Adjustable Balloons Research Articles

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.

Real World Experience with ProACT for Post-prostatectomy Incontinence: First 14 Cases

ABSTRACT Introduction While there are several treatment options available for post-prostatectomy incontinence (PPI), the goal of this study is to describe the first United States (US) post-market, real world experience with adjustable balloon devices (ProACT) for PPI. Objective Demonstrate real-world learning curve and efficacy of a novel device for male post-prostatectomy incontinence. Methods After institutional IRB approval, a retrospective review of prospectively collected data was performed on men treated with percutaneous ProACT implantation from December of 2019 to October of 2020. Data collected on 14 men from an academic practice and a private practice . Data were analyzed using the paired students t-test to determine statistical significance. Results The mean patient age was 75.2 years, and the average time from prostatectomy was 7.4 years. A total of 35.7% of patients had mild PPI (0-2 pads per day (ppd)), and 57.1% had moderate PPI (2-5 ppd), and 7.1% had severe PPI (> 5 ppd). Other relevant demographic information includes 7.1% of the study population had previous radiation, and 42.9% of the patients had failed prior surgical treatments (some multiple) for PPI including 2 bulking injections, 3 slings, 1 TUIBNC, an indwelling AUS, and an eroded AUS. At follow up, patients saw a dramatic improvement in continence from 3.2 ppd at baseline to 1.9 ppd at 1 month follow up (p < 0.05), 1.3 ppd at 2 months (p < 0.01), 2.3 ppd at 3 months, 1.4 ppd at 4-6 months (p < 0.01), and 1.3 ppd at 7-9 months (p < 0.01), 0.67 ppd at 10-12 months (p < 0.05), and 0.8 ppd at 13-15 months (p < 0.001). Average length of follow-up data was available for 12.4 months for this cohort. At the most recent clinic visit for each patient 79.6% were dry using ≤ 1 ppd. There was a 28.6% rate of complication, one involving local wound infection cleared by antibiotics and 3 erosions of the device requiring revision. Two of the three revision patients ultimately attained improved continence levels (1.5 ppd and 0 ppd) and one erosion is still pending revision at this time. Conclusions Initial real-world experience in the US demonstrates that ProACT adjustable balloons for PPI is safe and efficacious. Longer follow up needed but short-term results are encouraging and statistically significant. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Uromedica

A0575 - Results of periurethral adjustable balloons (ACT™) in the treatment of stress urinary incontinence in women after pelvic radiotherapy

A0575 - Results of periurethral adjustable balloons (ACT™) in the treatment of stress urinary incontinence in women after pelvic radiotherapy

Efficacy and safety of adjustable balloons (Proact™) to treat male stress urinary incontinence after prostate surgery: Medium and long‐term follow‐up data of a national multicentric retrospective study

Male stress urinary incontinence (SUI) represents a complication after radical prostatectomy or benign prostatic obstruction surgery. The artificial urinary sphincter is considered the standard treatment but interest on minimally invasive devices, such as adjustable balloons, has recently increased. Aim of this study is to evaluate the efficacy and safety of the ProACT system. In this multicentric retrospective study, we reported the data from nine centers. Patients with SUI who underwent a ProACT device implantation for postoperative SUI and had a minimum follow-up of 24 months were included. Efficacy was evaluated at the maximum available follow-up and was assessed utilizing a 24-hour pad test. Patients were considered: "Dry" if presenting a urine leak weight lower than 8 g at the 24-hour pad test; "Improved" if presenting a reduction of urine leak higher than 50% (but >8 g/24 hours); "Failure" if presenting a reduction in urine leak lower than 50%. The evaluation included a record of intraoperative and long-term complications. Safety and efficacy results are reported on 240 patients. 29.6% of patients were dry at 24 months, 37.5% were improved and 32.9% of patients were considered failures. The baseline mean pad weight of 367 g was reduced to 123 g at 24 months. Five-year follow-up on 152 patients showed similar efficacy. The complication rate was 22.5%, with the top complication being long-term balloon failure. ProACT implantation represents a safe and efficacious treatment for male postoperative SUI at both medium and long-term follow up. 67.1% of patients were dry or improved at 24 months. The majority of complications are low grade.

