NCT01806350

Pelvic Floor Muscle Training in Treating Urinary Incontinence in Gynecologic Cancer Survivors

A Pilot Randomized Control Trial to Evaluate Pelvic Floor Muscle Training for Urinary Incontinence Among Gynecologic Cancer Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: Female
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

This randomized pilot clinical trial studies pelvic floor muscle training in treating urinary incontinence in gynecologic cancer survivors. Pelvic floor muscle training may help control symptoms and improve physical function and quality of life in gynecologic cancer survivors.

Detailed description

PRIMARY OBJECTIVES: I. To assess whether pelvic floor muscle training and behavioral therapy in gynecologic cancer survivors results in improvement in incontinence symptoms as measured by a validated questionnaire (Patient Global Impression of Improvement) at three month follow-up when compared to women who do not undergo pelvic floor muscle training. II. To evaluate whether women who undergo pelvic floor muscle training and behavioral therapy report greater improvement in validated urinary incontinence symptom severity, pelvic floor distress and quality of life measures than women who do not undergo pelvic floor muscle training. III. To evaluate the acceptability of pelvic floor muscle training (PFMT) among gynecological cancer survivors and to provide preliminary data to inform a power analysis for a larger randomized trial. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive a handout describing behavioral management tips for urinary incontinence, including information and suggestions about optimal volume fluid intake, constipation management, measures to reduce urgency by spreading fluid intake, and avoiding caffeine and other bladder irritants that have proved effective in other intervention trials. Patients undergo PFMT over 20-30 minutes teaching them to contract the pelvic floor muscles correctly and receive feedback to avoid the contraction of abdominal, gluteal or adductor muscles. Patients are asked to perform 3 sets of 10 pelvic muscle contractions with a goal of holding the contraction for 5 seconds daily for 12 weeks and also receive a reminder phone call to address concerns and review the instructions at 4 weeks. ARM II: Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study. After completion of study treatment, patients are followed up at 3 months.

Conditions

• Cervical Cancer
• Endometrial Cancer
• Ovarian Epithelial Cancer
• Ovarian Germ Cell Tumor
• Uterine Sarcoma
• Vulvar Cancer

Interventions

Type	Name	Description
OTHER	questionnaire administration	Ancillary studies
PROCEDURE	standard follow-up care	Receive usual care
OTHER	educational intervention	Undergo PFMT

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2013-03-07
• Last updated: 2013-03-07

Locations

1 site across 1 country: United States