Adherence to pelvic floor muscle training with or without vaginal spheres in women with urinary incontinence: a secondary analysis from a randomized trial.

INTRODUCTION AND HYPOTHESIS: Pelvic floor muscle training (PFMT) is widely recommended as first-line therapy for women with urinary incontinence. However, adherence to PFMT decreases over time, and information regarding barriers to PFMT is scarce. The primary aim of our study was to investigate whether a vaginal spheres device helped improve adherence to PFMT. The secondary aim was to assess determinants of adherence and the association with treatment outcome. METHODS: This was a secondary analysis of a randomized trial with a 6-month follow-up in women with urinary incontinence (UI) in whom we evaluated adherence to PFMT, performed either with (spheres group) or without (control group) vaginal spheres. The Morisky-Green Questionnaire (MGQ) was used to assess adherence, defined as the extent to which participants corresponded to the agreed recommendations; participants were classified as adherent or nonadherent according to their responses. Efficacy of PFMT was assessed using the International Consultation on Incontinence Questionnaire Short Form scale (ICIQ-SF). RESULTS: Seventy women were enrolled and data from 65 (35 treated and 30 controls) were suitable for analysis. There were no significant differences in adherence to treatment between groups at the end of follow-up (33.3 % in controls and 42.9 % in spheres). The largest group of nonadherent women in both arms were those who mainly forgot to do the exercises. ICIQ-SF results between adherent and nonadherent women did not differ significantly [mean 0.55, 95 % confidence interval (CI) 1.13-2.25]. No significant difference was observed between women who attained greater and lesser improvement in UI after treatment (4.5 %; 95 % CI -11.7 to 20.6). CONCLUSIONS: In patients with UI, vaginal spheres as an adjunct to PFMT did not increase adherence to pelvic muscle exercises. Lack of persistence appeared to be due to forgetfulness and did not seem to be influenced by the efficacy of PFMT.

Effect of vaginal spheres and pelvic floor muscle training in women with urinary incontinence: a randomized, controlled trial.

AIMS: To compare the efficacy and safety of Kegel exercises performed with or without, vaginal spheres as treatment for women with urinary incontinence. METHODS: Multicentre parallel-group, open, randomized controlled trial. Women were allocated to either a pelvic floor muscle-training program consisting of Kegel exercises performed twice daily, 5 days/week at home, over 6 months with vaginal spheres, or to the same program without spheres. The primary endpoint was women's report of urinary incontinence at 6 months using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI-SF). Secondary outcome measures were the 1 hr pad-test, King's Health Questionnaire (KHQ) and a five-point Likert scale for subjective evaluation. Adherence was measured with the Morisky-Green test. RESULTS: Thirty-seven women were randomized to the spheres group and 33 to the control group. The primary endpoint was evaluated in 65 women (35 in the spheres group vs. 30 controls). ICIQ-UI-SF results improved significantly at 1-month follow-up in the spheres group (P < 0.01) and at 6 months in the controls. The 1 hr pad-test improved in the spheres group but not in the control group. No significant differences were found in the KHQ results or in the subjective evaluation of efficacy and safety. Adherence was higher in the spheres group but differences were not significant. Mild transient side effects were reported in four patients in the spheres group and one in the control group. CONCLUSIONS: Both treatments improved urinary incontinence but women who performed the exercises with vaginal spheres showed an earlier improvement. Vaginal spheres were well tolerated and safe.