Int Urogynecol J DOI 10.1007/s00192-015-2912-5

ORIGINAL ARTICLE

Risk factors for failure of repeat midurethral sling surgery for recurrent or persistent stress urinary incontinence Tsia-Shu Lo 1,2,3 & Leng Boi Pue 4 & Yiap Loong Tan 5 & Pei-Ying Wu 1

Received: 16 September 2015 / Accepted: 23 November 2015 # The International Urogynecological Association 2015

Abstract Introduction and hypothesis To study the outcomes following repeat midurethral sling (MUS) surgery in patients with persistent or recurrent stress urinary incontinence after failure of primary MUS surgery and risk factors for surgical failure. Methods The medical records of 24 patients who underwent repeat MUS surgery at a single tertiary center from January 2004 to February 2014 were reviewed. The types of MUS used for the repeat surgey were transobturator, retropubic and single incision slings. Objective cure was defined as no demonstrable involuntary leakage of urine during increased abdominal pressure in the absence of a detrusor contraction observed during filling cystometry, and subjective cure was defined as a negative response to Urogenital Distress Inventory six (UDI-6) question 3 during follow-up between 6 months and 1 year postoperatively. The change in the inclination angle between the urethra and pubic axis was measured

with introital ultrasonography and the cotton swab test performed. Results The objective and subjective cure rates were 79.2 % and 75 %, respectively. There were no differences in demographics between the patients with failure of surgery and those with successful surgery. Significant independent risk factors for failure of repeat MUS surgery were a change in cotton swab angle at rest and straining of <30° (OR 4.6, 95 % CI 2.5 – 7.9°), a change in inclination angle of <30° (OR 4.6, 95 % CI 2.5 – 7.9°), intrinsic sphincter deficiency (OR 3.4, 95 % CI 1.8 – 6.1) and a mean urethral closure pressure of <60 cm H2O (OR 2.9, 95 % CI 1.5 – 4.5). In one patient the bladder was perforated. Conclusions Repeat MUS surgery is safe and has a good short-term success rate, both objectively and subjectively, with independent risk factors for failure related to bladder neck hypomobility and poor urethral function. Keywords Cotton swab test . Midurethral sling . Recurrent . Stress urinary incontinence . Ultrasound

* Tsia-Shu Lo [email protected]

Introduction 1

Department of Obstetrics and Gynecology, Keelung Medical Center, Chang Gung Memorial Hospital, 222, Maijin Road, Keelung, Taiwan 204, Republic of China

2

Division of Urogynecology, Department of Obstetrics and Gynecology, Linkou Medical Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan, Republic of China

3

School of Medicine, Chang Gung University, Taoyuan, Taiwan, Republic of China

4

Department of Obstetrics and Gynecology, Kuala Lumpur Hospital, Kuala Lumpur, Malaysia

5

Department of Obstetrics and Gynecology, Kuching Specialist Hospital, Sarawak, Malaysia

The development of the midurethral sling (MUS) was a real breakthrough in the armamentarium of anti-incontinence surgery and it has now supplanted Burch colposuspension as the new gold standard for surgical treatment of primary stress urinary incontinence (SUI) [1]. Three generations of MUS are recognized: the original retropubic tension-free vaginal tape (TVT), the second generation transobturator tapes (TOTs), and the third generation single-incision ‘minislings’ [2]. The overall risk of reoperation after initial SUI surgery is approximately 8 – 9 % [3, 4], and specifically if the initial surgery is placement of a MUS, the risk is 3.2 % [3]. Unlike

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primary SUI, the management of recurrent SUI remains a challenge to the surgeon. There is a lack of consensus as to the best procedure for repeat anti-incontinence surgery. Since the MUS procedure is simple and has a high primary success rate, repeat MUS surgery is an attractive option for failure of initial surgery [5]. Meyer et al. reported a success rate of 76.8 % after repeat MUS surgery and the outcomes typically determined within the first 6 months after surgery were stable over a mean follow-up of 21 months [6]. In the present study, we aimed to study the outcomes of repeat MUS surgery in patients with persistent or recurrent SUI after failure of primary MUS surgery and factors associated with failure. We hypothesized that repeat MUS surgery would be effective and safe in patients with failure of prior MUS surgery. We explored the risk factors associated with failure of repeat MUS surgery. The inclusion of ultrasound assessment in our study added valuable information in understanding the risks of failure of repeat MUS surgery.

