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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the Rosy app treatment for sexual dysfunction?

Research shows that internet- and mobile-based psychological interventions can effectively improve sexual functioning and satisfaction, especially for women. These treatments are accessible and allow individuals to manage their sexual health privately, making them a valuable addition to traditional care. ^{1 2 3 4 5}

Is the Rosy app or similar mobile apps for sexual dysfunction safe to use?

There is no specific safety data available for the Rosy app or similar mobile apps for sexual dysfunction. However, studies on other treatments for sexual dysfunction, like Zestra, show mild side effects such as genital burning. More research is needed to confirm the safety of mobile apps for sexual health. ^{1 2 6 7 8}

How is the Rosy app treatment for sexual dysfunction different from other treatments?

The Rosy app is unique because it offers a mobile-based approach to addressing sexual dysfunction, providing accessibility and anonymity that traditional treatments may lack. Unlike many existing treatments that require clinician guidance, the Rosy app can be used independently, making it a scalable option for individuals seeking self-help solutions. ^{1 2 5 9 10}

What is the purpose of this trial?

The purpose of this study is to identify breast and gynecologic cancer patients with sexual dysfunction, to measure sexual dysfunction with the Female Sexual Function Index (FSFI) and to provide Patients with the opportunity during this six-month period to follow up with a healthcare provider to discuss the sexual dysfunction needs and to see if a medical intervention can be of aid.

Research Team

Lavanya P Parsons, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Internet- and mobile-based psychological interventions for sexual dysfunctions: a systematic review and meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

mSexHealth: An Overview of Mobile Sexual Health Applications. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Measuring women's satisfaction with treatment for sexual dysfunction: development and initial validation of the Women's Inventory of Treatment Satisfaction (WITS-9). [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Standards for Clinical Trials in Male and Female Sexual Dysfunction: II. Patient-Reported Outcome Measures. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Construction, Validation, and Standardization of the Sexual-DSMapp Application. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Topical alprostadil in the treatment of Female Sexual Arousal Disorder: a pilot study. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Randomized, placebo-controlled, double blind, crossover design trial of the efficacy and safety of Zestra for Women in women with and without female sexual arousal disorder. [2015]

8. England 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. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Effectiveness trial of an online self-help intervention for sexual problems after cancer. [2021]

10. Italy pubmed.ncbi.nlm.nih.gov

Erectile dysfunction and mobile phone applications: Quality, content and adherence to European Association guidelines on male sexual dysfunction. [2022]