Genito-Pelvic Pain/Penetration DisorderVIBRENTNCT06840314
VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia
A study testing Pelvic floor therapy in people with Genito-Pelvic Pain/Penetration Disorder and Dyspareunia, run by Medstar Health Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Genito-Pelvic Pain/Penetration Disorder, Dyspareunia, Vaginismus
- What is being tested?
- Pelvic floor therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MedStar Health
Washington D.C., District of Columbia, 20010
Kendra Green, 202-997-4536, kendra.s.green@medstar.net
Helen Y Zhang, MD, helen.y.zhang@medstar.net
About this study
Official title: VIBRENT- 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 vaginal dilators.
The main questions it aims to answer are:
Read more
- Does the use of the Kiwi device lead to higher sexual function scores compared to traditional vaginal dilators
- 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.
Read the 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:
- Kiwi device group - a commercially available vibrating pelvic floor therapeutic product.
- 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.
- Conditions
- Genito-Pelvic Pain/Penetration Disorder, Dyspareunia, Vaginismus, Pelvic Pain, Vestibulodynia, Vulvodynia (Chronic Vulvar Pain)
- Being tested
- Pelvic floor therapy
- Keywords
- genito-pelvic pain/penetration disorder, dyspareunia, entry dyspareunia, vaginismus, pelvic pain, female sexual function, pain with sex, vulvodynia, vestibulodynia
- Medical subject headings
- Dyspareunia, Vaginismus, Pelvic Pain, Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor therapyDevice
Also called PFPT, Pelvic floor physical therapy, pelvic floor massage
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks
Secondary outcomes (5)
FSDS-DAO (Female Sexual Distress Scale- Distress/Arousal/Orgasm) Questionnaire
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.
Measured: Four weeks
Primary Outcome Questionnaire (PEQ)
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.
Measured: Four weeks
PGI-S- Patient Global Impression of Severity
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.
Measured: Four weeks
Patient Global Impression Of Improvement (PGI-I)
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.
Measured: Four weeks
VPAQ-screen Subscale: Self Stimulation/Penetration Interference (Vulvar Pain Assessment Questionnaire- Screening Form)
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.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Mar 2025
- Primary completionNov 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genito-Pelvic Pain/Penetration DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheryl Iglesia, MD, Principal investigator, Medstar Washington Hospital Center National Center for Advanced Pelvic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840314
- Sponsor's protocol ID
- STUDY00008357
- Acronym
- VIBRENT
- Status last verified
- May 2025
- First submitted
- 17 Feb 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be collected and analyzed as an aggregate for any results.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIBRENT- VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia
- ClinicalTrials.gov ID
- NCT06840314
- Acronym / sponsor ID
- VIBRENT / STUDY00008357
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the use of the Kiwi device lead to higher sexual function scores compared to traditional vaginal dilators
- 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:
- Kiwi device group - a commercially available vibrating pelvic floor therapeutic product.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kiwi (Commercially available therapeutic vibrating pelvic floor product) | Experimental | Device: Pelvic floor therapyKiwi 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor therapyAlso: PFPT, Pelvic floor physical therapy, pelvic floor massageOnce 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. | Device | Kiwi (Commercially available therapeutic vibrating pelvic floor product) |
Primary outcome
Female Sexual Function Index (FSFI)
Time frame: 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.
5 secondary outcomes
FSDS-DAO (Female Sexual Distress Scale- Distress/Arousal/Orgasm) Questionnaire
Time frame: Four weeks
Primary Outcome Questionnaire (PEQ)
Time frame: Four weeks
PGI-S- Patient Global Impression of Severity
Time frame: Four weeks
Patient Global Impression Of Improvement (PGI-I)
Time frame: Four weeks
VPAQ-screen Subscale: Self Stimulation/Penetration Interference (Vulvar Pain Assessment Questionnaire- Screening Form)
Time frame: Four weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No. Participant data will be collected and analyzed as an aggregate for any results.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cheryl Iglesia, MD principal investigator
Medstar Washington Hospital Center National Center for Advanced Pelvic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor therapy in people with Genito-Pelvic Pain/Penetration Disorder and Dyspareunia, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helen Y Zhang, MD (202-877-6526, helen.y.zhang@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (FSFI) (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.