Clinical Research Directory

Retrospective Analysis of Erectile Dysfunction (ED) Patients Based on a Large-scale Clinical Database

The goal of this observational study is to analyze existing clinical data to characterize in male patients aged 18 and older diagnosed with Erectile Dysfunction (ED). The main questions it aims to answer are: What are the epidemiological features and comorbidity patterns (e.g., metabolic syndrome) in this patient population? How do sex hormone levels and penile hemodynamic parameters correlate with the severity of ED? Is there consistency between objective NPTR monitoring parameters and subjective patient-reported scores (IIEF-5, EHS)? This study does not have a comparison group or interventions. It is a retrospective analysis of existing data. Participants will not be asked to do anything new. The research involves analyzing their de-identified data that was previously collected during routine clinical visits, which includes: Demographic information, medical history, and lifestyle factors. Results from laboratory tests (e.g., blood biochemistry, sex hormones). Outcomes from diagnostic assessments (e.g., IIEF-5 questionnaires, CDDU, NPTR).

The Impact of a Plant-based Meat Meal Versus an Animal Meat Meal on Erectile Function in Healthy Men.

The goal of this study is to determine whether erectile function is differentially impacted by a single plant-based meat meal versus a single animal meat meal in healthy men with normal erectile function.

Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy

This study will test whether injections of platelet-rich plasma (PRP) can improve erectile function in men with persistent erectile dysfunction (ED) at least 12 months after nerve-sparing radical prostatectomy for prostate cancer. Participants will be randomly assigned to receive either two PRP injections or two saline (placebo) injections into the penis, administered one month apart in a double-blind fashion. Erectile function will be assessed using the International Index of Erectile Function (IIEF) questionnaire at baseline and at 1, 3, 6, and 12 months after the last injection. The primary objective is to determine whether PRP improves the erectile function domain of the IIEF more than saline at one month after the last injection

Effect of Testofen on Erectile Function in an Adult Male Population

This is a double blind, randomised, placebo-controlled clinical study with a 12-week participation and 3 groups (2 active groups and 1 placebo group) designed to monitor erectile function symptom severity and the effect Testofen may have on improving erectile function, sexual function, and quality of life.

Investigation of Serum Sclerostin Levels in Patients With Erectile Dysfunction

This prospective, observational case-control study aims to investigate the potential role of sclerostin-a molecule associated with cardiovascular pathologies-in the vascular pathogenesis of erectile dysfunction (ED). The study compares peripheral venous sclerostin levels between men diagnosed with ED and healthy volunteers. Additionally, it evaluates cavernosal blood sclerostin levels within the ED group to explore localized vascular changes.

A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients

A Multicenter, Randomized, Double-blind, Phase Ⅲ Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients

Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.

Erectile dysfunction is known as any alteration that produces a modification in the erectile response, whether it is due to organic, psychogenic or relational causes. Peripheral percutaneous nerve stimulation is performed using a needle to stimulate the peripheral nerves in such a way as to stimulate most of the area of the structure, stimulating sensory and motor nerve endings in the deeper tissues.

Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction

Erectile dysfunction is known as any alteration that produces a modification in the erectile response, whether of organic, psychogenic or relational cause. In this case the pudendal nerve is addressed, since it has its origin in the sacral plexus, deriving from the S2, S3 and S4 nerve branches. Its fibers have different innervation, being the pudendal nerve a mixed nerve, and estimating that it has 30% of autonomic innervation, and 70% of somatic innervation (50% sensory and 20% motor). Peripheral percutaneous nerve stimulation (proposed treatment) is performed with a needle to stimulate the peripheral nerves in such a way as to stimulate most of the area of the structure, stimulating sensory and motor nerve endings of the deeper tissues.

Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Peyronie's Disease, ED, and Interstitial Cystitis

This trial will study the safety and efficacy of intravenous and intracavernosal or interstitial delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Peyronie's disease, erectile dysfunction , and Interstitial Cystitis

Erectile and Ejaculatory Function Following Coronary Revascularization

This observational, cross-sectional study aims to compare erectile and ejaculatory function between men with a history of coronary revascularization and men without known coronary artery disease. The study included 135 adult male participants, including 66 men who had previously undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) and 69 men without known coronary artery disease. Erectile function was evaluated using the Sexual Health Inventory for Men (SHIM), premature ejaculation symptoms using the Premature Ejaculation Diagnostic Tool (PEDT), and ejaculatory function using the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD). Self-reported ejaculation latency was also assessed. The primary objective was to investigate the association between previous coronary revascularization and erectile function. Secondary objectives included comparing premature ejaculation symptoms, ejaculatory function, and ejaculation latency between the two groups.

Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease

The purpose of this research is to determine whether or not low-intensity shockwave therapy (LiSWT) with Xiaflex treatment will result in greater improvements to the curvature of the penis.

IT Matters: The Erectile Restoration Registry

The objective of the It MATTERS registry is to collect Real-World Data (RWD) to monitor the safe and effective use of commercially available Boston Scientific Corporation (BSC) penile prostheses

Male Pelvic Floor Muscle Rehabilitation Exercises

Phase I G128 Study Objective The ischiocavernosus (IC) and bulbospongiosus (BS) muscles are vital components of the superficial perineal layer, serving as the foundation for male sexual health and performance. These muscles play a primary role in achieving and maintaining erections by compressing the veins to trap blood within the erectile tissues. Furthermore, they are responsible for the rhythmic contractions necessary for ejaculation and the physiological sensations associated with orgasm. Beyond their role in sexual function, these muscles provide critical structural support to the pelvic floor and assist in urinary control. By working in tandem, the IC and BS muscles ensure penile rigidity while stabilizing the surrounding pelvic structures. Maintaining the strength and coordination of these muscles is essential for overall reproductive health and the prevention of pelvic floor dysfunction. The primary objective of this clinical trial is to evaluate the clinical efficacy and therapeutic potential of Exercise G128 in strengthening the male pelvic floor musculature. Furthermore, the study aims to establish a comprehensive safety profile for Exercise G128 during active participation. The research seeks to address the following core investigative questions: To what extent does Exercise G128 improve the tonicity and contractile strength of the IC and BS muscles? What is the incidence and nature of adverse medical events or physiological stressors reported by participants while performing the Exercise G128 protocol? Researchers will conduct a comparative analysis, benchmarking the physiological outcomes of Exercise G128 against existing clinical data regarding the efficacy of traditional Kegel exercises. Participant Requirements: Adhere to a structured regimen, performing Exercise G128 four times weekly over a one-month intervention period. Attend bi-weekly telehealth consultations via video conferencing for supervised clinical assessments, progress monitoring, and physiological testing. Maintain a detailed daily log documenting functional progress, as well as any instances of physical exertion or soreness that necessitated a temporary cessation of the exercise protocol. UPDATE: The G128 inventor and user scheduled an appointment with a Certified Pelvic Rehab Practitioner, who has over 10 years of experience treating complex diagnoses and pelvic impairments. During the appointment, a male pelvic floor muscle test was performed using Rehabilitative Ultrasound Imaging (RUSI). Ultrasound Findings (suprapubic RUSI): Muscle bulk is visually above average compared to clinician's clinical experience; good bilateral muscle mass noted with asymmetry as described. Voluntary Contraction / Coordination: Patient demonstrated visible pelvic floor lift on ultrasound with volitional kegel contraction. Contraction quality: good lift observed; clinician noted contraction quality as above average relative to clinical experience.

