Stress urine-incontinentie (SUI) is een gekende complicatie van radicale prostatectomie, als gevolg van de denervatie van het sfinctercomplex. Post prostatectomie SUI heeft een significante invloed op de kwaliteit van leven.

De artificiële sfincter wordt al tientallen jaren beschouwd als de gouden standaard in de behandeling van post-prostatectomie SUI, bij patiënten waarbij postoperatief natuurlijk herstel niet optreedt en waarbij bekkenfysiotherapie geen of onvoldoende resultaat heeft gehad. De artificiële sfincter bestaat uit een hydraulisch systeem welke compressie geeft rondom de urethra. In principe kan de sfincterprothese gebruikt worden voor alle vormen van post-prostatectomie SUI, ongeacht de ernst.

Tegenwoordig zijn er ook andere chirurgische behandelingen van SUI bij de man beschikbaar, die elk berusten op een ander chirurgisch principe. Het gaat dan om slings (al dan niet gefixeerd), bulkmateriaal en compressieballonnen. Al deze behandelingen hebben een meer minimaal invasief karakter wanneer vergeleken met de sfincter.

In deze module beperken we ons tot de waarde van de sling in vergelijk met de andere behandelingen van post-prostatectomie SUI.

De sling wordt gepositioneerd op het niveau van de bulbaire urethra, middels een retropubische of transobturatoire benadering. Er zijn slings op de markt die peroperatief worden gefixeerd en slings waar bij de spanning postoperatief nog aanpasbaar is.

Met de gefixeerde slings wordt de urethra gepositioneerd naar een meer proximale positie, zonder dat daarbij het sfinctermechanisme wordt beïnvloed.

De aanpasbare slings bieden de mogelijkheid om postoperatief de uiteinden van de sling aan te trekken of een kussen onder de urethra in meer of mindere mate op te blazen. De druk op de urethra is dus aanpasbaar.

In de praktijk wordt de artificiële sfincter toegepast voor matige tot ernstige SUI, daar waar de slings meestal worden gereserveerd voor milde tot matige SUI. Bulkmateriaal en ook plaatsing van compressieve ballonnen wordt met name verricht voor milde SUI. Echter de definities van milde en matige incontinentie lopen sterk uiteen.

1. Effect/recovery of SUI-complaints (critical)

2. Subjective improvement (critical)

3. Quality of life (important)

4.1 Adverse events - infection

4.2 Adverse events - erosion

4.3 Adverse events - retention

Male sling versus bulking agents; PRO-ACT

5.1 Adverse events - infection

Results

1. Effect/recovery of SUI-complaints (critical)

Abrams (2021) reported on effect/recovery of SUI-complaints using the 24-hour pad-test, reporting on pad weight in grams. In the male sling-group (n= 50), mean pad weight after 24 hours was 30.0 gram (SD[1] 85.3). In the AUS group (n= 44), mean pad weight after 24 hours was 73.7 gram (SD 451.6). Analysis resulted in a mean difference of -43.70 gram (95% CI -179.22 to 91.82).

Lin (2022) reported on effect/recovery of SUI-complaints using the number of pads as indication for success (success, yes/no defined by ≤1 pad per day at follow-up). Five studies contributed to this outcome (Hoy, 2014; Lim, 2014; Kim, 2018; Khouri, 2020; and Sacco, 2020). In the groups receiving slings, 220 out of 295 patients were cured of their SUI-complaints. In the groups receiving AUS, 180 out of 214 participants were cured. Pooling the results using a random effect model led to an odds ratio of 0.61 (95% CI 0.34 to 1.11). Results are depicted in figure 1.

Figure 1: The effect of male-sling on number of pads.

Z: p-value of the pooled effect; df: degrees of freedom; I2: statistic heterogeneity; CI: confidence interval.

2. Subjective improvement (critical)

Abrams (2021) reported on subjective improvement using the International

Consultation of Incontinence Questionnaire (ICIQ, range 0-21, higher scores indicate more severe UI). In the male sling-group (n= 151), the mean difference at 12 months was 8.7 (SD 0.6.1). In the AUS-group (n= 153), the mean difference was 7.5 (SD? 5.3). The adjusted mean difference was 1.4 (95% CI 0.2 to 2.6). This difference was not clinically relevant.

