Behavioral Intervention Program and Vaginal Cones on SUI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01628991
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : June 27, 2012
Information provided by (Responsible Party):
nahid golmakani, Mashhad University of Medical Sciences

Brief 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).

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

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of the Effect of Vaginal Cones and Behavioral Intervention Program on Urinary Stress Incontinence in Women
Study Start Date : April 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. severity of Stress Urinary Incontinence [ Time Frame: three months ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: three months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01628991

Iran, Islamic Republic of
Mashhad university of medical science
Mashhad, Iran, Islamic Republic of
Sponsors and Collaborators
Mashhad University of Medical Sciences
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

Responsible Party: nahid golmakani, Faculty member,MSc of Midwifery, Mashhad University of Medical Sciences Identifier: NCT01628991     History of Changes
Other Study ID Numbers: clinical trial
First Posted: June 27, 2012    Key Record Dates
Last Update Posted: June 27, 2012
Last Verified: June 2012

Keywords provided by nahid golmakani, Mashhad University of Medical Sciences:
Behavioral Intervention Program
Vaginal Cones
Stress Urinary Incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders