Trial of SVTampons vs Glass Vaginal Dilators in Treatment of Vaginismus

Not Applicable

• Conditions: Vaginismus
• Interventions: Device: Simple Vaginal Tampon; Device: Glass Vaginal Trainer

• Registration Number: NCT05529407
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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 Timeline

• Study Start: 2020-06-01
• Status Verified: 2022-05
• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-02
• Last Update Submitted: 2022-09-02
• Study First Posted: 2022-09-07
• Last Update Posted: 2022-09-07
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 21

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simple Vaginal Tampon	Simple Vaginal Tampon	Dilation exercises will be performed with tampon
Glass Vaginal Dilator	Glass Vaginal Trainer	Dilation exercises will be performed with vaginal dilator

Primary Outcome Measures

Name	Time	Method
Sucessfull Intercourse-Diary	30 days	3 point scale: 1-did not try. 2- try but unseccesfull. 3- successfull intercourse

Secondary Outcome Measures

Name	Time	Method
GRISS: Golombuk Rust Inventory of Sexual Satisfaction	30 day	Higher scores indicate greater problems
FSFI Score	30 day	Higher scores indicate less problem
Fear of Coitus Subscale	30 day	Fear of sexuality

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Turkey