Behavioral Intervention Program and Vaginal Cones on SUI

Phase 2

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Behavioral: behavioural program; Device: Iranian version of vaginal cones

• Registration Number: NCT01628991
• Lead Sponsor: Mashhad University of Medical Sciences

Brief 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.

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2012-06
• Study First Submitted: 2012-06-17
• Study First Submitted QC: 2012-06-26
• Last Update Submitted: 2012-06-26
• Study First Posted: 2012-06-27
• Last Update Posted: 2012-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• symptoms of SUI , at least three episodes of stress incontinence per week
• Age 25-65
• body mass index (BMI) ≤ 30 kg/m2
• physical health

Exclusion Criteria

• chronic degenerative diseases affected on muscular and nerve tissues
• vulvovaginitis, atrophic vaginitis,
• pregnancy
• active or recurrent urinary tract infections
• advanced genital prolepses
• patients with cardiac pacemakers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
behavioural intervention	behavioural program	Recieving interventional behavioural program
vaginal cone	Iranian version of vaginal cones	intravaginal device insertion(vaginal cone)

Primary Outcome Measures

Name	Time	Method
severity of Stress Urinary Incontinence	three months

Secondary Outcome Measures

Name	Time	Method
Quality of life	three months

Trial Locations

Locations (1)

Mashhad university of medical science; 🇮🇷 Mashhad, Iran, Islamic Republic of