Suspended

The Efficacy of Pelvic Floor Muscle Training in Gynecological Cancer Survivors: A Pilot Study

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What is being tested

Training

+ Usual Care

Other
Who is being recruted

Urogenital Diseases+8

+ Female Urogenital Diseases and Pregnancy Complications

+ Signs and Symptoms

From 19 to 65 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: December 2013
See protocol details

Summary

Principal SponsorUniversity of British Columbia
Study ContactKristin Campbell, PhDMore contacts
Last updated: April 13, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2013

Actual date on which the first participant was enrolled.

A randomized controlled trial pilot study to test the efficacy of a pelvic muscular training intervention led by a physiotherapist on urinary incontinence, quality of life and sexual health in women who report urinary urgency and incontinence following surgery and radiation treatment for gynecological cancer vs. usual care (a 1-page sheet on Kegel exercises).

NCT01811602
Principal SponsorUniversity of British Columbia
Study ContactKristin Campbell, PhDMore contacts
Last updated: April 13, 2015
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.

From 19 to 65 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 DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesUrological ManifestationsFemale Urogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrinary Incontinence

Criteria

Inclusion Criteria: - treated with surgery and adjuvant treatment, including radiation, for gynecological cancer within the last 3 years Exclusion Criteria: stage IV cancer or stage III and IV cervical cancer radiation not part of treatment known spinal or long bone metastases diagnosis with a neuromuscular disorder that may impact pelvic floor muscle function urinary incontinence issues prior to cancer diagnosis scheduled or previous surgical treatment of incontinence fecal incontinence body mass index (BMI) > 35 use of medications to improve bladder function unable to complete questionnaires in English or unable to actively participate in physiotherapy treatment provided in English.

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

Pelvic floor muscle training delivered by a physiotherapist with clinical expertise and training in treating pelvic floor dysfunction

Group II

Participants randomized to this arm will receive a 1-page educational pamphlet on pelvic floor muscle training, specifically Kegel exercises, which is equivalent to current standard care. Individuals randomized to this group will be placed on the clinic waiting list and be eligible for treatment following completion of the 12 week (end of study) measures.

Study Objectives

Primary 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

Recruiting

Women's Health Centre

Vancouver, CanadaOpen Women's Health Centre in Google Maps
SuspendedOne Study Center