Materials and methods The medical records of 628 consecutive women (mean age 58 ±18.6 years) who underwent MUS surgery from January 2004 to February 2014 were retrospectively reviewed. A total of 24 patients who underwent repeat MUS surgery in a single tertiary center during the study period were identified. Exclusion criteria included mixed urinary incontinence, concomitant pelvic organ prolapse surgery, incontinence surgery other than MUS, incomplete or missing records and follow-up less than 1 year. Any type of MUS was allowed for the primary or repeat surgery. Preoperative assessment consisted of detailed medical and surgical history, urogynecologic examination, a 1-h pad test, cough stress test, urine analysis, multichannel urodynamic evaluation and introital ultrasonography. A Q-tip test was performed in all patients who had failed prior anti-incontinence surgery according to a previously described technique [7]. A small pediatric size cotton swab lubricated with water-based lubricant (K-Y Jelly) was inserted in the urethra and mobility was assessed by measuring the deflection of the shaft of the swab with an orthopedic goniometer at rest and during Valsalva maneuver in the lithotomy position. All patients completed a 72-h voiding diary and subjective evaluation using the Urogenital Distress Inventory (UDI-6) [8], the Incontinence Impact Questionnaire (IIQ-7) [9] and the Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire (PISQ-12) [10]. Chinese translated questionnaires, which have been previously validated by Su et al., were used in this study [11]. The type of sling used for the repeat surgery was chosen by the surgeon, reflecting the current standard of care in our practice. Patients were operated on by one of the authors using the standard transobturator outside-in technique (Monarc; AMS,

Minnetonka, MN), TVT (Gynecare; Ethicon Inc, Somerville, NJ) and MiniArcTM single-incision sling system (AMS, Minnetonka, MN). The surgical procedures were performed as previously described [12–15]. Tensioning of the tapes for TVT and Monarc was achieved by ensuring there was sufficient space to place a Metzenbaum scissors between the urethra and the tape in a tension-free manner. However, for MiniArc, no specific standard tensioning technique was implemented, but care was taken to ensure that the sling abutted the urethra with no space [16]. It was also imperative that the curved needle be angled ventrally towards the obturator internus muscle during anchoring of the self-fixing tips. The primary slings were not excised and no attempt was made to locate them. All patients were followed up at 1 week, 1 month, 3 months and 6 months postoperatively, and annually thereafter. Postvoid residual urine measurements, urine analyses and pelvic examinations were performed during follow-up visits. Multichannel urodynamics and ultrasonography were performed and questionnaires (UDI-6, IIQ-7 and PISQ-12) completed within 6 months and 1 year of follow-up. The introital ultrasound examination was performed by the senior author (L.T.S), using a Philips HD11XE ultrasound system (Philips Ltd., The Netherlands) equipped with a 3.5MHz volume-array transducer. With the patient in a semisupine position the transducer was placed between the labia majora and underneath the external urethral orifice. The ultrasound parameters exploring the sling (xt, yt) and bladder neck position (xbn, ybn; Fig. 1) were measured using the rectangular coordinate system in the sagittal plane with a reference marker at the lower margin of the symphysis pubis at rest and maximal Valsalva maneuver [17]. The inferior margin of the sling was used as a reference point. Patients were asked to perform the Valsalva maneuver three times and the most effective recording was used. The mobility of the sling and bladder neck were calculated using the formulas √[(xtstrain − xtrest)2 +(ytstrain − ytrest)2] and √[(xbnstrain − xbnrest)2 +(ybnstrain − ybnrest)2], respectively, where Bstrain^ is the value during the Valsalva maneuver and Brest^ is the value at rest [18]. In addition, the percentile of the urethra where the sling was located and the presence of urethral kinking during the Valsalva maneuver were recorded. Urethral kinking was shown as sling angularity on ultrasonography during maximum straining as described by Lo et al. [17]. The angle of inclination between the urethral axis and the pubic axis was measured at rest and during the Valsalva maneuver, and the difference between these angles determined (Fig. 2). If the MUS used in the repeat procedure was the same type as used in the first procedure, the archived scan data were used prior to the second procedure in order to differentiate the MUS placed during primary and repeat surgery. The methods, definitions and units conform to the standards jointly reco mmende d b y the International

