AdVance™ male sling for stress urinary incontinence: Long‐term follow‐up and patient satisfaction

Abstract Objectives To evaluate long‐term effects, complications and satisfaction among patients treated with AdVance™ and AdVance™ XP slings (AS) at a Norwegian specialist care hospital. Materials and Methods Patients who had an AS implanted due to stress urinary incontinence (SUI) 2009–2016 were identified retrospectively. Demographic and perioperative data were extracted from electronic patient files. We did a patient‐reported outcome measure (PROM) survey with the Expanded Prostate Cancer Index Composite (EPIC‐26) urinary domain and a Satisfaction Questionnaire (SQ) 2018–2020. Cure was defined as use of ≤1 pad/day. Results The AS was implanted in 165 patients, mainly due to mild to moderate SUI (median leakage 112 g, range 13–589 g/24 h). Preoperative urodynamics showed mild detrusor overactivity (DO) in 11 patients. At 6‐week follow‐up, 148 patients (90%) were cured. The most common complication was urinary retention (N = 38), transient in 32 patients (range 1–42 days). Two patients were later operated with division of the sling due to persistent retention. During clinical follow‐up of up to 12 years, 27 patients were reoperated due to persistent/recurrent incontinence. The PROM survey was sent to 125 patients and 115 (92%) replied at median 73 (20–134) months postoperatively. Ninety‐one (79%) used ≤1 pads/day, 97 (85%) were satisfied, one patient‐reported pain. Regression analyses showed that failure (>1 pad/day) was significantly associated with a higher amount of leakage preoperatively and at the 6‐week follow‐up. Total cure rate in the complete cohort was 64% at median 73 (20–134) months follow‐up. Conclusions The AS shows good and persistent long‐term results in patients with mild to moderate SUI. The only identified risk factor for long‐term failure was higher amount of leakage preoperatively. The incidence of high body mass index (BMI), DO and previous radiotherapy was low and not significantly associated with failure but is still considered risk factors.


| INTRODUCTION
Urinary incontinence can be incapacitating and lead to reduced health related quality of life. 1,24][5] Despite improved RP surgical techniques, postprostatectomy incontinence (PPI) is still a significant problem, although reported incidence rates vary according to definition applied. 6During the last two decades, the prevalence of PPI has increased dramatically due to the increased frequency of surgical treatment of prostate cancer and the long life expectancy of those treated. 2ntinence may improve up to 12 months post RP with conservative treatment, including pelvic floor exercises and lifestyle interventions. 7,8When conservative measures fail, further investigation may reveal sphincter insufficiency, bladder dysfunction or other complications after RP, including vesicourethral anastomosis stenosis (VUAS), or any combination of these.Radiation therapy may severely complicate the condition and exclude available surgical treatments. 9eatment needs to be directed to the exact underlying pathology.
To improve continence in case of sphincter insufficiency in men, implantation of the artificial urinary sphincter (AUS) is still considered the gold standard. 10In cases of mild to moderate leakage, there are several other surgical techniques to treat male stress urinary incontinence (SUI) available. 11In 2006 the AdVance™ male sling (American Medical Systems, Minnetonka, MN, USA) was introduced by Rehder and Gozzi. 12The AdVance™ male sling is a retrourethral, transobturator sling of polypropylene mesh.In 2010, the improved version AdVance™ XP was introduced with added directional chevron anchors for enhanced tissue fixation.
We present a long-term observational study of men treated for mainly mild to moderate SUI, as well as a cross-sectional long-term study of the same cohort.The objectives of the study were to evaluate the short and long-term effects, complications and patient satisfaction with the AdVance™ and AdVance™ XP.

