Behavioral Intervention Program and Vaginal Cones on SUI

June 26, 2012 updated by: nahid golmakani, Mashhad University of Medical Sciences

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
severity of Stress Urinary Incontinence
Time Frame: three months
three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: three months
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Investigators

  • Study Director: Nahid golmakani, M.Sc., Mashhad university of medical science, faculty of nursing and midwifery, Mashhad, Iran
  • Study Chair: Nayereh khadem, M.D., Mashhad university of medical science, Mashhad, Iran
  • Principal Investigator: Arezoo Arabipoor, M.Sc., Mashhad university of science, faculty of nursing and midwifery, Mashhad, Iran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

June 17, 2012

First Submitted That Met QC Criteria

June 26, 2012

First Posted (Estimate)

June 27, 2012

Study Record Updates

Last Update Posted (Estimate)

June 27, 2012

Last Update Submitted That Met QC Criteria

June 26, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • clinical trial (Registry Identifier: Minia University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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