Genito-Pelvic Pain/Penetration Disorder study: Pelvic floor therapy
Official title VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia
ClinicalTrials.gov ID: NCT06840314
What this study is testing
- What it's testing
- This study wants to find out if a new vibrating device improves sexual function and reduces pain more than traditional vaginal dilators.
- Who it's for
- Sexually active women aged 18 and older who experience pain during sex or have difficulty with penetration.
- What's involved
- Participants will use either the vibrating device or standard dilators for 15 minutes, three times a week, for four weeks. They will also fill out surveys about their pain and sexual health before and after the study.
- Time commitment
- The study lasts four weeks and requires using the device at home three times per week.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Assigned female at birth
- Age ≥ 18 years old
- Genito-pelvic pain/penetration disorder (per ICD-10 diagnosis codes: F52.5 Vaginismus not due to a substance or known physiological condition, F52.6...
You likely can't join if
- Current or prior use of a therapeutic vaginal device used to treat GPPPD
- Unmanaged genitourinary syndrome of menopause
- History of pelvic radiation
- History of genital tract malignancy
- History of female genital mutilation
- History of prior surgery for prolapse or incontinence, including vaginal mesh or midurethral sling mesh
See the full eligibility criteria
- Assigned female at birth
- Age ≥ 18 years old
- Genito-pelvic pain/penetration disorder (per ICD-10 diagnosis codes: F52.5 Vaginismus not due to a substance or known physiological condition, F52.6 Dyspareunia not due to a substance or known physiological condition...
- Current or prior use of a therapeutic vaginal device used to treat GPPPD
- Unmanaged genitourinary syndrome of menopause
- History of pelvic radiation
- History of genital tract malignancy
- History of female genital mutilation
- History of prior surgery for prolapse or incontinence, including vaginal mesh or midurethral sling mesh
- Silicone allergy
The study team makes the final eligibility decision.
Where it is enrolling
- Washington D.C., District of Columbia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Washington D.C., District of Columbia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.