Clinical trial NCT01628991: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stress Urinary Incontinence
Keywords: Behavioral Intervention Program
Vaginal Cones
Stress Urinary Incontinence
treatment
Women
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: severity of Stress Urinary Incontinence
timeFrame: three months
Secondary outcomes:
measure: Quality of life
timeFrame: three months
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad university of medical science
Study officials:
affiliation: Mashhad university of medical science, faculty of nursing and midwifery, Mashhad, Iran
name: Nahid golmakani, M.Sc.
role: STUDY_DIRECTOR
affiliation: Mashhad university of medical science, Mashhad, Iran
name: Nayereh khadem, M.D.
role: STUDY_CHAIR
affiliation: Mashhad university of science, faculty of nursing and midwifery, Mashhad, Iran
name: Arezoo Arabipoor, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: