Rectal Balloon Training in Female Urinary Incontinence
|ClinicalTrials.gov Identifier: NCT01245153|
Recruitment Status : Completed
First Posted : November 22, 2010
Last Update Posted : February 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence||Other: Rectal Balloon Training Other: Pelvic floor muscle training (PFMT)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2B Study of Rectal Ballooning Training in Female Urinary Incontinence|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||October 2011|
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.
- 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.
- Clinical symptoms [ Time Frame: At the first time then 6 weeks later ]Clinical symptoms are assessed from questionaire and one-hour pad test
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01245153
|Principal Investigator:||Natthiya Tantisiriwat||King Chulalongkorn Memorial Hospital|