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

NCT ID: NCT01806350

Last Updated: 2013-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

questionnaire administration

Intervention Type: OTHER

Ancillary studies

educational intervention

Intervention Type: OTHER

Undergo PFMT

Arm II (usual care)

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

Group Type: ACTIVE_COMPARATOR

questionnaire administration

Intervention Type: OTHER

Ancillary studies

standard follow-up care

Intervention Type: PROCEDURE

Receive usual care

Interventions

questionnaire administration

Ancillary studies

Intervention Type: OTHER

standard follow-up care

Receive usual care

Intervention Type: PROCEDURE

educational intervention

Undergo PFMT

Intervention Type: OTHER

Other Intervention Names

intervention, educational

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

New Mexico Cancer Research Alliance

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teresa Rutledge, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico Cancer Center

Locations

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Countries

United States

Related Links

http://www.cancer.unm.edu

University of New Mexico Cancer Center

http://www.nmcca.org

New Mexico Cancer Care Alliance

Other Identifiers

NCI-2012-01319

Identifier Type: REGISTRY

Identifier Source: secondary_id

INST 0912

Identifier Type: -

Identifier Source: org_study_id