Prospective on Market Patient-reported Outcomes for Milli (POMPOM)

November 18, 2024 updated by: Materna Medical
To assess the effectiveness of the Milli device in achieving vaginal intercourse

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mountain View, California, United States, 94040
        • Materna Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penetration Efficiency Questionnaire
Time Frame: 3 months
Ability to achieve full vaginal penetration with the penis of the partner (intercourse) as
3 months
Penetration Efficiency Questionnaire
Time Frame: 3 months, 6 months
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.
3 months, 6 months
Female Sexual Function Index (FSFI)
Time Frame: 3 months, 6 months
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.
3 months, 6 months
Numerical Rating Scale
Time Frame: 3 months, 6 months
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
3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Materna Medical

Investigators

  • Principal Investigator: Sheryl Kingsberg, Ph.D, Materna Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP0004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dyspareunia

Clinical Trials on Milli Vaginal Dilator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe