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

30 Years
Not Enrolling
Cervical Cancer, Endometrial Cancer, Ovarian Epithelial Cancer, Ovarian Germ Cell Tumor, Uterine Sarcoma, Vulvar Cancer

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Trial Information

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.

Inclusion Criteria:

- History of uterine, cervical, ovarian or vulvar malignancy

- Treatment free interval of >= one year and currently have no evidence of cancer

- Reports urinary incontinence based on screening questionnaire

- Must have a stable address for the three month period

Exclusion Criteria:

- Current clinical evidence of urinary tract infection

- Within three months of failed surgery for urinary incontinence

- Planned surgery for urinary incontinence in the next three months

- Presence of neurologic condition that may impact bladder symptoms such as multiple
sclerosis, stroke

- Pregnancy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Improvement in the Patient Global Impression of Improvement (PGI-I) rating

Outcome Description:

Fisher's exact test will be used to test whether the chance of success is identical for the two groups (intervention vs. control).

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Teresa Rutledge, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico Cancer Center


United States: Institutional Review Board

Study ID:

INST 0912



Start Date:

November 2009

Completion Date:

September 2012

Related Keywords:

  • Cervical Cancer
  • Endometrial Cancer
  • Ovarian Epithelial Cancer
  • Ovarian Germ Cell Tumor
  • Uterine Sarcoma
  • Vulvar Cancer
  • Pelvic floor muscle training; incontinence; quality of life
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Urinary Incontinence
  • Vulvar Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Adenoma
  • Germinoma
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Sarcoma



University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636