NCT01245153

Rectal Balloon Training in Female Urinary Incontinence

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: Female
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
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
OTHER	Pelvic floor muscle training (PFMT)	Standard pelvic floor muscle exercise (Pelvic floor muscle training;PFMT) is assigned for 6 weeks.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-05-01
• Completion: 2011-10-01
• First posted: 2010-11-22
• Last updated: 2016-02-02