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

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. 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. Single center retrospective study of patients treated with male sling (17Advance™, 1TOMS™) between 2009and 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. 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. The PUAB Pro-ACT™ have a significant efficiency for use after male sling failure and can be used in second line therapy. 3.

Mo1296a Adjustable Balloons for Weight Loss: A Higher Yield of Responders Compared With Non-Adjustable Balloons

Mo1296a Adjustable Balloons for Weight Loss: A Higher Yield of Responders Compared With Non-Adjustable Balloons

Tu1467 Spatz Adjustable Balloons: Results of Adjustment for Intolerance and for Weight Loss Plateau

Tu1467 Spatz Adjustable Balloons: Results of Adjustment for Intolerance and for Weight Loss Plateau

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

To report efficacy and morbidity of periurethral adjustable balloons (PUAB) in the treatment of stress urinary incontinence (SUI) with intrinsic sphincter deficiency (ISD). 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. 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. 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. 4.

One year adjustable intragastric balloon: safety and efficacy of the Spatz3 adjustable balloons

Background: The Spatz3 Adjustable balloon system is approved for 1 year implantation and allows multiple changes in the balloon volume during the course of implantation.Other intragastric balloons are currently approved for 6 months and their balloon volumes cannot be adjusted after implantation.Aim: To determine the efficacy and safety of the Spatz3 adjustable balloon system.Methods: Seventy seven consecutive patients (66 females and 11 males) in two medical centers were implanted with the Spatz3 adjustable balloon device and were followed prospectively. The patients’ mean BMI was 37.2; the mean weight was 108.7 kg; the mean age was 41 (16-68); the mean balloon volume was 469 ml (450-500 ml). Adjustments were made for intolerance or weight loss plateau.Results: The mean weight loss at 1 year was 17.2 kg with 15.9 % weight loss and 42.9 % Excess Weight Loss (%EWL). Eighteen patients underwent balloon volume adjustments: three downward adjustments of 100 -150 cc which alleviated early intolerance; 15 upward adjustments (mean 320 ml; range 200-500) at a mean 4.1 months (range 2-5 months) yielded additional mean wt loss of 8.2 kg (range 0-25 kg) after the adjustment. Three balloons were removed before the 1 year completion date due to intolerance and three others were removed for other reasons (pregnancy, gall bladder surgery, and alcoholism). There was one episode of gastric ulceration which required endoscopic therapy and balloon removal. There were no deflations or perforations. Conclusions: The Spatz3 adjustable balloon is a safe and effective treatment for weight loss. The adjustability function can yield greater weight loss for those who show weight loss plateau and can mitigate intolerance.

Adjustable balloons in the treatment of neurogenic stress urinary incontinence: A French retrospective multicentric study

Adjustable balloons in the treatment of neurogenic stress urinary incontinence: A French retrospective multicentric study

One-Year Adjustable Intragastric Balloons: Do They Offer More than Two Consecutive Nonadjustable 6-Month Balloons? A response to Genco et al

One-Year Adjustable Intragastric Balloons: Do They Offer More than Two Consecutive Nonadjustable 6-Month Balloons? A response to Genco et al

Management of Stress Urinary Incontinence Following Prostate Surgery With Minimally Invasive Adjustable Continence Balloon Implants: Functional Results From a Single Center Prospective Study

We determined the functional results and morbidity of balloon (ProACT™) implants for the treatment of male stress urinary incontinence after prostate surgery. Between 2002 and 2008 a prospective, noncontrolled study was conducted. The ProACT implant consists of 2 adjustable balloons placed on either side of the native striated sphincter. The implants are adjusted by inflation during followup visits. The primary efficacy end point was postoperative continence as defined by the use of 0 to 1 pad daily. A total of 128 consecutive patients underwent implantation. Mean ± SD patient age was 71 ± 42.3 years (range 52 to 87). The severity of incontinence before ProACT was moderate (71), mild (40) and severe (17). Overall 25% of patients previously underwent pelvic radiotherapy. The mean number of daily pads per patient was 1.46 (vs 4.2 at baseline). Mean followup was 56.3 months (range 24 to 95). The functional result was success in 68% of patients with moderate/mild incontinence and the explantation rate was 18%. Among the 30 patients treated with radiotherapy before ProACT the success rate was only 46% and the incidence of urethral erosion was significantly higher (p = 0.005). The ProACT implant appears to be an option for the treatment of moderate male stress urinary incontinence, especially given the minimally invasive modalities of insertion, the capacity to adjust the inflation of the balloons to achieve postoperative continence and the relative reversibility.

