Clinical Research Directory

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.

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.

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.

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

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.

Penile Lengthening Pre-Penile Prosthesis Implantation

The goal of this study is to determine whether or not the use of a penile traction therapy device known as RestoreX prior to implantation of a penile prosthesis can increase the length of the implant used during surgery. The device used in this study is commercially available and has been used successfully to facilitate penile lengthening in patients with diabetes and after a certain type of prostate surgery. Use of the device has not been shown to have any detrimental effects on sexual or overall health.

Efficacy of Transcutaneous Electrical Neural Stimulation and Tadalafil in Men With Erectile Dysfunction: A Randomized, Double-Blind, Bi-centric, Placebo- and Sham-Controlled Trial

Organic erectile failure is thought to be caused predominantly by neurogenic or vascular disorders. Venoocclusive dysfunction of the corpora cavernosa induces erectile dysfunction in 20-30% and appears clinically by premature erection loss. The increased venous outflow from the corpora cavernosa can be illustrated as a so called 'venous leakage' by cavernosography being responsible for the therapeutical failure of intracavernously applied vasoactive substances. Cavernous smooth muscle pathology proven in some of the patients with venous leakage gave little hope to reconstructive surgery. However, own examinations let assume that the etiology of 'venous leakage' is caused by endogenic and exogenic factors. Furthermore, reversible venous leakage was observed. Any therapeutic option of the veno-occlusive dysfunction showed disappointing results with a respective success rate of 20% in the long-term follow-up (surgical venous resection, percutaneous transpenile venous embolisms). Finally the vacuum device or penile prosthetics are the only therapeutical option for the patients. Physiologically, bulbocavernous and ischiocavernous muscles increase the intracavernous pressure of the tumescent penis. Regular pelvic floor exercise can be achieved by a physiotherapist which seems to be a time-consuming and expensive procedure, or an advantageous transcutaneous electrical stimulation which is the standard therapy for the treatment of posttraumatic atrophy of the striated muscular system. Thus an external stimulator device has been developed to evaluate the therapeutical potency of striated muscle exercise in patients with erectile dysfunction. The present clinical study documents the first experiences with this EIS device and outlines its potency for the treatment of erectile dysfunction.

Atherogenic Index of Plasma and Tadalafil Response in Erectile Dysfunction

This prospective single-center observational cohort study examined whether baseline atherogenic index of plasma (AIP), calculated from routine triglyceride and high-density lipoprotein cholesterol measurements, was associated with response to once-daily tadalafil in men aged 40 years or older with erectile dysfunction. Tadalafil 5 mg once daily was prescribed as part of routine clinical care, independently of study participation, and participants were prospectively followed for 12 weeks. Erectile function was assessed using the six-item International Index of Erectile Function-Erectile Function domain (IIEF-EF) at baseline and Week 12. Treatment response was defined as an increase of at least 4 points in the IIEF-EF score from baseline. All participants received tadalafil, and there was no untreated or placebo comparator; therefore, the study evaluated the association between baseline AIP and observed outcome during tadalafil treatment.

Daily Tadalafil as Adjunctive Therapy Versus Monotherapy for PDE5 Inhibitor-Resistant Erectile Dysfunction

This randomized trial will compare daily tadalafil 5 mg as adjunct therapy versus monotherapy in men with on-demand PDE5 inhibitor-resistant erectile dysfunction. The study will evaluate changes in erectile function, treatment satisfaction, partner satisfaction, and safety over 12 weeks.

Male Sexual Function and Sexual Quality of Life in Polygamous Versus Monogamous Marriages

This web-based comparative cross-sectional survey will assess sexual function, sexual quality of life, psychological status, and marital satisfaction among Egyptian men in monogamous and polygamous marriages. Eligible participants will be married Egyptian men aged 18 years or older who provide electronic informed consent and complete an anonymous Arabic-language questionnaire. The primary outcome will be sexual function measured using the Sexual Health Inventory for Men (SHIM/IIEF-5). Secondary outcomes will include Sexual Quality of Life-Male (SQOL-M), Depression Anxiety Stress Scales-21 (DASS-21), marital satisfaction, and sociodemographic and clinical predictors of impaired sexual function. Data will be analyzed using descriptive, comparative, correlation, and multivariable regression methods.

Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain

The purpose of this study to perform a randomized, sham controlled analysis of the effectiveness of both fSWT and rWT in the relief of erectile dysfunction and chronic pelvic pain syndrome.

Lifestyle Modification for Erectile Dysfunction in Men With Metabolic Syndrome

Metabolic syndrome is associated with erectile dysfunction through obesity, insulin resistance, abnormal blood lipids, high blood pressure, and impaired blood-vessel function. This study will evaluate whether a structured six-month lifestyle-modification program can improve penile blood flow and erectile function in men with metabolic syndrome-associated erectile dysfunction. Eligible participants will receive dietary counseling, exercise guidance, weight-management advice, smoking-cessation counseling when applicable, sleep and sedentary-behavior advice, and repeated behavioral reinforcement. Erectile function, penile blood-flow measurements obtained by penile duplex Doppler ultrasonography, body measurements, and selected metabolic laboratory parameters will be assessed before the program and after six months.

