VaginismusPOMPOMNCT06397885
Prospective on Market Patient-reported Outcomes for Milli
An observational study of Vaginismus and Dyspareunia, run by Materna Medical at 1 site in United States.
Trial summary
To assess the effectiveness of the Milli device in achieving vaginal intercourse Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginismus, Dyspareunia
- What is being tested?
- Milli Vaginal Dilator
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2024to 30 Dec 2025
- Phase
- Observational
- 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
Study population: The study population shall include subjects seeking relief for the symptoms of vaginismus and/or associated dyspareunia (painful sex). The Milli Vaginal Dilator is cleared for use as an Over-The-Counter device (K220035). As such, the study population shall be comprised of all adult subjects who provide (≥18 years of age) Informed Consent.
Who may be able to join
- Subject is a female at birth aged ≥18 years of age
- Subject is able to read and understand the approved, informed consent form (ICF)
- Subject meets vaginismus and related painful sex/GPPPD criteria as defined in the DSM-5, as confirmed by having one or more of the following for greater than 6 months:
- Pelvic pain
- Vaginal pain
- Pain with vaginal intercourse
Show all 15Show fewer
- Pain with vaginal penetration
- Fear or anxiety about vaginal or pelvic pain with vaginal penetration
- The inability to achieve vaginal penetration
- Subject currently has a sexual partner with a functional penis
- Subject is currently seeking vaginal penetration to achieve sexual intercourse
- Subject is currently unable to tolerate vaginal penetration to achieve sexual intercourse (Score of ≤1 on PEQ Question #1)
- Subject purchased Milli vaginal dilator
- Subject is not contraindicated for Milli vaginal dilator use
- Subject is able and willing to comply with study protocol
Who cannot join
- Subject has previously participated in any studies by the company in the past 12 months or has used Milli prior to enrollment
- Subject is pregnant
- Subject has an active pelvic infection (vagina or vulva)
- Subject has open wounds in the tissue inside or surrounding the vagina
- Subject has an untreated major mental health disorder (e.g., affective disorder, psychosis, PTSD)
- Subject has prior history of gender-confirming surgery, vaginal reconstruction surgery, pelvic radiation, and/or vaginal procedures that result in extensive scarring (with the exception of hysterectomy procedures)
- Subject or subject's partner experiences other conditions preventing intercourse (e.g., erectile dysfunction, lack of libido)
Trial locations and contacts
1 site in 1 country.
About this study
To assess the effectiveness of the Milli device in achieving vaginal intercourse
Read the detailed description
The Milli Vaginal Dilator is a patient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion.
This study is intended to provide data in support of the Milli Vaginal Dilator as a commercially available, over-the-counter medical device.
The Milli has been granted marketing authorization by the FDA under premarket notification K220035 for the following Indications for Use statement:
The Milli Vaginal Dilator is a tool indicated for controlled dilation of the vagina. It can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.
.
- Conditions
- Vaginismus, Dyspareunia
- Being tested
- Milli Vaginal Dilator
- Keywords
- painful sex, dilation
- Medical subject headings
- Vaginismus, Dyspareunia, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milli Vaginal DilatorDevice
Patient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration Efficiency Questionnaire
Ability to achieve full vaginal penetration with the penis of the partner (intercourse) as measured by the Penetration Efficiency Questionnaire (Score of ≥2 on PEQ Question #1) at six months
Measured: 6 months
Secondary outcomes (4)
Penetration Efficiency Questionnaire
Ability to achieve full vaginal penetration with the penis of the partner (intercourse) as
Measured: 3 months
Penetration Efficiency Questionnaire
Improvement in ability to achieve vaginal penetration (intercourse and non-intercourse) as measured by a change in baseline in the overall score on the Penetration Efficiency Questionnaire at 3 and 6 months.
Measured: 3 months, 6 months
Female Sexual Function Index (FSFI)
Improvement in self-reported sexual function as reported on a change in baseline in the Female Sexual Function Index (FSFI) total score at 3 and 6 months.
Measured: 3 months, 6 months
Numerical Rating Scale
Improvement in self-reported pain intensity with intercourse as reported as a change in baseline on a numeric rating scale (NRS) (0= no pain, 10 = worst pain imaginable) at 3 and 6 months
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start12 May 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginismusStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Materna Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sheryl Kingsberg, Ph.D, Principal investigator, Materna Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397885
- Sponsor's protocol ID
- CP0004
- Acronym
- POMPOM
- Status last verified
- Nov 2024
- First submitted
- 30 Apr 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective on Market Patient-reported Outcomes for Milli
- ClinicalTrials.gov ID
- NCT06397885
- Acronym / sponsor ID
- POMPOM / CP0004
- Conditions
- Vaginismus, Dyspareunia
- Keywords
- painful sex, dilation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Materna MedicalIndustry (pharma, biotech, devices)
- Study start
- 12 May 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 3 May 2024 (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.
To assess the effectiveness of the Milli device in achieving vaginal intercourse
Detailed description
The Milli Vaginal Dilator is a patient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion.
This study is intended to provide data in support of the Milli Vaginal Dilator as a commercially available, over-the-counter medical device.
The Milli has been granted marketing authorization by the FDA under premarket notification K220035 for the following Indications for Use statement:
The Milli Vaginal Dilator is a tool indicated for controlled dilation of the vagina. It can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.
.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population shall include subjects seeking relief for the symptoms of vaginismus and/or associated dyspareunia (painful sex). The Milli Vaginal Dilator is cleared for use as an Over-The-Counter device (K220035). As such, the study population shall be comprised of all adult subjects who provide (≥18 years of age) Informed Consent.
Key inclusion criteria (15 listed)
- Subject is a female at birth aged ≥18 years of age
- Subject is able to read and understand the approved, informed consent form (ICF)
- Subject meets vaginismus and related painful sex/GPPPD criteria as defined in the DSM-5, as confirmed by having one or more of the following for greater than 6 months:
- Pelvic pain
- Vaginal pain
Key exclusion criteria (7 listed)
- Subject has previously participated in any studies by the company in the past 12 months or has used Milli prior to enrollment
- Subject is pregnant
- Subject has an active pelvic infection (vagina or vulva)
- Subject has open wounds in the tissue inside or surrounding the vagina
- Subject has an untreated major mental health disorder (e.g., affective disorder, psychosis, PTSD)
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 |
|---|---|---|
| Milli Vaginal DilatorPatient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion | Device | – |
Primary outcome
Penetration Efficiency Questionnaire
Time frame: 6 months
Ability to achieve full vaginal penetration with the penis of the partner (intercourse) as measured by the Penetration Efficiency Questionnaire (Score of ≥2 on PEQ Question #1) at six months
4 secondary outcomes
Penetration Efficiency Questionnaire
Time frame: 3 months
Penetration Efficiency Questionnaire
Time frame: 3 months, 6 months
Female Sexual Function Index (FSFI)
Time frame: 3 months, 6 months
Numerical Rating Scale
Time frame: 3 months, 6 months
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 20 Nov 2024.
- Individual participant dataSharing planned: No
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Virtual Reality Exposure for Vaginismus: A Replicated Single-Case Design
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Measuring Pelvic Floor Muscle Fitness Before and After Treatment
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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. This study is not recruiting at the moment.
Sheryl Kingsberg, Ph.D principal investigator
Materna Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginismus and Dyspareunia, run by Materna Medical 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 15 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration Efficiency Questionnaire (time frame: 6 months). 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 20 Nov 2024.