Adjustable Continence Therapy Research Articles

Adjustable continence therapy (ProACT/ACTTM) with periurethral balloons for treatment of stress urinary incontinence: a narrative review.

First-line surgical management of stress urinary incontinence (SUI) currently involves implantation of an artificial urinary sphincter (AUS) in male patients and midurethral sling in female patients. Still, there is demand for a less invasive treatment option without the need to use a device during voiding. Since its first description in 2005, many clinics have implemented adjustable continence therapy balloons in male (ProACTTM) and female patients (ACTTM). Publications on the use of ProACT/ACTTM were reviewed from 2002 until September 2022, focusing on functional and safety outcomes, including predictors of treatment failure and complications. Most publications report the use of ProACTTM in patients after prostate surgery, with approximately 60% experiencing a cure rate and 82% achieving over 50% improvement. Consistent functional outcome assessment in female and neurogenic lower urinary tract dysfunction (NLUTD) patients lacks. Few predictors of treatment failure were described, resulting in an advise to not use the balloons after male pelvic radiation therapy. High revision rates were observed in all patient groups, with balloon defects as one of the most common causes for revision. Based on the current literature, ProACTTM is safe and effective in male patients after prostate surgery, but the role of ProACT/ACTTM in female and NLUTD patients is still unclear. There is need for research of higher level of evidence with uniform outcome assessments. Preferably, ProACTTM is prospectively compared with AUS in a randomized setting. In addition, development of better-quality balloons should reduce mechanical failure and revision surgeries, resulting in improved functional and patient satisfaction outcomes.

Initial experience with ACT™ periurethral adjustable balloons to treat urinary incontinence due to intrinsic sphincter deficiency in the pediatric population.

To present our initial experience with periurethral adjustable continence therapy (ACT™) for urinary incontinence due to intrinsic sphincter deficiency (ISD) in children. This is an approved prospective non-randomized pilot study (NCT03351634) aiming to treat children born with spinal dysraphism (SD) or exstrophy epispadias complex (EEC) with ACT™. Endpoints were patient-reported changes in daily pad count, 24-h Pad test and complications. Since April 2018, 13 children (six girls, seven boys) were implanted at the median age of 12years (5-16). The etiology of incontinence was neurogenic ISD (7/13, 54%) and EEC (6/13, 46%). After ACT™ implantation, continence (no pad or 1 security pad/day) was achieved in 9(69%) patients (5/7 SD, 4/6 EEC). Additionally, two (15%) patients had a significant improvement (decreasing Pad test from 1049 to 310g at 3months). One patient (7%) had no improvement. Results were stable at 21months (6-43) of follow-up. Mean final balloon volume was 2.89ml (± 0.85) with a median of 3 fillings to obtain continence. We had four revisions due to cutaneous port erosion (n = 3) and balloon migration (n = 1) and two definitive explantations. PinQ score was significantly improved (47 vs 40.5 with balloon, p = ns). Neither degradation of the upper urinary tract nor cystomanometric changes have been observed at 6 and 12months postoperatively. Urinary incontinence due to ISD owing to EEC or SD can be successfully treated with ACT™ periurethral balloons. Given the minimal invasiveness of this therapy, it might be a first-line option treatment in children with complex stress urinary incontinence.

Adjustable continence therapy (proACT) for the treatment of male stress urinary incontinence post-prostatectomy: a systematic review and meta-analysis (2023 update).

