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Completed

NCT Number: NCT01245153

Rectal Balloon 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

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

25 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rectal Balloon Training

Other

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

pelvic floor muscle training (PFMT)

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Clinical symptoms

    Time frame: At the first time then 6 weeks later

    Clinical symptoms are assessed from questionaire and one-hour pad test

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 22, 2010
Registry last updated
Feb 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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