Rectal Balloon Training in Female Urinary Incontinence

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01245153

Enrollment

Registered

2010-11-22

Start date

2010-11-30

Completion date

2011-10-31

Last updated

2016-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Keywords

Urinary incontinence, Pelvic floor muscle training

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.

Interventions

OTHERRectal 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

OTHERPelvic floor muscle training (PFMT)

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Pelvic floor muscle strength	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

Measure	Time frame	Description
Clinical symptoms	At the first time then 6 weeks later	Clinical symptoms are assessed from questionaire and one-hour pad test

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026