title: Effect of vaginal spheres and pelvic floor muscle training in women with urinary incontinence: a randomized, controlled trial.
abstract: OBJECTIVE
  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.
authors.affiliation: Service of Gynaecology and Obstetrics, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Oriol
authors.initials: O
authors.lastname: Porta-Roda
authors.affiliation: Service of Physical Medicine and Rehabilitation, Pelvic Floor Unit, Hospital Universitario, Madrid, Spain.
authors.forename: Jesús
authors.initials: J
authors.lastname: Vara-Paniagua
authors.affiliation: Service of Gynaecology and Obstetrics, Hospital Universitario Virgen de las Nieves, Granada, Spain.
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Díaz-López
authors.affiliation: Service of Physical Medicine and Rehabilitation, Pelvic Floor Unit, Hospital Universitario, Madrid, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Sobrado-Lozano
authors.affiliation: Service of Gynaecology and Obstetrics, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Simó-González
authors.affiliation: Service of Gynaecology and Obstetrics, Hospital Universitario Virgen de las Nieves, Granada, Spain.
authors.forename: Paloma
authors.initials: P
authors.lastname: Díaz-Bellido
authors.affiliation: Service of Gynaecology and Obstetrics, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: María C
authors.initials: MC
authors.lastname: Reula-Blasco
authors.affiliation: Service of Gynaecology and Obstetrics, Hospital Universitario, Madrid, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Muñoz-Garrido
mesh_terms: D000328:Adult; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D010349:Patient Compliance; D017773:Pelvic Floor; D010865:Pilot Projects; D011446:Prospective Studies; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000628:therapy*; D014621:Vagina / Q000601:surgery*
keywords: exercise therapy; female urinary incontinence; medical device; muscle contraction; pelvic floor