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Trial of SVTampons vs Glass Vaginal Dilators in Treatment of Vaginismus

Primary Purpose

Vaginismus

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Simple Vaginal Tampon
Glass Vaginal Trainer
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginismus focused on measuring genitopelvic pain disorder, vaginismus

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Bezmialem Vakif UniversityRecruiting
  • Bezmialem Vakif UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Simple Vaginal Tampon

Glass Vaginal Dilator

Arm Description

Dilation exercises will be performed with tampon

Dilation exercises will be performed with vaginal dilator

Outcomes

Primary Outcome Measures

Sucessfull Intercourse-Diary
3 point scale: 1-did not try. 2- try but unseccesfull. 3- successfull intercourse

Secondary Outcome Measures

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

Full Information

First Posted
September 2, 2022
Last Updated
September 2, 2022
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT05529407
Brief Title
Trial of SVTampons vs Glass Vaginal Dilators in Treatment of Vaginismus
Official Title
Trial of Simple Vaginal Tampons vs Glass Vaginal Dilators in Treatment of Genitopelvic Penetration Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginismus
Keywords
genitopelvic pain disorder, vaginismus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simple Vaginal Tampon
Arm Type
Experimental
Arm Description
Dilation exercises will be performed with tampon
Arm Title
Glass Vaginal Dilator
Arm Type
Experimental
Arm Description
Dilation exercises will be performed with vaginal dilator
Intervention Type
Device
Intervention Name(s)
Simple Vaginal Tampon
Other Intervention Name(s)
SVT
Intervention Description
Use of single use vaginal tampons
Intervention Type
Device
Intervention Name(s)
Glass Vaginal Trainer
Other Intervention Name(s)
GVT
Intervention Description
Use of glass vaginal trainers
Primary Outcome Measure Information:
Title
Sucessfull Intercourse-Diary
Description
3 point scale: 1-did not try. 2- try but unseccesfull. 3- successfull intercourse
Time Frame
30 days
Secondary Outcome Measure Information:
Title
GRISS: Golombuk Rust Inventory of Sexual Satisfaction
Description
Higher scores indicate greater problems
Time Frame
30 day
Title
FSFI Score
Description
Higher scores indicate less problem
Time Frame
30 day
Title
Fear of Coitus Subscale
Description
Fear of sexuality
Time Frame
30 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayse Filiz Gokmen Karasu
Phone
+905465144142
Email
afgokmen@gmail.com
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayse Filiz Gokmen Karasu, M.D
Phone
+905465144142
Email
agokmenkaarsu@bezmialem.edu.tr
First Name & Middle Initial & Last Name & Degree
Ayse Filiz Ayse Filiz
Email
afgokmen@gmail.com
Facility Name
Bezmialem Vakif University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caglar Cetin, MD
Phone
+905321673930
Email
drcaglarcetin@outlook.com
First Name & Middle Initial & Last Name & Degree
Ayse Filiz Gokmen Karasu
Phone
+905465144142
Email
afgokmen@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32052704
Citation
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.
Results Reference
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Trial of SVTampons vs Glass Vaginal Dilators in Treatment of Vaginismus

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