Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

All Drugs and Chemicals

Aromatase Inhibitors

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

Ryan Spencer

Breast cancer patients commonly take medications to reduce the risk of recurrence, including aromatase inhibitors (AIs). AIs can cause significant side effects that reduce patient adherence. Early discontinuation of AI therapy results in an increased risk of cancer recurrence and increased risk of breast cancer-related death. Common side effects include vaginal dryness and vulvovaginal atrophy leading to worsening sexual function. To increase AI adherence, the investigators will study a non-pharmaceutical Vaginal Renewal Program (VRP) aimed at stimulating nitric oxide production to consequently increase vaginal lubrication, and improve the symptoms of vulvovaginal atrophy.

Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention

Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention for Breast Cancer Patients Treated With Aromatase Inhibitors

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

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.

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).

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.

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.

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.

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.

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.

American Cancer Society, Inc.

University of Wisconsin, Madison

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.

VRP Therapy

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

This study was terminated early with 2 participants due to the COVID-19 pandemic. It is not powered for meaningful results.

Ryan Spencer, MD, MS

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.

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

Percentage of Superficial Vaginal Cells

Change in Vaginal pH

Patient Reported Outcomes: Number of Subjects With Improved Anxiety

Patient Reported Outcomes: Number of Subjects With Improved Depression

Patient Reported Outcomes: Number of Subjects With Improved Sexual Function Outcomes

Patient Reported Outcomes: Number of Subjects With Improved Global Health

Patient Reported Outcomes: Number of Subjects With Improved Sex Life

Adherence to AI Therapy

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Sexual Dysfunction, Physiological

Genital Diseases

Urogenital Diseases

This will consist of still vaginal dilator and/or lubricant.

The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.

Vaginal Dilator

David M Kushner, MD

This is a randomized controlled trial designed to evaluate the effect of the Vaginal Renewal™ Program (VRP), consisting of the use of a vibrating vaginal wand, manual massage and a water based lubricant, on sexual dysfunction, compared to the current standard care for women with no evidence of disease after treatment for gynecologic cancers.

In the University of Wisconsin gynecologic oncology and radiation oncology clinics, patients are generally asked about sexual function. Those women who report sexual dysfunction will be given the option to enroll in the study. After enrollment, the Female Sexual Function Index (FSFI) and other quality of life surveys will be administered at baseline. The participants will be randomized to either the control arm, composed of standard of care therapy for the physical components of sexual dysfunction, or the experimental arm (VRP).

Throughout the study, the participants will undergo physical exams to assess the rate of improvement in their comfort with pelvic exams and changes in vaginal length. They will also be evaluated with the FSFI, Marinoff Scale for Dyspareunia, and Functional Assessment of Cancer Therapy-General (FACT-G) surveys at the end of the study to assess the magnitude of improvement in sexual function and quality of life.

Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction

Evaluation of a Multifaceted Vaginal Renewal™ Program Utilizing Vibrating Wands in Gynecologic Cancer Patients Experiencing Sexual Dysfunction: A Randomized Controlled Trial

Female Sexual Function Index (FSFI), uses a 19-item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported.

The Marinoff dyspareunia scale measures pain with intercourse, measured from 0-3, according to the following scale:

0 = no pain with intercourse

1. = pain with intercourse that doesn't prevent the completion
2. = pain with intercourse requiring interruption or discontinuance
3. = pain with intercourse preventing any intercourse

Difference in Marinoff scores reported, value at 6 months minus value at baseline.

The FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire assesses general cancer quality-of-life measure for evaluating patients receiving cancer treatment. Scores range from 0 to 108, where 0 is low well-being and 108 is the highest well-being possible. Difference in score from baseline to 6 months is reported.

Change in vaginal length as measured from baseline to 6 months.

Participants were assessed for toxicity at each study visit. All events at least possibly related to the study intervention will be collected. Participants were instructed to call the study team for adverse events that occurred between visits. The study team or an on-call physician were available 24 hours a day.

Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.

This will consist of still vaginal dilator and/or lubricant.

Vaginal Dilator: Still vaginal dilator with lubricant.

Standard of Care

Total

Prior Pelvic Radiation

No Prior Pelvic Radiation

Pelvic Radiation

Ovary

Endometrium

Cervix

Vulva

Dual Primary (Ovary and Endometrium)

Primary Disease Site

The study was closed before completion due to a slowing accrual rate.

Dr. David Kushner

Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months

Data for eleven subjects (2 from Standard of Care and 9 from VRP) was not collected at one or more study visits, and the change in scores could not be calculated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention	NCT03739983	Adherence, Medi...	Vaginal Renewal...	18 Years -	University of Wisconsin, Madison
Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction	NCT01444911	Sexual Dysfunct...	Vaginal Renewal... Vaginal Dilator	18 Years -	University of Wisconsin, Madison

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