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Rectal Balloon Training in Female Urinary Incontinence

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Rectal Balloon Training
Pelvic floor muscle training (PFMT)
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary incontinence, Pelvic floor muscle training

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Rectal Balloon Training

    Control group

    Arm Description

    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.

    Patients receive Pelvic floor muscle training without inserting any kinds of equipment.

    Outcomes

    Primary Outcome Measures

    Pelvic floor muscle strength
    Pelvic floor muscle strength will be assessed by biofeedback and recorded in unit of mmHg.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    November 17, 2010
    Last Updated
    January 31, 2016
    Sponsor
    Chulalongkorn University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01245153
    Brief Title
    Rectal Balloon Training in Female Urinary Incontinence
    Official Title
    Phase 2B Study of Rectal Ballooning Training in Female Urinary Incontinence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2010 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    October 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chulalongkorn University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Incontinence
    Keywords
    Urinary incontinence, Pelvic floor muscle training

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rectal Balloon Training
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Patients receive Pelvic floor muscle training without inserting any kinds of equipment.
    Intervention Type
    Other
    Intervention Name(s)
    Rectal Balloon Training
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Pelvic floor muscle training (PFMT)
    Intervention Description
    Standard pelvic floor muscle exercise (Pelvic floor muscle training;PFMT) is assigned for 6 weeks.
    Primary Outcome Measure Information:
    Title
    Pelvic floor muscle strength
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Clinical symptoms
    Description
    Clinical symptoms are assessed from questionaire and one-hour pad test
    Time Frame
    At the first time then 6 weeks later

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Natthiya Tantisiriwat
    Organizational Affiliation
    King Chulalongkorn Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    18096041
    Citation
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    result

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    Rectal Balloon Training in Female Urinary Incontinence

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