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Fig. 1 Graphical representation and sonographic images exploring the primary sling (1st tape), bladder neck (BN) position and angle of inclination ∠α (the angle between the urethral axis and the pubic axis at rest and with straining). SP symphysis pubis

Fig. 2 Sonographic images following repeat surgery evaluating the sling, bladder neck (BN) position and angle of inclination ∠α (the angle between the urethral axis and the pubic axis at rest and with straining). SP symphysis pubis

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Urogynecological Association (IUGA) and the International Continence Society (ICS) [19]. Urodynamic SUI was defined as involuntary urine leakage with stress in the absence of detrusor contraction during filling cystometry. Persistent SUI was defined as SUI within 6 weeks of the first MUS procedure. Recurrent SUI was defined as SUI later than 6 weeks after initial success of the first MUS procedure. Intrinsic sphincter deficiency (ISD) was defined as a pressure increase from baseline required to cause urinary incontinence (Δ Valsalva or cough leak-point pressure) of 60 cm H2O or less [20]. Objective cure was defined as no demonstrable involuntary leakage of urine during increased abdominal pressure in the absence of detrusor contraction observed during filling cystometry, and subjective cure was considered a negative response to UDI-6 question 3 (no urinary leakage on coughing, laughing or sneezing), both assessed during follow-up between 6 months to 1 year postoperatively. Statistical analysis was performed using the chi-squared test or Fisher’s exact test for categorical variables. When the assumption of the chi-squared test was violated (i.e., when more than one cell had an expected count of <1 or >20 % of the cells had an expected count of <5), Fisher’s exact test was used. Odds ratios (with 95 % confidence intervals, CI) were determined using the chi-squared test or Fisher’s exact test to assess the independent prognostic value of the variables associated with postoperative SUI. All statistical tests were twosided. P values <0.05 were considered statistically significant.

Table 1 Demographics of patients undergoing repeat MUS surgery divided according to success and failure of the procedure

Age (years) Median parity BMI (kg/m2) Postmenopausal Diabetes mellitus Prior pelvic surgery Hysterectomy Operating time (min) Intraoperative blood loss (ml) Hemoglobin difference (g/dl) Hospital stay (days) Sling type TVT TOT MiniArc Anesthesia General Local and heavy sedation

All of the statistical calculations were performed using the SPSS for Windows, release 17.0 (SPSS, Chicago, IL). The institutional review board of Chang-Gung Memorial Hospital approved the chart evaluation of this study (IRB no. 1014053B).

Results Of the 628 patients, 24 (3.8 %) had repeat MUS surgery, and were further divided into those who were objectively cured (success group, 19 patients) and those in whom surgery failed (failure group, 5 patients). The mean follow-up period was 54.8±17.47 months (range 13.6 – 126.7 months). There were no differences in demographics between the two groups in terms of age, parity, body mass index, postmenopausal status, diabetes mellitus, prior pelvic surgery, operating time, intraoperative blood loss, hemoglobin, hospital stay, sling type adopted and method of anesthesia (Table 1). The objective and subjective cure rates were 79.2 % and 75 %, respectively, at 1 year. The majority of patients had TOT as the second MUS (54.5 %), followed by single-incision minisling (25 %) and TVT (20.8 %). Two patients in the success group had voiding dysfunction requiring bladder catheterization for 2 days, but none in the failure group. Neither group needed any sling release.

All patients (n=24)

Success group (n=19)

Failure group (n=5)

P value

58.7±11.7 3.2±1.1 24.8±3.2 19 (79.2) 6 (25.0)

57.2±10.6 3.1±1.2 24.6±3.5 15 (78.9) 5 (26.3)

59.2±9.3 3.4±1.2 25.2±2.7 4 (80.0) 1 (20.0)

0.641 0.547 0.178 0.730 0.634

5 (20.8) 32.3±16.6 27.1±15.0 0.15±0.17 1.1±0.4

3 (15.8) 35.2±15.8 25.2±10.3 0.14±0.37 1.1±0.3

2 (40.0) 38.8±12.9 29.6±14.7 0.18±0.22 1.1±0.3

0.270 0.347 0.135 0.247 0.541

3 14 7

3 10 6

0 4 1

0.341

20 4

15 3

4 1

0.748

The data are presented as mean±SD or number (%) of patients BMI body mass index, TVT retropubic tension-free vaginal tape, TOT transobturator tape (Monarc)

