Effect of Vaginal Electrical Stimulation on Female Sexual Dysfunction

NCT ID: NCT02220946

Last Updated: 2014-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-10-31

Brief Summary

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vaginal electrical stimulation improves female sexual dysfunction

Detailed Description

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Conditions

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Female Sexual Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Vaginal Electrical Stimulation

Intervention Type 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

plasebo

sham electrical stimulation

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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MyoBravo Electrical Stimulation Device

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role collaborator

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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serdar aydin

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Obstetric and Gynecology, Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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EVESFDS

Identifier Type: -

Identifier Source: org_study_id

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