Female Sexual DysfunctionEVESOFSNCT02220946
Effect of Vaginal Electrical Stimulation on Female Sexual Dysfunction
A study testing Vaginal Electrical Stimulation in people with Female Sexual Dysfunction, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
vaginal electrical stimulation improves female sexual dysfunction Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Female Sexual Dysfunction
- What is being tested?
- Vaginal Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women with complaint of sexual dysfunction at any part of sexual cycle
Who cannot join
- pregnancy previous gynecologic surgery pelvic organ prolapsus greater than stage 1 women with neurological disease and anatomical defect women with anatomical defect
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Obstetric and Gynecology, Bezmialem Vakif University
Istanbul, 34093
About this study
vaginal electrical stimulation improves female sexual dysfunction
- Conditions
- Female Sexual Dysfunction
- Being tested
- Vaginal Electrical Stimulation
- Keywords
- Vaginal Electrical Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Electrical StimulationDevice
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Vaginal Electrical Stimulation |
| plasebo | Placebo comparator | sham electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in on domains and total score of Female Sexual Function Index (FSFI) at week 8
Measured: Baseline, Week 8
Secondary outcomes (1)
Change from baseline in power, endurance, dynamic endurance and fast contractions on the PERFECT scheme at week 8
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University
- Responsible party
- Principal investigator, serdar aydin, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220946
- Sponsor's protocol ID
- EVESFDS
- Acronym
- EVESOFS
- Status last verified
- Aug 2014
- First submitted
- 17 Aug 2014
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vaginal Electrical Stimulation on Female Sexual Dysfunction
- ClinicalTrials.gov ID
- NCT02220946
- Acronym / sponsor ID
- EVESOFS / EVESFDS
- Conditions
- Female Sexual Dysfunction
- Keywords
- Vaginal Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Collaborators
- Bezmialem Vakif University
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
vaginal electrical stimulation improves female sexual dysfunction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Electrical Stimulation | Active comparator | Device: Vaginal Electrical StimulationA 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 |
| plasebo | Placebo comparator | –sham electrical stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women with complaint of sexual dysfunction at any part of sexual cycle
Key exclusion criteria (1 listed)
- pregnancy previous gynecologic surgery pelvic organ prolapsus greater than stage 1 women with neurological disease and anatomical defect women with anatomical defect
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal Electrical StimulationAlso: MyoBravo Electrical Stimulation DeviceA 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 | Device | Vaginal Electrical Stimulation |
Primary outcome
Change from baseline in on domains and total score of Female Sexual Function Index (FSFI) at week 8
Time frame: Baseline, Week 8
1 secondary outcome
Change from baseline in power, endurance, dynamic endurance and fast contractions on the PERFECT scheme at week 8
Time frame: Baseline, Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Electrical Stimulation in people with Female Sexual Dysfunction, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in on domains and total score of Female Sexual Function Index (FSFI) at week 8 (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.