Treatment for Female Stress Urinary Incontinence

NCT00270738 | Completed DMC

• 1 other identifier: 9461700665
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary incontinence (UI) is the complaint of any involuntary leakage of urine. Stress urinary incontinence (SUI) is the complaint of involuntary leakage on effort or exertion, or on sneezing or coughing. The prevalence of female UI is greater than that of male, and the commonest type is SUI. UI has significant impact on the quality of life including physical, mental and social issues. SUI may also lead to withdraw from regular physical exercise and fitness activities that important in the prevention of osteoporosis, coronary heart disease, and so on. The cause of SUI is related to the impairment of pelvic floor muscles (PFM). So far, the effects of intensive pelvic floor muscle training for female SUI were proved in many randomized controlled trials. However, training of accurate contraction of PFM depends on vaginal palpation. The willingness to seek for medical help may be reduced due to being embarrassed with vaginal palpation. Sapsford proposed a concept to treat SUI via transversus abdominis (TrA) that does not need to palpate the vagina. Maybe the new intervention can promote the willingness to seek medical help. However, to date there is no randomized controlled trial comparing the effect of indirect training of the PFM via TrA with either untreated control or other intervention. Therefore, there are two purposes in this study, to compare the effect of indirect training of PFM via TrA with control group and to compare the effect of indirect training of PFM via TrA with PFMT for female SUI.

Conditions

Female Urinary Incontinence

Keywords

urinary incontinence; transversus abdominis; pelvic floor muscles; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• women's observations

  4 months

Secondary Outcomes (3)

• quantification of symptoms

  4 months

• clinical measures

  4 months

• quality of life

  4 months

Study Arms (3)

1

EXPERIMENTAL

TrA training group

Procedure: Indirect training of the PFMs via transversus abdominis

2

ACTIVE COMPARATOR

PFMT group

Procedure: pelvic floor muscle training

3

ACTIVE COMPARATOR

control group (PFM exercise at home)

Procedure: home exercise

Interventions

Indirect training of the PFMs via transversus abdominis PROCEDURE

Individual visit: twice a month for 4 months. Exercise regimen: diaphragmatic breathing, tonic activation, muscle strengthening, functional expiratory patterns, and impact activities.

Also known as: TrA training

1

pelvic floor muscle training PROCEDURE

Individual visit: twice a month for 4 months. Exercise: intensive pelvic floor muscle training

Also known as: PFMT

2

home exercise PROCEDURE

PFM exercise at home: at least six high-intensity (near-maximum) contractions 3 times per day at home, with an aim at holding each muscle contraction for 10 seconds, with at least a 10-second rest between contractions.

3

Eligibility Criteria

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

You may qualify if:

• female with stress urinary incontinence episodes during last month

You may not qualify if:

• Systemic neuromuscular disease
• Previous medication、surgery、PFMT for urinary incontinence
• Previous surgery of bladder or low back
• RAH
• During pregnancy or after childbirth\<3 m/o
• Severe prolapse of bladder or uterus

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (2)

• Hung HC, Chih SY, Lin HH, Tsauo JY. Exercise adherence to pelvic floor muscle strengthening is not a significant predictor of symptom reduction for women with urinary incontinence. Arch Phys Med Rehabil. 2012 Oct;93(10):1795-800. doi: 10.1016/j.apmr.2012.03.010. Epub 2012 Mar 23.

  PMID: 22446154 DERIVED

• Hung HC, Hsiao SM, Chih SY, Lin HH, Tsauo JY. Effect of pelvic-floor muscle strengthening on bladder neck mobility: a clinical trial. Phys Ther. 2011 Jul;91(7):1030-8. doi: 10.2522/ptj.20100186. Epub 2011 May 12.

  PMID: 21566065 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

• Jau-Yih Tsauo, PhD

  Graduate School of Physical Therapy, College of Medicine, NTU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2005
• First Posted: December 28, 2005
• Study Start: December 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: March 1, 2010
• Last Updated: December 6, 2012

Record last verified: 2012-12

Locations

TW (1)