3. Quality of life (important)

Abrams (2021) reported on quality of life using the EQ-5D (range 0-100, higher scores indicate higher quality of life). In the male sling-group (n= 151), the mean difference at 12 months was 0.809 (SD 0.260). In the AUS-group (n= 158), the mean difference was 0.813 (SD 0.274). The adjusted mean difference was -0.019 (95% CI -0.062 to 0.024). This difference was not clinically relevant.

4. Adverse events (important)

4.1 Infection

In the study by Abrams (2021), one participant in the sling-group developed urosepsis, and three participants in the AUS group developed an infection.

In the study by Alwaal 2016), 30-day complications including separate amounts of surgical site infections were reported. In the patients receiving sling (n= 597), 6 (1%) developed a surgical site infection. In the patients receiving AUS (n= 608), 7 (1.2%) developed a surgical site infection. Comparing sling to AUS, this resulted in an odds ratio of 0.87 (95% CI 0.29 to 2.61).

In the study by Chughtai (2016), infection after 90 days including kidney infection, UTI or cystitis, post-operative infections and wound infections were reported. In the patients receiving sling (n= 453), 26 (5.7%) developed an infection. In the patients receiving AUS, n= 436), 40 (9.2%) developed an infection, and in the patients receiving injections with bulking material (n= 357), 19 (5.3%) developed an infection. Comparing slings to AUS, odds ratio for infection was 0.60 (95% CI 0.36 to 1.01). Comparing slings to bulking material, odds ratio for infection was 1.08 (95% CI 0.59 to 1.99).

In the study by Kretschmer (2017), adverse events including postoperative infections within the first 6 months were reported. In the patients receiving sling (n=113), 4 (3.5%) developed postoperative infection. In the patients receiving AUS (n= 120), 8 (6.7%) developed postoperative infection. Comparing sling to AUS, this resulted in an odds ratio of 0.51 (95% CI 0.15 to 1.76).

Lin (2022) reported on infection pooling the results of four studies (Hoy, 2014; Lim, 2014; Kim, 2018; and Sacco, 2020). In the groups receiving slings, in 8 out of 181 patients infection was reported. In the groups receiving AUS, in 10 out of 149 patients infection was reported. Pooling the results using a random effect model led to an odds ratio of 0.65 (95% CI 0.16 to 2.67). Results are depicted in figure 2.

Figure 2: The odds ratio on infection for sling versus AUS

Z: p-value of the pooled effect; df: degrees of freedom; I2: statistic heterogeneity; CI: confidence interval.

4.2 Erosion

In the study by Abrams (2021), one participant in the sling-group developed mesh erosion, and in three participants in the AUS group erosion of the device was reported.

Lin (2022) reported on erosion pooling the results of four studies (Hoy, 2014; Lim, 2014; Kim, 2018; and Sacco, 2020). In the groups receiving slings, in 5 out of 181 patients infection was reported. In the groups receiving AUS, in 11 out of 149

patients infection was reported. Pooling the results using a random effect model led to an odds ratio of 0.48 (95% CI 0.17 to 1.37). Results are depicted in figure 3.

Figure 3: The odds ratio on erosion for slings versus AUS

Z: p-value of the pooled effect; df: degrees of freedom; I2: statistic heterogeneity; CI: confidence interval.

4.3 Retention

In the study by Abrams (2021), one participant in the AUS group reported urinary retention.

In the study by Kretschmer (2017), adverse events including postoperative urinary retention within the first 6 months was reported. In the group receiving sling (n= 113), 11 (9.7%) participants developed urinary retention post-surgery. In the group receiving AUS (n= 120), 13 (10.8%) developed urinary retention post-surgery. Comparing sling to AUS, this resulted in an odds ratio of 0.89 (95% CI 0.38 to 2.07).

Lin (2022) reported on retention pooling the results of four studies (Hoy, 2014; Lim, 2014; Kim, 2018; and Sacco, 2020). In the groups receiving slings, in 18 out of 181 patients infection was reported. In the groups receiving AUS, in 4 out of 149 patients infection was reported. Pooling the results using a random effect model led to an odds ratio of 2.46 (95% CI 0.31 to 19.45). Results are depicted in figure 4.

Figure 4: The odds ratio on retention for slings versus AUS

Z: p-value of the pooled effect; df: degrees of freedom; I2: statistic heterogeneity; CI: confidence interval.

