Prostate Stimulation for Sexual Dysfunction
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Disqualifiers: Prostatectomy, Inability to operate device, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial uses a special device to help men with sexual dysfunction by stimulating their prostate. The goal is to help these men achieve faster ejaculation and better erections. The Viberect handheld device is a new treatment that uses vibrations to help improve sexual function.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of prostate stimulation devices for sexual dysfunction?
The research suggests that innovative approaches, like using a strap-on dildo, can help men with erectile dysfunction (ED) by reducing the fear of erectile failure and increasing partner satisfaction. While not directly about prostate stimulators, this indicates that alternative sexual aids can be beneficial for sexual dysfunction.
12345How does the prostate stimulator treatment for sexual dysfunction differ from other treatments?
The prostate stimulator is unique because it uses vibratory stimulation to enhance sexual function, which can increase sexual desire and improve erectile and ejaculatory function. Unlike traditional medical treatments, it offers a non-invasive, mechanical approach that can be used at home and may also help with pelvic floor dysfunction.
46789Eligibility Criteria
This trial is for men over the age of 18 who are experiencing sexual dysfunction, including erectile dysfunction, delayed ejaculation, or anorgasmia. It's not suitable for women, men under 18, those unable to operate the device, or men who have had their prostate removed.Inclusion Criteria
I am a man over 18 with sexual dysfunction.
Exclusion Criteria
I am a male and under 18 years old.
Inability to operate the device for any reason
I have had my prostate removed.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants use the prostate stimulation device to improve symptoms of sexual dysfunction
4 weeks
Follow-up
Participants are monitored for changes in erectile function and other symptoms after treatment
4 weeks
Participant Groups
The study is testing a prostate stimulator device to see if it can help improve symptoms of sexual dysfunction in men. Participants will use this device as part of the treatment being studied.
1Treatment groups
Experimental Treatment
Group I: Prostate stimulation device armExperimental Treatment1 Intervention
Participants will be asked to use our prostate stimulation device.
Prostate stimulator is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Prostate stimulator for:
- Sexual dysfunction
- Erectile dysfunction
🇪🇺 Approved in European Union as Prostate massager for:
- Sexual dysfunction
- Erectile dysfunction
- Prostatitis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford Healthcare, Stanford HospitalStanford, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
References
Ejaculatory and Orgasmic Dysfunction Following Prostate Cancer Therapy: Clinical Management. [2020]The majority of sexual health research has focused on erectile dysfunction following prostate cancer treatment. Ejaculatory and orgasmic dysfunction are significant side effects following the treatment of prostate cancer. Orgasmic dysfunction covers a range of issues including premature ejaculation, anorgasmia, dysorgasmia, and climacturia. This review provides an overview of prevalence and management options to deal with orgasmic dysfunction. A Medline Pubmed search was used to identify articles relating to these problems. We found that orgasmic dysfunction has a very large impact on patients' lives following prostate cancer treatment and there are ways for physicians to treat it. Management of patients' sexual health should be focused not only on erectile dysfunction, but on orgasmic dysfunction as well in order to ensure a healthy sexual life for patients and their partners.
Importance of considering interest in sex when evaluating satisfaction after robot-assisted radical prostatectomy. [2022]To assess the impact of patients' interest in sex on the satisfaction after robot-assisted radical prostatectomy, longitudinal changes of urinary and sexual functions and bothers were evaluated.
Correlations with satisfaction measures in men treated with phosphodiesterase inhibitors for erectile dysfunction. [2015]This literature review examined the relationship of erectile function to patient satisfaction. Published correlation coefficients (r values) were sought between patient-reported outcomes (PROs; i.e., instruments/questionnaires) assessing erection or erectile function and PROs assessing individual sexual satisfaction, satisfaction in the context of the couple or relationship, or satisfaction with erection. The U.S. National Library of Medicine's PubMed database was searched for English-language, randomized, double-blind, placebo-controlled trials of treatment with a phosphodiesterase type 5 inhibitor in men with erectile dysfunction (ED) who were not selected for any concomitant disease. Trials that reported correlations between an ED-specific and psychometrically validated PRO for an erection/erectile function concept and for a selected satisfaction concept were included. All correlations were positive, with almost all r values >.50. The positive relationship between results on erection/erectile function PROs and results on satisfaction PROs is probably reinforced bidirectionally such that improved erection/erectile function improves satisfaction, which further improves erection and/or erectile function.
Restoring sexual function in prostate cancer patients: an innovative approach. [2007]It has been extremely difficult for men with prostate cancer to obtain reasonable estimates of the likelihood of remaining potent after first line therapy, partly because of differences in defining potency. If, as in more recent studies, the definition requires that men are usually (not just occasionally) able to get and sustain an erection, then the picture is not encouraging. Additional strategies are needed to help men sustain sexual activity. In this paper we draw on the experiences of a rather remarkable prostate cancer patient to help consider the possibilities for a different kind of intervention for men with ED--use of a strap-on dildo (an external prosthetic penis fastened by a harness around the hips). The dildo is a simple and inexpensive strategy for dealing with impotence and in certain circumstances it can work better than more established medical treatments for ED. Use of a dildo potentially removes the fear of erectile failure, allows for increased stimulation of the glans, facilitates full-body contact between partners, and offers potential satisfaction to one's partner. Urologists (and other health professionals) are encouraged to explore dildos as an option during discussions with patients about sexual rehabilitation. The potential benefits are discussed of specialty sexuality clinics that facilitate introduction of innovative approaches like dildos.
Are we targeting the right outcome for sexual health after prostate cancer treatment? [2019]Satisfaction with sex life is a patient-centered, attainable sexual health outcome after prostate cancer treatment. Its achievement combines the necessary components of erectile dysfunction prevention and treatment and reliance on patients' and partners' psychosocial strengths, regardless of either partner's sexual function.
The use of vibrotactile stimulation for determining sexual potency in the laboratory in men with erectile problems: methodological considerations. [2007]Vibrotactile stimulation, when used in combination with visual sexual stimulation, has been shown to enhance erectile response in sexually functional men. The present study attempted to describe a diagnostic methodology, including the development and application of a new mini-vibrator, that might enhance penile response in men with erection problems. Tests on 78 men with either erectile dysfunction (ED), or a combination of erectile dysfunction and premature ejaculation (ED+PE), showed that vibratory stimulation together with an erotic video (EV+VT), produced greater penile response than the erotic video alone (EV). The new mini-vibrator was more effective than a previously used model, and produced clinically significant increases in erectile response in ED+PE men. In addition, the enhancing effect of the combined stimulation on self-reported penile response was greater when it followed EV than when it preceded it. The use of vibrotactile stimulation and visual sexual stimulation together may therefore assist in determining the potential sexual potency of men experiencing erection problems during the process of differential diagnosis.
Genital vibration for sexual function and enhancement: a review of evidence. [2020]Vibration, as provided by a genital vibrator, is commonly regarded as a tool to enhance sexual pleasure and in modern day society falls under the category of a sex toy. However, the vibrator was not originally intended to be a toy, and its benefits reach far beyond that of a plaything. This article is a narrative review of the current evidence regarding the use of vibratory stimulation for the treatment of sexual dysfunction and/or sexual and relationship enhancement. The literature indicates that vibratory stimulation has evidence-based support for the treatment of erectile dysfunction, ejaculatory dysfunction and anorgasmia. Vibratory stimulation is positively correlated with increased sexual desire and overall sexual function. It has also shown benefit for sexual arousal difficulties and pelvic floor dysfunction. Though definitive evidence is lacking, genital vibration is a potential treatment for sexual dysfunction related to a wide variety of sexual health concerns in men and women.
Prevalence and characteristics of vibrator use by men in the United States. [2009]While vibrating products have been recommended by clinicians for the treatment of male sexual dysfunctions, knowledge is lacking with regard to the prevalence of vibrator use among men in the United States, the characteristics of men who use vibrators, and whether there are relations between vibrator use and sexual function among men.
Genital vibration for sexual function and enhancement: best practice recommendations for choosing and safely using a vibrator. [2020]Vibrators are an evidence-based treatment for a variety of sexual dysfunctions and sexual enhancement; however, the use of a genital vibrator lacks best practice recommendations. This aim of this article is to provide current, best practice recommendations regarding the use of vibratory stimulation for the treatment of sexual dysfunction and/or sexual or relationship enhancement. A multidisciplinary team of sexual health specialists collaborated to develop best practice recommendations based on a narrative literature review. Recommendations for the use of vibratory stimulation for the treatment of sexual dysfunction are provided, with special attention to counseling patients on choosing and safely using a vibrator. Further study is needed to determine the most effective methods to counsel patients on vibrator use and to provide evidence-based cleaning recommendations.