Sonography, postoperative (second sling)

Sonography, preoperative (first sling)

6.0±2.7 13.2±3.2 6.2±2.9 17.1±4.1

xbn (mm) rest xbn (mm) strain

14 (58.3) 17.3±2.6 22.7±2.7 18.2±2.9

Urethral kinking xt (mm) rest xt (mm) strain yt (mm) rest yt (mm) strain Mobility of the slinga

29.8±3.9 22.1±3.4 13.9±3.5 5 (20.8) 23 (95.8)

18.0±2.9 6.2±2.9 12.8±1.2 6.1±2.7 17.4±3.9

yt (mm) rest yt (mm) strain Mobility of the slinga xbn (mm) rest xbn (mm) strain ybn (mm) rest ybn (mm) strain Mobility of the bladder neckb Change of inclination angle <30° Second sling at mid-urethra

17.6±3.0 22.0±3.1

5 (20.8) 19 (79) 0

xt (mm) rest xt (mm) strain

Change in inclination angle <30° First sling at mid-urethra Urethral kinking

6.2±2.8 19.0±3.9

5.8±2.3 13.6±3.1

14 (73.7) 17.4±2.7 22.9±3.1 18.3±2.6

30.3±3.7 21.9±3.9 15.6±3.1 1 (5.3) 19 (100)

18.0±2.1 6.1 ±2.7 12.9±1.1 6.1±3.3 19.3±3.7

17.3±2.9 22.2±3.1

1 (5.3) 15 (78.9) 0

15.6±8.4 69.5±25.2 1 (5.3)

4 (21.1)

15.3±8.4 65.2±31.3 4 (16.7)

6 (25.0)

Dmax Valsalva leak-point pressure (cm H2O) Intrinsic sphincter deficiency

<2

412.1±82.1 82.8±17.2 17 (89.5) 2 (10.5) 23.4±6.1 15 (78.9)

409.7±98.5 77.2±21.3 19 (79.2) 5 (20.8) 22.0±7.4 18 (75.0)

Cystometric capacity (ml) Maximum urethral closure pressure (cm H2O) ≧60 <60 Functional urethral length (cm) ≧2

25.2±11.7 34.0±21.5

Success group (n=19)

26.1±12.4 32.8±30.9

All patients (n=24)

Qmax Postvoid residual urine (ml)

Parameter

Urodynamic and sonographic parameters in patients undergoing repeat MUS surgery divided according to success and failure of the procedure

Urodynamics, preoperative

Table 2

6.3±2.0 11.0±3.6

6.3±3.0 12.4±2.9

0 (0) 17.6±1.6 22.1±1.9 17.9±2.1

29.7±3.1 24.1±4.1 8.1±3.6 4 (80) 4 (80)

17.9 ±3.1 6.3±3.1 12.6±0.9 6.2±2.2 12.1±4.0

17.7 ± 2.1 22.5 ± 1.9

4 (80) 3 (60) 0

14.6±8.4 51.1±19.4 3 (60)

2 (40)

392.4±88.3 56.1±19.4 2 (40) 3 (60) 19.2±4.3 3 (60)

26.5±10.7 31.5±22.4

Failure group (n=5)

0.684 <0.001

0.371 0.292

0.006 0.639 0.851 0.218

0.289 <0.001 <0.001 0.002 0.208

0.431 0.481 0.392 0.751 <0.001

0.647 0.752

0.002 0.568

0.628 <0.001 0.018

<0.001 0.366

0.637 <0.001 0.042

0.487 0.349

P value

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ybn (mm) rest ybn (mm) strain Mobility of the bladder neckb

Parameter 29.3±4.2 30.1±3.4 12.5±4.5 5 (20.8)

All patients (n=24) 29.4±4.1 21.2±5.1 15.2±4.4 1 (5.3)

Success group (n=19) 29.1±2.6 25.2±3.5 6.1±3.2 4 (80)

Failure group (n=5)

0.753 <0.001 <0.001 0.002

P value

4.74 4.74 2.37 2.24

Intrinsic sphincter deficiency Maximum urethral closure pressure <60 cm H2O

Odds ratio

Multivariate analysis: independent risk factors for failure of repeat MUS surgery

