VaginismusNCT05529407
Trial of SVTampons vs Glass Vaginal Dilators in Treatment of Vaginismus
A study testing Simple Vaginal Tampon and Glass Vaginal Trainer in people with Vaginismus, run by Bezmialem Vakif University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the success rates of vaginismus therapy using a tampon or a dilator during exposure Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginismus
- What is being tested?
- Simple Vaginal Tampon and Glass Vaginal Trainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 30 Aug 2023
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-pregnant/non lactating women aged between 18-50
- diagnosed with primary vaginismus of Lamont level II or higher
Who cannot join
- hymenal abnormalities, congenital vaginal abnormalities, vulvodynia, secondary vaginismus following physical or psychological trauma, infection, menopausal period or pelvic pathology and with any psychiatric or physiological disease.
- Patients with husbands possessing a history of sexual dysfunction (erectile dysfunction or premature ejaculation, for example)
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul, 34093
Ayse Filiz Gokmen Karasu, M.D, +905465144142, agokmenkaarsu@bezmialem.edu.tr
Ayse Filiz Ayse Filiz, afgokmen@gmail.com
- Recruiting
Bezmialem Vakif University
Istanbul
Caglar Cetin, MD, +905321673930, drcaglarcetin@outlook.com
Ayse Filiz Gokmen Karasu, +905465144142, afgokmen@gmail.com
About this study
Official title: Trial of Simple Vaginal Tampons vs Glass Vaginal Dilators in Treatment of Genitopelvic Penetration Disorder
The aim of this study is to compare the success rates of vaginismus therapy using a tampon or a dilator during exposure
Read the detailed description
Tampon Group
Exercises will be performed with tampon
Dilator Group
Exercises wil be performed with dilator
- Conditions
- Vaginismus
- Being tested
- Simple Vaginal Tampon, Glass Vaginal Trainer
- Keywords
- genitopelvic pain disorder, vaginismus
- Medical subject headings
- Vaginismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple Vaginal TamponDevice
Also called SVT
Use of single use vaginal tampons
Glass Vaginal TrainerDevice
Also called GVT
Use of glass vaginal trainers
| Study group | Role | What they receive |
|---|---|---|
| Simple Vaginal Tampon | Experimental | Dilation exercises will be performed with tampon Receives: Device: Simple Vaginal Tampon |
| Glass Vaginal Dilator | Experimental | Dilation exercises will be performed with vaginal dilator Receives: Device: Glass Vaginal Trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sucessfull Intercourse-Diary
3 point scale: 1-did not try. 2- try but unseccesfull. 3- successfull intercourse
Measured: 30 days
Secondary outcomes (3)
GRISS: Golombuk Rust Inventory of Sexual Satisfaction
Higher scores indicate greater problems
Measured: 30 day
FSFI Score
Higher scores indicate less problem
Measured: 30 day
Fear of Coitus Subscale
Fear of sexuality
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Jun 2020
- Primary completion1 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VaginismusStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Filiz Gökmen Karasu, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529407
- Sponsor's protocol ID
- Bezmialem.5.22. 553
- Status last verified
- May 2022
- First submitted
- 2 Sep 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aslan M, Yavuzkir S, Baykara S. Is "Dilator Use" More Effective Than "Finger Use" in Exposure Therapy in Vaginismus Treatment? J Sex Marital Ther. 2020;46(4):354-360. doi: 10.1080/0092623X.2020.1716907. Epub 2020 Feb 13.
PubMed 32052704
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Simple Vaginal Tampons vs Glass Vaginal Dilators in Treatment of Genitopelvic Penetration Disorder
- ClinicalTrials.gov ID
- NCT05529407
- Acronym / sponsor ID
- Bezmialem.5.22. 553
- Conditions
- Vaginismus
- Keywords
- genitopelvic pain disorder, vaginismus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 7 Sep 2022 (actual)
- 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.
The aim of this study is to compare the success rates of vaginismus therapy using a tampon or a dilator during exposure
Detailed description
Tampon Group
Exercises will be performed with tampon
Dilator Group
Exercises wil be performed with dilator
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple Vaginal Tampon | Experimental | Device: Simple Vaginal TamponDilation exercises will be performed with tampon |
| Glass Vaginal Dilator | Experimental | Device: Glass Vaginal TrainerDilation exercises will be performed with vaginal dilator |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- non-pregnant/non lactating women aged between 18-50
- diagnosed with primary vaginismus of Lamont level II or higher
Key exclusion criteria (2 listed)
- hymenal abnormalities, congenital vaginal abnormalities, vulvodynia, secondary vaginismus following physical or psychological trauma, infection, menopausal period or pelvic pathology and with any psychiatric or physiological disease.
- Patients with husbands possessing a history of sexual dysfunction (erectile dysfunction or premature ejaculation, for example)
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 |
|---|---|---|
| Simple Vaginal TamponAlso: SVTUse of single use vaginal tampons | Device | Simple Vaginal Tampon |
| Glass Vaginal TrainerAlso: GVTUse of glass vaginal trainers | Device | Glass Vaginal Dilator |
Primary outcome
Sucessfull Intercourse-Diary
Time frame: 30 days
3 point scale: 1-did not try. 2- try but unseccesfull. 3- successfull intercourse
3 secondary outcomes
GRISS: Golombuk Rust Inventory of Sexual Satisfaction
Time frame: 30 day
FSFI Score
Time frame: 30 day
Fear of Coitus Subscale
Time frame: 30 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Background: PubMed 32052704Aslan M, Yavuzkir S, Baykara S. Is "Dilator Use" More Effective Than "Finger Use" in Exposure Therapy in Vaginismus Treatment? J Sex Marital Ther. 2020;46(4):354-360. doi: 10.1080/0092623X.2020.1716907. Epub 2020 Feb 13.
- Individual participant dataSharing planned: No
Related trials for Vaginismus
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple Vaginal Tampon and Glass Vaginal Trainer in people with Vaginismus, run by Bezmialem Vakif University at 2 sites 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 2 inclusion and 2 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 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Contact Ayse Filiz Gokmen Karasu (+905465144142, afgokmen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sucessfull Intercourse-Diary (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05529407, which also lists 1 linked publication.
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 7 Sep 2022.