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

Not Applicable

Completed

• Conditions: Endometrial Cancer; Uterine Sarcoma; Vulvar Cancer; Ovarian Epithelial Cancer; Ovarian Germ Cell Tumor; Cervical Cancer
• Interventions: Other: questionnaire administration; Procedure: standard follow-up care; Other: educational intervention

• Registration Number: NCT01806350
• Lead Sponsor: New Mexico Cancer Care Alliance

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 Timeline

• Study Start: 2009-11
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-03
• Study First Submitted: 2013-03-05
• Study First Submitted QC: 2013-03-06
• Last Update Submitted: 2013-03-06
• Study First Posted: 2013-03-07
• Last Update Posted: 2013-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (usual care)	standard follow-up care	Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study.
Arm I (PFMT)	questionnaire administration	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 I (PFMT)	educational intervention	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 (usual care)	questionnaire administration	Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study.

Primary Outcome Measures

Name	Time	Method
Improvement in the Patient Global Impression of Improvement (PGI-I) rating	12 weeks	Fisher's exact test will be used to test whether the chance of success is identical for the two groups (intervention vs. control).

Secondary Outcome Measures

Name	Time	Method
Changes in the Incontinence Severity Index (ISI) score	Baseline to 3 months	The Brinks scale will be used by the trainers for the treatment group follow-up to evaluate the adequacy of the contractions in a qualitative manner. A two sample t-test on the within individual differences will be used. A non-parametric Mann-Whitney test will be used if the sample differences are non-normally distributed.
Changes in Urinary Distress Inventory (UDI)	Baseline to 3 months	The Brinks scale will be used by the trainers for the treatment group follow-up to evaluate the adequacy of the contractions in a qualitative manner. A two sample t-test on the within individual differences will be used. A non-parametric Mann-Whitney test will be used if the sample differences are non-normally distributed.
Changes in Incontinence Impact Questionnaire (IIQ), which measures the impact of urinary incontinence on quality of life	Baseline to 3 months	The Brinks scale will be used by the trainers for the treatment group follow-up to evaluate the adequacy of the contractions in a qualitative manner. A two sample t-test on the within individual differences will be used. A non-parametric Mann-Whitney test will be used if the sample differences are non-normally distributed.

Trial Locations

Locations (1)

University of New Mexico Cancer Center; 🇺🇸 Albuquerque, New Mexico, United States