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Completed

NCT Number: NCT01628991

Behavioral Intervention Program and Vaginal Cones on SUI

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioural program

Behavioral

interventional behavioural program

Other names: bladder training program, exercise therapy

Iranian version of vaginal cones

Device

intravaginal device(vaginal cone) for promote the pelvic floor exercises

Other names: intravaginal cones with different weights,Physical Therapy

Primary outcomes

  1. severity of Stress Urinary Incontinence

    Time frame: three months

Secondary outcomes

  1. Quality of life

    Time frame: three months

Sponsors and collaborators

Lead sponsor

Mashhad University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 27, 2012
Registry last updated
Jun 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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