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Rectal Balloon Training in Female Urinary Incontinence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Natthiya Tantisiriwat, MD, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01245153
First received: November 17, 2010
Last updated: January 31, 2016
Last verified: January 2016
  Purpose
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

Condition Intervention Phase
Urinary Incontinence
Other: Rectal Balloon Training
Other: Pelvic floor muscle training (PFMT)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2B Study of Rectal Ballooning Training in Female Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 28
Study Start Date: November 2010
Study Completion Date: October 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245153

Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Natthiya Tantisiriwat King Chulalongkorn Memorial Hospital
  More Information

Publications:

Responsible Party: Natthiya Tantisiriwat, MD, Assist (hon), Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01245153     History of Changes
Other Study ID Numbers: REHAB_201011 
Study First Received: November 17, 2010
Last Updated: January 31, 2016
Health Authority: Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:
Urinary incontinence, Pelvic floor muscle training

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2016