Non-Surgical Management of Urinary Incontinence in Cystic Fibrosis

Objectives: Urinary incontinence (UI) is an understudied, yet common, component of the lives of many females with cystic fibrosis (CF). We investigated baseline symptoms and quality of life in females with CF and UI and completed a pilot randomized trial of non-surgical UI treatment modalities.

Methods: We recruited English-speaking, 18 years or older female participants from two CF centers with a diagnosis of CF and self-reported UI. We obtained consent and participants completed demographic questions, the King’s Health Questionnaire (KHQ), and a 2-day bladder diary followed by randomization to one-week use of either a disable urethral support device (USD), reusable underwear, or pelvic floor muscle therapy (PFMT). All but one PFMT visit was performed via telemedicine. During use, participants completed a daily bladder diary and after one week completed the KHQ, the patient global impression of improvement (PGI-I), the Benefit, Satisfaction, and Willingness to Continue (BSW) questionnaire, and a modified product performance questionnaire (PPQ). To explore preliminary efficacy, we compared scores between groups utilizing either ANOVA or paired t-test.

Results: Overall fifteen participants were consented, thirteen participants completed a baseline visit, twelve completed at least one week of follow-up (n=4 PFMT, n=4 reusable underwear, and n=4 urethral insert), and five decided to participate in an additional week of therapy. (Figure) Baseline 2-day bladder diaries revealed median leaks of 2 (IQR 1.25,3.75) on day 1 and 2.5 (IQR 2,3) on day 2. At baseline, the average KHQ was 49.7 (SD 10.6). (Table 1) After one week of treatment with any therapy, most participants still reported 1-4 leaks per day and there was no difference between KHQ change scores between groups (p=0.10). Among the full cohort, for the PGI-I, there was a significant difference between groups (p=0.04) with the PFMT group showing significant improvement compared to the USD group (mean PGI-I 2.25, SD 0.05 PFMT v. mean PGI-1 3.75, SD 0.05; p=0.04). For the 5 participants that chose a second week of therapy, all reported being between a little and much better without differences between groups (p=0.50). On the BSW questions, 100% of participants in the reusable underwear and PFMT groups reported having benefit from treatment, satisfaction with treatment and were willing to continue treatment. Unfortunately, zero participants in the USD arm reported they were continue treatment. Regarding the PPQ, all participants in the reusable underwear group and only 25% in the USD rated the product as good (highest score).

Conclusions: This pilot randomized trial of non-surgical interventions for UI in females with CF demonstrated that PFMT appears to improve symptoms of UI and that both PFMT and reusable underwear have high satisfaction ratings. Future larger trials could continue to build on our data to improve the care of those with UI and CF.