Adjustable Continence Therapy Balloons in Female Patients with Stress Urinary Incontinence: A Systematic Review.

INTRODUCTION: The aim of this study was to perform a systematic review of studies reporting the outcomes of ACT® balloons in female patients with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). METHODS: In accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) standards, a systematic search of the PubMed (Medline) and Scopus electronic database was performed in June 2022. Terms used for the query were ("female" or "women") and ("adjustable continence therapy" OR "periurethral balloons"). RESULTS: Thirteen studies were included. All were retrospective or prospective case series. The success rates ranged from 13.6% to 68% and the improvement rates from 16% to 83%. The intraoperative complication rate ranged from 3.5 to 25% and consisted of urethral, bladder, or vaginal perforations. The rate of postoperative complications varied from 11 to 56% without major complications. Between 6% and 38% of ACT® balloons were explanted and subsequently reimplanted in 15.2-63% of cases. CONCLUSION: ACT® balloons can be considered as an option to treat SUI due to ISD in female patients with a relatively modest success rate and quite a high complication rate. Well-designed prospective studies and long-term follow-up data are needed to fully elucidate their role.

Single center experience and long-term outcomes of implantable devices ACT and Pro-ACT (Uromedica, Irvin, CA, USA) - Adjustable continence Therapy for treatment of stress urinary incontinence.

PURPOSE: In this study, we aimed at evaluating the long-term adjustable peri-urethral balloons (PUB) durability in both male and female with neurogenic or non-neurogenic stress urinary incontinence. MATERIAL AND METHODS: Each consecutive patient who underwent surgery for PUB placement before 2008 was included in this study. A PUB was proposed for patients with refractory to perineal reeducation stress urinary incontinence (SUI) caused by intrinsic sphincter deficiency. There were no exclusion criteria. Demographic, clinical and perioperative data were collected retrospectively from our clinical follow-up notes. RESULTS: A total of 177 patients were included in the study. Median [IQR] follow-up was 5 years [1.8-11.2]. The 3 main causes of SUI were radical prostatectomy (n=82, 46.3%), idiopathic intrinsic sphincter deficiency (n=55, 31.1%) and neurogenic sphincter deficiency (n=32, 18.1%). Complete continence (no pad necessary) was achieved for 109 patients (61.6%). At the end of the follow-up, the PUB global survival rate was 47.5% (Fig. 1). Median [IQR] PUB survival without removal was 57.8 months [42.3-81.7]. PUB survival without failure rate was 68.4% accounting for a median [IQR] survival duration of 116.9 months [86.2-176.9] CONCLUSION: In this study, we evidenced acceptable long-term efficiency and survival of PUB in the management of SUI in both neurogenic and non-neurogenic population. Given those results it could be a good alternative to AUS on unfit or unwilling population.

What if artificial urinary sphincter is not possible? Feasibility and effectiveness of ProACT for patients with persistent stress urinary incontinence after radical prostatectomy treated by sling.

BACKGROUND: Stress urinary incontinence (SUI) is a major component of the post radical prostatectomy (RP) trifecta. Surgical treatments are sub-urethral slings, artificial urinary sphincter (AUS) and adjustable peri-urethral balloons (PUB) ProACT. All options are imperfect at best and persistent SUI is challenging when AUS is not manageable. AIMS: This study analyzed the cumulate experience of our 2 centers with offering PUB implantation for SUI post RP in patients with insufficient improvement from slings. MATERIALS & METHODS: This retrospective study reviewed all patients implanted with second line ProACT. The primary endpoint was continence, defined as 0 pads per day (PPD). The secondary endpoints were 50% decrease in PPD and increases in the Incontinence Quality of Life score (IQOL). Refilling and complications were reported. RESULTS: Between 2007 and 2016, 26 patients were implanted. Five patients have had adjuvant radiotherapy (18%). The mean follow-up was 36 months (±20; min 14-max 128). All patient presented with persistent SUI, using 2.3 PPD (±1; min 1-max 6), and only one sling was removed due to infection. After ProACT with an average 3 mL refilling (±1.2 min 2-max 6), 18 patients (66.7%) were continent. Eight of the remaining patients (29.6%) were improved; their number of PPD decreased from 2.6 to 1. The average IQOL score of those 8 patients increased by 20 points, from 53.4 up to 74.2 (P = .005). Overall 26 patients (96.3%) were improved. The remaining patient was not implanted because of an intraoperative urethral injury and is considered a failed case (3.7%). He had instead an AUS implantation. Three patients (14.8%) needed PUB replacement. CONCLUSION: The limited population of patients from both our centers who presented with persistent SUI after RP, despite sling placement, improved with PUB ProACT implantations without significant complications.