| Setting and surgical technique
Oslo University Hospital Rikshospitalet is a tertiary referral centre for the treatment of male urinary incontinence.Implantation of AdVance™ male sling was introduced at our department in 2009 as an alternative for patients with mild to moderate SUI.
The indication for AdVance™/AdVance™ XP sling was male SUI.Contraindications included significant bladder dysfunction, nocturnal enuresis and neurogenic lower urinary tract dysfunction.Patients with daily urinary leakage of more than 400 g were usually not offered a sling, with few exceptions.History of pelvic radiation therapy was a relative contraindication during the first part of the study period and an absolute contraindication in the latter part.There was no age limit.
Preoperatively the patients completed voiding diaries and 24-h pad test for 3 days and underwent clinical examination, urethrocystoscopy and urodynamic evaluations.A detailed patient history was obtained and included patient-reported residual function of the external sphincter (ability to stop the urinary stream).A preoperative urethrocystoscopy was done to confirm concentric sphincter contraction and the absence of anastomotic or urethral strictures.The urodynamic evaluation was performed primarily to study bladder function, including detrusor activity during both filling and voiding phases, bladder compliance and any sign of obstructive outflow.A prerequisite for sling surgery was absence of detrusor overactivity (DO) during the filling phase (cystometry) and a good detrusor contraction during the pressure flow study.There were no cut-off limits for these urodynamic findings but the evaluation was at each surgeon's discretion.Preoperatively all patients had negative urine culture.Surgery was performed as described by Rehder and Gozzi in 2007, in general anaesthesia and with prophylactic antibiotics (cefalotin 2 g iv).A transurethral catheter was routinely left in place for less than 24 h.The patients were discharged the first postoperative day after measurement of post-void residual (PVR).In case of a high PVR (limit assessed individually), patients were taught clean intermittent self-catheterization (CISC) or a permanent transurethral/suprapubic catheter was placed.They received extended prophylaxis with cefalexin 500 mg QID for 5 days.
At clinical follow-up 6 weeks postoperatively, any early complications and continence status was recorded.Most patients did not have further routine follow-up but were encouraged to return in case of any complications or recurrence of SUI.

| Patient sampling-retrospective study
We conducted a study of all patients treated with the AdVance™ or AdVance™ XP male sling at Oslo University Hospital Rikshospitalet during the period of 2009-2016.
The electronic patient files were accessed in 2021 for the retrospective part of this study.Demographic and perioperative data were collected.Preoperative leakage was defined from mild to severe according to amount, with <100 g defined as mild, 100-400 g defined as moderate and >400 g defined as severe.Successful outcome/cure after sling implantation was defined as social continence (0-1 pad/day), and failure was defined as the need for two or more pads/day.Both early and late complications had been documented in the electronic patient files and were recorded for this study.Early complications assessed included wound infection, urinary tract infection, urinary retention, pain, lower urinary tract symptoms and persistent or recurrent incontinence within the first 6 weeks.Late complications were the same as the abovementioned recorded at any time after the first 6 weeks, as well as any reoperation (division of sling, new sling or implantation of AUS).

| PROM survey-cross-sectional study
A cross-sectional study with patient-reported outcome measures (PROMs) for long-term follow-up was performed during 2018-2020.
Questionnaires were sent to all identified patients operated during the study period 2009-2016 described above, except patients who had later been reoperated, were deceased or in case of missing contact info (Figure 1).We used the Expanded Prostate Cancer Index Composite (EPIC-26) score system for urinary assessment and a questionnaire about patients' satisfaction with the incontinence surgery. 13,14The EPIC-26 questionnaire concerns self-rating of urinary functions and sexual, bowel and overall problems after RP.The urinary domain was used for this study (Appendix S1).Definitions of cure and failure were the same as for the retrospective study (0-1 pads/day vs. ≥2 pads/day).
The Satisfaction Questionnaire (SQ) rated further aspects of the outcome of the sling surgery, including patient satisfaction, pain and problem with bladder emptying.It has previously been used in a similar study but is not a validated questionnaire (Appendix S2). 15

| Statistical methods
Descriptive statistics were presented using mean and standard deviation (SD) or median and range for continuous variables and frequencies and proportions for categorical variables.
Patients experiencing treatment success were compared to patients experiencing treatment failure using independent t tests for continuous variables and Fisher's exact tests for categorical variables.
Non-parametric tests were used if normality could not be assumed.
To investigate associations between treatment success/failure and possible prognostic factors, we estimated a multivariable logistic regression, from which odds ratios (OR) and corresponding confidence intervals (CIs) and p values were presented.
Two alternative continuous outcome measures were also defined using EPIC total score and EPIC 'pad question'.Here, multivariable linear regressions were estimated to identify potential prognostic factors, and regression coefficients and corresponding CIs and p values were presented.Potential prognostic factors were identified a priori using a combination of clinical experience and previously published articles on this topic.
Attrition analyses were done to compare baseline characteristics among those who did not respond to the questionnaire (N = 15) to those who did respond.Analyses were done using Stata version 17.0.
To calculate the total cure rate in this cohort, we included all patients operated with AS 2009-2016 except those deceased and lost to follow-up, with unknown long-term results.Patients reoperated due to incontinence or urinary retention were considered failures.
The level of significance was set at p < 0.05, and all tests were two sided.

