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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:
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:
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:
Participants (n=60) will be randomized into two arms:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Cheryl Iglesia, MD | Medstar Washington Hospital Center National Center for Advanced Pelvic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Health | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
Participant data will be collected and analyzed as an aggregate for any results.
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| ID | Term |
|---|---|
| D004414 | Dyspareunia |
| D052065 | Vaginismus |
| D017699 | Pelvic Pain |
| D056650 | Vulvodynia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 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. | 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. | 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. | 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. | Four weeks |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D014623 | Vaginal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014845 | Vulvar Diseases |