Prospective On Market Patient-reported Outcomes for Milli

Dyspareunia Clinical Trial

— POMPOM  

Official title:

Prospective On Market Patient-reported Outcomes for Milli

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06397885
• Other study ID #: CP0004
• Status: Recruiting
• Start date: April 30, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: Materna Medical
• Contact: Sheryl Kingsberg, Ph.D
• Phone: 866-433-6933
• Email: POMPOM[@]hellomilli.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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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Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dyspareunia
• Vaginismus

Intervention

Device:
• Milli Vaginal Dilator
Patient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion

Locations

Country	Name	City	State
United States	Materna Clinic	Mountain View	California

Sponsors (1)

Lead Sponsor	Collaborator
Materna Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Penetration Efficiency Questionnaire	Ability to achieve full vaginal penetration with the penis of the partner (intercourse) as	3 months
Secondary	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.	3 months, 6 months
Secondary	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.	3 months, 6 months
Secondary	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	3 months, 6 months