Rectal Balloon Training in Female Urinary Incontinence

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Other: Rectal Balloon Training
* Other: Pelvic floor muscle training (PFMT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rectal Balloon Training<br>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<br>* 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<br>|
| Active Comparator: Control group<br>Patients receive Pelvic floor muscle training without inserting any kinds of equipment. | Other: Pelvic floor muscle training (PFMT)<br>* Standard pelvic floor muscle exercise (Pelvic floor muscle training;PFMT) is assigned for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary incontinence, Pelvic floor muscle training