Trial of SVTampons vs Glass Vaginal Dilators in Treatment of Vaginismus
Trial of Simple Vaginal Tampons vs Glass Vaginal Dilators in Treatment of Genitopelvic Penetration Disorder
1 other identifier
interventional
21
1 country
2
Brief Summary
The aim of this study is to compare the success rates of vaginismus therapy using a tampon or a dilator during exposure
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 2, 2022
CompletedFirst Posted
Study publicly available on registry
September 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2023
CompletedSeptember 7, 2022
May 1, 2022
3.2 years
September 2, 2022
September 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sucessfull Intercourse-Diary
3 point scale: 1-did not try. 2- try but unseccesfull. 3- successfull intercourse
30 days
Secondary Outcomes (3)
GRISS: Golombuk Rust Inventory of Sexual Satisfaction
30 day
FSFI Score
30 day
Fear of Coitus Subscale
30 day
Study Arms (2)
Simple Vaginal Tampon
EXPERIMENTALDilation exercises will be performed with tampon
Glass Vaginal Dilator
EXPERIMENTALDilation exercises will be performed with vaginal dilator
Interventions
Eligibility Criteria
You may qualify if:
- non-pregnant/non lactating women aged between 18-50
- diagnosed with primary vaginismus of Lamont level II or higher
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Bezmialem Vakif University
Istanbul, 34093, Turkey (Türkiye)
Bezmialem Vakif University
Istanbul, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 32052704BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
September 2, 2022
First Posted
September 7, 2022
Study Start
June 1, 2020
Primary Completion
August 1, 2023
Study Completion
August 30, 2023
Last Updated
September 7, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share