Behavioral Intervention Program and Vaginal Cones on SUI

Sponsor

Mashhad University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01628991

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

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).

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 Design

Study Type:

Interventional

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 :

Apr 1, 2008

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: behavioural intervention Recieving interventional behavioural program	Behavioral: behavioural program interventional behavioural program Other Names: 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 Names: intravaginal cones with different weights,Physical Therapy

Arm

Intervention/Treatment

Experimental: behavioural intervention

Recieving interventional behavioural program

Behavioral: behavioural program

interventional behavioural program

Other Names:

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 Names:

intravaginal cones with different weights,Physical Therapy

Outcome Measures

Primary Outcome Measures

severity of Stress Urinary Incontinence [three months]

Secondary Outcome Measures

Quality of life [three months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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