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Effect of vaginal spheres and pelvic floor muscle training in women with urinary incontinence: A randomized, controlled trial
Author(s) -
PortaRoda Oriol,
VaraPaniagua Jesús,
DíazLópez Miguel A.,
SobradoLozano Pilar,
SimóGonzález Marta,
DíazBellido Paloma,
ReulaBlasco María C.,
MuñozGarrido Francisco
Publication year - 2015
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.22640
Subject(s) - medicine , urinary incontinence , randomized controlled trial , clinical endpoint , pelvic floor muscle , physical therapy , pelvic floor , gynecology , urology , surgery
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. Neurourol. Urodynam. 34:533–538, 2015 . © 2014 Wiley Periodicals, Inc.