[Pro-ACT™ device implantation efficiency in second line treatment of post-radical prostatectomy urinary incontinence after sub-urethral male sling failure]. / Efficacité des ballons Pro-ACT™ dans le traitement de seconde ligne de l'incontinence urinaire d'effort post-prostatectomie après échec des bandelettes sous-urétrales.

INTRODUCTION AND OBJECTIVES: The periurethral adjustable balloons (PUAB) Pro-ACT™ are less invasive technique to treat non-severe forms of post-radical prostatectomy urinary incontinence (pRP-UI), like sub-urethral trans-obturator male sling. Few data of efficiency are available for their use in second line treatment after male sling failure. OBJECTIVE: To evaluate the efficiency of PUAB Pro-ACT™ (Uromedica, Inc., MN, USA) in the second line treatment for non-severe pRP-UI after male sling failure. MATERIALS AND METHODS: Single center retrospective study of patients treated with male sling (17 Advance™, 1 TOMS™) between 2009 and 2015. The continence results were evaluated by the number of pad per day and the quality of life assessment by the I-QOL questionnaire. The "cure" was defined as no pad and "improved" as decreased more than 50 % of pads use. RESULTS: Eighteen patients were included with median follow-up of 21.5 [14-44] months. Two patients (11.1 %) had a past history of pelvic radiotherapy. The median pads per day used was 2 [1-3] after male sling insertion and before Pro-ACT™ device insertion. After Pro-ACT™ device insertion, the median pads per day used was 0 [0-1], with 77.7 % of patients cured and 22.2 % improved. The median quality of life score I-QOL, was 52.2 [23.3-62.6] and 83 [31.8-97.7], respectively before and after Pro-ACT™ device insertion (P<0.001). Nine (60 %) patients rated their incontinence severity as mild, four (26.6 %) as middle and two (13.3 %) as severe, after balloon insertion. The median volume of adjustment was 3 [2-6] mL. CONCLUSIONS: The PUAB Pro-ACT™ have a significant efficiency for use after male sling failure and can be used in second line therapy. LEVEL OF EVIDENCE: 3.

[Rigid cystoscopy versus retrovision for adjustable peri-urethral balloons guidance: Comparison of precision thanks to a surgical navigation system]. / Cystoscopie rigide versus rétro-vision pour le guidage des ballonnets péri-urétraux : comparaison de la précision grâce à un système de navigation chirurgicale.

OBJECTIVES: The main goal of our phantom study was to compare the precision of adjustable periurethral balloons positioning depending whether the guidance was obtained by retrovision or rigid cystoscopy. MATERIAL AND METHODS: A navigation guidance system was used to localize the introduction mandrel which was equipped with tracking targets. Two ideal sites of implantation were predefined and recorded into the navigation system. The two points were placed symmetrically to the phantom reproducing the urethra. Four different users were asked to position the tip of the introduction mandrel as close as possible to the ideal site of implantation with the help of each method of guidance. For each attempt, the distance (mm) between the tip of the introduction mandrel and the ideal position was recorded by the navigation system. RESULTS: For each method of guidance, a total of 20 attempts on each side were made by direct puncture on one side and a symmetrical contralateral puncture. For direct puncture, the median distances were 5.20 (±3.96) and 4.38 (±1.55) mm with rigid cystoscopy and retrovision respectively (P=0.29). For symmetrical contralateral puncture, the median distance were 7,19 (±3,78) and 6,86 (±2,76) mm with rigid cystoscopy and retrovision respectively (P=0,32) CONCLUSION: This study could not demonstrate any significant difference between the two guidance systems. Nevertheless, it showed that navigation guidance system could be used to compare the precision of surgical interventions. LEVEL OF EVIDENCE: 4.

Combined Implantation of a Penile Prosthesis and Adjustable Continence Therapy ProACT in Patients with Erectile Dysfunction and Urinary Incontinence after Radical Prostatectomy: Results of a Prospective Pilot Study.

