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

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ClinicalTrials.gov Identifier: NCT01806350
Recruitment Status : Completed
First Posted : March 7, 2013
Last Update Posted : March 7, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Endometrial Cancer Ovarian Epithelial Cancer Ovarian Germ Cell Tumor Uterine Sarcoma Vulvar Cancer Other: questionnaire administration Procedure: standard follow-up care Other: educational intervention Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Randomized Control Trial to Evaluate Pelvic Floor Muscle Training for Urinary Incontinence Among Gynecologic Cancer Survivors
Study Start Date : November 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012


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.
Other: questionnaire administration
Ancillary studies

Other: educational intervention
Undergo PFMT
Other Name: intervention, educational

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.
Other: questionnaire administration
Ancillary studies

Procedure: standard follow-up care
Receive usual care




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806350


Locations
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
New Mexico Cancer Care Alliance
National Cancer Institute (NCI)
Investigators
Principal Investigator: Teresa Rutledge, MD University of New Mexico Cancer Center

Additional Information:
Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01806350     History of Changes
Other Study ID Numbers: INST 0912
NCI-2012-01319 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: March 7, 2013    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013

Keywords provided by New Mexico Cancer Care Alliance:
Pelvic floor muscle training; incontinence; quality of life

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Endometrial Neoplasms
Vulvar Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Vulvar Diseases
Urinary Incontinence
Enuresis
Germinoma
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Ovarian Diseases
Adnexal Diseases