Adjustable continence balloons: Clinical results of a new minimally invasive treatment for male urinary incontinence

Kjær, Line; Fode, Mikkel; Nørgaard, Nis; Sønksen, Jens; Nordling, Jørgen

doi:10.3109/00365599.2012.660986

Cited by 21 publications

(11 citation statements)

References 12 publications

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“…In our population, 15.5% of the patients had previously undergone SUI surgery, which is higher than other series (5%–15%) 13,14,18–25 . However, no impact was seen on postoperative results.…”

Section: Discussioncontrasting

confidence: 51%

Adjustable continence balloons in postprostatectomy incontinence: Outcomes and complications

Ricard

Léon

Branchereau

et al. 2022

Neurourology and Urodynamics

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Objective: 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).Patients and Methods: 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. Results: Two hundred men 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%. Conclusion: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.

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Section: Discussioncontrasting

confidence: 51%

Adjustable continence balloons in postprostatectomy incontinence: Outcomes and complications

Ricard

Léon

Branchereau

et al. 2022

Neurourology and Urodynamics

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“…Studies highlight the brevity and minimally invasiveness of the explant procedure which can be done in the office using topical anesthesia . After explant of the ProACT device, patients can either be reimplanted or continue on to a more invasive treatment option . Rates of explantation for fixed and adjustable slings are estimated at 5% (95% CI: 3%‐9%) and 14% (95% CI: 10%‐18%), respectively, while the AUS revision rate was 26.0% .…”

Section: Discussionmentioning

confidence: 99%

“…The only consequence of urethral erosion of the ProACT balloon is a worse functional result and explant of the affected device . Patients can have the explanted balloon replaced as soon as the tissues have healed or be implanted with an AUS . Irradiated patients should be cautioned about the greater risk of failure of the ProACT technique and increased risk of urethral erosion.…”

Section: Discussionmentioning

confidence: 99%

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

Larson

Jhaveri

Yeung

2019

Neurourology and Urodynamics

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Aims 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. Method 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. Results 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%). Conclusions 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.

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“…Moreover, 9 patients experienced device failure. In another prospective study ( 14 ), the authors evaluated the results of ProAct™ in 114 men with PPI at a mean follow-up time of 58 months and reported an overall dry rate of 50%. In that study, complications included balloon leakage (11%), migration (5%) and wound erosion (4%).…”

Section: Discussionmentioning

confidence: 99%

Adjustable perineal male sling using tissue expander as an effective treatment of post-prostatectomy urinary incontinence

et al. 2015

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Purpose To report our intermediate experience in treating patients with severe incontinence using an adjustable perineal male sling with a tissue expander.Materials and Methods An adjustable male sling procedure was performed on 21 patients with severe incontinence. The underlying etiology of urinary incontinence was radical prostatectomy in 13 patients, open prostatectomy in 5 patients and transurethral prostate resection in 3 patients. The difference between the classical and the adjustable sling is that in the latter there is a 25 mL tissue expander between the two layers of polypropylene mesh with an injection port. Adjustment of the sling was performed with saline via an inflation port, in case of recurrence or persistence of incontinence.Results The mean age of the patients was 66.2±7.3 (50-79) years and mean pad usage was 6.4±0.6 per day. The mean follow-up time was 40.1±23.2 (6-74) months. The balloon was postoperatively inflated on average with 11.6±5.7 (5-25) mL. After the mean 40.1 months of follow-up, 16 of the 21 patients (76.2%) were dry (11 patients, 0 pads; 5 patients using safety pads), 3 patients (14%) had mild and 2 (9.8%) had moderate degree post-prostatectomy urinary incontinence (PPI). The average maximum urine flow rate of the patients was 15.6±4.7 (10-31) mL/s. No residual urine was found. In 2 patients, all parts of the device were removed due to infection and discomfort, and in 3 patients only the inflation component was removed due to local scrotal infection.Conclusions Our results show that using an adjustable perineal male sling with a tissue expander seems to be an efficient, and safe surgical treatment option in patients with PPI.

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Adjustable continence balloons: Clinical results of a new minimally invasive treatment for male urinary incontinence

Abstract: Adjustable continence balloons seem to be a good alternative in the treatment of male urinary incontinence. Complications are mild and easily treated.

Cited by 21 publications

References 12 publications

Adjustable continence balloons in postprostatectomy incontinence: Outcomes and complications

Adjustable continence balloons in postprostatectomy incontinence: Outcomes and complications

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

Adjustable perineal male sling using tissue expander as an effective treatment of post-prostatectomy urinary incontinence

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