European Journal of Obstetrics & Gynecology and Reproductive Biology 182 (2014) 48–52
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Single incision sling (AjustTM) for the treatment of female stress urinary incontinence: 2-year follow-up Franca Natale a,*, Stefano Dati b, Chiara La Penna c, Pasquale Rombola` c, Stefania Cappello c, Emilio Piccione c a b c
Department of Urogynecology—S. Carlo-IDI Hospital, Rome, Italy Unit of Urogynecology, ‘‘Casilino’’ General Hospital, Rome, Italy Section of Gynecology and Obstetrics, Department of Surgery, ‘‘Tor Vergata’’ University, Rome, Italy
A R T I C L E I N F O
A B S T R A C T
Article history: Received 16 March 2014 Received in revised form 13 June 2014 Accepted 7 August 2014
Objective: The primary outcome of this study was to evaluate the subjective and objective outcomes of an adjustable Single Incision Sling (AjustTM C.R. Bard Inc., New Providence, NJ, USA) for the treatment of SUI, with a 2-year follow-up. The secondary outcome was to evaluate the safety of this procedure and the impact of this mini-sling on the filling and voiding phases of the bladder. Study design: In our prospective multicenter study we included 95 females with a clinical symptomatic and urodynamic diagnosis of primary SUI, and unsuccessful previous conservative treatment. Cure rate was evaluated objectively, using a standardized cough stress test and subjectively using the patient global impression of improvement. The King’s Health questionnaire was used to evaluate quality of life (QoL). Urgency was evaluated using the patient perception of intensity of urgency scale. Complications were assessed intra-, peri- and post-operatively. All patients underwent urodynamic studies pre-operatively and at 6 months. The McNemar chi-square test was used to compare categorical variables, the paired t-test for continuous parametric variables, and the Fisher exact test for continuous non-parametric variables. A logistic regression model and odds ratios (with 95 percent confidence intervals) were used to assess the independent prognostic value of four variables for the outcome (age, parity, body mass index and menopausal status). Results: 92 Patients completed the 2-year follow-up. The objective cure rate was 83.7% and the subjective cure rate was 81.5%. De novo urgency was present in 9 patients (9.8%) and was associated with de novo urge incontinence in 6 patients (6.5%). Only 1 patient with de novo urge incontinence showed de novo detrusor overactivity. Regarding QoL, the King’s Health Questionnaire indicated a statistically significant improvement in all domains except sleep. We observed no intraoperative complications. Post-operatively 1 patient referred pain in the right leg, 3 patients had mesh extrusions, 1 patient had recurrent urinary tract infections. Post-operative urodynamics showed a statistically significant increase of detrusor pressure at maximum flow and a reduction of maximum flow rate. No patients were obstructed according to the Blaivas and Groutz nomogram. ß 2014 Elsevier Ireland Ltd. All rights reserved.
Keywords: Stress urinary incontinence Surgery Single incision sling Quality of life Urodynamics
Introduction The publication in 1995 of integral theory by Petros and Ulmsten dramatically changed the pathophysiology of stress
* Corresponding author. Tel.:+39 3387324268; fax: +39 0639736177. E-mail addresses: [email protected], [email protected] (F. Natale). http://dx.doi.org/10.1016/j.ejogrb.2014.08.011 0301-2115/ß 2014 Elsevier Ireland Ltd. All rights reserved.