INTRODUCTION: The treatment of postradical prostatectomy erectile dysfunction (post-RP-ED) and stress urinary incontinence (post-RP-SUI) may require the combined implantation of a penile prosthesis and incontinence surgery. However, there is a lack of consensus regarding which incontinence surgery should be associated with a penile implant. AIMS: To evaluate the combined implantation of a penile prosthesis and the adjustable continence therapy ProACT in patients with post-RP-ED and post-RP-SUI. METHODS: We implanted the ProACT device and a penile prosthesis synchronously (n = 6) and asynchronously (n = 4) in 10 patients with moderate post-RP-SUI and severe post-RP-ED. We evaluated the effects on urinary incontinence using the ICIQ and PGI-I scores and pad use. We evaluated the effect on sexual function using the EHS and Global Assessment Questionnaire (GAQ), and we evaluated satisfaction with the penile prosthesis on a 5-point scale. Postoperative pain associated with each procedure was evaluated by a numeric rating scale. RESULTS: No cases of urinary retention or prosthesis infection were observed. Postoperative pain was mainly related to penile prosthesis implantation. After a mean follow-up of 22.7 ± 20.9 months (range: 6-53), significant improvements of the ICIQ score (15.3 ± 3.7 vs. 4.7 ± 2.3, P < 0.001) and pad use per day (2.8 ± 1.2 vs. 0.3 ± 0.5, P < 0.001) were observed compared with baseline. According to the PGI-I questionnaire, eight patients described a very much improved (n = 6) or much improved (n = 2) urinary condition. All patients declared an EHS = 4 with the use of penile prosthesis; all patients were very satisfied (n = 6) or satisfied (n = 4) with their penile prosthesis. All patients answered the GAQ positively. CONCLUSION: The combined implantation of a Pro-ACT device and penile prosthesis represents a feasible therapeutic option in patients with post-RP-SUI and post-RP-ED. The absence of postoperative pain associated with the ProACT procedure may represent the main interest in this therapy.

[Intrinsic sphincter deficiency and female urinary incontinence]. / Insuffisance sphinctérienne et incontinence urinaire de la femme.

OBJECTIVE: Stress urinary female incontinence (SUI) is primary due to intrinsic sphincter deficiency (ISD) and urethral hypermobility. Despite a lack of standardised international definition, ISD needs to be clearly diagnosed in order to be correctly treated. This work is an update about the female ISD produced from a review of a published article. MATERIAL AND METHODS: This review of article published on this subject in the Medline (Pubmed database), selected according to their scientific relevants, of consensus conferences and published guidelines, has been performed by the committee for women pelvic floor surgery of the French Urological Association. RESULTS: Although there is no international consensus definition, we can consider that the ISD is a composite concept combining urodynamic data (MUCP < 20 or 30 cmH20) and one or more clinical information (no urethral mobility, negative urethral support test, failure of a first surgery, leakage during abdominal straining, high stress incontinence scores). Imaging can provide additional evidence for intrinsic sphincter deficiency diagnosis, but the correlation between imaging and function remains low. By standardizing methodology and interpretations to better diagnose women with ISD, it may be possible to improve preoperative planning and outcomes for these patients. A retropubic midurethral sling can be performed as a first surgery. In case of a lack of urethral mobility, the artificial urinary sphincter (AUS) remains the gold standard. Adjustable continence therapy (ACT(®)) can be proposed as an alternative option. The efficacy and safety of muscle-derived cell therapy in ISD needs more studies. Injection of bulking agents may be an option according to the severity and the expectations of the patient. Bladder overactivity needs to be treated as first-line in case of mixed urinary incontinence. In elderly women, a careful evaluation of the bladder contractility and comorbidity must be performed. A geriatric evaluation can be necessary. CONCLUSION: Clinical and paraclinical assessment allow to confirm the diagnosis of female ISD, to estimate its severity, and to identify associated mechanisms of incontinence (urethral hypermobility, bladder overactivity) to choose the most adapted treatment.

[Initial results of adjustable periurethral balloons (ACT™ and pro ACT™) in the treatment of adult stress urinary incontinence with intrinsic sphincter deficiency]. / Résultats initiaux de l'utilisation des ballons périurétraux ajustables (ACT™ et pro ACT™) dans le traitement de l'incontinence urinaire d'effort par insuffisance sphinctérienne de l'adulte.

