Completed

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

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What is being tested

questionnaire administration

+ educational intervention

+ questionnaire administration

OtherProcedure
Who is being recruted

Urogenital Diseases+23

+ Genital Diseases

+ Adnexal Diseases

Over 30 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: November 2009
See protocol details

Summary

Principal SponsorNew Mexico Cancer Research Alliance
Last updated: March 7, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2009

Actual date on which the first participant was enrolled.

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.

NCT01806350
Principal SponsorNew Mexico Cancer Research Alliance
Last updated: March 7, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesCarcinomaUterine Cervical DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOvarian DiseasesOvarian NeoplasmsUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsVulvar DiseasesFemale Urogenital DiseasesCarcinoma, Ovarian EpithelialUterine Cervical NeoplasmsVulvar NeoplasmsEndometrial Neoplasms

Criteria

4 inclusion criteria required to participate
History of uterine, cervical, ovarian or vulvar malignancy

Must have a stable address for the three month period

Reports urinary incontinence based on screening questionnaire

Treatment free interval of >= one year and currently have no evidence of cancer

5 exclusion criteria prevent from participating
Current clinical evidence of urinary tract infection

Planned surgery for urinary incontinence in the next three months

Pregnancy

Presence of neurologic condition that may impact bladder symptoms such as multiple sclerosis, stroke

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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 II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of New Mexico Cancer Center

Albuquerque, United StatesOpen University of New Mexico Cancer Center in Google Maps
CompletedOne Study Center