Trial of SVTampons vs Glass Vaginal Dilators in Treatment of Vaginismus

Bezmialem Vakif University

Status: Unknown

Conditions: Vaginismus

Treatments: Device: Glass Vaginal Trainer; Device: Simple Vaginal Tampon

Study type: Interventional

Funder types: Other

Identifiers

NCT05529407

Bezmialem.5.22. 553

Details and patient eligibility

About

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

Full description

Tampon Group

Exercises will be performed with tampon

Dilator Group

Exercises wil be performed with dilator

Enrollment: 21 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

Simple Vaginal Tampon

Experimental group

Description:

Dilation exercises will be performed with tampon

Treatment:

Device: Simple Vaginal Tampon

Glass Vaginal Dilator

Experimental group

Description:

Dilation exercises will be performed with vaginal dilator

Treatment:

Device: Glass Vaginal Trainer