| Ethics
The Ethics Committee for Health Research of the South Eastern Health Region of Norway approved the study (18/01391).Patients returned the questionnaire with written informed consent.
We found no baseline characteristics that were significantly associated with continence status at the 6-week postoperative clinical follow-up.
Seven patients, none of whom had DO at preoperative urodynamic evaluation, reported de novo urgency.Urinary tract infection occurred in two patients (Clavien-Dindo grade 2).There were no wound infections.The most common early complication was unacceptable PVR or urinary retention (N = 38, 23.0%).For most of these patients (N = 32, 19.4%), the urinary retention was transient (Clavien-Dindo grade 3a).They were managed with indwelling transurethral/suprapubic catheter or CISC for a median of 14 days (range 1-42 days) before regaining normal voiding without significant PVR.Reoperations for urinary incontinence and/or urinary retention (sling division) were done at a median of 25 months (range 1-111) after primary sling surgery.Of 36 patients who reported incontinence during follow-up, 26 patients (16.4%) were reoperated with a continence procedure (second sling or AUS), of which three had had transient urinary retention postoperatively.Of the 10 incontinent patients who were not reoperated, four reported de novo urgency and were effectively treated with antimuscarinics.

| Long-term clinical follow-up after 6 weeks
T A B L E 1 Baseline characteristics at time of evaluation prior to sling surgery.A second sling was implanted in seven patients, with median leakage of 112 g (range 50-217 g/24 h).An AUS was implanted in 20 patients, with median leakage of 150 g (range 100-200 g/24 h).
Sling division was done in two of the patients with persistent urinary retention (Clavien-Dindo grade 3b).One of these patients had an AUS implanted in the same procedure.The other patient (post-TURP) was continent after sling division but still had incomplete bladder emptying in need of CISC.
Of the four patients with a history of salvage radiotherapy, two had urinary retention postoperatively, and three were later reoperated with an AUS due to persistent/recurrent incontinence.
Of the six post-TURP patients, three had urinary retention postoperatively, one of whom had the sling divided.All reported continence and satisfaction at the 6-week follow-up and beyond.

| PROM survey
In 2018-2020, 125 patients were invited to the PROM survey by filling out questionnaires sent to them by mail (Figure 1).The reply rate was 92% (N = 115) at a median of 73 (20-134) months after sling implantation (Table 3).Two thirds of the patients (N = 77) had longer follow-up than 60 months.One questionnaire was incomplete, missing the reply to two questions (EPIC total, satisfaction), and three to five patients did not to reply to page two of the questionnaire (EPIC-26 Q6).The remaining patients replied to all questions.
The results of the PROM survey are listed in detail in Table 2.
Use of no pads was reported by 42% of the patients, use of one pad daily was reported by 37% of the patients, that is, a total of 79% of the patients were defined as socially continent or cured according to our definition.Eighty-one per cent reported no or small problem with their urinary function, and 85% reported satisfaction with the result of the sling operation.
Among the six post-TURP patients, four were included in the PROM survey, of whom three replied; all were satisfied.Of the remaining two, one had been reoperated with sling division due to urinary retention and one was deceased.
Among the 32 patients with transient urinary retention, 26 patients were included in the PROM survey, of whom 23 replied: 21 reported satisfaction and two dissatisfaction.
To calculate the total cure rate of this cohort operated 2009-2016, at the time of the PROM survey (median follow-up 73 months, range 20-134), we included the 115 patients who replied to the PROM survey (91 cured, 24 failures, Table 2) as well as those already defined as failures at that time (28 reoperated, not included in the PROM survey, Figure 1).Hence, we identified 91 cured patients and 52 failures (total 143) during the follow-up, that is, the total cure rate was 63.6%.Of the remaining 22 patients, seven are deceased and 15 have an unknown long-term result.An attrition analysis of these 15 lost to follow-up showed no baseline differences to those included in this analysis.
Of the four patients with a history of pelvic radiotherapy, three were failures; however, this information could not be included in multivariable analyses due to the low number of patients.

