A Phase 2 interventional study of Rectal Balloon Training and Pelvic floor muscle training (PFMT) in Urinary Incontinence, sponsored by Chulalongkorn University. Completed. Open to female participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-02-02.
Sponsored by Chulalongkorn University · Phase 2, Interventional, and Treatment
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
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 28 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Patients receive Pelvic floor muscle training without inserting any kinds of equipment.
Other: Pelvic floor muscle training (PFMT)
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
Standard pelvic floor muscle exercise (Pelvic floor muscle training;PFMT) is assigned for 6 weeks.
Pelvic floor muscle strength
Pelvic floor muscle strength will be assessed by biofeedback and recorded in unit of mmHg.
Time frame: Change from baseline in pelvic floor muscle strength at 6 weeks
Clinical symptoms
Clinical symptoms are assessed from questionaire and one-hour pad test
Time frame: At the first time then 6 weeks later
No study locations are listed for this record.
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chulalongkorn University