectomy, 39 had a vaginal hysterectomy for a non-prolapse indication, and 43 had a colporrhaphy for symptomatic stage 1 prolapse). Four (0.9%) women had an accidental bladder injury during dissection, which was managed by placement of an indwelling urinary catheter for 10 days, and 6 (1.4%) women had a vaginal perforation, which was repaired on the spot. There were no statistically significant differences between the two groups in terms of the operative data and outcomes (Table 2). All participants had regular follow-up for a minimum period of 60 months (median 69). At the end of the 5-year follow-up period, 392 (91.0%) women had an objective cure, and 357 (82.8%) had a subjective cure. Frequency of objective cure and subjective cure did not differ according to the type of tape used (Table 3). In total, 13 (3.0%) women had vaginal erosion, but the occurrence of vaginal erosion was not related to the type of mesh used (P = 0.557) (Table 3). Women with vaginal erosion had a mean age of 49.3 ± 9.5 years and a body mass index of 25.6 ± 5.3 (calculated as weight in kilograms divided by the square of height in meters). Additionally, 9 (69.2%) were postmenopausal, 4 (30.8%) had diabetes mellitus, 5 (38.5%) had previous vaginal surgery, 7 (53.8%) had a concomitant procedure, and 1 (7.7%) had an intraoperative vaginal perforation.

Please cite this article as: Abougamrah A, et al, Treatment of stress urinary incontinence with a generic transobturator tape, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2015.03.038

A. Abougamrah et al. / International Journal of Gynecology and Obstetrics xxx (2015) xxx–xxx

vaginal erosion, TOT-related reoperation, or repeat anti-incontinence procedure (Table 3).

Table 1 Preoperative data.a Variable

Monarc tape (n = 152)

Generic tape (n = 279)

P value

Age, y Body mass indexb Parity 0 1 2 3 4 ≥5 Menopause Diabetes mellitus Hypertension Previous prolapse surgery Previous SUI surgery Previous hysterectomy Urinary frequency Urinary urgency Associated genital prolapse Urodynamic parameters Volume at which patient notes first desire to void during cystometry, mL Cytometric capacity, mL MUCP stress, cm H2O Pressure transmission ratio, % MUCP, cm H2O Functional urethral length, mm Leak point pressure, cm H2O Maximum flow rate, mm/s Residual volume, mL

45.0 ± 9.6 27.9 ± 5.5

46.3 ± 12.1 28.5 ± 3.6

0.254 0.173 0.557

8 (5.3) 16 (10.5) 31 (20.4) 30 (19.7) 28 (18.4) 39 (25.7) 73 (48) 23 (15.1) 31 (20.4) 20 (13.2) 7 (4.6) 16 (10.5) 26 (17.1) 23 (15.1) 16 (10.5)

16 (5.7) 34 (12.2) 47 (16.9) 75 (26.9) 52 (18.6) 55 (19.7) 130 (46.6) 29 (10.4) 54 (19.4) 53 (19.0) 6 (2.2) 26 (9.3) 51 (18.3) 26 (9.3) 47 (16.8)

0.840 0.198 0.801 0.159 0.259 0.291 0.863 0.098 0.103

151 (142 to 159)

157 (148 to 166)

0.057

415 (369–444) −41 (−29 to −55) 54 (44 to 65) 78 (65 to 88) 24 (21 to 26) 74 (67 to 95) 26 (24 to 30) 22 (8 to 30)

424 (399–460) −40 (−33 to −48) 55 (43 to 65) 72 (59 to 84) 26 (21 to 30) 83 (73 to 93) 24 (21 to 31) 19 (14 to 24)

0.136 0.764 0.964 0.073 0.055 0.235 0.220 0.785

4. Discussion

Abbreviations: SUI, stress urinary incontinence; MUCP, maximum urethral closure pressure. a Values are given as mean ± SD, number (percentage), or median (interquartile range), unless indicated otherwise. b Calculated as weight in kilograms divided by the square of height in meters.

