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.

Ruggiero M1, Pinar U1, Popelin M1, Rod X1, Denys P2, Chartier-Kastler E1

Research Type


Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 493
Open Discussion ePosters
Scientific Open Discussion Session 19
Thursday 28th September 2023
13:05 - 13:10 (ePoster Station 2)
Exhibit Hall
Incontinence Retrospective Study Stress Urinary Incontinence
1. Hospital la Pitié-Salpetrière PARIS, department of urology, 2. Hospital Raymond Poincaré, GARCHES, department of neuro-urology

Emmanuel Chartier-Kastler




Hypothesis / aims of study
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.
Study design, materials 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. 

Primary study outcomes were PUB global survival rate and survival without failure. Global survival was defined as the device survival without removal for any reasons (mechanical failure, complication such as infection or erosion). Survival without failure was defined as the device survival without mechanical failure.
A total of 177 consecutive patients from 2002 to 2008 were included in the study. Median age at PUB placement was 70.5 years [IQR: 61‒76], 103 patients (58.2%) were men and 27 (15.3%) previously received radiotherapy. 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%). Of the 177 procedures, 7 patients (4%) had post-operative acute urinary retention and only 3 patients (1.7%) had a post-operative complication Clavien-Dindo ≥3. 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% (Figure 1). Median [IQR] PUB survival without removal was 57.8 months [42.3-81.7]. When the cause of SUI was previous BPH treatment, cox univariate analysis evidenced that it was a balloon removal risk factor (HR=3.8 [1.1-12.9], p=0.04) (Table 4).
PUB survival without failure rate was 68.4% accounting for a median [IQR] survival duration of 116.9 months [86.2-176.9] (Figure 2).
Interpretation of results
This study reports a large cohort of both neurogenic and non-neurogenic patients, male and female, adjustable continence therapy implantation. It has been able to give an update on long term survival rate which are 68.4 % for the device itself without any failure, 47.5% without any removal for any cause.
Concluding message
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. The procedure was safe with a low number of intraoperative adverse event. However, we evidenced 25% long-term postoperative complications mostly due to balloon erosion. Except for a history of BPH treatment, we did not find balloon removal significant risk factor. Prospective study with close follow-up is necessary to confirm these results.
Given those results it could be a good alternative to AUS on unfit or unwilling population.
Figure 1 Figure 1 - Balloon removal-free survival
Figure 2 Figure 2- Balloon failure-free survival
Funding None Clinical Trial No Subjects Human Ethics not Req'd Retrospective data and non drugs allocated Helsinki Yes Informed Consent Yes
04/04/2024 11:45:29