Behavioral Intervention Program and Vaginal Cones on SUI

NCT ID: NCT01628991

Last Updated: 2012-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-08-31

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).

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

behavioural intervention

Recieving interventional behavioural program

Group Type: EXPERIMENTAL

behavioural program

Intervention Type: BEHAVIORAL

interventional behavioural program

vaginal cone

intravaginal device insertion(vaginal cone)

Group Type: EXPERIMENTAL

Iranian version of vaginal cones

Intervention Type: DEVICE

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

Interventions

behavioural program

interventional behavioural program

Intervention Type: BEHAVIORAL

Iranian version of vaginal cones

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

Intervention Type: DEVICE

Other Intervention Names

bladder training program, exercise therapy; intravaginal cones with different weights,Physical Therapy

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mashhad University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

nahid golmakani

Faculty member,MSc of Midwifery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nahid golmakani, M.Sc.

Role: STUDY_DIRECTOR

Mashhad university of medical science, faculty of nursing and midwifery, Mashhad, Iran

Nayereh khadem, M.D.

Role: STUDY_CHAIR

Mashhad university of medical science, Mashhad, Iran

Arezoo Arabipoor, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Mashhad university of science, faculty of nursing and midwifery, Mashhad, Iran

Locations

Mashhad university of medical science

Mashhad, , Iran

Countries

Iran

Other Identifiers

clinical trial

Identifier Type: -

Identifier Source: org_study_id