Behavioral Intervention Program and Vaginal Cones on SUI

Comparison of the Effect of Vaginal Cones and Behavioral Intervention Program on Urinary Stress Incontinence in Women

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01628991

Enrollment

Registered

2012-06-27

Start date

2008-04-30

Completion date

2009-08-31

Last updated

2012-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

Keywords

Behavioral Intervention Program, Vaginal Cones, Stress Urinary Incontinence, treatment, Women

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.

Interventions

BEHAVIORALbehavioural program

interventional behavioural program

DEVICEIranian version of vaginal cones

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
severity of Stress Urinary Incontinence	three months

Secondary

Measure	Time frame
Quality of life	three months

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026