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Rectal Balloon Training in Female Urinary Incontinence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Chulalongkorn University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01245153
First received: November 17, 2010
Last updated: November 19, 2010
Last verified: November 2010

November 17, 2010
November 19, 2010
November 2010
May 2011   (final data collection date for primary outcome measure)
Pelvic floor muscle strength [ Time Frame: Change from baseline in pelvic floor muscle strength at 6 weeks ] [ Designated as safety issue: Yes ]
Pelvic floor muscle strength will be assessed by biofeedback and recorded in unit of mmHg.
Same as current
Complete list of historical versions of study NCT01245153 on ClinicalTrials.gov Archive Site
Clinical symptoms [ Time Frame: At the first time then 6 weeks later ] [ Designated as safety issue: Yes ]
Clinical symptoms are assessed from questionaire and one-hour pad test
Same as current
Not Provided
Not Provided
 
Rectal Balloon Training in Female Urinary Incontinence
Phase 2B Study of Rectal Ballooning Training in Female Urinary Incontinence

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Urinary Incontinence
  • 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.
  • 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.
    Intervention: Other: Rectal Balloon Training
  • Active Comparator: Control group
    Patients receive Pelvic floor muscle training without inserting any kinds of equipment.
    Intervention: Other: Pelvic floor muscle training (PFMT)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
October 2011
May 2011   (final data collection date for primary outcome measure)

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
Female
25 Years to 70 Years
No
Thailand
 
NCT01245153
REHAB_201011
Yes
Deparment of Rehabilitation Medicine, Faculty of Medicine,, Chulalongkorn university
Chulalongkorn University
Not Provided
Not Provided
Chulalongkorn University
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP