Behavioral Intervention Program and Vaginal Cones on SUI

Mashhad University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Stress Urinary Incontinence

Treatments: Behavioral: behavioural program; Device: Iranian version of vaginal cones

Study type: Interventional

Funder types: Other

Identifiers

NCT01628991

clinical trial

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

behavioural intervention

Experimental group

Description:

Recieving interventional behavioural program

Treatment:

Behavioral: behavioural program

vaginal cone

Experimental group

Description:

intravaginal device insertion(vaginal cone)

Treatment:

Device: Iranian version of vaginal cones