Behavioral Intervention Program and Vaginal Cones on SUI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
nahid golmakani, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01628991
First received: June 17, 2012
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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).


Condition Intervention Phase
Stress Urinary Incontinence
Behavioral: behavioural program
Device: Iranian version of vaginal cones
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of the Effect of Vaginal Cones and Behavioral Intervention Program on Urinary Stress Incontinence in Women

Resource links provided by NLM:


Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • severity of Stress Urinary Incontinence [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: April 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: behavioural intervention
Recieving interventional behavioural program
Behavioral: behavioural program
interventional behavioural program
Other Name: 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 Name: intravaginal cones with different weights,Physical Therapy

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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628991

Locations
Iran, Islamic Republic of
Mashhad university of medical science
Mashhad, Iran, Islamic Republic of
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: nahid golmakani, Faculty member,MSc of Midwifery, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01628991     History of Changes
Other Study ID Numbers: clinical trial
Study First Received: June 17, 2012
Last Updated: June 26, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Mashhad University of Medical Sciences:
Behavioral Intervention Program
Vaginal Cones
Stress Urinary Incontinence
treatment
Women

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014