VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia

NCT06840314 | Recruiting

• 1 other identifier: STUDY00008357
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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:

• 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.

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

Outcome Measures

Primary Outcomes (1)

• Female Sexual Function Index (FSFI)

  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.

  Four weeks

Secondary Outcomes (5)

• FSDS-DAO (Female Sexual Distress Scale- Distress/Arousal/Orgasm) Questionnaire

  Four weeks

• Primary Outcome Questionnaire (PEQ)

  Four weeks

• PGI-S- Patient Global Impression of Severity

  Four weeks

• Patient Global Impression Of Improvement (PGI-I)

  Four weeks

• VPAQ-screen Subscale: Self Stimulation/Penetration Interference (Vulvar Pain Assessment Questionnaire- Screening Form)

  Four weeks

Study Arms (2)

Kiwi (Commercially available therapeutic vibrating pelvic floor product)

EXPERIMENTAL

Kiwi is a therapeutic vibrating pelvic floor product that includes an option for external massage and stimulation. The V- shaped massager, is designed to bridge anatomical variety and has three main massage ends. 1. The cylindrical end is comparable in application to traditional vaginal dilators. However, one significant difference is its tapered shape; this allows for continuous and gradual diameter increase, as opposed to discrete increments in the traditional dilator sets. The tapered end has an optional vibration mode with 4 different intensity settings. This cylindrical shape can also be used as a tool to apply external pressure point massage to the muscles of the urogenital triangle, such as the perineal muscle and the bulbospongiosus muscles. 2. A wider flat surface area has an additional motor to apply vibration to the glans clitoris. This end can also be used for massage. 3. The rounded bottom end of Kiwi can be used as a broad area massage tool.

Device: Pelvic floor therapy

Silicone Dilator Arm

ACTIVE COMPARATOR

A commercially available set of graduated cylindrical vaginal dilators. The standard of care is a 6-piece, progressive-sizing, silicone dilator set. Dimensions of the silicone dilators are (WxH): (1) 0.7"x4.75", (2) 0.9"x5.25", (3) 1.0"x5.45", (4) 1.1"x5.85", (5) 1.3"x6.35", (6) 1.5"x6.85". These dilators are not battery powered, have no buttons, and no removable pieces.

Interventions

Pelvic floor therapy DEVICE

Once randomized to either the vibrating pelvic floor massage arm or the traditional vaginal dilator arm, they will receive instructions on frequency of device use and will use manufacturer's instructions for specifics of device use. We will not dictate more specific instructions on use, nor is this standard of care, as every patient is unique and will need to retain autonomy in terms of how quickly they progress in the use of the product. They will then complete a survey at 4 weeks which includes measures of sexual function and pelvic pain, as well of global impressions of improvement in their symptoms.

Also known as: PFPT, Pelvic floor physical therapy, pelvic floor massage

Kiwi (Commercially available therapeutic vibrating pelvic floor product)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 Dyspareunia not due to a substance or known physiological condition, N94.1 Dyspareunia, N94.2 Vaginismus, N94.81 Vulvodynia)

You may not qualify 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
• Silicone allergy

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Health

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

Dyspareunia; Vaginismus; Pelvic Pain; Vulvodynia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Vaginal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vulvar Diseases

Study Officials

• Cheryl Iglesia, MD

  Medstar Washington Hospital Center National Center for Advanced Pelvic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Y Zhang, MD

CONTACT

202-877-6526; helen.y.zhang@medstar.net

Eun Sook Choi, MD

CONTACT

202-877-6526; eunsook.choi@medstar.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: March 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: March 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)