Stress urinary incontinence (SUI) is a widespread and embarrassing condition impairing women's quality of life. Two physiopathological mechanisms are involved, i.e urethral hypermobility (UH) and intrinsic sphincter deficiency (ISD).  While the management of SUI related to the UH is well codified, the one related to the ISD is more controversial. Therapeutic strategies are multiples such as fascial slings, bulking agents or artificial urinary sphincter.  Another alternative is available, the ACT® (Adjustable Continence Therapy) balloons, developed by Uromedica (Irvine, CA, USA). Two silicone balloons are implanted by perineal rout and act on ISD by  mechanism of coaptation of the urethra and support of the urethro-vesical junction.
The aim of this series was to determine the functional outcomes and the morbidity of ACT® balloons in the treatment of stress urinary incontinence (SIU) due to insufficient sphincter deficiency (ISD).

A monocentric retrospective series included all 68 women who underwent a surgical treatment with ACT® balloons for IU due to ISD from 2007 to 2021. Primary endpoint was functional outcomes categorized as continence (no pad), improvement (decrease of number of pads/24h) or failure (no decrease of number of pads/24h). Urinary Symptoms Profile (USP) questionnaires scores were compared to baseline score. Patient Global Impression of Improvement (PGI-I) were collected at 6 months and 1 year. The complications were reported according to Clavien dindo classification. Explantation-free survival and failure free survival were studied with a Kaplan meier method.

The mean follow up was 24.5 months. At the follow up end, 18.5% of patients were fully continent (12/66), 40% (n=26/66) were improved and 41% (n=27/66) were in condition of failure. At one year of surgery, SIU and overactivity bladder USP score significantly decreased to 50% (p<0.01) and 23% (p=0.04) respectively. According to the PGII questionnaire, 53% (n=21/40) of patients reported feeling very much improved or much improved at 6 months after the procedure. Seven intraoperative complications occurred (10%), three vaginal perforations, three bladder perforations and one urethral perforation. Thirty patients experienced postoperative complications (44.1%).  Seventeen complications of grade III according to the clavien dindo classification were observed. The rate of explantation was 27.9% (n=19/68).

Functional outcomes of ACT® Balloons are limited and the morbidity is and morbidity is not negligible. However, this is an alternative useful for patient non eligible to SUA or in failure of second line treatment.

Functional outcomes of ACT® Balloons are limited and the morbidity is and morbidity is not negligible. However, this is an alternative useful for patient non eligible to SUA or in failure of second line treatment.