Trial of SVTampons vs Glass Vaginal Dilators in Treatment of Vaginismus

September 2, 2022 updated by: Ayşe Filiz Gökmen Karasu, Bezmialem Vakif University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Tampon Group

Exercises will be performed with tampon

Dilator Group

Exercises wil be performed with dilator

Study Type

Interventional

Enrollment (Anticipated)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Simple Vaginal Tampon
Dilation exercises will be performed with tampon
Device: Simple Vaginal Tampon
Use of single use vaginal tampons
Other Names:
  • SVT
Experimental: Glass Vaginal Dilator
Dilation exercises will be performed with vaginal dilator
Device: Glass Vaginal Trainer
Use of glass vaginal trainers
Other Names:
  • GVT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sucessfull Intercourse-Diary
Time Frame: 30 days
3 point scale: 1-did not try. 2- try but unseccesfull. 3- successfull intercourse
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 30, 2023

Study Registration Dates

First Submitted

September 2, 2022

First Submitted That Met QC Criteria

September 2, 2022

First Posted (Actual)

September 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 2, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bezmialem.5.22. 553

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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