Trial of SVTampons vs Glass Vaginal Dilators in Treatment... | NCT05529407

Studies
Trial of SVTampons vs Glass Vaginal Dilators in Treatment of Vaginismus

NCT05529407

Sponsor

Bezmialem Vakif University

Status

Unknown status

Last Update Posted

Sep 7, 2022Actual

Enrollment

21Estimated

Phase

Not Applicable

Conditions

Vaginismus

Interventions

Simple Vaginal Tampon
Glass Vaginal Trainer

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Aug 1, 2023Estimated

Completion Date

Aug 30, 2023Estimated

First Submitted Date

Sep 2, 2022

First Submission Date that Met QC Criteria

Sep 2, 2022

First Posted Date

Sep 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2022

Last Update Posted Date

Sep 7, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Simple Vaginal Tampon	Experimental	Dilation exercises will be performed with tampon	Device: Simple Vaginal Tampon
Glass Vaginal Dilator	Experimental	Dilation exercises will be performed with vaginal dilator	Device: Glass Vaginal Trainer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Simple Vaginal Tampon	Device	Use of single use vaginal tampons	Simple Vaginal Tampon

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ayse Filiz Gokmen Karasu	Contact	+905465144142		afgokmen@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bezmialem Vakif University	Recruiting	Istanbul		34093	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32052704	Background	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.

ID	Term
D014623	Vaginal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications