Rectal Balloon Training in Female Urinary Incontinence

NCT01245153 | Completed Phase 2 DMC

• 1 other identifier: REHAB_201011
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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

Conditions

Urinary Incontinence

Keywords

Urinary incontinence, Pelvic floor muscle training

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Clinical symptoms

  At the first time then 6 weeks later

Study Arms (2)

Rectal Balloon Training

EXPERIMENTAL

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.

Other: Rectal Balloon Training

Control group

ACTIVE COMPARATOR

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

Other: Pelvic floor muscle training (PFMT)

Interventions

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

Rectal Balloon Training

Pelvic floor muscle training (PFMT) OTHER

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

Control group

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Age 25 - 70 years
• Have urinary incontinence problem
• Follow command
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Related Publications (14)

• 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. doi: 10.1186/1471-2458-7-355.

  PMID: 18096041 BACKGROUND

• Whitehead WE, Burgio KL, Engel BT. Biofeedback treatment of fecal incontinence in geriatric patients. J Am Geriatr Soc. 1985 May;33(5):320-4. doi: 10.1111/j.1532-5415.1985.tb07130.x.

  PMID: 3989196 BACKGROUND

• 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. doi: 10.1046/j.1464-410x.2000.00664.x.

  PMID: 10792172 BACKGROUND

• 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. doi: 10.1007/s00404-005-0011-4. Epub 2005 Jul 6.

  PMID: 16001201 BACKGROUND

• 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. doi: 10.1016/s0301-2115(97)00237-6.

  PMID: 9550207 BACKGROUND

• Bo 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. doi: 10.1136/bmj.318.7182.487.

  PMID: 10024253 BACKGROUND

• 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.

  PMID: 20091581 BACKGROUND

• 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.

  PMID: 16623015 BACKGROUND

• 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.

  PMID: 18386703 BACKGROUND

• 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.

  PMID: 16858941 BACKGROUND

• 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. doi: 10.1007/s00192-005-0002-9. Epub 2005 Sep 24.

  PMID: 16184317 BACKGROUND

• Minassian VA, Drutz HP, Al-Badr A. Urinary incontinence as a worldwide problem. Int J Gynaecol Obstet. 2003 Sep;82(3):327-38. doi: 10.1016/s0020-7292(03)00220-0.

  PMID: 14499979 BACKGROUND

• 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. doi: 10.3346/jkms.2000.15.3.303.

  PMID: 10895973 RESULT

• Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

  PMID: 39704322 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

• Natthiya Tantisiriwat

  King Chulalongkorn Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist (hon)

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 22, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 2, 2016

Record last verified: 2016-01