Behavioral Intervention Program and Vaginal Cones on SUI

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628991
• Other study ID #: clinical trial
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 17, 2012
• Last updated: June 26, 2012
• Start date: April 2008
• Est. completion date: August 2009

Study information

• Verified date: June 2012
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Behavioral:
• behavioural program
interventional behavioural program

Device:
• Iranian version of vaginal cones
intravaginal device(vaginal cone) for promote the pelvic floor exercises

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mashhad university of medical science	Mashhad

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of Stress Urinary Incontinence		three months	Yes
Secondary	Quality of life		three months	Yes