urinary incontinence (SUI) [1]. According to this theory, the mid-urethra, and not the bladder neck, has the most important role in the maintenance of urinary continence and new slings applied to the mid-urethra were devised. There have been three generations of mid-urethral sling (MUS). The first to be introduced were retropubic slings. These are accepted as the standard surgical treatment of SUI with a longterm subjective success rate (77–80% over 5–11 years) [2],
F. Natale et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 182 (2014) 48–52
however they can be subject to intraoperative complications, some of which may be serious [3–6]. Transobturator slings (TOT) were introduced to avoid the blind and problematic passage through the retropubic space, and the consequent complications. Even if they have a lower objective cure rate than retropublic slings, there is no difference in subjective cure rate [7]. There are no major complications, however there is a significant risk of post-op thigh and groin pain. In an attempt to find an even less invasive approach, while still providing the benefit of a ‘‘suburethral hammock’’, single incision slings (SIS) were introduced. As their name suggests, these are shorter slings inserted through a single vaginal incision and consequently they need a more robust anchoring mechanism. The various types vary according to the anchoring mechanism employed and the fact that some are adjustable. Of these, AjustTM single-incision transobturator mid-urethral sling (C.R. Bard Inc., New Providence, NJ, USA) was devised to be anchored directly on the obturator muscle or membrane and to allow the tension of the sling to be regulated. Primary outcome: To evaluate the subjective and objective cure rates of an adjustable SIS (AjustTM) for the treatment of SUI, with a 2-year follow-up. Secondary outcome: To evaluate the safety of this procedure and the impact of this mini-sling on the filling and voiding phases of the bladder. Material and methods This is a prospective, single-arm, observational, multi-center study conducted at 2 study centers. We included female patients with primary stress urinary incontinence (SUI) or mixed urinary incontinence with predominant SUI. SUI was diagnosed using both the cough stress test and urodynamics. All patients had unsuccessfully undergone pelvic floor training prior to our study. Exclusion criteria were: - presence of mixed incontinence with predominantly bothersome urgency symptoms - presence of concomitant Pelvic Organ Prolapse (POP) 2 stage according to the Pelvic Organ Prolapse Staging System (POP-Q) [8] - previous SUI surgery - previous surgical procedures at the anterior vaginal wall - Intrinsic Sphincter Deficiency (ISD), with Valsalva Leak Point Pressure 30 Menopause *
36/75 (48%) 39/75 (52%)
Failure rate
p Value*
Odds ratio
0.2621
2.3845
0.2466
1.6035
0.3559
1.9020
0.1484
0.3161
9/17 (52.9%) 8/17 (47.1%)
64/75 (85.3%) 11/75 (14.7%)
12/17 (70.6%) 5/17 (29.4%)
58/75 (77.3%) 17/75 (22.7%) 52/75 (69.3%)
13/17 (76.5%) 4/17 (23.5%) 11 (64.7%)
Chi-square test.
Table 5 Patient perception of intensity of urgency scale (PPIUS). PPIUS grade
Severity of urgency
Pre-op scores
Post-op scores
0 1 2 3 4
None Mild Moderate Severe Incontinence
31 10 14 1 36
37 30 1 1 23
(33.7%) (10.9%) (15.2%) (1.1%) (39.1%)
(40.2%) (32.6%) (1.1%) (1.1%) (25%)
Considering only the group of 36 patients with pre-op mixed urinary incontinence, we found a persistence of urgency in 27 patients (75%); among these, only 17 patients complained a persistence of urge incontinence. All these patients with post-op OAB symptoms were given antimuscarinic drugs (solifenacin): 18 patients out of 27 (66.7%) had a good response to the pharmacologic treatment. Regarding QoL, the King’s Health Questionnaire indicated a statistically significant improvement in all domains except sleep. We observed no intraoperative complications. Post-operatively 1 patient referred pain in the right leg, which resolved in 4 weeks with administration of FANS; 3 patients had mesh extrusions, of which only 1 patient underwent mesh removal; 1 patient had recurrent UTI. Urodynamic data are reported in Table 6. No patients were obstructed according to Blaivas and Groutz nomogram [17]. Comment SIS were introduced in the treatment of SUI to minimize the risk of post-operative pain and injury, avoiding both blind retropubic and groin muscle trajectories. All currently available SIS share the same tape material (type 1 polypropylene) and the same insertion technique through a single vaginal incision; however, they differ in the type and robustness of their anchorage mechanism. The first meta-analysis comparing SIS and standard midurethral slings (SMUS) was published by Madhuvrata et al. in 2011 [18], according to which, SIS are associated with: lower post-op pain score; significantly higher rate of tape erosion, higher incidence of de novo urgency (probably related to the positioning of SIS in close proximity to, or in contact with, the urethra);
F. Natale et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 182 (2014) 48–52
51
Table 6 Urodynamic data.
