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Trial of SVTampons vs Glass Vaginal Dilators in Treatment of Vaginismus

Trial of Simple Vaginal Tampons vs Glass Vaginal Dilators in Treatment of Genitopelvic Penetration Disorder

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05529407
Enrollment
21
Registered
2022-09-07
Start date
2020-06-01
Completion date
2023-08-30
Last updated
2022-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginismus

Keywords

genitopelvic pain disorder, vaginismus

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

Interventions

DEVICESimple Vaginal Tampon

Use of single use vaginal tampons

DEVICEGlass Vaginal Trainer

Use of glass vaginal trainers

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Sucessfull Intercourse-Diary30 days3 point scale: 1-did not try. 2- try but unseccesfull. 3- successfull intercourse

Secondary

MeasureTime frameDescription
GRISS: Golombuk Rust Inventory of Sexual Satisfaction30 dayHigher scores indicate greater problems
FSFI Score30 dayHigher scores indicate less problem
Fear of Coitus Subscale30 dayFear of sexuality

Countries

Turkey (Türkiye)

Contacts

Primary ContactAyse Filiz Gokmen Karasu
afgokmen@gmail.com+905465144142

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026