Stress urinary incontinence (SUI) is a key factor for post-prostatectomy (RP) quality of life. Current international guidelines struggle to find the adequate place for each kind of surgeries. The aim of this systematic review and meta-analysis considering updated evidence is to assess the efficacy and safety of proACT in treating male patients with post-RP SUI. A review of the literature was performed by searching the PubMed database. We narrowed included studies with adult male patients with SUI; outcomes included pads or pad weight per day and quality of life (QOL) questionnaires, as well as safety outcomes. 18 studies involving 1570 patients mean age of 68.8 (EC 2.1) were included. The mean follow-up reported was 34.7months (EC 17.7; median 38.5; range 1-128months). An average of 60.7% (EC 27) and 40.4% of patients suffered from mild-to-moderate and severe incontinence, respectively. The overall dryness rate was 55.1% (EC 19.3) while respecting the definition of 0-1 pads per day, and the mean dryness rate was 53% (EC 0.2). The mean overall complication rate was 31.2% (EC 18.3%), including an explantation rate of 26.5% (EC 15.3) and a reoperation rate of 22.7% (EC 8.7). The methodological quality of the 18 studies was very heterogeneous. Implantation of proACT adjustable balloons is a minimally invasive technique that provides medium outcomes (53%) with a strict definition of dryness (0-1 PPD) and important complication rate (31.2%). Past of irradiation is a negative predictive factor for incontinence.

Pro-Act substitution for mechanical rupture of the periurethral balloon: Step-by-step surgical education video

Stress urinary incontinence (SUI) is a feared complication after radical prostatectomy because it impacts on the quality of life and determines a high rate of emotional distress (Nash et al., 2018 [1]).When the conservative approach in terms of behavioral, physical (pelvic-floor rehabilitation) and pharmacological treatments fails, a surgical management is usually recommended to treat the post-prostatectomy stress urinary incontinence.The Adjustable Continence Therapy prosthesis (Pro-ACT) is a postoperatively adjustable device that aims to achieve optimal outlet resistance by progressively increasing the volume of the periurethral balloons.Furthermore, in case of mechanical rupture or balloon leakage it can be easily substituted (removed and reimplanted) in centers with experience (Finazzi Agrò et al., 2019 [2]).In this video we present the clinical case of a male patient who had undergone PRO-ACT implantation about 10 years ago. Due to the right balloon leakage, its substitution was indicated and performed under ultrasound guidance (Gregori et al., 2010 [3]).The aim of the current manuscript is to provide a description of the surgical technique. The related video shows the technique as a set of simple steps that make the surgical procedure safe and reproducible.

Single centre 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.

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. 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. 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.

Single centre 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

Single centre 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

Adjustable Continence Therapy (ACT®) balloons to treat female stress urinary incontinence: effectiveness, safety and risk factors of failure and complication.

To assess the effectiveness, safety and risk factors of failure and complications associated with Adjustable Continence Therapy (ACT®) balloons as a treatment for female stress urinary incontinence (SUI). In the present multicentric retrospective study, all women implanted with ACT® balloons between 2000 and 2018 were considered eligible. Effectiveness and safety were assessed at 1 year, and risk factors for failure and complications were sought. The effectiveness was categorized into three distinct groups: Success = maximum 1 pad/day and patient's impression of improvement using a numerical rating scale (NRS) ≥ 8/10; Improvement = decrease of daily pad use and NRS ≥ 5/10; Failure = increase or stability of daily pad use or NRS < 5/10. The intra- and postoperative surgical complications were collected. Over the study period, 281 women were included. Among them, 104 (37.0%), 94 (33.5%) and 83 (29.5%) were categorized as success, improvement, and failure, respectively. Intra-, early and late postoperative complications occurred in 13 (4.6%), 35 (12.5%) and 75 (26.7%) women, respectively. Most early surgical complications were minor according to the Dindo-Clavien classification. Of women that presented a late postoperative surgical complication, 64 (22.8%) underwent an explantation performed under local or general anesthesia without associated sequalae. The short-term effectiveness associated with ACT® balloons, their minimally invasive implantation and the frequent but easily manageable and sequelae-free complications suggest that they should be part of the therapeutic arsenal for female SUI.

Adjustable continence balloons in postprostatectomy incontinence: Outcomes and complications.