791 Adjustable Intragastric Balloons: A 12 Month Pilot Trial in Endoscopic Weight Loss Management

791 Adjustable Intragastric Balloons: A 12 Month Pilot Trial in Endoscopic Weight Loss Management

Treatment of Postprostatectomy Stress Urinary Incontinence Using a Minimally Invasive Adjustable Continence Balloon Device, ProACT: Results of a Preliminary, Multicenter, Pilot Study

To evaluate the safety and efficacy of a new minimally invasive device, Adjustable Continence Therapy (ProACT) for patients with postprostatectomy stress urinary incontinence (SUI). Sixty-two patients with urodynamic SUI after prostate surgery were evaluated according to daily pad count and a specific validated evaluation for persons with urinary incontinence. All patients were successfully implanted in a single procedure using general or spinal anaesthesia. Procedural time was 37 minutes (range, 18 to 80 minutes). Daily pad usage decreased from 4.6 pads per day to 1.06 pads per day at 12 months. Mean quality-of-life index score increased from 48 to 67 at 12 months.Fifty-nine percent of patients without adjuvant radiation were improved (greater than 50% reduction in pad use), and 30% were cured (no pads), whereas 83% of postirradiated patients failed intervention. Fifty-five patients (88%) required percutaneous balloon adjustments. The mean optimal volume after adjustments for all 45 improved patients was 3.8 mL per balloon. Complications necessitating removal occurred in 19 patients and included erosion, infection, migration, and failure to respond. Of these, 4 were successfully reimplanted. All complications occurred in the first postoperative month. Implantation of postoperatively adjustable balloons in postprostatecomy men is technically feasible, with an improvement in continence particularly in patients with nonirradiated periurethral tissues. Optimal urethral resistance is achieved, with easy postoperative adjustment. Implantation of ProACT balloons may represent a promising development in the treatment of postprostatectomy SUI.

Etude française prospective multicentrique de l’utilisation des ballons ACT ® pour le traitement de l’incontinence urinaire d’effort chez la femme

French multicentre prospective study to evaluate the efficacy and feasibility of ACT (Adjustable Continence Therapy) balloons for the management of female stress urinary incontinence (SUI). The ACT system comprises two adjustable balloons implanted on either side of the bladder neck in order to restore continence. The feasibility of this technique was evaluated perioperatively. Adverse events were recorded to evaluate the acceptability of the technique. Evaluation of efficacy was based on individual interviews to determine the severity of incontinence (use of pads and quality of life questionnaire (I-QoL)) and by Direct Visual Stress Testing (DVST). 68 patients with SUI were included. The mean operating time was 31.8 +/- 11.7 minutes. The ACT was implanted with no particular difficulties in 91% of cases. Evaluation of patients (mean follow-up: 2 years) after implantation revealed a marked improvement of incontinence (87%), DVST (85%) and I-Qol (score: 75/100). The ACT was removed in 18 patients for various reasons and was reimplanted in 6 cases. The ACTI was removed in 8 patients at their request due to complete absence of efficacy. ACT balloon implantation is a new, reversible and promising minimally invasive technique for the management of female stress urinary incontinence. The possibility of percutaneous adjustment of the size of the balloons according to clinical efficacy appears to be an essential advantage of this technique.

Adjustable continence therapy for the treatment of urinary incontinence after radical cystectomy and orthotopic neobladder in women

The management of urinary incontinence after radical cystectomy and orthotopic neobladder reconstruction is a very challenging situation. We report on a patient that developed a neobladder-urethro-vaginal fistula successfully treated but resulting in severe urinary incontinence that was cured after the periurethral insertion of adjustable silicone balloons.

