VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia

Not Applicable

Recruiting

• Conditions: Genito-Pelvic Pain/Penetration Disorder; Dyspareunia; Vulvodynia (Chronic Vulvar Pain); Vaginismus; Pelvic Pain; Vestibulodynia

• Registration Number: NCT06840314
• Lead Sponsor: Medstar Health Research Institute

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.

Study Timeline

• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-17
• Study First Posted: 2025-02-21
• Study Start: 2025-03-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-11
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Female Sexual Function Index (FSFI)	Four weeks	FSFI is considered the gold standard for the measurement of sexual function in women. It's a 19-item questionnaire that uses a 5 point Likert scale ranging from 1-5, with higher scores indicating greater levels of sexual functioning on the respective item. To score the measure, the sum of each domain score is multipled by a domain factor ratio (0.6 for desire, 0.3 for arousal, 0.3 for lubrication, 0.4 for orgasm, 0.4 for satisfaction, and 0.4 for pain) in order to place all domain tools on a comparable scale. The subsequent scores are summed to derive a total FSFI score. The possible range of scores is 2-36. A score less than or equal to 26.55 reflects clinically relevant sexual dysfunction.

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression Of Improvement (PGI-I)	Four weeks	The Patient Global Impression of Improvement (PGI-I) is a single item questionnaire to assess an individual's impression of change in urinary symptoms. For purposes of this trial the PGI-S has been adapted by removing "taking medication" and it will ask participants to "Check the one number that best describes how your urinary tract condition is now, compared with how it was before you began this study" on a 7-point Likert scale ranging from (1) "very much better" to (7) "very much worse". The PASS threshold PGI-I score is \< 3.
FSDS-DAO (Female Sexual Distress Scale- Distress/Arousal/Orgasm) Questionnaire	Four weeks	The Female Sexual Distress Scale - Distress/Arousal/Orgasm (FSDS-DAO) Questionnaire is a validated patient-reported outcome measure designed to assess sexually related distress in women, with a particular focus on distress associated with arousal and orgasmic difficulties. The FSDS-DAO consists of 15 items that assess three key domains: sexually related distress, arousal difficulties, and orgasmic dysfunction. Each item is rated on a five-point Likert scale, ranging from 0 (Never) to 4 (Always), with higher total scores indicating greater distress and dysfunction.
PGI-S- Patient Global Impression of Severity	Four weeks	Patient Global Impression of Severity (PGI-S) is a single item questionnaire to assess a person's impression of disease severity. For purposes of this trial, it will ask participants to "Check the one number that best describes how your urinary tract condition is now" on a 4-point Likert scale ranging from (1) "normal" to (4) "severe". The PASS threshold PGI-S score is \< 3.
Primary Outcome Questionnaire (PEQ)	Four weeks	This is a seven item questionnaire in which each question queries whether the subject has in the last four weeks attempted intercourse, insertion of one or two fingers (by self or by partner), insertion of other objects (by self or by partner). There are four responses to choose from for each question: not attempted, attempted but not successful, attempted and sometimes successful, attempted and always successful.
VPAQ-screen Subscale: Self Stimulation/Penetration Interference (Vulvar Pain Assessment Questionnaire- Screening Form)	Four weeks	The Self Stimulation/Penetration Interference and Q7 (Vulvar Pain Assessment Questionnaire- Screening Form) asks the subject "How often do the following situations/activities cause vulvar pain?" The following situations/activities are queried: using tampons, solitary masturbation, masturbation while partner is present, solitary self penetration with fingers, solitary self penetration with sex toy.

Trial Locations

Locations (1)

MedStar Health; 🇺🇸 Washington, District of Columbia, United States