The objective of this study was to assess the mid-term efficacy and safety of adjustable continence therapy (ProACT™) for the treatment of male stress urinary incontinence (SUI) after radical prostatectomy (RP). Single-center retrospective study including male patients implanted with ProACT™ periurethral balloons for SUI after RP between 2007 and 2017, mainly with flexible cystoscopic guidance. Efficacy was assessed using a composite endpoint with subjective (patient's impression of improvement (PII), using a 0-100 numeral rating scale) and objective outcomes (decrease in daily pad use). Postoperative success was defined as a PII ≥ 80%, associated with the use of 0-1 pad daily. Improvement was defined as a PII ≥ 50% and a decrease ≥50% in the number of daily pads used. Two hundredmen with a median age of 68 (64-73) years were included. Seventeen percent(n = 34) had had prior radiotherapy and 15.5% (n = 31) had had prior SUI surgery. The median follow-up was 43 (19-71) months. The severity of SUI was as follows: mild in 119 (59.5%), moderate in 48 (24%), and severe in 33 patients (16.5%). Severe SUI and a history of prior radiotherapy were associated with a lower success rate (p = 0.033 and p < 0.0001). The overall reoperation rate was 34%, with 5.6% (n = 11) requiring a third implantation. Of the patients,29.4% (n = 58) required an artificial urinary sphincter to treat SUI. At the last follow up, among the overall population, the success rate was 40.1% and the median PII was 18.3%. For patients in whom the balloons were still in place (n = 132), the cumulative success and improvement rate was 78%, with a median PII of 72%. The minimally invasive ProACT™ device provides a clear beneficial continence outcome in patients with SUI after radical prostatectomy. Severe SUI or prior radiotherapy were associated with a lower success rate in our study.

Long-term outcomes of polyacrylamide hydrogel treatment in women with stress urinary incontinence.

Long-term outcomes of polyacrylamide hydrogel treatment in women with stress urinary incontinence.

Adjustable continence therapy (ACT®) balloons to treat neurogenic and non-neurogenic female urinary incontinence.

To compare efficacy and safety between neurogenic and non-neurogenic women after adjustable continence therapy (ACT®) balloons implantation to treat stress urinary incontinence (SUI) due to intrinsic sphincter deficiency. In the present retrospective multicentric study, all neurogenic and non-neurogenic women implanted with ACT® balloons between 2000 and 2018 were considered for inclusion. Efficacy was compared 1 year after implantation, and women were allocated in three different groups as follows. Success: maximum 1 pad per day and patient's impression of improvement assessed using a numeral rating scale (NRS) ≥8/10. Improvement: decrease of daily pad use and/or NRS ≥5/10. Failure: increase or stability of daily pad use or NRS <5/10. Overall surgical complications and explantations were compared 1 year after implantation. Among the 277 included women, 51 presented with a neurologic underlying disease. Mean age at implantation was 68.5 years. There was no significant difference in efficacy between neurogenic and non-neurogenic women with a success rate of 39.2% and 36.3%, respectively (p = 0.69). Similarly, improvement rate was reported to be 31.4% and 33.6%, in neurogenic and non-neurogenic women, respectively (p = 0.92). The overall surgical complications rate (24% vs. 34.5%, p = 0.15) and the explantation rate (19.6% vs. 28.8%, p = 0.18) were not significantly different. ACT balloons may be proposed to treat mixed or SUI in females with ISD. Efficacy and safety profiles appear to be similar in both neurogenic and non-neurogenic patients.

MP52-19 ADJUSTABLE CONTINENCE THERAPY (ACT®) BALLOONS AND FEMALE URINARY INCONTINENCE: EFFICACY, SAFETY AND RISK FACTORS FOR FAILURE AND COMPLICATIONS

INTRODUCTION AND OBJECTIVE:Adjustable Continence Therapy (ACT®) balloons has been underused and often underestimated to treat urinary incontinence (UI) due to intrinsic sphincter deficiency (ISD) i...

