Rectal Balloon Training in Female Urinary Incontinence

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245153
• Other study ID #: REHAB_201011
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2010
• Last updated: January 31, 2016
• Start date: November 2010
• Est. completion date: October 2011

Study information

• Verified date: January 2016
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1002/14651858.CD005654.pub2. Review. Update in: Cochrane Database Syst Rev. 2014;5:CD005654. — View Citation

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. — View Citation

Minassian VA, Drutz HP, Al-Badr A. Urinary incontinence as a worldwide problem. Int J Gynaecol Obstet. 2003 Sep;82(3):327-38. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Whitehead WE, Burgio KL, Engel BT. Biofeedback treatment of fecal incontinence in geriatric patients. J Am Geriatr Soc. 1985 May;33(5):320-4. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic floor muscle strength	Pelvic floor muscle strength will be assessed by biofeedback and recorded in unit of mmHg.	Change from baseline in pelvic floor muscle strength at 6 weeks	Yes
Secondary	Clinical symptoms	Clinical symptoms are assessed from questionaire and one-hour pad test	At the first time then 6 weeks later	Yes