Adjustable continence therapy (ACT®) balloons to treat neurogenic and non‐neurogenic female urinary incontinence

Abstract

Aims: To compare efficacy and safety between neurogenic and nonneurogenic women after adjustable continence therapy (ACT®) balloons implantation to treat stress urinary incontinence (SUI) due to intrinsic sphincter deficiency. Methods: In the present retrospective multicentric study, all neurogenic and non-neurogenic women implanted with ACT® balloons between 2000 and 2018 were considered for inclusion. Efficacy was compared 1 year after implantation, and women were allocated in three different groups as follows.Success: maximum 1 pad per day and patient's impression of improvement assessed using a numeral rating scale (NRS) ≥8/10. Improvement: decrease of daily pad use and/or NRS ≥5/10. Failure: increase or stability of daily pad use or NRS <5/10. Overall surgical complications and explantations were compared 1 year after implantation.Results: Among the 277 included women, 51 presented with a neurologic underlying disease. Mean age at implantation was 68.5 years. There was no significant difference in efficacy between neurogenic and non-neurogenic women with a success rate of 39.2% and 36.3%, respectively (p = 0.69).Similarly, improvement rate was reported to be 31.4% and 33.6%, in neurogenic and non-neurogenic women, respectively (p = 0.92). The overall surgical complications rate (24% vs. 34.5%, p = 0.15) and the explantation rate (19.6% vs. 28.8%, p = 0.18) were not significantly different. Conclusion: ACT balloons may be proposed to treat mixed or SUI in females with ISD. Efficacy and safety profiles appear to be similar in both neurogenic and non-neurogenic patients.

Adjustable Continence Therapy Balloons in Female Patients with Stress Urinary Incontinence: A Systematic Review

“…The positioning was checked by fluoroscopic +/− cystoscopic control. Some authors used a flexible cystoscope to facilitate balloon positioning and rule out bladder neck perforation in real-time using retrovision [12, 18]. The stylet was then removed, and the balloon was inserted after the ancillary has been lubricated.…”

“…One study compared the clinical results and complications of ACT ® balloons with the AUS [11]. Another study compared outcomes based on the presence or absence of neurological diseases [12]. Seven studies had a level of evidence of III according to the Oxford classification and six studies a level of evidence of IV.…”

“…Some of them may be underestimated because of the short follow-up and of the lack of data regarding worsening of postoperative lower urinary tract symptoms such as de novo urgency which were described by only one study. The explantation rate was 18.3% at 1 year in the series of Aboseif et al and was as high as 42% in patients over 80 years old in the series of Billault et al [12, 20]. The high rate of complication may be related to the learning curve and may dwindle with surgeons’ experience as it has been shown with ProACT ® balloons in male patients [30].…”

“…The removal can be performed under topical anaesthesia in an office and does not contraindicate a second implantation or an AUS. Finally, when we compare the morbidity of the larger cohort to that of other implanted devices such as the AUS, it was not so different: 24.7% [18] of the patients with early complications for AUS versus 32.5% [12].…”

“…One study compared patients with neurological disease to patients without neurological disease. No difference was observed between the two groups with a success rate of 39.2% and 36.3%, respectively [12] Discussion SUI related to ISD differs from UI due to urethral hypermobility in several aspects, including those related to severity of incontinence and history of previous anti-incontinence surgery [27,28]. The management of female SUI underpinned by ISD is controversial and relies on multiple surgical procedures including ACT ® balloon implantation.…”