Comparison of low-energy radiofrequency thermal vaginal therapy vs. sham for female stress urinary incontinence: a randomized controlled trial
Phase 4
- Conditions
- Female stress urinary incontinenceradiofrequencynon-surgical SUI treatment
- Registration Number
- TCTR20181115004
- Lead Sponsor
- Ramathibodi Hospital, Mahidol University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
Inclusion criteria
-Postmenopausal women aged ≥ 50 years who suffers from mild to moderate SUI
-Last menstrual period more than 1 year
-Positive Q-tip test
-Never received transvaginal laser or radiofrequency treatment
-Never undergone anti-incontinence procedures
-Did not use vaginal estrogen within 3 months
-Informed consent
Exclusion Criteria
Pelvic organ prolapse of anterior compartment stage 3 and 4
-Urinary retention
-obesity (body mass index >35 kg/m2)
-Urinary tract infection
- Severe SUI which illustrated with more than 2 pads used per day or 1-hour pad test more than 50 mL/h
-Photosensitivity
-Using HRT
-Had contraindication for estrogen
-Undiagnosed abnormal vaginal bleeding
-Taking corticosteroid, or immunosuppresants
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method female stress urinary incontinence pre-treatment,1 month, 3 months, 6 months, and 1 year post treatment 1-hour pad test
- Secondary Outcome Measures
Name Time Method voiding diary pre-treatment,1 month, 3 months, 6 months, and 1 year post treatment number and severity of SUI per day, number of pad/day,quality of life outcome by questionnaires pre-treatment,1 month, 3 months, 6 months, and 1 year post treatment IQOL, IIQ-7, and PGI-I,Adverse events pre-treatment,1 month, 3 months, 6 months, and 1 year post treatment incidence of adverse events related to treatment