The median time until appearance of these erosions was 8 weeks (IQR 6–10). All affected women were managed by excision of the extruded portion of the tape; 7 (53.8%) had a complete mesh excision and six (46.2%) had a partial excision. Ten (76.9%) women remained continent after mesh excision, whereas 3 (23.1%) required a repeat antiincontinence procedure 3 months later. In total, 20 (4.6%) women underwent TOT-related reoperations, and 16 (3.7%) women needed a repeat anti-incontinence procedure (tension-free vaginal tape [TVT] or Burch colposuspension). Follow-up was significantly longer among women who received the Monarc tape than among those with the generic tape (Table 3), which is because its participants were recruited earlier. There were no other significant differences between the two groups in terms of postoperative urgency, de novo urgency, urge incontinence, short-term and prolonged voiding dysfunction, recurrent urinary tract infection, urinary retention,

Table 2 Operative data for women undergoing transobturator tape insertion.a Variable Operative time, min Anesthesia General Spinal Operative blood loss, mL Blood loss ≥200 mL Concomitant surgery Bladder injury during dissection Vaginal perforation a

3

Monarc tape (n = 152)

Generic tape (n = 279)

24 (17–31)

28 (22–32)

49 (32.2) 103 (67.8) 47 (45–90) 14 (9.2) 43 (28.3) 2 (1.3) 3 (2.0)

99 (35.5) 180 (64.5) 54 (48–89) 12 (4.3) 77 (27.6) 2 (0.7) 3 (1.1)

P value 0.073 0.567

0.121 0.065 0.911 0.616 0.430

Values are given as median (interquartile range) or number (percentage), unless indicated otherwise.

In the current study, the generic tape and Monarc tape had similar cure rates, functional outcomes, and perioperative and longterm complications. Few studies [2,10,11] have discussed the use of generic tapes in the treatment of SUI (Supplementary Material S1). Chen et al. [2,10] prospectively compared the efficacy and safety of TVT (n = 55) and a modified transobturator vaginal tape inside-out (TVT-O; n = 95) tailored from a monofilamentous, macroporous polypropylene mesh in the treatment of 150 women with SUI. An objective cure, defined by the presence of a negative cough stress test, or an improvement was achieved in 94.5% and 95.8% of women in the TVT and modified TVT-O groups, respectively. No significant difference was found between the two groups in terms of objective cure rate and patient satisfaction. The authors reported a significantly shorter operation time (cystoscopy was omitted in the modified TVT-O group), decreased blood loss, and lower medical costs in the modified TVT-O group. Zhang et al. [11] conducted a randomized clinical trial to evaluate the safety and efficacy of using an inexpensive modified tape in performing the TVT-O procedure to treat 156 women with SUI. The cure and improvement rates for the modified and original tapes were comparable (modified tape: 93.8% [75/80] and 6.2% [5/80], respectively; original tape: 92% [70/76] and 8% [6/76], respectively). Surprisingly, the modified inexpensive tape was associated with a shorter operative time, decreased blood loss, a shorter hospital stay, and lower medical costs. The authors claimed that saving the time needed to slowly and carefully remove the plastic sheath covering the original tape (Gynecare) decreased the operative time in the modified tape group. However, they could not provide a plausible explanation of how use of the generic tape decreased blood loss and hospital stay [11]. Unfortunately, these studies [2,10,11] were not sufficiently powered to test the safety of this new economic approach because of small sample sizes and short follow-ups. By contrast, the current study recruited a relatively large number of participants (n = 431) and had an extended and comprehensive follow-up (minimum of

Table 3 Postoperative data for women undergoing transobturator tape insertion.a Variable

Monarc tape (n = 152)

Generic tape (n = 279)

P value

Surgical cost, US$ Duration of follow-up, mo Hospital stay, d Postoperative pain Urinary retention Short-term voiding dysfunction Vaginal erosion TOT-related reoperation Tape loosening Tape cutting Tape excision, partial Tape excision, complete Repeat anti-incontinence procedure Objective cure Subjective cure Dissatisfaction after the procedure Persistent SUI Urgency De novo urgency Urge incontinence Prolonged voiding dysfunction

