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Effect of Vaginal Electrical Stimulation on Female Sexual Dysfunction (EVESOFS)

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ClinicalTrials.gov Identifier: NCT02220946
Recruitment Status : Unknown
Verified August 2014 by serdar aydin, Kanuni Sultan Suleyman Training and Research.
Recruitment status was:  Active, not recruiting
First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
vaginal electrical stimulation improves female sexual dysfunction

Condition or disease Intervention/treatment
Female Sexual Dysfunction Device: Vaginal Electrical Stimulation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2014
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : October 2014
Arms and Interventions

Arm Intervention/treatment
Active Comparator: 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 sessions
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
Other Name: MyoBravo Electrical Stimulation Device
Placebo Comparator: plasebo
sham electrical stimulation


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in on domains and total score of Female Sexual Function Index (FSFI) at week 8 [ Time Frame: Baseline, Week 8 ]

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220946


Locations
Turkey
Department of Obstetric and Gynecology, Bezmialem Vakif University
İstanbul, Turkey, 34093
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
Bezmialem Vakif University
More Information

Responsible Party: serdar aydin, MD, Kanuni Sultan Suleyman Training and Research
ClinicalTrials.gov Identifier: NCT02220946     History of Changes
Other Study ID Numbers: EVESFDS
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014

Keywords provided by serdar aydin, Kanuni Sultan Suleyman Training and Research:
Vaginal Electrical Stimulation