First desire Cystometric capacity Detrusor overactivity PdetQmax Qmax Urodynamic SUI * §
Pre-op
Post-op
p
Mean 139.5 69 (150–379 ml) Mean 378.2 65.9 (186–503 ml) 9 Patients (9.8%) Mean 15.8 5.7 (7–33 cmH2O) Mean 26.1 10.1 (11–64 ml/s) 92 Patients (100%)
Mean 124.5 59.1 (24–283 ml) Mean 365.2 57.5 (197–460 ml) 8 patients (8.7%) Mean 18.1 7.2 (5–40 cmH2O) Mean 21.8 6.6 (9–39 ml/s) 15 Patients (16.3%)
0.1292§ 0.1205§ 1.0000* 0.0390§ 0.0007§ 0.0000*
MacNemar test. t-Test.
significantly lower patient-reported cure rate; significantly lower objective cure rate; a significantly higher reoperation rate for SUI surgery. A more recent meta-analysis reported that (with the exclusion of TVT-Secur) there are no significant differences between SIS and SMUS in patient-reported and objective cure rates with a mean follow-up of 18.6 months. Moreover, SIS had a significantly lower post-operative pain scores, more favorable recovery time and an earlier return to normal activities [19]. None of the RCTs considering in this meta-analysis assessed the recently developed adjustable and robustly anchored SIS, such as AjustTM, AltisTM and TFSTM. The AjustTM sling has the same anchoring as TOT to the obturator muscle or membrane complex, which was not possible with the previous ‘‘mini-slings’’, and it allows the tension of the tape to be adjusted. In our study, the objective cure rate was 83.7% and the subjective cure rate was 81.5%, and these data are similar to those reported in other studies using the same sling. With a mean of 21 months follow-up, Cornu et al. reported a cure rate of 80% (76 dry patients out of 95) [20]. In a multicenter prospective cohort study with 90 patients, Abdel-Fattah et al. reported a cure rate for SUI of 80% at a 12-months follow-up [21]. In an observational multicenter study with a follow-up of 29 months, Naumann et al. reported a total restoration of continence in 82.4% of a sample of 52 patients with an improvement of 3.9% [22]. In a randomized controlled study comparing AjustTM with TVT-O, Mostafa et al. showed no significant differences in objective and subjective cure rates, or in post-operative complications [23]. In a prospective closely matched controlled study comparing TVT-O and AjustTM, Grigoriadis et al. found that the Ajust sling procedure presents success rates, at 22 months’ mean follow up, comparable to the TVT-O method (objective cure rate 84.7% in Ajust group vs 86% in TVT-O group; subjective cure rate 81.2% in Ajust group vs 82.6% in TVT-O group) [24]. In an RCT comparing TVT-O and AjustTM, Boyers et al. found no significant differences between the groups in term of the KHQ total score (p = 0.27) or the patient-reported success rate (p = 1.00) [25]. For de novo OAB symptoms, we observed de novo urgency in 9 patients (9.8%) associated with de novo urge incontinence in 6 patients (6.5%); again these results are in line with other studies. Naumann et al. reported de novo urgency in 7.8% of patients [22]. Cornu et al. observed de novo OAB symptoms in 10 patients (10.5% of the sample) [20]. It is worth noting that this rate is comparable with that given for retropubic and transobturator tape implantation. In a study comparing AjustTM and TVT-O, Mostafa et al. reported results with higher urgency for AjustTM (AjustTM 21.7% vs TVT-O 8.8%), grouping de novo urgency and worsening of pre-existing urgency, however, despite the considerable difference in percentages, these results were not statistically significant (p = 0.063) [23]. The strength of our study is that it is the only paper in which all patients reached the 2-year follow-up. Secondly, our sample was sufficiently big to allow conclusive statistical analysis.
