Clinical trial NCT06840314: VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia
Official title: VIBRENT- VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Genito-Pelvic Pain/Penetration Disorder
Dyspareunia
Vaginismus
Pelvic Pain
Vestibulodynia
Vulvodynia (Chronic Vulvar Pain)
Keywords: genito-pelvic pain/penetration disorder
dyspareunia
entry dyspareunia
vaginismus
pelvic pain
female sexual function
pain with sex
vulvodynia
vestibulodynia
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to determine whether the use of a novel vibrating pelvic floor therapeutic device ("Kiwi") improves sexual function in sexually active women aged 18 and older with genito-pelvic pain and penetration disorder (GPPPD) more effectively than traditional vaginal dilators.

The main questions it aims to answer are:

1. Does the use of the Kiwi device lead to higher sexual function scores compared to traditional vaginal dilators
2. Does the Kiwi device improve sexual distress, pain, and overall symptom severity more effectively than traditional vaginal dilators?

Researchers will compare the Kiwi vibrating device to traditional cylindrical vaginal dilators to assess whether the Kiwi device results in greater improvements in sexual function and symptom relief.

Participants will:

* Be randomly assigned to use either the Kiwi device or traditional vaginal dilators.
* Use the assigned device three times per week for 15 minutes per session over four weeks.
* Complete surveys before and after the study, including assessments of sexual function, pain, and overall improvement.

Detailed description: This randomized controlled trial (RCT) aims to evaluate the efficacy of a novel vibrating pelvic floor therapeutic device (the "Kiwi") compared to traditional vaginal dilators in improving sexual function outcomes in sexually active women aged 18 and older with genito-pelvic pain and penetration disorder (GPPPD).

The primary objective is to determine whether the Kiwi device leads to higher Female Sexual Function Index (FSFI) scores after four weeks of use compared to traditional dilators.

Secondary objectives include assessing improvements in:

* Sexual distress (Female Sexual Distress Scale - Desire/Arousal/Orgasm, FSDS-DAO)
* Pelvic pain (Vulvar Pain Assessment Questionnaire, VPAQ-screen subscale)
* Overall symptom severity (Patient Global Impression of Severity, PGI-S)
* Perceived improvement (Patient Global Impression of Improvement, PGI-I)

Participants (n=60) will be randomized into two arms:

1. Kiwi device group - a commercially available vibrating pelvic floor therapeutic product.
2. Traditional dilator group - a standard graduated cylindrical vaginal dilator set.

Participants will use their assigned device three times per week for 15 minutes per session over a four-week period. Data will be collected at baseline and at the end of the study using validated questionnaires.

The study hypothesizes that participants using the Kiwi device will demonstrate greater improvements in FSFI scores compared to those using traditional vaginal dilators, reflecting enhanced sexual function and reduced symptom severity.

Eligibility criteria: Inclusion 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, N94.1 Dyspareunia, N94.2 Vaginismus, N94.81 Vulvodynia)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Female Sexual Function Index (FSFI)
timeFrame: Four weeks
Secondary outcomes:
measure: FSDS-DAO (Female Sexual Distress Scale- Distress/Arousal/Orgasm) Questionnaire
timeFrame: Four weeks
measure: Primary Outcome Questionnaire (PEQ)
timeFrame: Four weeks
measure: PGI-S- Patient Global Impression of Severity
timeFrame: Four weeks
measure: Patient Global Impression Of Improvement (PGI-I)
timeFrame: Four weeks
measure: VPAQ-screen Subscale: Self Stimulation/Penetration Interference (Vulvar Pain Assessment Questionnaire- Screening Form)
timeFrame: Four weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Health
state: District of Columbia
Study officials:
affiliation: Medstar Washington Hospital Center National Center for Advanced Pelvic Surgery
name: Cheryl Iglesia, MD
role: PRINCIPAL_INVESTIGATOR
References: