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NCT06840314 · ClinicalTrials.gov registry record · NA
VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia
A NA study of Pelvic Pain and Dyspareunia, sponsored by Medstar Health Research Institute.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06840314: Recruiting NA study of Pelvic Pain and Dyspareunia, sponsored by Medstar Health Research Institute.
NCT06840314 is a NA study of Pelvic Pain and Dyspareunia that is actively recruiting participants, run by Medstar Health Research Institute. The registered enrollment target is 60 participants, below the 369-participant average among 23 other Pelvic Pain trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06840314, a NA study of Pelvic Pain and Dyspareunia, is actively recruiting participants, sponsored by Medstar Health Research Institute.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 com
Conditions Studied
Interventions
- DEVICE Pelvic floor therapy
Study Locations (1)
District of Columbia
- MedStar Health - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-03-01 |
| Est. Completion | 2026-03 |
| Phase | NA |
What NCT06840314 shows while recruiting
NCT06840314 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 369-participant average among 23 other Pelvic Pain trials with a reported enrollment target (84% lower).
The record links to 6 conditions, with Pelvic Pain appearing as the primary indexed condition, and to 1 intervention - of which Pelvic floor therapy is the first listed.
NCT06840314 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT06840314 about?
NCT06840314 is a clinical study titled "VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia". 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 va...
What is the current status of trial NCT06840314?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-03-01. Estimated completion is 2026-03.
What conditions does trial NCT06840314 study?
This clinical trial studies the following conditions: Pelvic Pain, Dyspareunia, Vaginismus, Genito-Pelvic Pain/Penetration Disorder, Vestibulodynia.
What interventions are being tested in trial NCT06840314?
The interventions under investigation include: Pelvic floor therapy (DEVICE).
Who is sponsoring clinical trial NCT06840314?
This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06840314 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06840314's enrollment target sits among peer trials
60 14th of 23 higher than 9 of 23 other Pelvic Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pelvic Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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