P0105 - Adjustable Continence Therapy (ACT®) balloons: A comparison between neurogenic female urinary incontinence and non-neurogenic

P0105 - Adjustable Continence Therapy (ACT®) balloons: A comparison between neurogenic female urinary incontinence and non-neurogenic

Real-life outcomes after artificial urinary sphincter explantation in women suffering from severe stress incontinence.

Artificial urinary sphincter (AUS) implantation in female patients results in high satisfaction rates and high functional outcomes, but implantation can be challenging and explantation of the device is fairly common. The objective of this study was to review outcomes after AUS explantation in women. This is a retrospective, monocentric study of all women who underwent open or laparoscopic AUS implantation between November 1994 and July 2019, and patients with AUS explantation were included. Management after AUS explantation using descriptive analysis was assessed. Over a span of 26years, 111 women had an AUS implanted by a single surgeon. Of these surgeries, 35 explantations in 29 patients were later required: 20 initial AUSs, nine revised AUSs and six reimplanted AUS (rAUSs). The median time to explantation was 15.5month (± 0.55). After explantation, 13 rAUSs in 10 patients were successful and two attempts failed. The median time between explantation and rAUS was 8 months (± 0.95). At the last follow-up, five patients still had their rAUS and six rAUSs had required explantation after a median time of 6.5months (± 0.65). Surgery was still possible for 12 patients who did not have a rAUS: three cystectomies, one bladder neck closure with continent urinary diversion, and six mid-urethral slings or adjustable continence therapy balloon implantations. Among the 23 patients who did not need a cystectomy or a bladder neck closure with continent urinary diversion, four were completely dry (17.4%), 11 were improved (47.8%), and eight (34.8%) experienced unchanged incontinence with the post-explantation management. Limitations include retrospective design, heterogeneous management over time and a relatively small population of patients in our cohort. Reimplantation of an AUS after an explantation seems feasible after at least 6 months. However, the surgery will be more difficult and satisfaction is not guaranteed. Multicenter databases should be created to help surgeons and patients decide on appropriate management strategies after explantation of an AUS.

Étude de survie des ballonnets ACT®/proACT® : un nouveau message pour les patients

The main purpose was to assess the failure free survival of adjustable continence therapy ACT®/proACT® after continence was obtained and to seek factors influencing it. Retrospective, single-center survival study of peri-urethral balloons implanted between 2007 and 2014. Efficacy was defined by the wearing of 0 or 1 safety pad per day. The primary end point was time to failure estimated from a survival curve (Kaplan-Meier). Factors that could influence failure free survival were: sex, age, radiotherapy, diabetes, number of pad before surgery, number of balloon inflation, early complications, mixed urinary incontinence and previous ACT®/proACT® placement. They were analyzed in a COX regression. Of the 82 peri-urethral balloons placed, 41 were effective in 36 patients. The failure free survival was 50 % at 60 months. Radiotherapy, diabetes and previous peri-urethral balloon placement appeared to significantly decrease survival (P=0.031;P=0.025;P=0.029, respectively). Fifteen peri-urethral balloons were still effective at the last follow-up, one was lost to follow-up and 25 required re-intervention for loss of efficacy. The main cause of efficacy loss was system leakage. Fifty-two percent of peri-urethral balloons that became ineffective were replaced by new peri-urethral balloons and 28% by an artificial urinary sphincter. Patients who became continent with adjustable continence therapy (ACT®/proACT®) had a 50 % new surgery probability at 5 years for a loss of efficacy. Radiotherapy seems to be the main risk factor of the efficacy loss. IV.

Adjustable Continence Therapy (ACT) for the Treatment of Female SUI

Adjustable Continence Therapy (ACT) for the Treatment of Female SUI

Adjustable continence therapy (ProACT) for the treatment of male stress urinary incontinence: A systematic review and meta-analysis.