Satisfaction of Patients With Erectile Dysfunction With the Use of Sildenafil Oral Suspension Compared to Orodispersible Tablets

The goal of this observational retrospective study is to to evaluate treatment satisfaction with sildenafil oral suspension in patients with mild-to-moderate ED who were previously taking orodispersible sildenafil. The secondary objective is to evaluate the efficacy and side effects of therapy with sildenafil oral suspension compared to orodispersible sildenafil. Patients who took sildenafil orodispersible 50 mg for 3 months and subsequently took sildenafil oral suspension for another 3 months will be enrolled.

Pudendal Atherosclerosis by IVUS-NIRS in Men With Coronary Artery Disease

This prospective, single-center, exploratory study will evaluate the association between atherosclerotic and lipid plaque burden in the internal pudendal arteries, assessed by intravascular ultrasound and near-infrared spectroscopy (IVUS-NIRS), and the severity of erectile dysfunction in adult men with documented or suspected coronary artery disease undergoing clinically indicated coronary angiography. After completion of the clinically indicated coronary procedure, eligible and hemodynamically stable participants with favorable pelvic vascular anatomy will undergo selective pudendal angiography and investigational IVUS-NIRS imaging of one or both internal pudendal arteries. Erectile function will subsequently be assessed within 30 days using the 5-item International Index of Erectile Function (IIEF-5). The primary outcome will be the correlation between pudendal maxLCBI4mm and IIEF-5 score. Secondary analyses will characterize pudendal and coronary plaque burden, assess the relationship between pudendal and coronary lipid burden, evaluate associations with cardiovascular risk factors, and describe the technical feasibility and safety of pudendal IVUS-NIRS imaging.

Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis

The purpose of the study is to determine the effects of testosterone treatment on erectile function, fatigue, depression, cognitive function, quality of life, urinary incontinence, pain, and damage to neurons in male Multiple Sclerosis patients with low testosterone, using questionnaires, blood samples and a rectal exam in volunteers 55 years and older.

Shockwave Therapy on Treating Erectile Dysfunction Following Nerve-sparing Radical Prostatectomy.

This study will investigate whether low-intensity extracorporeal shockwave therapy (LiESWT) can help men recover erectile function after nerve-sparing prostate cancer surgery. Erectile dysfunction is common after this surgery, and current rehabilitation treatments mainly help manage symptoms rather than directly promoting recovery of the affected penile tissues. LiESWT is a non-invasive treatment that uses low-intensity shockwaves and may help improve blood flow and tissue recovery. The study will include 80 men undergoing nerve-sparing radical prostatectomy. Participants will be randomly assigned to receive either standard penile rehabilitation alone or standard rehabilitation plus eight LiESWT treatments. Erectile function, urinary function, pain, and potential side effects will be assessed throughout the 36-week study period. The main goal is to determine whether adding LiESWT increases the number of men who recover normal erectile function 24 weeks after surgery. The findings may help improve penile rehabilitation and sexual health outcomes for men recovering from prostate cancer surgery.

Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED

Adult subjects with mild to moderate and moderate ED who meet the study eligibility criteria will be enrolled in the study. The enrolled subjects will be randomized by a 1:1 ratio to receive the Active or Sham VERTICA® treatment. Baseline assessments will include collection of demographic data, medical history, concomitant medications and baseline clinical examinations. The initial treatment session will be performed in a clinical setting simulating home use to determine proper device use and to evaluate device tolerability, followed by continued home use of the device for a total of 6 months. Patients will be instructed to attempt sexual activity periodically over the course of the study. Every time a sexual intercourse is attempted, the patient will be requested to complete an event log using validated assessments. Patients will present for monthly follow-up visits, during which safety will be evaluated and additional efficacy assessments will be performed.

The Impact of Dietary Pattern on Erectile Function

The goal of this study is to determine whether erectile function is impacted by dietary patterns in healthy men with normal erectile function.

Phase IIa Clinical Trial of YN001 in Patients With Atherosclerotic Cardiovascular and Cerebrovascular Diseases and Erectile Dysfunction

This is a randomized, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy and safety of YN001 in patients with atherosclerotic cardiovascular and cerebrovascular diseases and erectile dysfunction

A Randomized Double-Blind Clinical Study of Intracavernosal OnabotulinumtoxinA Injection in Patients With Erectile Dysfunction Refractory to Phosphodiesterase-5 Inhibitors

This study aims to evaluate the clinical efficacy of intracavernosal treatment with onabotulinumtoxinA (Botox) in 114 men aged 30 years or older with erectile dysfunction who have not responded to first-line oral pharmacological treatment. For this purpose, the effects of onabotulinumtoxinA are compared with those of a placebo consisting of an intracavernosal injection of physiological saline. The study is patient-blinded. Participants in the experimental group receive 100 U of onabotulinumtoxinA diluted in 1 mL of physiological saline, while participants in the control group receive 1 mL of physiological saline.

EECP for Erectile Dysfunction in Elderly Hypertensive Patients

Hypertension and erectile dysfunction are common health problems in older men and may share vascular dysfunction as an underlying mechanism. Enhanced external counterpulsation (EECP) is a noninvasive treatment in which inflatable cuffs placed around the legs and buttocks are inflated and deflated in synchronization with the heartbeat to improve blood flow. The purpose of this randomized controlled trial is to determine whether EECP, when added to usual antihypertensive treatment, improves blood pressure and is safe in older men with both hypertension and erectile dysfunction. The study will also evaluate whether EECP improves erectile function and other measures related to vascular function, circulation, quality of life, sleep, and psychological well-being. A total of 106 men aged 60 to 75 years will be enrolled at two study centers. Participants will be randomly assigned in a 1:1 ratio to receive either active EECP or sham EECP in addition to their usual antihypertensive treatment. Active EECP will be administered for 1 hour per session, once daily, for 35 sessions over 5 weeks. Sham EECP will be administered using the same device and treatment schedule but at a low cuff pressure that is not expected to produce effective counterpulsation. Participants will not know which treatment they receive. The main study outcome is the change from baseline to the end of the treatment period in average office blood pressure, calculated from three consecutive blood pressure measurements obtained at the study visit. Additional assessments will include office blood pressure during follow-up, 24-hour ambulatory blood pressure monitoring, erectile function, vascular function, hemodynamic measures, quality of life, and adverse events. Participants will be assessed at baseline, after 20 treatment sessions, at the end of treatment, and at 1, 3, and 6 months after treatment.

Linear Piezoelectric Low Intensity Shockwave Treatment (LI-SWT) for the Treatment of Erectile Dysfunction in PDE5i Non Responder

The goal of this clinical trial is to assess the efficacy and safety of linear piezoelectric Li-SWT for erectile dysfunction patients who have poor treatment respond from PDE5i oral treatment. Participants will be randomised to either receive 4 cycles, once per week, of Li-SWT treatment on the penis or the Sham group, where the treatment appears to be identical but the shockwave machine is deactivated. Investigators will compare the before and after treatment erectile function using the IIEF questionnaire of the two groups 1 month after treatment to assess the treatment outcome. After that, the Sham group patient would be offered to receive compensatory Li-SWT treatment and their post treatment response will be assessed. All the patients completing the Li-SWT treatment will be followed up at 6 and 12 months to assess the efficacy and adverse events.

Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment

This study is being done at Duke Health and includes adult men who have been treated for localized prostate cancer. The goal is to see if it is feasible and acceptable to offer sex therapy by telehealth after prostate cancer treatment. All participants receive pelvic floor physical therapy and education about penile rehabilitation, including use of a vacuum erection device. Participants are randomly assigned to one of two groups. One group receives pelvic floor physical therapy plus telehealth sex therapy, with about ten sessions over six months. The other group receives pelvic floor physical therapy alone. Participants complete questionnaires about urinary and sexual health at the start of the study and over the next two years. Short interviews are also done at 6 and 12 months. Medicines for erectile function are prescribed as part of usual clinical care and are not part of the study treatment.