Furthermore, in our study all patients underwent urodynamics pre and post-operatively. We chose to perform urodynamics postoperatively on all patients in order to be able to evaluate bladder function after the positioning of the sling to exclude any interference from the sling. We observed no modification in the storage phase while, in the voiding phase, there was a statistically significant increase of PdetQmax and a reduction of Qmax. No patients were obstructed according to Blaivas and Groutz nomogram [17]. The weakness of our study is the absence of control group with treatment carried out according to consolidated techniques such as retropubic and transoburator slings. In our hands AjustTM sling is a safe and reliable treatment for female SUI with good subjective and objective rates and few complications. Further studies with longer follow-ups and RCTs comparing AjustTM to MUS are needed. Conclusion In our hands AjustTM sling is a safe and reliable treatment for female SUI with good subjective and objective rates and few complications. Condensation Our data suggest that AjustTM sling is a safe and reliable treatment for female SUI with good subjective and objective rates and few complications. Acknowledgement Thanks go to David Nicholson for help with English. References [1] Petros PE, Ulmsten U. Urethral pressure increase on effort originates from within the urethra, and continence from musculovaginal closure. Neurourol Urodyn 1995;14(4):337–46. discussion 346–350. [2] Svenningsen R, Staff AC, Schiøtz HA, Western K, Kulseng-Hanssen S. Long-term follow-up of the retropubic tension-free vaginal tape procedure. Int Urogynecol J 2013;24(8):1271–8. [3] Aslam MF, Denman MA. Delayed diagnosis of vascular injury with a retropubic midurethral sling. Obstet Gynecol 2013;122(2 Pt 2):444–6. http://dx.doi.org/ 10.1097/AOG.0b013e31829919b3. [4] Kroon ND, Smith KM. Gill J.J Bowel injury at TVT: an issue of consent. Obstet Gynaecol 2007;27(7):741. [5] Bafghi A, Iannelli A, Trastour C, et al. Bowel perforation as late complication of tension-free vaginal tape. Gynecol Obstet Biol Reprod (Paris) 2005;34(6):606– 7 [Article in French]. [6] Vervest HA, Bongers MY, van der Wurff AA. Nerve injury: an exceptional cause of pain after TVT. Int Urogynecol J Pelvic Floor Dysfunct 2006;17(6):665–7. Epub 2006 Apr 22. [7] Novara G, Artibani W, Barber MD, Chapple CR, Costantini E, Ficarra V, Hilton P, Nilsson CG, Waltregny D. Updated systematic review and meta-analysis of the comparative data on colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress urinary incontinence. Eur Urol 2010;58(2):218–38. [8] Bump RC, Mattiasson A, Bo K, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 1996;175:10–7.
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[9] Chen HY, Ho M, Chang YY, Hung YC, Chen WC. Risk factors for surgical failure after posterior intravaginal slingplasty: a case series. Eur J Obstet Gynecol Reprod Biol 2011;155(1):106–9. Epub 2011 Jan 5. [10] Kokanali MK, Dog˘anay M, Aksakal O, Cavkaytar S, Topc¸u HO, Ozer I. Risk factors for mesh erosion after vaginal sling procedures for urinary incontinence. Eur J Obstet Gynecol Reprod Biol 2014;177:146–50. Epub 2014 Apr 13. [11] Abdel-Fattah M, Rizk DE. Diabetes mellitus and female urinary incontinence: a time for change. Int Urogynecol J 2012;23(11):1481–2. Epub 2012 May 15. [12] Ingelman-Sundberg A. Urinary incontinence in woman, excluding fistulas. Acta Obstet Gynecol Scand 1952;31:266–91. [13] Yalcin I, Bump R. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol 2003;189:98–101. [14] Digesu GA, Santamato S, Kullar V, et al. Validation of an Italian version of prolapse quality of life questionnaire. Eur J Obstet Gynecol Reprod Biol 2003;106:184–92. [15] Notte SM, Marshall TS, Lee M, et al. Content validity and test-retest reliability of Patient Perception of Intensity of Urgency Scale (PPIUS) for overactive bladder. BMC Urol 2012;12:26. http://dx.doi.org/10.1186/1471-2490-12-26. [16] Haylen BT, Freeman RM, Swift SE, et al., International Urogynecological Association; International Continence Society; Joint IUGA/ICS Working Group on Complications Terminology. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery. Neurourol Urodyn 2011;30(1):2–12. [17] Blaivas JG, Groutz A. Bladder outlet obstruction nomogram for women with lower urinary tract symptomatology. Neurourol Urodyn 2000;19(5):553–64. [18] Madhuvrata P, Riad M, Ammembal MK, Agur W, Abdel-Fattah M. Systematic review and meta-analysis of ‘‘inside-out’’ versus ‘‘outside-in’’ transobturator
[19]
[20]
[21]
[22]
[23]
[24]
[25]
