Effect of Vaginal Electrical Stimulation on Female Sexual Dysfunction

Female Sexual Dysfunction Clinical Trial

— EVESOFS  

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02220946
• Other study ID #: EVESFDS
• Status: Active, not recruiting
• Phase: N/A
• First received: August 17, 2014
• Last updated: August 19, 2014
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: August 2014
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

vaginal electrical stimulation improves female sexual dysfunction

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Female Sexual Dysfunction

Intervention

Device:
• Vaginal Electrical Stimulation
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

Locations

Country	Name	City	State
Turkey	Department of Obstetric and Gynecology, Bezmialem Vakif University	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital	Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in on domains and total score of Female Sexual Function Index (FSFI) at week 8		Baseline, Week 8	Yes
Secondary	Change from baseline in power, endurance, dynamic endurance and fast contractions on the PERFECT scheme at week 8		Baseline, Week 8	Yes