Prospective on Market Patient-reported Outcomes for Milli

NCT ID: NCT06397885

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-12
• Study Completion Date: 2025-12-30

Brief Summary

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.

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Conditions

Vaginismus; Dyspareunia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Milli Vaginal Dilator

Patient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Materna Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheryl Kingsberg, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Materna Clinic

Locations

Materna Clinic

Mountain View, California, United States

Countries

United States

Other Identifiers

CP0004

Identifier Type: -

Identifier Source: org_study_id