1598 ± 61 87 (79–105) 2 (2–3) 19 (12.5) 4 (2.6) 3 (2.0) 3 (2.0) 5 (3.3) 1 (0.7) 1 (0.7) 2 (1.3) 1 (0.7) 4 (2.6) 143 (94.1) 121 (79.6) 31 (20.4) 4 (2.6) 17 (11.2) 6 (3.9) 4 (2.6) 0 (0.0)

321 ± 32 79 (66–92) 2 (2–4) 23 (8.2) 9 (3.2) 5 (1.8) 10 (3.6) 15 (5.4) 3 (1.1) 2 (0.7) 4 (1.4) 6 (2.2) 12 (4.3) 249 (89.2) 236 (84.6) 43 (15.4) 12 (4.3) 18 (6.5) 7 (2.5) 5 (1.8) 1 (0.4)

b0.001 0.029 0.526 0.175 N0.99 0.754 0.557 0.473

0.438 0.135 0.229 0.229 0.438 0.125 0.581 0.726 N0.99

Abbreviations: TOT, transobturator tape; SUI, stress urinary incontinence. a Values are given as mean ± SD, median (interquartile range), or number (percentage), unless indicated otherwise.

Please cite this article as: Abougamrah A, et al, Treatment of stress urinary incontinence with a generic transobturator tape, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2015.03.038

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5 years), improving the reliability of the results regarding the safety and efficacy of using generic tape when performing TOT surgery in low-resource settings. In the present study, type 1 macroporous polypropylene mesh was used. Ideally, the sling should be synthesized from non-allergenic and inert material that is relatively resistant to infection and inflammation. Slings made from type 1 mesh are therefore better than other slings; they elicit a quick and sustained filling with capillaries and fibrous connective tissue, with subsequent integrative host-tissue ingrowth and mesh anchoring. As time passes, the provoked inflammatory response decreases considerably, reducing the infection risk [12]. In the current study, no significant differences were observed in the objective and subjective cure rates. The reported rates are within the range of previously reported rates (83–98% and 77–88.7% for the objective and subjective cure rates, respectively) [13–15]. In the present study, vaginal erosions were detected either in the anterior vaginal wall or in the lateral vaginal sulci (mostly attributable to stretch and weakness of the vagina in these areas as a result of the dissection). All women with vaginal erosion were initially managed by antibiotic and estrogen therapy, followed by total (if feasible) or partial surgical removal of the tape. The etiology of vaginal erosion is not clear. Two mechanisms could be involved: the occurrence of subclinical infection and impaired wound healing [16], and rubbing/friction against the host tissue [17]. The current study is limited by not being a randomized clinical trial; however, this design was not applicable because patients who could afford the Monarc tape would be unlikely to accept the use of generic tapes with unknown safety and efficacy profiles. Randomized clinical trials, if feasible, are recommended. Another potential area of criticism is the recruitment of patients with concomitant surgeries. This approach was used to increase the number of recruited patients, because many patients had concomitant problems. The respective procedures are not known to affect the studied outcomes and were not statistically different between the two groups. In conclusion, the present results indicate that TOT outside-in procedures can be safely and effectively implemented in low-resource settings using cheap, generic tapes tailored from type 1 monofilamentous, macroporous polypropylene mesh. The same may apply to other procedures such as TVT-O and TVT surgery [2,10,11]. Supplementary data to this article can be found online at http://dx. doi.org/10.1016/j.ijgo.2015.03.038.

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Conflict of interest The authors have no conflicts of interest.

Please cite this article as: Abougamrah A, et al, Treatment of stress urinary incontinence with a generic transobturator tape, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2015.03.038

Treatment of stress urinary incontinence with a generic transobturator tape.

To evaluate the efficacy and safety of using a generic tape tailored from type 1 monofilamentous, macroporous polypropylene mesh during transobturator...
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