tapes in management of stress urinary incontinence in women. Eur J Obstet Gynecol Reprod Biol 2012;162(1):1–10. Mostafa A, Lim CP, Hopper L, Madhuvrata P, Abdel-Fattah M. Single-incision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: an updated systematic review and meta-analysis of effectiveness and complications. Eur Urol 2014;65(2): 402–27. Cornu JN, Peyrat L, Skurnik A, Ciofu C, Lucente VR, Haab F. Ajust single incision transobturator sling procedure for stress urinary incontinence: results after 1year follow-up. Int Urogynecol J 2012;23(9):1265–70. Abdel-Fattah M, Agur W, Abdel-All M, et al. Prospective multi-centre study of adjustable single-incision mini-sling (Ajust(1)) in the management of stress urinary incontinence in women: 1-year follow-up study. BJU Int 2012;109(6): 880–6. Naumann G, Hagemeier T, Zachmann S, et al. Long-term outcomes of the Ajust adjustable single-incision sling for the treatment of stress urinary incontinence. Int Urogynecol J 2013;24(2):231–9. Mostafa A, Agur W, Abdel-All M, et al. Multicenter prospective randomized study of single-incision mini-sling vs tension-free vaginal tape-obturator in management of female stress urinary incontinence: a minimum of 1-year follow-up. Urology 2013;82(3):552–9. Grigoriadis 1 C, Bakas P, Derpapas A, Creatsa M, Liapis A. Tension-free vaginal tape obturator versus Ajust adjustable single incision sling procedure in women with urodynamic stress urinary incontinence. Eur J Obstet Gynecol Reprod Biol 2013;170(2):563–6. Boyers D, Kilonzo M, Mostafa A, Abdel-Fattah M. Comparison of an adjustable anchored single-incision mini-sling, Ajust(1), with a standard mid-urethral sling, TVT-O(TM): a health economic evaluation. BJU Int 2013;112(8): 1169–77.
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Single incision sling (AjustTM) for the treatment of female stress urinary incontinence: 2-year follow-up Franca Natale a,*, Stefano Dati b, Chiara La Penna c, Pasquale Rombola` c, Stefania Cappello c, Emilio Piccione c a b c
Department of Urogynecology—S. Carlo-IDI Hospital, Rome, Italy Unit of Urogynecology, ‘‘Casilino’’ General Hospital, Rome, Italy Section of Gynecology and Obstetrics, Department of Surgery, ‘‘Tor Vergata’’ University, Rome, Italy
A R T I C L E I N F O
A B S T R A C T
Article history: Received 16 March 2014 Received in revised form 13 June 2014 Accepted 7 August 2014
Objective: The primary outcome of this study was to evaluate the subjective and objective outcomes of an adjustable Single Incision Sling (AjustTM C.R. Bard Inc., New Providence, NJ, USA) for the treatment of SUI, with a 2-year follow-up. The secondary outcome was to evaluate the safety of this procedure and the impact of this mini-sling on the filling and voiding phases of the bladder. Study design: In our prospective multicenter study we included 95 females with a clinical symptomatic and urodynamic diagnosis of primary SUI, and unsuccessful previous conservative treatment. Cure rate was evaluated objectively, using a standardized cough stress test and subjectively using the patient global impression of improvement. The King’s Health questionnaire was used to evaluate quality of life (QoL). Urgency was evaluated using the patient perception of intensity of urgency scale. Complications were assessed intra-, peri- and post-operatively. All patients underwent urodynamic studies pre-operatively and at 6 months. The McNemar chi-square test was used to compare categorical variables, the paired t-test for continuous parametric variables, and the Fisher exact test for continuous non-parametric variables. A logistic regression model and odds ratios (with 95 percent confidence intervals) were used to assess the independent prognostic value of four variables for the outcome (age, parity, body mass index and menopausal status). Results: 92 Patients completed the 2-year follow-up. The objective cure rate was 83.7% and the subjective cure rate was 81.5%. De novo urgency was present in 9 patients (9.8%) and was associated with de novo urge incontinence in 6 patients (6.5%). Only 1 patient with de novo urge incontinence showed de novo detrusor overactivity. Regarding QoL, the King’s Health Questionnaire indicated a statistically significant improvement in all domains except sleep. We observed no intraoperative complications. Post-operatively 1 patient referred pain in the right leg, 3 patients had mesh extrusions, 1 patient had recurrent urinary tract infections. Post-operative urodynamics showed a statistically significant increase of detrusor pressure at maximum flow and a reduction of maximum flow rate. No patients were obstructed according to the Blaivas and Groutz nomogram. ß 2014 Elsevier Ireland Ltd. All rights reserved.