First, to evaluate the efficacy of adjustable balloon devices or adjustable continence therapy (ProACT) in the treatment for male stress urinary incontinence (SUI). Second, to investigate the safety profile and rates of adverse events associated with the implantation of adjustable balloon devices. A review of the literature was performed by searching the PubMed database with the most applicable search terms. We narrowed included studies with adult male patients with SUI; outcomes included pads or pad weight per day and quality of life (QOL) questionnaires, as well as safety outcomes. In total, 19 studies were included with a total of 1264 patients and 4517 patient-years of follow-up data (mean follow-up time 3.6 years). ProACT implantation resulted in an incontinence QOL improvement of 30.8 points from baseline. At baseline, patients on average were using 4.0 pads per day (PPD) (95% confidence interval [CI]: 2.6-5.4), which was reduced to an average of 1.1 PPD(95% CI: 0.5-1.7) after ProACT implantation. The number of patients that were considered "dry" was 60.2% (95% CI: 54.2%-65.9%) and the number of patients who were found to be either "dry" or improved greater than 50% was 81.9% (95% CI: 74%-87.8%). Implantation of adjustable balloon devices is efficacious and safe for the treatment of male SUI. Given the minimal invasiveness of the therapy, adjustable balloon devices may be a serious option as a first-line treatment in nonirradiated patients with SUI who are not ideal candidates for the artificial urinary sphincter.

Outcome and complications of adjustable continence therapy (ProACTTM ) in the treatment of urinary incontinence aftertransurethral resection of the prostate: A multicenter study.

AimTo evaluate the outcome of adjustable continence balloons in the treatment of stress urinary incontinence (SUI) after transurethral resection of the prostate (TURP).MethodsIn two tertiary centers, adjustable continence balloons were implanted in 29 patients with post‐TURP SUI between 2007 and 2018. Endpoints of this retrospective multicenter study were patient‐reported changes in pad count and complications. Dry was defined as no pad or one security pad.ResultsPreoperative urinary incontinence was mild in 7 (24%), moderate in 12 (41%), and severe in 10 (35%) patients. The median follow‐up duration was 21 (interquartile range [IQR], 11‐43) months. Within 30 days postoperatively, a Clavien‐Dindo grade less than or equal to II complication occurred in 24% of the patients. Reintervention rate was 24%. Six and 12 months after implantation, the International Prostate Symptom Score (IPSS) quality‐of‐life item improved significantly from 5 (IQR, 5‐6) preoperatively to 3 (IQR, 1‐4.5) and 1 (IQR, 0‐3), respectively. At last visit (median 21 months after implantation), the outcome on continence had improved in 76% of the patients, including, 45% dry patients. After a median follow‐up of 28 months (IQR, 13‐63; N = 23), all but one patient reported improvement on the Patient Global Impression of Improvement (PGI‐I) scale. In detail, 10 patients reported “very much better” condition compared with before the implantation, 10 patients “much better,” two patients “a little better,” and one patient “no change.” Daily pad use decreased from three (IQR, 2‐5) to one (IQR, 0‐2) pads/day (P < 0.001).ConclusionsThis is hitherto, the first study reporting results of adjustable continence balloons in the treatment of post‐TURP SUI. The therapy was found to be safe and efficient. The majority of our study population reported improvement on their condition and greater than or equal to 50% reduction in daily pad use.

Neurogenic stress urinary incontinence: is there a place for Adjustable Continence Therapy (ACT™ and ProACT™, Uromedica, Plymouth, MN, USA)? A retrospective multicenter study.

