Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT01806350
Brief 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.
Study:
NCT01806350
Study Brief:
Protocol Section:
NCT01806350