Trial of SVTampons vs Glass Vaginal Dilators in Treatment of Vaginismus

Vaginismus Clinical Trial

Official title:

Trial of Simple Vaginal Tampons vs Glass Vaginal Dilators in Treatment of Genitopelvic Penetration Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05529407
• Other study ID #: Bezmialem.5.22. 553
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: August 30, 2023

Study information

• Verified date: May 2022
• Source: Bezmialem Vakif University
• Contact: Ayse Filiz Gokmen Karasu
• Phone: +905465144142
• Email: afgokmen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the success rates of vaginismus therapy using a tampon or a dilator during exposure

Description:

Tampon Group

Exercises will be performed with tampon

Dilator Group

Exercises wil be performed with dilator

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: August 30, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• non-pregnant/non lactating women aged between 18-50

• diagnosed with primary vaginismus of Lamont level II or higher

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Vaginismus

Intervention

Device:
• Simple Vaginal Tampon
Use of single use vaginal tampons
• Glass Vaginal Trainer
Use of glass vaginal trainers

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sucessfull Intercourse-Diary	3 point scale: 1-did not try. 2- try but unseccesfull. 3- successfull intercourse	30 days
Secondary	GRISS: Golombuk Rust Inventory of Sexual Satisfaction	Higher scores indicate greater problems	30 day
Secondary	FSFI Score	Higher scores indicate less problem	30 day
Secondary	Fear of Coitus Subscale	Fear of sexuality	30 day