NCT02220946UnknownNot Applicable
Effect of Vaginal Electrical Stimulation on Female Sexual Dysfunction
Kanuni Sultan Suleyman Training and Research Hospital2 sites in 2 countries54 target enrollmentStarted: January 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- Change from baseline in on domains and total score of Female Sexual Function Index (FSFI) at week 8
Study Overview
Brief Summary
vaginal electrical stimulation improves female sexual dysfunction
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •women with complaint of sexual dysfunction at any part of sexual cycle
Exclusion Criteria
- •pregnancy previous gynecologic surgery pelvic organ prolapsus greater than stage 1 women with neurological disease and anatomical defect women with anatomical defect
Arms & Interventions
plasebo
Placebo Comparator
sham electrical stimulation
Vaginal Electrical Stimulation
Active Comparator
A vaginal probe inserted, and a medium frequency (50 Hz) alternating current was administered for 5 seconds on, 5 seconds off the intensity of the current was started at 0 mA, and gradually increased until pelvic muscle contractions was observed, then increased according to patient tolerance. Each patient received a 20 minute session once a week for total 8 sessions
Intervention: Vaginal Electrical Stimulation (Device)
Outcomes
Primary Outcomes
Change from baseline in on domains and total score of Female Sexual Function Index (FSFI) at week 8
Time Frame: Baseline, Week 8
Secondary Outcomes
- Change from baseline in power, endurance, dynamic endurance and fast contractions on the PERFECT scheme at week 8(Baseline, Week 8)
Investigators
serdar aydin
MD
Kanuni Sultan Suleyman Training and Research Hospital
Study Sites (2)
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