Clinical Research Directory

Actual Use Trial of Tadalafil 5 mg

The purpose of this actual use trial (AUT) is to evaluate if participants can appropriately select and use the study product \[Cialis over the counter (OTC)\] using the labeling and the mandatory health survey assessment (HSA) for duration of 4-months.

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

Stem Cells for Erectile Dysfunction Post RALP

This is a phase 1/2 single center, pilot study to assess safety and efficacy of allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) and to evaluate the timing and combination effects of active treatment versus placebo in promoting the recovery of erectile function in patients undergoing radical retropubic prostatectomy (RALP) of localized prostate cancer.

Efficacy and Safety Study of Tunodafil Hydrochloride Tablets in Erectile Dysfunction

This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of Tunodafil Hydrochloride Tablets in men with erectile dysfunction.

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.

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

Urethroplasty is considered as a gold standard in treatment of urethral stricture disease having success rate of more than 93% in terms of recurrence of stricture. The objective of the study is to compare the outcome between 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 stricture upto 2cm in length. It will be a Randomized Controlled Trial (RCT) in which 94 patients admitted in Sahiwal Teaching Hospital, Sahiwal will be included. The patients will be divided into two equal groups. Randomization will be performed using a computer-generated random sequence. The 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 carried out. Detailed history of urinary symptoms, Sexual function, catheterization, instrumentation, urinary tract infection and trauma will be taken to obtain the cause of stricture. Demographic information like name, age, and contact number will be recorded. Investigations will include preoperative complete blood count, renal function test, liver function test, urine complete examination, ultrasonogram kidney, ureter and bladder with post void residual volume (PVR) uroflowmetry and retrograde urethrogram for diagnosis and length of stricture. Other parameters of study will be length of hospital stay, postoperative complication such as graft failure, wound infection, urinary tract infection and fistula formation. Data will be collected through proforma, which will be entered and analyzed using statistical package for social sciences version 26.0. For quantitative variables mean and standard deviation will be calculated and for qualitative variables frequency and percentages will be calculated. Data will be presented in tables and graphs for both quantitative and qualitative variables. Chi-square test will be used to estimate the association between qualitative variables. An Independent sample t-test will be applied for quantitative variables. P-value \<0.05 will be considered significant. It is anticipated that the Tunica Vaginalis Graft (TVG) Urethroplasty provides better outcome as compared to excision and primary anastomosis (EPA) urethroplasty.

Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction

Prospective collection of pre-defined parameters on the surgical treatment of male erectile dysfunction using Penile Prosthesis Implants (PPIs).

L-Citrulline and Tadalafil for Mild to Moderate Erectile Dysfunction

Erectile dysfunction is a common male sexual health problem that may affect quality of life and sexual relationships. Tadalafil 5 mg once daily is an established oral treatment for erectile dysfunction. L-citrulline is an oral nitric oxide pathway supplement that may improve erectile function by increasing L-arginine availability. This randomized trial will compare three oral treatment regimens in men with mild to moderate erectile dysfunction: L-citrulline 1500 mg/day, tadalafil 5 mg/day, and the combination of L-citrulline 1500 mg/day plus tadalafil 5 mg/day. Participants will receive treatment for 12 weeks and will be followed at baseline, week 4, week 8, and week 12. The primary outcome will be the change in the International Index of Erectile Function-Erectile Function domain score from baseline to 12 weeks. Secondary outcomes will include changes in IIEF-5/SHIM score, Erection Hardness Score, SEP diary outcomes, treatment adherence, adverse events, and treatment discontinuation.

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.

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.

Autologous PRP and Focal Shock Waves for Erectile Dysfunction

The goal of this clinical trial is to learn if Platelet-rich plasma (PRP) combined with Shock-wave therapy (SWT) works to treat moderate or mild to moderate erectile dysfunction. It will also learn about the safety of this combined therapy. The main questions it aims to answer are: * Does Combined therapy PRP + SWT improve erection in men with moderate or mild to moderate erectile dysfunction? * What medical problems do participants have when receiving Combined therapy PRP + SWT? Researchers will compare Combined therapy PRP + SWT to placebo therapy (a look-alike substance that contains no PRP) to see if Combined therapy PRP + SWT works to treat moderate or mild to moderate erectile dysfunction. Participants will: * Take a lab test to evaluate their platelets * Answer some questionnaires to assess your erectile function * Receive Combined therapy PRP + SWT (3 sessions PRP + 6 sessions SWT) or placebo therapy for 9 weeks * Visit the clinic one month, 3 months, and 6 months after finishing the treatment for checkups and tests

Penile Injection Anxiety

The purpose of this study is to help us understand more about your experience with penile injection therapy. Many men become anxious when thinking about penile injections. We would like to understand more about this anxiety. You will be asked to fill out questionnaires before you start penile injection training, at each training visit, and then at your four month follow-up visit.

Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery

The purpose of this study is to test two different ways to help men with sexual rehabilitation.

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.

The Effectiveness of Exercise in the Treatment of Erectile Dysfunction and Premature Ejaculation

The aim is to investigate the effectiveness of exercise in the treatment of erectile dysfunction and premature ejaculation.

Safety Follow-up Study of Cellgram-ED in Post-Radical Prostatectomy Erectile Dysfunction

This phase II clinical trial with safety follow-up is designed to evaluate the efficacy and safety of Cellgram-ED (autologous bone marrow-derived mesenchymal stem cells) administered via intracavernous injection in patients with erectile dysfunction after radical prostatectomy.

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.

EndoPAT Device for Endothelial Dysfunction in ED

To assess endothelial dysfunction in young men (aged 30-50) with vasculogenic ED identified through penile Doppler ultrasound. To evaluate changes in endothelial function using EndoPAT before and 3-6 months after daily low-dose phosphodiesterase type 5 (PDE5) inhibitor therapy. To investigate endothelial function alterations in hypogonadal patients before and 3-6 months after initiating testosterone (T) therapy

Collaborative Urological Prosthetics Investigation Directive Research Group

The purpose of this study is to determine if an additional 6 days of oral antibiotics decreases the risk of penile prosthesis infection after implantation.

Is There a Benefit From Addition of Exercise in Diabetic Patients With ED Who Complain Low Vitamin D?

males with diabetes complain impotence in the presence of low vitamin D deficiency. pharacmological treatment of low vitamin D levels is necessary but changing lifestyle by performing exercise is also important

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.

Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.

The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation. The main question to answer is: What is the effectiveness of pelvic floor therapy (electrostimulation, biofeedback, and therapeutic exercise) for the treatment of patients with erectile dysfunction and or premature ejaculation? Patients will: * Have an initial consultation of pelvic floor rehabilitation before therapy. * Be given pelvic floor therapy. * Have a secondary consultation of pelvic floor rehabilitation after therapy. Three intervention groups will be included: Group 1: Patients with premature ejaculation Group 2: Patients with erectile dysfunction Group 3: Patients with erectile dysfunction and premature ejaculation.

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.

Primary Care ERectile Function Outcome Registry for Men

The PERFORM registry is a structured, real-world data platform designed to systematically capture patient characteristics, disease severity and treatment patterns of Erectile Dysfunction (ED) across Pakistan. By reflecting routine clinical practice, an ED registry provides valuable insights into the disease epidemiology, unmet needs, and variations in care across populations. It supports evidence-based decision-making, helps identifying early predictors, and inform guideline development, health policy, and personalized management strategies in male sexual health.