NCT01628991

Behavioral Intervention Program and Vaginal Cones on SUI

Comparison of the Effect of Vaginal Cones and Behavioral Intervention Program on Urinary Stress Incontinence in Women

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mashhad University of Medical Sciences · Academic / Other
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is a single blind randomized clinical trial to compare the efficacy of a behavioral intervention program versus vaginal cones on Stress Urinary Incontinence (SUI).

Detailed description

Detailed Description: In this single-blind randomized clinical trial, 60 women aged 25-65 yrs with stress urinary incontinence were randomly divided in two groups by blocked randomization method; behavioral intervention program (n=30) and insertion vaginal device,vaginal cones (n=30). Women in behavioral intervention group were instructed for pelvic floor exercise and bladder control strategies. Other group was allocated to use vaginal cones. They were treated for 12 weeks and followed up every 2 weeks. The subjective changes in severity of SUI were measured using a Detection SUI Severity Questionnaire and leakage index and 3-day urinary dairy. The objective changes were measured by pad test. These two groups were then compared according to the scores of special questionnaires for quality of life, strength of pelvic floor muscles, capability to participate in social activities, severity of urinary incontinence, and the number of involuntary urine passage, taken before, and after 1 and 3 months after finishing interventions. Data analysis will be done through descriptive and perceptive statistical methods by using SPSS.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
BEHAVIORAL	behavioural program	interventional behavioural program
DEVICE	Iranian version of vaginal cones	intravaginal device(vaginal cone) for promote the pelvic floor exercises

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2012-06-27
• Last updated: 2012-06-27

Locations

1 site across 1 country: Iran