Behavioral Intervention Program versus Vaginal Cones on Stress Urinary Incontinence and Related Quality of Life: A Randomized Clinical Trial.
OBJECTIVE
To compare the efficacy of behavioral intervention program and vaginal cones on stress urinary incontinence.


METHODS
In this randomized clinical trial, 60 women aged 25-65 years with stress urinary incontinence were randomly divided into two groups, those who participated in a behavioral intervention program (n=30) and those who used vaginal cones (n=30). The women in the behavioral intervention group were instructed on pelvic floor exercise and bladder control strategies. In the other group, pelvic floor exercises were performed using the vaginal cones. All participants were treated for 12 weeks and followed-up every 2 weeks. The subjective changes in severity of stress urinary incontinence were measured using a detection stress urinary incontinence severity questionnaire, leakage index, and a 3-day urinary diary. The objective changes were measured by pad test. For better evaluation of the effects, two questionnaires were used: Incontinence Quality of Life and King's Health Questionnaire.


RESULTS
Among the 51 women who completed the study, 25 subjects were in the vaginal cones group and 26 participated in the behavioral intervention program. The changes in leakage rate on pad test and leakage index in the behavioral intervention program group were significantly higher than in the vaginal cones group (p=0.001 and p=0.008, respectively), but the severity of stress urinary incontinence was not significantly different between the two groups (p=0.2). The changes in strength of the pelvic floor, Incontinence Quality of Life, and King's Health Questionnaire scores showed no significant differences between the two groups after 12 weeks of intervention.


CONCLUSIONS
Vaginal cones and behavioral intervention programs are both effective methods of treatment for mild to moderate stress urinary incontinence, but the behavioral intervention program is superior to vaginal cones in terms of cost-effectiveness and side effects.
Master of Science in Midwifery, Lecturer and Faculty Member of Department of Midwifery, School of Nursing & Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.
Nahid
N
Golmakani
Professor of Obstetrics and Gynecology, Women's Health Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
Nayereh
N
Khadem
Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Arezoo
A
Arabipoor
Department of Urology, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.
Behzad Feizzadeh
BF
Kerigh
Associate Professor of Health Sciences Research Center, Department of Biostatistics and Epidemiology, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran.
Habibollah
H
Esmaily
Behavioral intervention program; Stress urinary incontinence; Vaginal cones