- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01806350
Pelvic Floor Muscle Training in Treating Urinary Incontinence in Gynecologic Cancer Survivors
A Pilot Randomized Control Trial to Evaluate Pelvic Floor Muscle Training for Urinary Incontinence Among Gynecologic Cancer Survivors
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87106
- University of New Mexico Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (PFMT)
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.
|
Ancillary studies
Undergo PFMT
Other Names:
|
Active Comparator: Arm II (usual care)
Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study.
|
Ancillary studies
Receive usual care
|
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
Time Frame: 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).
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the Incontinence Severity Index (ISI) score
Time Frame: 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.
|
Baseline to 3 months
|
Changes in Urinary Distress Inventory (UDI)
Time Frame: 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.
|
Baseline to 3 months
|
Changes in Incontinence Impact Questionnaire (IIQ), which measures the impact of urinary incontinence on quality of life
Time Frame: 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.
|
Baseline to 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Teresa Rutledge, MD, University of New Mexico Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Urination Disorders
- Vulvar Diseases
- Ovarian Neoplasms
- Urinary Incontinence
- Endometrial Neoplasms
- Carcinoma, Ovarian Epithelial
- Vulvar Neoplasms
Other Study ID Numbers
- INST 0912
- NCI-2012-01319 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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