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

Study Overview
=================
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.

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

Conditions
-----------------
Cervical Cancer, Endometrial Cancer, Ovarian Epithelial Cancer, Ovarian Germ Cell Tumor, Uterine Sarcoma, Vulvar Cancer

Intervention / Treatment
-----------------
* Other: questionnaire administration
* Procedure: standard follow-up care
* Other: educational intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (PFMT)<br>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. | Other: questionnaire administration<br>* Ancillary studies<br>Other: educational intervention<br>* Undergo PFMT<br>* Other names: intervention, educational;|
| Active Comparator: Arm II (usual care)<br>Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study. | Other: questionnaire administration<br>* Ancillary studies<br>Procedure: standard follow-up care<br>* Receive usual care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Incontinence Severity Index (ISI) score | 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. | Baseline to 3 months | 
| Changes in Urinary Distress Inventory (UDI) | 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. | Baseline to 3 months | 
| Changes in Incontinence Impact Questionnaire (IIQ), which measures the impact of urinary incontinence on quality of life | 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. | Baseline to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic floor muscle training; incontinence; quality of life