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

History of Changes

Tracking Information
First Received Date ^ICMJE	November 17, 2010
Last Updated Date	November 19, 2010
Start Date ^ICMJE	November 2010
Estimated Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 19, 2010)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01245153 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 19, 2010)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Rectal Balloon Training in Female Urinary Incontinence
Official Title ^ICMJE	Phase 2B Study of Rectal Ballooning Training in Female Urinary Incontinence
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Urinary Incontinence
Intervention ^ICMJE	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.
Study Arm (s)	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)
Publications *	Sung MS, Hong JY, Choi YH, Baik SH, Yoon H. FES-biofeedback versus intensive pelvic floor muscle exercise for the prevention and treatment of genuine stress incontinence. J Korean Med Sci. 2000 Jun;15(3):303-8. Bols EM, Berghmans BC, Hendriks EJ, de Bie RA, Melenhorst J, van Gemert WG, Baeten CG. A randomized physiotherapy trial in patients with fecal incontinence: design of the PhysioFIT-study. BMC Public Health. 2007 Dec 20;7:355. Whitehead WE, Burgio KL, Engel BT. Biofeedback treatment of fecal incontinence in geriatric patients. J Am Geriatr Soc. 1985 May;33(5):320-4. De Paepe H, Renson C, Van Laecke E, Raes A, Vande Walle J, Hoebeke P. Pelvic-floor therapy and toilet training in young children with dysfunctional voiding and obstipation. BJU Int. 2000 May;85(7):889-93. Dannecker C, Wolf V, Raab R, Hepp H, Anthuber C. EMG-biofeedback assisted pelvic floor muscle training is an effective therapy of stress urinary or mixed incontinence: a 7-year experience with 390 patients. Arch Gynecol Obstet. 2005 Dec;273(2):93-7. Epub 2005 Jul 6. Cammu H, Van Nylen M. Pelvic floor exercises versus vaginal weight cones in genuine stress incontinence. Eur J Obstet Gynecol Reprod Biol. 1998 Mar;77(1):89-93. Bø K, Talseth T, Holme I. Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women. BMJ. 1999 Feb 20;318(7182):487-93. Dumoulin C, Hay-Smith J. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD005654. Review. Bunyavejchevin S. Risk factors of female urinary incontinence and overactive bladder in Thai postmenopausal women. J Med Assoc Thai. 2005 Sep;88 Suppl 4:S119-23. Sakondhavat C, Choosuwan C, Kaewrudee S, Soontrapa S, Louanka K. Prevalence and risk factors of urinary incontinence in Khon Kaen menopausal women. J Med Assoc Thai. 2007 Dec;90(12):2553-8. Panugthong P, Chulyamitporn T, Tanapat Y. Prevalence and risk factors of urinary incontinence in Thai menopausal women at Phramongkutklao Hospital. J Med Assoc Thai. 2005 Nov;88 Suppl 3:S25-30. Manonai J, Poowapirom A, Kittipiboon S, Patrachai S, Udomsubpayakul U, Chittacharoen A. Female urinary incontinence: a cross-sectional study from a Thai rural area. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Jun;17(4):321-5. Epub 2005 Sep 24. Minassian VA, Drutz HP, Al-Badr A. Urinary incontinence as a worldwide problem. Int J Gynaecol Obstet. 2003 Sep;82(3):327-38. Review.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	60
Estimated Completion Date	October 2011
Estimated Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	25 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Thailand

Administrative Information
NCT Number ^ICMJE	NCT01245153
Other Study ID Numbers ^ICMJE	REHAB_201011
Has Data Monitoring Committee	Yes
Responsible Party	Deparment of Rehabilitation Medicine, Faculty of Medicine,, Chulalongkorn university
Study Sponsor ^ICMJE	Chulalongkorn University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Chulalongkorn University
Verification Date	November 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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