Level of evidence of the literature

1. Effect/recovery of SUI-complaints (critical)

The level of evidence regarding the outcome measure effect/recovery of SUI-complaints started as low because it was partly based on observational studies and was downgraded by one level to very low because of the confidence interval crossing a border of clinical decision making (-1, imprecision).

2. Subjective improvement (critical)

The level of evidence regarding the outcome measure incontinence episodes started as high because it was based on an RCT and was downgraded by two levels to low because of lack of blinding and patient reported outcome (-2, risk of bias); and a small number of participants (-1, imprecision).

3. Quality of life (important)

The level of evidence regarding the outcome measure incontinence episodes started as high because it was based on an RCT and was downgraded by two levels to low because of and lack of blinding and patient reported outcome (-2, risk of bias); and a small number of participants (-1, imprecision).

4. Adverse events/complications (important)

4.1 Infection

The level of evidence regarding the outcome measure infection started as low because it was based on observational studies and was downgraded by one level to very low because of the confidence interval crossing borders of clinical decision making (-1, imprecision).

4.2 Erosion

The level of evidence regarding the outcome measure erosion started as low because it was based on observational studies and was downgraded by one level to very low because of the confidence interval crossing a border of clinical decision making (-1, imprecision).

4.3 Retention

The level of evidence regarding the outcome measure retention started as low because it was based on observational studies and was downgraded by one level to very low because of the confidence interval crossing a border of clinical decision making (-1, imprecision).

A systematic review of the literature was performed to answer the following question: What is the effectiveness and safety of male sling in men with post-prostatectomy stress urine incontinence, compared with bulking material, artificial urinary sphincter (AUS) or PRO-ACT?

P: Men with stress urine incontinence after radical prostatectomy.

I: Male sling.

C: Bulking agents; PRO-ACT; artificial urinary sphincter (AUS).

O: Effect/recovery of SUI-complaints (objective, e.g. pads) subjective improvement, quality of life, adverse events, long term results (explantation/revision).

Relevant outcome measures

The guideline development group considered effect/recovery of SUI-complaints and subjective improvement as a critical outcome measure for decision making; and as an important outcome measure for decision making.

A priori, the working group defined adverse events as retention, complicated infections (material-related) and erosion. For other outcomes, the working group did not define the outcome measures listed above but used the definitions used in the studies.

The working group defined the following minimal clinically (patient) important differences:

Subjective improvement:

• • Urinary Distress Inventory (UDI-6, 0-100): ≥ 33.33 (Skorupska, 2021)
  • International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF, 0-21): ≥ 5 at 12 months, ≥ 4 at 24 months (Sirls, 2013)
  • The overactive bladder questionnaire (OAB-q, 0-100): ≥ 10 points (Coyne, 2006)
  • The overactive bladder quality of life short-form questionnaire (OAB-q SF, 0-100): ≥ 11 points (Blanker, 2019)

In all other cases, the working group defined the GRADE-standard limit of 25% difference for dichotomous outcomes (RR < 0.8 or > 1.25), and 0.5 SD for continuous outcomes as a minimal clinically (patient) important difference.

Search and select (Methods)

The databases Medline (via OVID) and Embase (via Embase.com) were searched with relevant search terms from 2010 until June 6^th  2022. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 285 hits. Studies were selected based on the following criteria:

• Systematic review (searched in at least two databases, and detailed search strategy, risk of bias assessment and results of individual studies available), randomized controlled trial or observational study comparing male sling with bulking agents; PRO-ACT; artificial urinary sphincter (AUS);
• Patients aged ≥ 18 years;
• Full-text English language publication;
• Studies including ≥ 20 (ten in each study arm) patients; and
• Studies according to PICO.

A total of 27 studies were initially selected based on title and abstract screening. After reading the full text, 22 studies were excluded (see the table with reasons for exclusion under the tab Methods), and five studies were included (Abrams, 2021, Alwaal, 2016; Chughtai, 2016; Kretschmer, 2017 and Lin, 2022).

Results

Five studies were included in the analysis of the literature (Abrams, 2021; Alwaal, 2016; Chughtai, 2016; Kretschmer, 2017; Lin, 2022). Important study characteristics and results are summarized in table 1 and the evidence tables. The assessment of the risk of bias is summarized in the risk of bias tables.