Neue Verfahren zur operativen Therapie der postoperativen Belastungsinkontinenz beim Mann

The impact of minimally invasive techniques for the treatment of postoperative male incontinence has significantly improved in recent years. These techniques are based on the continuous increase in urethral resistance. This resistance can be readjusted with balloons placed paraurethrally or with readjustable suburethral slings. The success rates depend on the preoperative degree of incontinence. With bulking agents that are transurethrally injected into the submucosa of the sphincter, continence rates between 12 and 90% can be seen. Severe complications are rare. The impact of the studies is often limited due to a short follow-up. After implantation of adjustable balloons that are placed paraurethrally close to the bladder neck, continence rates up to 70% can be seen. The overall improvement of incontinence is observed in up to 90% of the treated patients. Complications such as balloon migration or mechanical disorders can cause operative revision. Suburethral sling systems are available as bone-anchored slings or as readjustable slings. Continence can be seen in up to 90% of the patients postoperatively. Severe complications such as sling erosion or sling infection are rare. In cases of mild and moderate incontinence, these minimally invasive techniques are good alternatives to the fascial sling or alloplastic sphincter implantation. To improve the evaluation and to compare these techniques with the conventional methods, further investigations with a longer follow-up are necessary.

88 The adjustable continence therapy (PROACT™) for the treatment of post‐prostatectomy stress urinary incontinence: a comparison of two techniques

Introduction: The Adjustable Continence Therapy (ProACT™) consists of two postoperatively adjustable balloons placed either at the level of bladder neck in postradical prostatectomy patients or, more recently, at the level of the apex in patients with residual prostate tissue. We compared the efficacy of ProACT in post radical and benign surgery patients.Materials and Methods: Thirty postradical prostatectomy (RP) and seven postbenign surgery have been evaluated beyond 6 months follow up. Three of the RP and one in the benign group had also undergone radiation therapy. Baseline assessment of pad usage; Quality of Life questionaries and assessment of adverse events were repeated at 6, 12, 24 and 36 months.Results: Mean follow‐up was 18.9 months in the RP group and 27.8 months in the benign group. Pad usage in the RP and postbenign group decreased from 2.6 and 3.8 at baseline to 0.7 and 1.2 at 6 months; 0.5 and 1 at 12 months; 0.6 and 1 at 24 months and 0.4 and 0.7 at 36 months respectively. Quality of Life increased in the RP and benign group from 49.6 and 49.7 at baseline to 71.7 and 77.9 at 6 months; 74.9 and 78.6 at 12 months; 70.6 and 76.1 at 24 months and 88 and 86.5 at 36 months respectively. Adverse events including balloon migration (two) and infection (three) were managed by outpatient removal and further re‐implantation.Conclusions: The results appear similar in both groups, though different techniques are required.

84 One year results of a French, multicentre, prospective clinical study of act® (adjustable continence therapy) for the treatment of female of stress urinary incontinence due to intrinsic sphincter deficiency

Introduction: This Prospective, multicentre clinical investigation sought to assess the feasibility and efficacy of the adjustable balloons ACT® for treatment of female Stress Urinary Incontinence SUI with ISD.Materials and Methods: The ACT® implant consists of a two‐lumen conduit of variable length with an expandable silicone balloon (0.5–8 cc) on the proximal end and a distal subcutaneous titanium port. Two balloons were placed periurethrally at the bladder neck. Continence rate (no leakage during direct visual stress test with 250 ml placed in the bladder), improvement, failures, quality of life (I‐QoL) and morbidity were assessed.Results: Sixty‐seven patients (62 ± 9.8‐years‐old) were implanted in France during 75 procedures (8 revisions). Average follow‐up was 12 months. At baseline, urethral closure pressure was 22.5 ± 10.8 cm H2Oand 39 patients (58%) had previously undergone at least one surgery for SUI. Continence increased from 0% at baseline to 57% at1 year and I‐QoL improved from 39.4 ± 19 at baseline to 63.7 ± 23.3 at one year. Balloon adjustment was required in 64% of patients. Complications included erosion (11%), spontaneously resolved retention (2%) and infection (4%).Conclusion: ACT® offers a viable alternative for the treatment of SUI in female with ISD. The implantation is a minimally invasive and efficient procedure and stable over time therapy for patients with severe SUI with ISD. Implantation can be done under local anaesthesia. The positioning of ACT® treatment versus artificial urinary sphincter still needs to be determined.