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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806350
• Other study ID #: INST 0912
• Secondary ID: NCI-2012-01319
• Status: Completed
• Phase: N/A
• First received: March 5, 2013
• Last updated: March 6, 2013
• Start date: November 2009
• Est. completion date: September 2012

Study information

• Verified date: March 2013
• Source: New Mexico Cancer Care Alliance
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Germinoma
• Neoplasms, Glandular and Epithelial
• Ovarian Epithelial Cancer
• Ovarian Germ Cell Tumor
• Ovarian Neoplasms
• Urinary Incontinence
• Uterine Cervical Neoplasms
• Uterine Sarcoma
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

Other:
• questionnaire administration
Ancillary studies

Procedure:
• standard follow-up care
Receive usual care

Other:
• educational intervention
Undergo PFMT

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
New Mexico Cancer Care Alliance	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   New Mexico Cancer Care Alliance
•   University of New Mexico Cancer Center