Keywords: Stress urinary incontinence Surgery Single incision sling Quality of life Urodynamics
Introduction The publication in 1995 of integral theory by Petros and Ulmsten dramatically changed the pathophysiology of stress
* Corresponding author. Tel.:+39 3387324268; fax: +39 0639736177. E-mail addresses: [email protected], [email protected] (F. Natale). http://dx.doi.org/10.1016/j.ejogrb.2014.08.011 0301-2115/ß 2014 Elsevier Ireland Ltd. All rights reserved.
urinary incontinence (SUI) [1]. According to this theory, the mid-urethra, and not the bladder neck, has the most important role in the maintenance of urinary continence and new slings applied to the mid-urethra were devised. There have been three generations of mid-urethral sling (MUS). The first to be introduced were retropubic slings. These are accepted as the standard surgical treatment of SUI with a longterm subjective success rate (77–80% over 5–11 years) [2],
F. Natale et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 182 (2014) 48–52
however they can be subject to intraoperative complications, some of which may be serious [3–6]. Transobturator slings (TOT) were introduced to avoid the blind and problematic passage through the retropubic space, and the consequent complications. Even if they have a lower objective cure rate than retropublic slings, there is no difference in subjective cure rate [7]. There are no major complications, however there is a significant risk of post-op thigh and groin pain. In an attempt to find an even less invasive approach, while still providing the benefit of a ‘‘suburethral hammock’’, single incision slings (SIS) were introduced. As their name suggests, these are shorter slings inserted through a single vaginal incision and consequently they need a more robust anchoring mechanism. The various types vary according to the anchoring mechanism employed and the fact that some are adjustable. Of these, AjustTM single-incision transobturator mid-urethral sling (C.R. Bard Inc., New Providence, NJ, USA) was devised to be anchored directly on the obturator muscle or membrane and to allow the tension of the sling to be regulated. Primary outcome: To evaluate the subjective and objective cure rates of an adjustable SIS (AjustTM) for the treatment of SUI, with a 2-year follow-up. Secondary outcome: To evaluate the safety of this procedure and the impact of this mini-sling on the filling and voiding phases of the bladder. Material and methods This is a prospective, single-arm, observational, multi-center study conducted at 2 study centers. We included female patients with primary stress urinary incontinence (SUI) or mixed urinary incontinence with predominant SUI. SUI was diagnosed using both the cough stress test and urodynamics. All patients had unsuccessfully undergone pelvic floor training prior to our study. Exclusion criteria were: - presence of mixed incontinence with predominantly bothersome urgency symptoms - presence of concomitant Pelvic Organ Prolapse (POP) 2 stage according to the Pelvic Organ Prolapse Staging System (POP-Q) [8] - previous SUI surgery - previous surgical procedures at the anterior vaginal wall - Intrinsic Sphincter Deficiency (ISD), with Valsalva Leak Point Pressure 30 Menopause *
36/75 (48%) 39/75 (52%)
Failure rate
p Value*
Odds ratio
0.2621
2.3845
0.2466
1.6035
0.3559
1.9020
0.1484
0.3161
9/17 (52.9%) 8/17 (47.1%)
64/75 (85.3%) 11/75 (14.7%)
12/17 (70.6%) 5/17 (29.4%)
58/75 (77.3%) 17/75 (22.7%) 52/75 (69.3%)
13/17 (76.5%) 4/17 (23.5%) 11 (64.7%)
Chi-square test.