OBJECTIVE: To report efficacy and morbidity of periurethral adjustable balloons (PUAB) in the treatment of stress urinary incontinence (SUI) with intrinsic sphincter deficiency (ISD). PATIENTS AND METHODS: Retrospective descriptive and analytic patients cohort study was performed from July 2010 to June 2012. We reviewed data from 43 patients (19 women and 24 men). The patients were categorized into 3 groups: i) women, ii) men after prostatectomy, iii) men with neurogenic SUI (prostate in position). Sandvick score and the average of 3 days 24 h Pad test evaluated the efficacy of the device. The patients impression of improvement was assessed in three degrees: completely improved, partially improved, not improved. RESULTS: After a median follow-up of 67 weeks (min. 40, max. 91) a significant improvement of the score of Sandvik was observed (8 to 4, P<0.005). The proportion of dry patients or with one security protection in the three groups was 57.9%, 64.3% and 50% respectively for women, men after prostatectomy, and men with neurological SUI. About 27.9% (12/43) of the patients had post-operative complications. These complications required an explantation of the PUAB in 11/12 patients among whom 7/11 (63.6%) had a delayed re-implantation of the device. CONCLUSION: In this series, the overall efficacy observed was 67.4% with a post-operative complication rate of 27.9%. The device adjustment was done in consultation as well as the complications management and the explantation when necessary. LEVEL OF EVIDENCE: 4.

Dual balloon adjustable continence therapy for urinary incontinence.

Dual balloon adjustable continence therapy (DBACT) has emerged as a promising option for treating stress urinary incontinence. DBACT is a minimally invasive and easily reversible procedure in which two periurethral balloons are placed just distal to the bladder neck to increase bladder outflow resistance. The device is connected to a small titanium port placed under the scrotal or labial skin. The port is used for adjustment to balloon volume in the clinic setting, allowing for refinement and optimization of urinary continence. DBACT placement is typically performed under general anesthesia and is considered an outpatient procedure. Several studies have evaluated the effectiveness of DBACT in treating urinary incontinence, and the results are promising. DBACT was effective in 91% of patients who underwent the procedure, 80% reported a significant improvement in their symptoms, and 70% reported being completely dry after the procedure. DBACT is a safe procedure with few reported complications. The most common complication is mild pain or discomfort at the site of device placement, which usually resolves within a few days. Overall, DBACT is minimally invasive, adjustable, and highly successful in restoring urinary continence.

Evaluation of Benefits and Harms of Surgical Treatments for Post-radical Prostatectomy Urinary Incontinence: A Systematic Review and Meta-analysis.

CONTEXT: No meta-analysis has comprehensively addressed both benefits and harms, or the certainty of evidence of the implantable continence devices used in men to treat postprostatectomy urinary incontinence (PPI). OBJECTIVE: To evaluate the benefits and harms of surgical treatments for patients suffering from PPI and assess the certainty of evidence. The primary benefit was cure (one or fewer pad per day), and the primary harm was reoperations defined by surgical procedures following implantation. EVIDENCE ACQUISITION: We perform a search of Medline, PubMed, Embase, Cochrane Library, and gray literature. We included observational studies addressing PPI surgical interventions if they involved cohorts of ≥50 participants. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach provided the framework for certainty of evidence assessment informed by value and preference judgments provided by patients, and an advocacy group member (Canadian Cancer Society). EVIDENCE SYNTHESIS: Of 85 observational studies involving 13 100 patients, three addressed bulking agents, 35 male synthetic slings, ten adjustable continence therapies (ACTs), and 37 artificial urinary sphincters (AUSs). Cure was 26.1% (95% confidence interval [CI]: 10.6-51.4, I2 = 92.8%, very-low-quality evidence) for bulking agents, 58.6% (95% CI: 51.3-65.5, I2 = 89.1%, low-quality evidence) for slings, 63.2% (95% CI: 57.6-68.5, I2 = 22.5%, very-low-quality evidence) for ACT, and 74.0% (95% CI:61.2-83.7, I2 = 92.1%, very-low-quality evidence) for AUS. Estimated rates of reoperation were 5.8% (95% CI: 1.9-11.6, I2 = 94.1%, moderate-quality evidence) for slings, 23.8% (95% CI: 5.9-61.0, I2 = 95.5%, low-quality evidence) for ACT, and 22.2% (95% CI: 15.2-31.3, I2 = 92.3%, high-quality evidence) for AUS. CONCLUSIONS: Available evidence regarding the benefits of surgical interventions for PPI remains mainly uncertain while suggesting important harms. These results should guide consent procedures for PPI surgery in the context of shared decision-making, with disclosure of the uncertainty of evidence. PATIENT SUMMARY: Despite being used worldwide, available evidence regarding the benefits of surgeries to treat postprostatectomy urinary incontinence remains mainly uncertain while suggesting important harms. This highlights the need for a more rigorous evaluation process for commercially available surgical devices.