Behavioral Intervention Program and Vaginal Cones on SUI

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Behavioral: behavioural program
* Device: Iranian version of vaginal cones


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: behavioural intervention<br>Recieving interventional behavioural program | Behavioral: behavioural program<br>* interventional behavioural program<br>* Other names: bladder training program, exercise therapy;|
| Experimental: vaginal cone<br>intravaginal device insertion(vaginal cone) | Device: Iranian version of vaginal cones<br>* intravaginal device(vaginal cone) for promote the pelvic floor exercises<br>* Other names: intravaginal cones with different weights,Physical Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of Stress Urinary Incontinence |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral Intervention Program, Vaginal Cones, Stress Urinary Incontinence, treatment, Women