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

New Mexico Cancer Care Alliance

Status: Completed

Conditions: Endometrial Cancer; Vulvar Cancer; Uterine Sarcoma; Ovarian Epithelial Cancer; Ovarian Germ Cell Tumor; Cervical Cancer

Treatments: Procedure: standard follow-up care; Other: educational intervention; Other: questionnaire administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01806350

NCI-2012-01319 (Registry Identifier)

INST 0912

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Arm I (PFMT)

Experimental group

Description:

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.

Treatment:

Other: educational intervention

Other: questionnaire administration

Arm II (usual care)

Active Comparator group

Description:

Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study.

Treatment:

Other: questionnaire administration

Procedure: standard follow-up care