Retrospective cohort study. To assess the effectiveness and complications of treatment for neurogenic stress urinary incontinence (nSUI) by Adjustable Continence Therapy (ACT™ and ProACT™). France. A retrospective multicentre study of consecutive patients with neurological pathologies treated for nSUI with ACT balloons. From January 2001 to January 2013, 102 patients were implanted. Mean (SD) age at implantation was 48.4 (16.5) years. Patients were followed-up for a mean 2.7 (2.3) years. After implantation, 5.9% of patients were totally continent, 51.2% had an improvement in symptoms of at least 50% (including 14.6% with improvements of at least 90%), and 48.8% had improvements of < 50%, including 7.3% of treatment failures. Complications occurred in 70 patients (120 balloons): 21 balloon infections, 34 migrations, 18 device failures, 28 urethral erosions and 28 cutaneous erosions. The procedure was ineffective for 35 patients. Twenty patients underwent permanent explantation. The rate of migrations was lower in patients with upper motor neuron lesion than in those with lower motor neuron lesion (p = 0.04). ACT is a minimally invasive treatment for SUI related to sphincter deficiency. This is one of the first reports in a sample of patients with neurological disorders implanted by multiple surgeons. ACT could be a less invasive, appropriate alternative to artificial urinary sphincters. However, it is associated with frequent local complications which are easy to manage but that should be reduced in this challenging population.

Four-year follow-up on 68 patients with a new post-operatively adjustable long-term implant for post-prostatectomy stress incontinence: ProACT™.

This paper presents 4-year follow-up results for patients enrolled in a pivotal study conducted to support an FDA premarket approval application (PMAA). The study evaluated the safety and efficacy of the ProACT Adjustable Continence Therapy for the treatment of post-prostatectomy stress urinary incontinence (SUI). The clinical study involved 11 clinical sites and enrolled 160 subjects, all male. A total of 124 subjects met study criteria and 123 were implanted with ProACT. Baseline and outcomes for 68 patients who completed 4-year follow-up visits are reported. Endpoints included 24-h pad weight, Incontinence Quality of Life Questionnaire (I-QOL), UCLA Prostate Cancer Index-Urinary Function (PCI-UF), residual volume, and incidence and severity of device or procedure-related adverse events. Statistically significant improvements during follow-up were observed in 24-h pad weight, for which the mean pre-implant urine loss was 293 g, which was reduced at 4 years to 73 g (P < 0.001). Reductions in pad weight were observed across all levels of pre-implant SUI severity. Significant improvements were also seen in quality of life as measured by the I-QOL (P < 0.001) as well as measures of urinary function and pad use. One procedure-related SAE (retention) was reported among the 68 subjects; the SAE was resolved without clinical meaningful sequalae. These results confirm the long-term safety and efficacy of this newly FDA-approved therapy, showing significant improvements in both objective and subjective measures of SUI in mild, moderate, and severely incontinent male patients. The implant procedure is minimally invasive, and complications are generally mild and easily resolvable.

Treatment with an adjustable long-term implant for post-prostatectomy stress incontinence: The ProACT™ pivotal trial.

This paper presents 18-month follow-up results for patients enrolled in a pivotal study conducted to support an FDA premarket approval application (PMAA). The trial evaluated the safety and efficacy of the ProACT Adjustable Continence Therapy for the treatment of post-prostatectomy stress urinary incontinence (SUI). The clinical study involved 11 clinical sites and enrolled 160 subjects. A total of 124 subjects met study criteria and 123 underwent ProACT implantation from July 2005 through June 2007, of whom 98 completed 18-month follow-up. Endpoints included 24-h pad weight, Incontinence Quality of Life Questionnaire (I-QOL), UCLA Prostate Cancer Index-Urinary Function (PCI-UF), residual volume, and device or procedure-related adverse events (AEs). The mean surgical time was 32 min. Statistically significant improvements during follow-up were observed in 24-h pad weight, for which the cohort mean pre-implant urine loss was 399 g, which was reduced at 18 months to 160 g (P < 0.001). Reductions in pad weight were observed across all levels of pre-implant SUI severity. Significant improvements were also seen in quality of life as measured by the I-QOL (P < 0.001) as well as measures of urinary function and pad count. One procedure-related serious adverse event (SAE), retention, was reported among the 124 subjects; the SAE was resolved without clinical meaningful sequalae. These results demonstrate the safety and efficacy of this newly FDA-approved therapy, showing significant improvements in objective and subjective measures of SUI in mild, moderate, and severely incontinent male patients. The duration of the implant procedure is short, and complications are mild and easily resolvable.