NCT02220946

Brief Summary

vaginal electrical stimulation improves female sexual dysfunction

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

August 20, 2014

Status Verified

August 1, 2014

Enrollment Period

8 months

First QC Date

August 17, 2014

Last Update Submit

August 19, 2014

Conditions

Female Sexual Dysfunction

Keywords

Vaginal Electrical Stimulation

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in on domains and total score of Female Sexual Function Index (FSFI) at week 8

    Baseline, Week 8

Secondary Outcomes (1)

  • Change from baseline in power, endurance, dynamic endurance and fast contractions on the PERFECT scheme at week 8

    Baseline, Week 8

Study Arms (2)

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

Device: Vaginal Electrical Stimulation

plasebo

PLACEBO COMPARATOR

sham electrical stimulation

Interventions

Vaginal Electrical StimulationDEVICE

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

Also known as: MyoBravo Electrical Stimulation Device
Vaginal Electrical Stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women with complaint of sexual dysfunction at any part of sexual cycle

You may not qualify if:

  • pregnancy previous gynecologic surgery pelvic organ prolapsus greater than stage 1 women with neurological disease and anatomical defect women with anatomical defect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetric and Gynecology, Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 17, 2014

First Posted

August 20, 2014

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

August 20, 2014

Record last verified: 2014-08

Locations

TU(1)