Rectal Balloon Training in Female Urinary Incontinence

January 31, 2016 updated by: Natthiya Tantisiriwat, MD, Chulalongkorn University

Phase 2B Study of Rectal Ballooning Training in Female Urinary Incontinence

Urinary incontinence (UI) is a common and worldwide problem.Although pelvic floor muscle training(PFMT) is the standard recommendation for conservative treatment but some patients had difficulty doing PFMT. They could not locate the pelvic floor muscles, and so could not perform the PFMT properly or increase intensity of the exercise. The authors hypothesized that rectal balloon training(RBT) may improve patients' pelvic floor recognition as well as it is another option of progressive strengthening of pelvic floor muscle. This study's aim is to combine RBT with PFMT using the water-filled balloons of Foley catheters

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study's aim is to combine RBT with PFMT using the water-filled balloons of Foley catheters. The catheter would be inserted into the rectum and used as a tool to help the patient recognize the pelvic floor muscles. The advantages of Foley catheters are that they are cheap, safe for contacting the mucosa, easy for self-insertion, and can be reused. Furthermore, we can increase the load of exercise by increasing the amount of water pushing into the balloon, and can use that as a tool for progressive resistive exercise.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • Age 25 - 70 years
  • Have urinary incontinence problem
  • Follow command
  • Informed consent

Exclusion Criteria:

  • Previous surgical correction of UI
  • Use medications for treating overactive bladder symptoms
  • Impaired recent and/or recall memory
  • Brain and/or Spinal cord lesion
  • Untreated Urinary tract infection
  • Anal lesion which contradicted for inserting instrument
  • Prolapsed rectum
  • Prolapsed uterus
  • History of pelvic injury
  • Pregnancy

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rectal Balloon Training
Subjects in combined RBT and PFMT group are taught Foley catheter insertion technique. The catheter is inserted into the rectum until the lower end of the balloon is 1 cm inside from the anus. Then the balloon is blown with clean water. Subjects will contract pelvic floor muscle in standing position by contracting the pelvic floor muscle, hold and count 1 to 5, then relax and count 1 to 5. Subjects are instructed to do the exercise 15 times/set, 3 sets/day, every day for 6 weeks.
Other: Rectal Balloon Training
Subjects in combined RBT and PFMT group are taught for foley catheter insertion technique. The catheter is inserted into the rectum until the lower end of the balloon is 1 cm inside from the anus. Then the balloon is blown with clean water starting at 10 cc. Then the volume is progress to 15 cc in 3rd week and 20 cc in 5th week
Active Comparator: Control group
Patients receive Pelvic floor muscle training without inserting any kinds of equipment.
Other: Pelvic floor muscle training (PFMT)
Standard pelvic floor muscle exercise (Pelvic floor muscle training;PFMT) is assigned for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic floor muscle strength
Time Frame: Change from baseline in pelvic floor muscle strength at 6 weeks
Pelvic floor muscle strength will be assessed by biofeedback and recorded in unit of mmHg.
Change from baseline in pelvic floor muscle strength at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical symptoms
Time Frame: At the first time then 6 weeks later
Clinical symptoms are assessed from questionaire and one-hour pad test
At the first time then 6 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Natthiya Tantisiriwat, King Chulalongkorn Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

November 17, 2010

First Submitted That Met QC Criteria

November 19, 2010

First Posted (Estimate)

November 22, 2010

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

January 31, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REHAB_201011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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