Cotton swab <30° Change in inclination angle <30°

Table 3

0.018 0.042

0.002 0.002

P value

Mobility of the bladder neck=√[(xbnstrain − xbnrest)2 +(ybnstrain − ybnrest)2 , where BstrainB is the value during the Valsalva maneuver and Brest^ is the value at rest

Mobility of the sling=√[(xtstrain − xtrest)2 +(ytstrain − ytrest)2 ], where BstrainB is the value during the Valsalva maneuver and Brest^ is the value at rest

b

a

0.81 – 6.97 0.75 – 6.17

0.82 – 27.43 0.82 – 27.43

95 % confidence interval

xt distance between the sling and axis perpendicular to the central line of the symphysis (cephalocaudal position), yt distance between the sling and the central line of the symphysis (ventrodorsal position), xbn distance between the bladder neck and the axis perpendicular to the central line of the symphysis (cephalocaudal position), ybn distance between the bladder neck and the central line of the symphysis (ventrodorsal position)

Qmax maximum urinary flow (m/s), Dmax detrusor pressure at maximum flow (cm H2O)

The data are presented as means±SD or number (%) of patients

Cotton swab <30°

Table 2 (continued)

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Table 2 shows urodynamic and sonographic parameters. Most parameters were significantly different between the success and failure groups. The mean length of functional urethra in the success group was significantly greater than in the failure group, but using more than 2 cm as the cut-off point, the difference was not significant. The mean Valsalva leak-point pressure was significantly lower in the failure group (success group 69.6±25.2cm H2O, failure group 51.1±19.4cm H2O; p <0.001). There were no differences in mean urethral closure pressure (MUCP) among different types of MUS. The sonographic measurements in the success and failure group showed similar trends in the preoperative and postoperative assessments with a significant change in inclination angle <30° and bladder neck mobility. No significant differences were found in the mobility of the tape or the position of the slings in the midurethral region. In one TVT procedure, the bladder was perforated during trocar insertion, but this was successfully managed conservatively with continuous bladder drainage for 3 days. No patient showed mesh extrusion. Table 3 shows the independent risk factors for failure of repeat MUS surgery. The following risk factors were significantly associated with failure: cotton swab <30° (OR 4.6, 95 % CI 2.5 – 7.9), change in inclination angle <30° (OR 4.6, 95 % CI 2.5 – 7.9), ISD (OR 3.4, 95 % CI 1.8 – 6.1), MUCP <60 cm H2O (OR 2.9, 95 % CI 1.5 – 4.5). Table 4 shows the mean preoperative and postoperative scores for UDI-6, IIQ-7 and PISQ-12. All of them, showed significant improvements. Only 10 of the 24 patients who were sexually active after repeat MUS surgery completed the PISQ-12 questionnaire.

Discussion To date, there is no high-quality, trial-based evidence that can inform treatment decisions on the management of recurrent SUI after a failed suburethral tape. There has been no randomized controlled trial that has investigated repeat MUS surgery [21]. Despite the lack of data, the most common management for recurrent SUI is repeat MUS surgery [22, 23]. MUS appears to be less effective as a repeat procedure than as a

Table 4 The UDI-6, IIQ-7 and PISQ-12 scores before and 6 months to 1 year after repeat MUS surgery

UDI-6 (n=24) IIQ-7 (n=24) PISQ-12 (n=10)