Table 5 Patient perception of intensity of urgency scale (PPIUS). PPIUS grade
Severity of urgency
Pre-op scores
Post-op scores
0 1 2 3 4
None Mild Moderate Severe Incontinence
31 10 14 1 36
37 30 1 1 23
(33.7%) (10.9%) (15.2%) (1.1%) (39.1%)
(40.2%) (32.6%) (1.1%) (1.1%) (25%)
Considering only the group of 36 patients with pre-op mixed urinary incontinence, we found a persistence of urgency in 27 patients (75%); among these, only 17 patients complained a persistence of urge incontinence. All these patients with post-op OAB symptoms were given antimuscarinic drugs (solifenacin): 18 patients out of 27 (66.7%) had a good response to the pharmacologic treatment. Regarding QoL, the King’s Health Questionnaire indicated a statistically significant improvement in all domains except sleep. We observed no intraoperative complications. Post-operatively 1 patient referred pain in the right leg, which resolved in 4 weeks with administration of FANS; 3 patients had mesh extrusions, of which only 1 patient underwent mesh removal; 1 patient had recurrent UTI. Urodynamic data are reported in Table 6. No patients were obstructed according to Blaivas and Groutz nomogram [17]. Comment SIS were introduced in the treatment of SUI to minimize the risk of post-operative pain and injury, avoiding both blind retropubic and groin muscle trajectories. All currently available SIS share the same tape material (type 1 polypropylene) and the same insertion technique through a single vaginal incision; however, they differ in the type and robustness of their anchorage mechanism. The first meta-analysis comparing SIS and standard midurethral slings (SMUS) was published by Madhuvrata et al. in 2011 [18], according to which, SIS are associated with: lower post-op pain score; significantly higher rate of tape erosion, higher incidence of de novo urgency (probably related to the positioning of SIS in close proximity to, or in contact with, the urethra);
F. Natale et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 182 (2014) 48–52
51
Table 6 Urodynamic data.
First desire Cystometric capacity Detrusor overactivity PdetQmax Qmax Urodynamic SUI * §
Pre-op
Post-op
p
Mean 139.5 69 (150–379 ml) Mean 378.2 65.9 (186–503 ml) 9 Patients (9.8%) Mean 15.8 5.7 (7–33 cmH2O) Mean 26.1 10.1 (11–64 ml/s) 92 Patients (100%)
Mean 124.5 59.1 (24–283 ml) Mean 365.2 57.5 (197–460 ml) 8 patients (8.7%) Mean 18.1 7.2 (5–40 cmH2O) Mean 21.8 6.6 (9–39 ml/s) 15 Patients (16.3%)
0.1292§ 0.1205§ 1.0000* 0.0390§ 0.0007§ 0.0000*
MacNemar test. t-Test.
significantly lower patient-reported cure rate; significantly lower objective cure rate; a significantly higher reoperation rate for SUI surgery. A more recent meta-analysis reported that (with the exclusion of TVT-Secur) there are no significant differences between SIS and SMUS in patient-reported and objective cure rates with a mean follow-up of 18.6 months. Moreover, SIS had a significantly lower post-operative pain scores, more favorable recovery time and an earlier return to normal activities [19]. None of the RCTs considering in this meta-analysis assessed the recently developed adjustable and robustly anchored SIS, such as AjustTM, AltisTM and TFSTM. The AjustTM sling has the same anchoring as TOT to the obturator muscle or membrane complex, which was not possible with the previous ‘‘mini-slings’’, and it allows the tension of the tape to be adjusted. In our study, the objective cure rate was 83.7% and the subjective cure rate was 81.5%, and these data are similar to those reported in other studies using the same sling. With a mean of 21 months follow-up, Cornu et al. reported a cure rate of 80% (76 dry patients out of 95) [20]. In a multicenter prospective cohort study with 90 patients, Abdel-Fattah et al. reported a cure rate for SUI of 80% at a 12-months follow-up [21]. In an observational multicenter study with a follow-up of 29 months, Naumann et al. reported a total restoration of continence in 82.4% of a sample of 52 patients with an improvement of 3.9% [22]. In a randomized controlled study comparing AjustTM with TVT-O, Mostafa et al. showed no significant differences in objective and subjective cure rates, or in post-operative complications [23]. In a prospective closely matched controlled