Clinical trial NCT01806350: Pelvic Floor Muscle Training in Treating Urinary Incontinence in Gynecologic Cancer Survivors
Official title: A Pilot Randomized Control Trial to Evaluate Pelvic Floor Muscle Training for Urinary Incontinence Among Gynecologic Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Endometrial Cancer
Ovarian Epithelial Cancer
Ovarian Germ Cell Tumor
Uterine Sarcoma
Vulvar Cancer
Keywords: Pelvic floor muscle training; incontinence; quality of life
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-03-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in the Patient Global Impression of Improvement (PGI-I) rating
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in the Incontinence Severity Index (ISI) score
timeFrame: Baseline to 3 months
measure: Changes in Urinary Distress Inventory (UDI)
timeFrame: Baseline to 3 months
measure: Changes in Incontinence Impact Questionnaire (IIQ), which measures the impact of urinary incontinence on quality of life
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
Study officials:
affiliation: University of New Mexico Cancer Center
name: Teresa Rutledge, MD
role: PRINCIPAL_INVESTIGATOR
References: