Prospective on Market Patient-reported Outcomes for Milli

NCT06397885 | Active Not Recruiting FDA Device

• 1 other identifier: CP0004
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the effectiveness of the Milli device in achieving vaginal intercourse

Conditions

Vaginismus; Dyspareunia

Keywords

painful sex; dilation

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (4)

• Penetration Efficiency Questionnaire

  3 months

• Penetration Efficiency Questionnaire

  3 months, 6 months

• Female Sexual Function Index (FSFI)

  3 months, 6 months

• Numerical Rating Scale

  3 months, 6 months

Interventions

Milli Vaginal Dilator DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Subjects eligible if female at birth, aged ≥18 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Materna Medical: lead

Study Sites (1)

Materna Clinic

Mountain View, California, 94040, United States

Location

MeSH Terms

Conditions

Vaginismus; Dyspareunia; Dilatation, Pathologic

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sheryl Kingsberg, Ph.D

  Materna Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: May 12, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)