Functional outcomes of adjustable continence therapy balloons in women : a multicentric retrospective study
To assess efficacy and safety of the adjustable continence therapy device (ACT) in the treatment of female pure stress (SUI) or mixed urinary incontinence (MUI).
This is a multicentric retrospective study. All women undergoing ACT device placement between 2008 and 2016 to treat SUI or MUI within one the 3 participating centers were considered eligible. The last consultation marked the end of the follow-up period. Regarding efficacy, the improvement in urinary incontinence was subjectively assessed by the woman herself using a numbered rating scale (NRS) from 0 to 10. Success was defined by a NRS > 8, while improvement was defined by a NRS between 0 and 8, and failure by a NRS = 0, at the end of the follow-up period. The continence was also assessed using the PGI-I (Patient's Global Impression of Improvement). Regarding safety, per- and post-operative complications were retrieved. Early complications (<30 days) were reported according to the Clavien-Dindo classification.</p>
Eighty-eight women with a mean age of 68 yo (20-90) were included. Among them, 25.0% had an underlying neurologic disease, 10.2% had a history of pelvic radiation therapy, and 79.5% had already undergone previous surgery for urinary incontinence (mean number of surgery was 1.5). 51.1% presented with SUI. After a mean follow-up period of 21.0 months (1-76), 25 patients (28.4%) achieved success, 28 patients (31.8%) showed improvement, and 35 patients (39.8%) were considered in failure. Considering all included women, PGI-I was quoted as 1, 2, 3 and 4 by 12 (13.6%), 17 (19.3%), 24 (27.3%) and 33 (37.5%) of them, respectively. Only two patients reported a PGI-I > 4. Mean volume per balloon was 3.5ml, with a mean of 3.3 balloon inflations. Among the 88 procedures, 6 per-operative complications (6.8%) were noted (vesical or vaginal injury), while 16 early post-operative complications (18.2%) were reported (all grade I or II, to the Clavien-Dindo classification). Late complications (infection, erosion or balloon migration) occurred in 18 patients (20.5%) and explantation was finally required in 29 patients (33.0%) (complication or failure). All complications resolved without any sequelae.
The ACT device implantation showed a limited efficacy, with a success or improvement rate of 60.2%. However, it was counterbalanced by an interesting safety profile, with no severe complication. These results should be interpreted with caution considering the high previous urinary incontinence surgery rate as well as the high neurogenic urinary incontinence among the studied population.