Overview

This trial is active, not recruiting.

Condition female sexual dysfunction
Treatment vaginal electrical stimulation
Sponsor Kanuni Sultan Suleyman Training and Research
Collaborator Bezmialem Vakif University
Start date January 2014
End date September 2014
Trial size 54 participants
Trial identifier NCT02220946, EVESFDS

Summary

vaginal electrical stimulation improves female sexual dysfunction

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(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
vaginal electrical stimulation MyoBravo Electrical Stimulation Device
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 session
(Placebo Comparator)
sham electrical stimulation

Primary Outcomes

Measure
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

Measure
Change from baseline in power, endurance, dynamic endurance and fast contractions on the PERFECT scheme at week 8
time frame: Baseline, Week 8

Eligibility Criteria

Female participants from 18 years up to 80 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Kanuni Sultan Suleyman Training and Research.