| DISCUSSION
In this cohort, the cure rate with the AdVance™ and AdVance™ XP sling was 63.6% at long-term follow-up of a median of more than 6 years.The most common postoperative complication was transient urinary retention.The main indication for reoperation was recurring incontinence.Among those not reoperated, 79% were still socially continent and 85% were satisfied up to more than 11 years after sling implantation.Failure of long-term continence was associated with more leakage preoperatively and at the 6-week follow-up.
Some known risk factors, like obesity and previous radiation, could not be identified as risk factors in this study.However, these characteristics were rare in our cohort and may have been missed as risk factors due to the small numbers.Patients with DO did not report statistically significant worse outcome than those without DO regarding continence, lower urinary tract symptoms or complications postoperatively, which may also be due to the low incidence and low grade of severity of this feature in our cohort.
The definition of cure after sling implantation varies in the literature, from pad free to 0-1 pad daily or up to 5 g/24 h.The latter two definitions (≤1 pad or ≤5 g daily) are considered interchangeable.
Those using the definition pad free have shown cure rates of 67% at 49 months median FU (N = 94) 16 and 62% at 21 months mean FU (N = 136). 17Reported cure rates with the definition 0-1 dry pad are 51% at 52 months median FU (N = 72) and 53% at 36 months FU (N = 151). 18,19Authors using the definition 0-1 pads 20 have reported a cure rate of 66% at 5 years FU (N = 172) while those using the definition leakage of up to 5 g/24 h 21-24 have shown cure rates of 46% to 72% at up to 5 years FU (N = 15-115).
A systematic review and meta-analysis of male slings from 2019 highlights this issue of different definitions of cure and continence, the most commonly used being 'social continence' (0-1 pad or minimal leakage in pad test). 25Cure rates with AdVance™/AdVance™ XP vary from 9% to 86.9% (20 studies, with FU 12-61.5 months).Cure rates with other slings (InVance, TONS, I-Stop TOMS, Surgimesh M-sling, TiLoop, Virtue, Argus/ArgusT, ATOMS, Remeex, 18 studies, with FU 12-58 months) vary from 15% to 90%. 25 Hence, the most common definition of cure after treatment of male SUI with a sling is so-called social continence (0-1 pad/day or ≤5 g/24 h).Using this definition, our results are comparable with previously published data (64% vs. 9% to 86.9%), especially considering the longer follow-up and this heterogenic population.
T A B L E 2 Results of the long-term follow-up cross-sectional study (the PROM survey).
An article from 2021 26 describes which definition of pad usage that best reflects patients' perception of quality of life, where the use of no pad was associated with better quality of life than using one safety pad or one pad.This may lead us to reconsider the definition of cure in future studies and rather use the definition pad free as a successful outcome.
As in most other studies of the AdVance™/AdVance™ XP slings, patients were carefully selected for this method: Patients with nocturnal incontinence, previous radiotherapy and a coaptive zone of <1 cm are usually not offered a sling. 27All our patients had a preoperative urethrocystoscopy to verify a healthy urethra and a concentric contraction of the sphincter, though evaluation of the coaptation zone with the repositioning test has not been systematically recorded in our patient files.
We follow largely the same criteria for recommending AdVance™ sling as reported in other studies.The practice of offering AdVance™ sling to previously irradiated patients was abandoned at our institution in 2011.Contemporary exclusion criteria are previous radiation therapy, severe urinary leakage, nocturnal enuresis and urgency urinary incontinence.Furthermore, the patients should have a normal urethrocystoscopy, good bladder capacity and function and some residual sphincter function.
Regarding the AdVance™ and AdVance™ XP male slings, no difference in success rates have been reported in the literature, but one study reports urinary retention rates of 3.7% and 10.3%, respectively. 28In our study, there are too few patients to compare success rates and complication rates between the two slings, so all patients are analysed together.
T A B L E 2 (Continued) Previously published studies have indicated low risk of complications after surgery with the AdVance™/AdVance™ XP. 21,23 Problems like urinary retention (up to 67.3%), pain (up to 1.5%) and de novo urgency are reported to varying degrees at long-term followup. 25In our cohort, urinary retention was quite common but transient for most, and at long-term follow-up (PROM survey), most of these patients reported satisfaction.Potential complications should nevertheless be addressed at preoperative counselling with patients.No risk factor for urinary retention has been identified, 29 but we are careful with offering slings to patients with a low bladder contractility index.
In patients without known risk factors like previous radiotherapy, that is, index patients, adjustable slings might lead to better continence results but are also associated with higher a risk of complications. 25e slings have the advantage that it has no mechanical components like the AUS.The risk of complications to an AUS is not negligible and includes infection, erosion and mechanical failure.Patients prefer to avoid a mechanical device and will therefore often choose a male sling over an AUS, if given the choice. 30Patients of higher age and with more severe leakage should be preoperatively counselled about a higher risk of persistent incontinence and lower urinary tract symptoms after sling surgery.There is a place for the male sling in the treatment of male SUI, but the AUS remains the best option for patients with severe leakage and/or concomitant bladder dysfunction.
There are limitations to our study.This is a retrospective single centre study of results after surgery performed by experienced surgeons.The patient selection was strict due to the recommendation of previous studies, changing somewhat during the study period.After a few patients in the early phase, we no longer offer the AS to patients with SUI after TURP or a history of pelvic radiation.The long-term cross-sectional study with questionnaires used both validated and non-validated PROMs, the latter being a limitation.

