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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: 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| behavioural intervention | Experimental | Recieving interventional behavioural program |
|
| vaginal cone | Experimental | intravaginal device insertion(vaginal cone) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| behavioural program | Behavioral | interventional behavioural program |
|
| Measure | Description | Time Frame |
|---|---|---|
| severity of Stress Urinary Incontinence | three months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nahid golmakani, M.Sc. | Mashhad university of medical science, faculty of nursing and midwifery, Mashhad, Iran | Study Director |
| Nayereh khadem, M.D. | Mashhad university of medical science, Mashhad, Iran | Study Chair |
| Arezoo Arabipoor, M.Sc. | Mashhad university of science, faculty of nursing and midwifery, Mashhad, Iran | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mashhad university of medical science | Mashhad | Iran |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Iranian version of vaginal cones | Device | intravaginal device(vaginal cone) for promote the pelvic floor exercises |
|
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |