What is the mechanism of action of this treatment?

Common treatments for sexual dysfunction, such as vaginal moisturizers and mind-body interventions, work through distinct mechanisms. Vaginal moisturizers improve vulvovaginal tissue quality and alleviate symptoms of atrophy by hydrating and maintaining the natural moisture balance of the vaginal tissues, which reduces discomfort and enhances sexual function. Mind-body interventions, including relaxation techniques and hypnotic induction, aim to boost sexual energy and self-image by reducing stress and fostering a positive self-perception. These treatments are significant for sexual dysfunction patients as they address both physical and psychological aspects, leading to a more comprehensive and effective approach to improving sexual health.

What side effects are associated with this type of intervention?

The use of vaginal moisturizers for vulvovaginal atrophy is generally well-tolerated, with minimal side effects, which may include mild local irritation or allergic reactions. Mind-body interventions, such as relaxation techniques and subconscious suggestions, are also considered safe, with rare side effects that might include temporary emotional discomfort or increased anxiety in some individuals. Overall, these treatments are low-risk and can be beneficial for improving sexual function and self-image.

What prior FDA approvals exist?

The FDA has approved several treatments for sexual dysfunction, particularly focusing on vulvovaginal atrophy and overall sexual health. For vulvovaginal atrophy, topical estrogen therapies such as estradiol creams and vaginal rings have been approved to improve tissue quality and alleviate symptoms. Additionally, non-hormonal moisturizers and lubricants are available over-the-counter to address vaginal dryness. While there are fewer FDA-approved treatments specifically targeting sexual energy and self-image, cognitive-behavioral therapy (CBT) and other mind-body interventions have shown promise in clinical studies for improving sexual function and psychological well-being in women.

What other types of research exist?

Promising novel alternatives for treating sexual dysfunction in 2024 include: 1) Laser therapy, such as fractional CO2 laser, which has shown efficacy in improving vulvovaginal atrophy and sexual function. 2) Hormonal treatments like DHEA (prasterone) vaginal inserts, which help in restoring vaginal tissue quality. 3) Cognitive-behavioral therapy (CBT) tailored for sexual dysfunction, which addresses psychological aspects and improves self-image and sexual energy. 4) Use of platelet-rich plasma (PRP) injections, which are being explored for their regenerative effects on vulvovaginal tissues.

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Behavioural Intervention

Hypnotic Relaxation for Sexual Dysfunction (WISH Trial)

N/A

Waitlist Available

Led By Debra L Barton, PhD,RN,FAAN

Research Sponsored by The University of Tennessee, Knoxville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days screening to consent

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help women who have survived breast cancer improve their sexual health. The treatment includes using a special cream for vaginal dryness and listening to relaxation audio files to boost sexual energy and self-image. The study will check if this combined approach is practical and acceptable for these women.

Who is the study for?

This trial is for women who've had breast cancer (stages I-III), finished primary treatment between 3 months and 5 years ago, and are experiencing vaginal dryness or pain during sex, body image issues, or low sexual desire since their diagnosis. They must be able to engage in sexual activity and read/write English. Those on stable antidepressant doses can join; however, those with a history of sexual abuse, severe psychiatric disorders, using certain hormone treatments, or participating in other sexual health studies cannot.

What is being tested?

The WISH trial aims to improve sexual health by testing two interventions: a vaginal moisturizer for vulvovaginal atrophy and an audio-delivered hypnotic relaxation technique to boost self-image and sexual energy. The study will check if these methods are practical and well-received by participants.

What are the potential side effects?

Potential side effects may include discomfort from the use of vaginal moisturizers or unexpected emotional responses to hypnotic relaxation intervention. However, as this is more focused on feasibility rather than clinical outcomes like drug trials, detailed side effects aren't specified.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days screening to consent

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days screening to consent

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days screening to consent for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accrual rate (a measure of feasibility)

Retention rate/Acceptability (a measure of feasibility)

Screen failure rate (a measure of feasibility)

Secondary study objectives

Breast- Impact of Treatment Scale (BITS)

Female Sexual Function Index (FSFI)

Patient reported outcomes measurement information system (PROMIS) Sexual Function and Satisfaction

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Vulvovaginal Atrophy (VVA)Experimental Treatment1 Intervention

This study arm might best be described as standard of care. Vulvovaginal dryness will be treated with a daily moisturizer for two weeks, then every other day for the remaining six weeks. Vaginal moisturizer will be applied at night, before sleep and after all sexual activity. Several moisturizers are available, including vaginal DHEA (IntraRosa®). Due to the need for reproducibility, we have decided to use one non-hormonal vaginal moisturizer, Replens™ moisture, which is a vaginal moisturizer consisting primarily of a purified water, glycerin, and mineral oil. Other ingredients included in the formulation are polycarbophyl, carbomer, homopolymer type B, hydrogenated palm oil glyceride, sorbic acid, sodium hydroxide. The moisturizing gel was determined to be a medical device for marketing by the FDA in 2010. It is non-hormonal (unlike vaginal DHEA) and therefore will be more likely to be acceptable by a broader range of oncology providers.

Group II: Hypnotic Relaxation Intervention (HRI)Experimental Treatment1 Intervention

The hypnotic relaxation intervention consists of three different audio files, each about 20 minutes in length. These three hypnotic inductions build upon each other. The first hypnotic induction audio focuses on relaxation, feelings of wellness, wholeness, strength, and confidence. The second hypnotic induction audio focuses more specifically on body image related to sexuality and being a sexual being. The third hypnotic induction audio focuses on sexual desire, passion, and energy. Each hypnotic induction will be used for two weeks, three times per week for a total of six weeks of hypnosis. The vaginal moisturizer component of this arm is the same as that described for the VVA study arm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vulvovaginal Atrophy (VVA)

2022

N/A

~30

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for sexual dysfunction, such as vaginal moisturizers and mind-body interventions, work through distinct mechanisms. Vaginal moisturizers improve vulvovaginal tissue quality and alleviate symptoms of atrophy by hydrating and maintaining the natural moisture balance of the vaginal tissues, which reduces discomfort and enhances sexual function. Mind-body interventions, including relaxation techniques and hypnotic induction, aim to boost sexual energy and self-image by reducing stress and fostering a positive self-perception. These treatments are significant for sexual dysfunction patients as they address both physical and psychological aspects, leading to a more comprehensive and effective approach to improving sexual health.

Patient-centered change in the day-to-day impact of postmenopausal vaginal symptoms: results from a multicenter randomized trial.Patterns in Vulvodynia Treatments and 6-Month Outcomes for Women Enrolled in the National Vulvodynia Registry-An Exploratory Prospective Study.Interventions for sexual dysfunction following treatments for cancer in women.