Rectal Balloon Training in Female Urinary Incontinence

Phase 2

Completed

• Conditions: Urinary Incontinence
• Interventions: Other: Pelvic floor muscle training (PFMT); Other: Rectal Balloon Training

• Registration Number: NCT01245153
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

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 Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-17
• Study First Submitted QC: 2010-11-19
• Study First Posted: 2010-11-22
• Primary Completion: 2011-05
• Study Completion: 2011-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-31
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control group	Pelvic floor muscle training (PFMT)	Patients receive Pelvic floor muscle training without inserting any kinds of equipment.
Rectal Balloon Training	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.

Primary Outcome Measures

Name	Time	Method
Pelvic floor muscle strength	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.

Secondary Outcome Measures

Name	Time	Method
Clinical symptoms	At the first time then 6 weeks later	Clinical symptoms are assessed from questionaire and one-hour pad test