| CONCLUSION
The AdVance™/AdVance™ XP show good and persistent long-term results in patients with mild to moderate SUI with a follow-up of up to 134 months.There was no evidence of a decrease of efficacy over the years.More leakage preoperatively was associated with long-term failure.The incidence of high BMI, mild DO and previous pelvic radiotherapy was low in this cohort and was not significantly associated with failure but is still considered risk factors.
AdVance™/AdVance™ XP was implanted in 165 male patients during the study period 2009-2016.The aetiology of SUI was RP (N = 155), RP and radiotherapy (N = 4) and transurethral resection of the prostate (N = 6).After 2011, no patients with a history of radiation were offered AdVance™/AdVance™ XP.The patients mainly had mild to moderate SUI (pad weight median 112 g/24 h, range 13-589).All but three patients had a preoperative urodynamic evaluation, showing normal bladder function in 151.The remaining 11 patients had mild DO at a median bladder volume of 320 mL (range 200-440).None of the patients had signs of obstruction on urodynamic investigation, and all had a good detrusor contraction during the pressure/flow study.Urethrocystoscopy was performed in all patients, confirming residual sphincter function with concentric contraction and absence of obvious pathology.Detailed baseline characteristics are shown in Table 1.There were no intraoperative complications.Urinary retention or high PVR was the only complication occurring during the 24-hour hospital stay, described in more detail below.F I G U R E 1 Flow chart of included patients.We included 165 patients, of whom 125 patients were sent questionnaires (PROM survey) during 2018-2020.Patients who had been reoperated after initial sling surgery, were diseased or had missing contact info were not included in the PROM survey.Of the 125 included in the PROM survey, 115 patients replied at a median of 107 months (range 43-202) postoperatively.
Clinical follow-up was up to almost 12 years, from the first implantation in 2009 to 2021 when the electronic patient files were accessed.During this period, 36 patients (21.8%) reported recurrent or persistent incontinence during long-term clinical follow-up.Six patients (3.6%) had persistent urinary retention and continued CISC.There were no other late complications, such as infections or erosions.
The Expanded Prostate Cancer Index Composite Urinary assessment: EPIC-26 urinary domain This section is about your urinary habits.Please consider only the last 4 weeks.
The Expanded Prostate Cancer Index Composite Urinary assessment: EPIC-26 urinary domain This section is about your urinary habits.Please consider only the last 4 weeks.The questionnaires are available in their complete versions as Appendices S1 and S2.Some questions were omitted in this table due to little relevance and very low incidence (e.g., EPIC-26 Q2, EPIC-26 Q3, EPIC-26 Q6 b and EPIC-26 Q6 c concerning haematuria and dysuria).N = number of patients replying to each of the questions and equals the denominator calculating the percentage of each reply.Abbreviations: EPIC, Expanded Prostate Cancer Index Composite Urinary assessment; PROM, patient-reported outcome measure; SQ, Satisfaction Questionnaire.