Behavioral Intervention Program and Vaginal Cones on SUI
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
behavioural program
Iranian version of vaginal cones
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Behavioral Intervention Program, Vaginal Cones, Stress Urinary Incontinence, treatment, Women
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
Sites / Locations
- Mashhad university of medical science
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
behavioural intervention
vaginal cone
Arm Description
Recieving interventional behavioural program
intravaginal device insertion(vaginal cone)
Outcomes
Primary Outcome Measures
severity of Stress Urinary Incontinence
Secondary Outcome Measures
Quality of life
Full Information
NCT ID
NCT01628991
First Posted
June 17, 2012
Last Updated
June 26, 2012
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01628991
Brief Title
Behavioral Intervention Program and Vaginal Cones on SUI
Official Title
Comparison of the Effect of Vaginal Cones and Behavioral Intervention Program on Urinary Stress Incontinence in Women
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Behavioral Intervention Program, Vaginal Cones, Stress Urinary Incontinence, treatment, Women
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
behavioural intervention
Arm Type
Experimental
Arm Description
Recieving interventional behavioural program
Arm Title
vaginal cone
Arm Type
Experimental
Arm Description
intravaginal device insertion(vaginal cone)
Intervention Type
Behavioral
Intervention Name(s)
behavioural program
Other Intervention Name(s)
bladder training program, exercise therapy
Intervention Description
interventional behavioural program
Intervention Type
Device
Intervention Name(s)
Iranian version of vaginal cones
Other Intervention Name(s)
intravaginal cones with different weights,Physical Therapy
Intervention Description
intravaginal device(vaginal cone) for promote the pelvic floor exercises
Primary Outcome Measure Information:
Title
severity of Stress Urinary Incontinence
Time Frame
three months
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
three months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nahid golmakani, M.Sc.
Organizational Affiliation
Mashhad university of medical science, faculty of nursing and midwifery, Mashhad, Iran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nayereh khadem, M.D.
Organizational Affiliation
Mashhad university of medical science, Mashhad, Iran
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Arezoo Arabipoor, M.Sc.
Organizational Affiliation
Mashhad university of science, faculty of nursing and midwifery, Mashhad, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mashhad university of medical science
City
Mashhad
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
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Behavioral Intervention Program and Vaginal Cones on SUI
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