Trial of SVTampons vs Glass Vaginal Dilators in Treatment of Vaginismus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2023-08-30

Brief Summary

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

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Detailed Description

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Tampon Group

Exercises will be performed with tampon

Dilator Group

Exercises wil be performed with dilator

Conditions

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Vaginismus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Simple Vaginal Tampon

Dilation exercises will be performed with tampon

Group Type EXPERIMENTAL

Simple Vaginal Tampon

Intervention Type DEVICE

Use of single use vaginal tampons

Glass Vaginal Dilator

Dilation exercises will be performed with vaginal dilator

Group Type EXPERIMENTAL

Glass Vaginal Trainer

Intervention Type DEVICE

Use of glass vaginal trainers

Interventions

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Simple Vaginal Tampon

Use of single use vaginal tampons

Intervention Type DEVICE

Glass Vaginal Trainer

Use of glass vaginal trainers

Intervention Type DEVICE

Other Intervention Names

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SVT GVT

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes