Trial Outcomes & Findings for Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention (NCT NCT03739983)

Last Updated: 2021-10-20

Results Overview

The investigators expect the percentage of superficial vaginal cells to be greater at the post-intervention time point when compared to the pre-intervention time point. If the percentage of superficial vaginal cells is ≥ 4% following the intervention, then the response will be considered positive.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

up to 12 weeks

Results posted on

2021-10-20

Participant Flow

Participants were recruited with the help of the University of Wisconsin Carbone Cancer Center in November and December 2019. Recruitment was suspended in March 2020 due to the COVID-19 pandemic.

Participant milestones

Participant milestones
Measure	VRP Therapy All subjects on this study will receive the Vaginal Renewal Program intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time. Vaginal Renewal Program: Therapeutic vibrating wand.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VRP Therapy n=2 Participants All subjects on this study will receive the Vaginal Renewal Program intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time. Vaginal Renewal Program: Therapeutic vibrating wand.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	2 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	2 participants n=93 Participants

PRIMARY outcome

Timeframe: up to 12 weeks

Population: End of study samples unavailable, decision was made not to analyze primary outcome as it was not powered to produce meaningful results.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 12 weeks

Population: No data to analyze.

Changes in the vaginal pH will be analyzed to determine the extent to which the changes correlate with changes in the primary outcome and with patient reported outcomes. Given the longitudinal nature of the study, linear and generalized linear mixed effects models will be fit to the data gathered. The restricted maximum likelihood (REML) criterion will be used and 95% semi-parametrically bootstrapped confidence intervals will be obtained for all parameters. All statistical analyses will be conducted using R (R Core Team 2014).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 12 weeks

Number of subjects with improved anxiety outcomes per over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Emotional Distress - Anxiety scale measures patient perceived changes in anxiety and includes 8 questions that they answer about their emotional state in the past 7 days. Descriptive answers are scored from 1 (never) to 5 (always). The total possible range of scores is from 8-40, with higher scores indicating a worse outcome.

Outcome measures

Outcome measures
Measure	VRP Therapy n=2 Participants All subjects on this study will receive the Vaginal Renewal Program (VRP) intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time.
Patient Reported Outcomes: Number of Subjects With Improved Anxiety	1 Participants

SECONDARY outcome

Timeframe: up to 12 weeks

Population: only 1 participant completed this survey

Number of subjects with improved depression outcomes over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Emotional Distress - Depression scale measures patient perceived changes in depression and includes 8 questions that they answer about their emotional state in the past 7 days. Descriptive answers are scored from 1 (never) to 5 (always). The total possible range of scores is from 8-40, with higher scores indicating a worse outcome.

Outcome measures

Outcome measures
Measure	VRP Therapy n=1 Participants All subjects on this study will receive the Vaginal Renewal Program (VRP) intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time.
Patient Reported Outcomes: Number of Subjects With Improved Depression	0 Participants

SECONDARY outcome

Timeframe: up to 12 weeks

Population: Incomplete data, unable to evaluate.

Number of subjects with improved sexual function outcomes over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Sexual Function Profile scale measures patient perceived changes in sexual function and includes 10 questions that they answer about their functional state. Descriptive answers include 'Not at all', 'A little bit', 'Somewhat', 'Quite a bit', or 'Very', and will be summarized with descriptive statistics.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 12 weeks

Number of subjects with improved global health over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Global Health scale measures patient perceived changes in health and includes 10 questions that they answer about their perceived health in the past 7 days. Higher scores indicate a higher perceived level of overall health.

Outcome measures

Outcome measures
Measure	VRP Therapy n=2 Participants All subjects on this study will receive the Vaginal Renewal Program (VRP) intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time.
Patient Reported Outcomes: Number of Subjects With Improved Global Health	0 Participants

SECONDARY outcome

Timeframe: up to 12 weeks

Population: Incomplete data, unable to evaluate.

Number of subjects with improved sex life over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Global Satisfaction with Sex Life scale measures patient perceived changes in the satisfaction of their sex life and includes 7 questions that they answer about their perceived state. Descriptive answers include 'Not at all', 'A little bit', 'Somewhat', 'Quite a bit', or 'Very', and will be summarized with descriptive statistics.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 12 weeks

Population: No data to analyze

Adherence to AI therapy will be determined using patient-reported logs.

Outcome measures

Outcome data not reported

Adverse Events

VRP Therapy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	VRP Therapy n=2 participants at risk All subjects on this study will receive the Vaginal Renewal Program intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time. Vaginal Renewal Program: Therapeutic vibrating wand.
Reproductive system and breast disorders Irritation	50.0% 1/2 • Number of events 1 • up to 3 months
Reproductive system and breast disorders Vulvar Stinging	50.0% 1/2 • Number of events 1 • up to 3 months
Reproductive system and breast disorders Perineal Chaffing	50.0% 1/2 • Number of events 1 • up to 3 months

Additional Information

Ryan Spencer, MD, MS

University of Wisconsin Carbone Cancer Center

Phone: 608-265-1700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place