Mobile App for Sexual Dysfunction

Overseen By Lavanya P Parsons, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Pregnancy, Non-English speaking

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist women who have had breast or gynecologic cancer and are experiencing sexual difficulties. Researchers will use the Female Sexual Function Index (FSFI) to measure these issues and evaluate whether a mobile app called Rosy can help. Participants will also have the opportunity to discuss their needs with a healthcare provider. Women who have or have had breast or gynecologic cancer and agree to use the Rosy app may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to research that may enhance sexual health support for women with cancer histories.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this mobile app is safe for patients with sexual dysfunction?

Research shows that specific safety information for the Rosy app, designed to help with sexual issues, is not available. However, using the app does not involve medication or medical procedures, suggesting a very low chance of physical side effects. Doctors and psychologists created the app, indicating a focus on user safety. Additionally, any health information shared through the app remains private and secure, as it is encrypted and not sold to other companies. While direct safety studies for the app are lacking, its non-invasive nature suggests it is generally safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Rosy app is unique because it leverages technology to address sexual dysfunction in a way that traditional treatments, like medications or therapy sessions, might not. Unlike standard options which often involve pharmaceutical interventions, the Rosy app provides a personalized and accessible platform that users can engage with discreetly at their own pace. Researchers are excited about this approach because it offers a non-invasive, user-friendly solution that can be integrated into daily life, potentially broadening access to treatment and empowering individuals to take control of their sexual health.

What evidence suggests that the Rosy app is effective for sexual dysfunction in breast and gynecologic cancer patients?

Research has shown that online and mobile tools can effectively improve sexual function and satisfaction, especially for women. In this trial, participants will use the Rosy app, designed to boost women's sexual desire and enhance their sexual health. Studies have found that mobile tools like Rosy can positively impact sexual health for people with chronic conditions. Developed by doctors and psychologists, Rosy offers various resources to support women's sexual wellness. This evidence suggests that the Rosy app could help improve sexual function for those experiencing sexual difficulties. ^{1 2 6 7 8}

Who Is on the Research Team?

Lavanya P Parsons, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for women who have breast or gynecologic cancers and are experiencing sexual dysfunction. Participants will use the Rosy mobile application, which aims to help with these issues.

Inclusion Criteria

Agree to participate in the study with completion of survey and use of ROSY mobile application

I have or had breast or gynecologic cancer.

Exclusion Criteria

Currently pregnant

I speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Rosy app to address sexual dysfunction over a six-month period

6 months

Follow-up

Participants are monitored for changes in sexual dysfunction and personal distress using FSFI and SDOH questionnaires

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rosy app

Trial Overview

The study tests the feasibility of using the Rosy app to address sexual dysfunction in affected patients. It involves measuring sexual function with a questionnaire and providing follow-up care.

How Is the Trial Designed?

Group I: Rosy app Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

In a 16-week study involving over 256 women aged 21 to 65 with sexual disorders, Zestra, a topical botanical preparation, was found to be well tolerated and effective in improving sexual desire, arousal, and treatment satisfaction.

The only notable safety concern was mild-to-moderate genital burning experienced by 14.6% of Zestra-treated participants, indicating that while generally safe, some users may experience discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, placebo-controlled, double-blind, parallel design trial of the efficacy and safety of Zestra in women with mixed desire/interest/arousal/orgasm disorders. Ferguson, DM., Hosmane, B., Heiman, JR.[2015]

In a trial involving 60 female cancer survivors, an online self-help intervention significantly increased the number of sexually active participants at follow-up, indicating its potential effectiveness in improving sexual function (p < 0.001).

Participants also reported improved sexual function and increased use of sexual aids, suggesting that the intervention can positively impact sexual health, although high attrition rates highlight the need for better patient engagement strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness trial of an online self-help intervention for sexual problems after cancer. Schover, LR., Strollo, S., Stein, K., et al.[2021]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1743609520305038

051 Effectiveness of App Based Intervention for the ...

Rosy is a mobile app designed with the goal of improving women's sexual function, particularly their sexual desire. This app has three primary sections (i.e., ...

2.

meetrosy.com

meetrosy.com/

MeetRosy

Developed by doctors & psychologists, Rosy is the first-ever app to bring the entire women's healthcare experience under one roof. Download for free today!

3.

withpower.com

withpower.com/trial/phase-sexual-dysfunctions-psychological-10-2024-bec86

Mobile App for Sexual Dysfunction · Info for Participants

Research shows that internet- and mobile-based psychological interventions can effectively improve sexual functioning and satisfaction, especially for women.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7036501/

Mobile health applications for improving the sexual health ...

Reviewed studies showed a positive effect of mobile interventions on sexual health outcomes in chronic patients.

5.

mmm-online.com

mmm-online.com/home/channel/rosy-quickies-sexual-wellness-womens-health/

With Quickies, Rosy expands past sexual wellness to ...

Rosy started off as a sexual wellness app but is now expanding into additional aspects of women's health. The company recently announced the ...

6.

meetrosy.com

meetrosy.com/treatment-options-for-orgasm-dysfunction

Treatment Options for Orgasm Dysfunction

Yes, you read that correctly, there is no FDA approved treatment option for orgasm dysfunction. As healthcare professionals, we can carefully measure the amount ...

7.

apps.apple.com

apps.apple.com/us/app/rosy-womens-health/id1444780510

Rosy - Women's Health - App Store - Apple

Private & Secure All health data is encrypted, anonymized, and securely stored. We don't collect any cycle information and never sell data to third parties.

8.

biospace.com

biospace.com/press-releases/dare-bioscience-and-rosy-wellness-announce-strategic-collaboration-to-educate-and-market-dares-dare-to-play-sildenafil-cream

Daré Bioscience and Rosy Wellness Announce Strategic ...

Concerns with arousal were reported by 65% of those women who completed the Female Sexual Function Index screener questionnaire. The ...