study comparing TVT-O and AjustTM, Grigoriadis et al. found that the Ajust sling procedure presents success rates, at 22 months’ mean follow up, comparable to the TVT-O method (objective cure rate 84.7% in Ajust group vs 86% in TVT-O group; subjective cure rate 81.2% in Ajust group vs 82.6% in TVT-O group) [24]. In an RCT comparing TVT-O and AjustTM, Boyers et al. found no significant differences between the groups in term of the KHQ total score (p = 0.27) or the patient-reported success rate (p = 1.00) [25]. For de novo OAB symptoms, we observed de novo urgency in 9 patients (9.8%) associated with de novo urge incontinence in 6 patients (6.5%); again these results are in line with other studies. Naumann et al. reported de novo urgency in 7.8% of patients [22]. Cornu et al. observed de novo OAB symptoms in 10 patients (10.5% of the sample) [20]. It is worth noting that this rate is comparable with that given for retropubic and transobturator tape implantation. In a study comparing AjustTM and TVT-O, Mostafa et al. reported results with higher urgency for AjustTM (AjustTM 21.7% vs TVT-O 8.8%), grouping de novo urgency and worsening of pre-existing urgency, however, despite the considerable difference in percentages, these results were not statistically significant (p = 0.063) [23]. The strength of our study is that it is the only paper in which all patients reached the 2-year follow-up. Secondly, our sample was sufficiently big to allow conclusive statistical analysis.
Furthermore, in our study all patients underwent urodynamics pre and post-operatively. We chose to perform urodynamics postoperatively on all patients in order to be able to evaluate bladder function after the positioning of the sling to exclude any interference from the sling. We observed no modification in the storage phase while, in the voiding phase, there was a statistically significant increase of PdetQmax and a reduction of Qmax. No patients were obstructed according to Blaivas and Groutz nomogram [17]. The weakness of our study is the absence of control group with treatment carried out according to consolidated techniques such as retropubic and transoburator slings. In our hands AjustTM sling is a safe and reliable treatment for female SUI with good subjective and objective rates and few complications. Further studies with longer follow-ups and RCTs comparing AjustTM to MUS are needed. Conclusion In our hands AjustTM sling is a safe and reliable treatment for female SUI with good subjective and objective rates and few complications. Condensation Our data suggest that AjustTM sling is a safe and reliable treatment for female SUI with good subjective and objective rates and few complications. Acknowledgement Thanks go to David Nicholson for help with English. References [1] Petros PE, Ulmsten U. Urethral pressure increase on effort originates from within the urethra, and continence from musculovaginal closure. Neurourol Urodyn 1995;14(4):337–46. discussion 346–350. [2] Svenningsen R, Staff AC, Schiøtz HA, Western K, Kulseng-Hanssen S. Long-term follow-up of the retropubic tension-free vaginal tape procedure. Int Urogynecol J 2013;24(8):1271–8. [3] Aslam MF, Denman MA. Delayed diagnosis of vascular injury with a retropubic midurethral sling. Obstet Gynecol 2013;122(2 Pt 2):444–6. http://dx.doi.org/ 10.1097/AOG.0b013e31829919b3. [4] Kroon ND, Smith KM. Gill J.J Bowel injury at TVT: an issue of consent. Obstet Gynaecol 2007;27(7):741. [5] Bafghi A, Iannelli A, Trastour C, et al. Bowel perforation as late complication of tension-free vaginal tape. Gynecol Obstet Biol Reprod (Paris) 2005;34(6):606– 7 [Article in French]. [6] Vervest HA, Bongers MY, van der Wurff AA. Nerve injury: an exceptional cause of pain after TVT. Int Urogynecol J Pelvic Floor Dysfunct 2006;17(6):665–7. Epub 2006 Apr 22. [7] Novara G, Artibani W, Barber MD, Chapple CR, Costantini E, Ficarra V, Hilton P, Nilsson CG, Waltregny D. Updated systematic review and meta-analysis of the comparative data on colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress urinary incontinence. Eur Urol 2010;58(2):218–38. [8] Bump RC, Mattiasson A, Bo K, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 1996;175:10–7.
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