Efficacy of Intracavernosal Xeomin With Tadalafil for Mild-Moderate Erectile Dysfunction

Erectile dysfunction (ED) affects approximately 30 million men in the United States and is associated with factors such as aging, smoking, diabetes, hypertension, obesity, and sedentary lifestyle. ED can also negatively impact the quality of life of patients and their partners. Treatment decisions are typically made jointly between patients and their urologists, often starting with less invasive options. Oral phosphodiesterase-5 inhibitors (PDE5 inhibitors), including sildenafil, tadalafil, and vardenafil, are commonly used as first-line therapy. While these medications improve erectile function in many patients, approximately 30-40% do not respond adequately to PDE5 inhibitor therapy alone. Patients who do not achieve sufficient benefit may require additional or more invasive treatment options.

Diagnostic Performance of a Flexible Penile Monitoring System for ED

This study aims to evaluate the diagnostic performance of a novel intelligent flexible penile monitoring system for erectile dysfunction (ED). The current gold standard, RigiScan Plus, often causes discomfort and disrupts sleep due to its mechanical rings, leading to potential "first-night effect" biases. This research utilizes a prospective crossover design to compare the accuracy of the new flexible system with RigiScan in measuring peak rigidity and tumescence. A total of 60 participants (30 ED patients and 30 healthy volunteers) will be enrolled. The study expects to confirm that the flexible system provides highly accurate diagnostic data while significantly improving patient comfort and maintaining natural sleep structures.

Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)

This study evaluates the long-term safety and efficacy of the use of the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis in patients with erectile dysfunction. This study follows patients implanted with the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for up to 3 years after implantation. This study will take approximately 6 months to enroll all subjects. (14 days, 6 weeks, 6 months, 12 months,18 months, 24 months, and 36 months, post-procedure. ) Subjects will be followed per protocol and institutional standard of care for ED and comorbidities.

Comparsion of Effect of PRP,PDE5 Inhibitor in Treatment of Erectile Dysfunction

Erectile dysfunction (ED) is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.Erectile dysfunction (ED) is one of the commonest disorders in adult males and affects 12-19% of men of reproductive age.Erectile dysfunction can be due to vasculogenic, neurogenic, hormonal, veno-occlusive, psychogenic and/or pharmacogenic factors. PRP is autologous plasma that has a platelet concentration above the concentrations typically found in whole blood and is derived from the patient's own blood (autologous) through a process of centrifugation. PDE5Is inhibit the enzyme phosphodiesterase-5 (PDE-5) leading to dilatation of the penile arteries leads to a more prolonged erection.

Comparison Between Excision And Primary Anastomosis Urethroplasty And Tunica Vaginalis Graft Urethroplasty.

Urethroplasty is considered the gold standard for the treatment of urethral stricture disease, with a success rate of more than 93% in terms of stricture recurrence. The objective of this study is to compare the outcomes of excision and primary anastomosis (EPA) urethroplasty, a transecting urethroplasty technique, and tunica vaginalis graft (TVG) urethroplasty, a non-transecting urethroplasty technique, in patients with bulbar urethral strictures up to 2 cm in length. This will be a randomized controlled trial (RCT) involving 94 patients admitted to Sahiwal Teaching Hospital, Sahiwal. The patients will be divided into two equal groups. Randomization will be performed using a computer-generated random sequence. Group A patients will undergo excision and primary anastomosis (EPA) urethroplasty, while Group B patients will undergo tunica vaginalis graft (TVG) urethroplasty. Non-probability convenience sampling will be used. A detailed history of urinary symptoms, sexual function, catheterization, instrumentation, urinary tract infection, and trauma will be obtained to determine the cause of the stricture. Demographic information, including name, age, and contact number, will be recorded. Preoperative investigations will include complete blood count, renal function test, liver function test, urine complete examination, ultrasonography of the kidneys, ureters, and bladder with post-void residual volume (PVR), uroflowmetry, and retrograde urethrogram for the diagnosis and measurement of stricture length. Other study parameters will include length of hospital stay and postoperative complications, such as graft failure, wound infection, urinary tract infection, and fistula formation. Data will be collected using a structured proforma and entered into the Statistical Package for the Social Sciences (SPSS) version 26.0 for analysis. For quantitative variables, the mean and standard deviation will be calculated. For qualitative variables, frequencies and percentages will be calculated. Data will be presented in tables and graphs for both quantitative and qualitative variables. The chi-square test will be used to assess the association between qualitative variables, while the independent samples t-test will be applied to quantitative variables. A p-value of less than 0.05 will be considered statistically significant. It is anticipated that tunica vaginalis graft (TVG) urethroplasty will provide better outcomes than excision and primary anastomosis (EPA) urethroplasty.

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.