Before surgery

After surgery

P value

12.9±4.1 13.6±5.1 21.1±4.5

4.4±3.5 4.0±3.3 24.9±4.2

<0.001 <0.001 0.0143

The data are presented as means±SD

primary procedure [21]. In our study, the objective and subjective cure rates after repeat MUS surgery were 79.2 % and 75.0 %, respectively. Our results are comparable with those of Abdel-Fattah et al. who reported objective and subjective cure rates of 77 % and 70 %, respectively [24], and Lee et al. who reported an overall cure rate of 76 % [25]. However, our cure rates are slightly higher than those found in some other studies, which range from 60 % to 64 % [5, 6, 26]. Nikolopoulos et al. in a recent meta-analysis including a total of 858 patients who had MUS surgery for recurrent SUI found a pooled success rate of 68.5 % [27]. Various factors have been associated with failure of surgery for SUI, including preoperative weight of greater than 80 kg, low preoperative urethral pressure, preoperative detrusor overactivity or its development postoperatively and intraoperative blood loss of more than 1 l [21]. In our study, independent risks factors that influenced failure of repeat surgery were ISD, MUCP <60 cm H2O, change in inclination angle of the urethra of <30° measured on ultrasonography or with the cotton swab test. In SUI associated with urethral hypermobility, MUS surgery achieves a good result as the sling acts as a fulcrum for dynamic kinking to occur during the Valsalva maneuver or increased abdominal pressure [12]. Also, most of the failures of MUS surgery occurred in patients who had an immobile urethra, especially in those also with ISD [7]. There were no difference in MUCP among the different types of MUS. Continence is achieved through a dynamic kinking mechanism, in which the sling acts as a fulcrum for kinking at the mid-urethra during the Valsalva maneuver or increased abdominal pressure [12]. This mechanism is shared by different types of MUS, irrespective of their route of insertion. In our study, dynamic kinking was observed in 73.7 % of patients in the success group, but in none of the patients in the failure group. Verbrugghe et al. found no differences in overall continence rates with different types of MUS, except for the biological sling [26]. However, a repeat TVT seems to be the most favored choice among experts in those who have failed primary TVT as it offers better results than a TOT [5, 23, 28]. In this study, the type of MUS used for the repeat surgery was chosen by the surgeon or patient and according to availability of the MUS kit. Some surgeons have suggested that if a TOT or minisling used as a second MUS is adjusted a little tighter than when used as a primary MUS better continence is achieved, but we do not agree with this approach as it may increase voiding dysfunction. We found no differences in continence rates with the various types of MUS, but the key to their success is mobility of the urethra and bladder neck as demonstrated by a preoperative cotton swab test and ultrasonography. Although the MUS should be positioned at the mid-urethra as the name implies, the position is not very crucial for success of repeat surgery. There were fewer primary slings at the mid-

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urethra (19/24) than second slings (23/24), as assessed by sonography. However, there was no significant difference in the number of patients with the primary sling at the midurethra between the success and failure groups. The mobility of the bladder neck is important for the success of MUS surgery whether primary or repeat. Our findings clearly demonstrated that both before and after surgery the success group showed significantly greater bladder neck mobility than the failure group. This reinforces the theory of dynamic kinking which was proposed by Lo et al. [12]. Our ultrasonography findings on bladder neck mobility and inclination angle of the urethra confirmed the findings of the cotton swab test. Preoperatively, a cotton swab test and urethral inclination (as measured by ultrasonography) of <30° was associated with a greater likelihood of failure of repeat MUS surgery. The cotton swab test has been used to measure bladder neck mobility for decades. It is a simple and cheap bedside test, but it is slightly invasive and may cause discomfort to the patient. Ultrasonography is an alternative noninvasive method for measuring bladder neck mobility by measuring urethral inclination from the midline. However, if ultrasonography is not available, the cotton swab test is still a reliable option to predict failure of repeat MUS surgery and should be recommended in those who have failed anti-incontinence surgery. Quality of life with regard to urinary incontinence as measured by UDI-6, IIQ-7 and PISQ-12 significantly improved following repeat MUS surgery. Jang et al. found no significant change in overall sexual function in women undergoing MUS surgery [29]. They also found no significant difference in sexual function between women receiving a retropubic MUS and those receiving a transobturator MUS [29]. One might expect improvement in sexual function following MUS surgery because of cessation of urinary incontinence and increased sexual activity, but on the other hand worsening may occur due to dyspareunia. In our study, only 10 of the 24 patients were sexually active after repeat MUS surgery. As our sample size was very small and the study was based on only the overall score and not on the specific domain of urinary leakage or fear of incontinence during sexual intercourse, we cannot draw a conclusion as to the effect of repeat MUS surgery on sexual function. Our study had limitations, including its retrospective design, the small number of patients and short follow-up. Randomized controlled trial studies with more patients and longer follow-up are necessary in the future. However, the strengths of our study include the use of validated questionnaires and standardized definitions. In conclusion, repeat MUS surgery is safe and has a good short-term success rate, both objectively and subjectively, with independent risks for failure related to bladder neck hypomobility and poor urethral function.

Acknowledgments The authors thank Dr. Norlelawati Ab. Latip for editorial assistance. Compliance with ethical standards Conflicts of interest None.

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