A Pilot Randomized Control Trial to Evaluate Pelvic Floor Muscle Training for Urinary Incontinence Among Gynecologic Cancer Survivors
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Improvement in the Patient Global Impression of Improvement (PGI-I) rating
Fisher's exact test will be used to test whether the chance of success is identical for the two groups (intervention vs. control).
Teresa Rutledge, MD
University of New Mexico Cancer Center
United States: Institutional Review Board
|University of New Mexico Cancer Center||Albuquerque, New Mexico 87131-5636|