Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical...
Orthopedic DisorderNeurologic Disorder15 moreTo determine the safety and efficacy of Amniotic and Umbilical Cord Tissue for the treatment of the following condition categories: Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions. The hypotheses are that the treatments are not only extremely safe, but also statistically beneficial for all conditions. Outcomes will be determined by numerous valid outcome instruments that compile general quality of life information along with condition-specific information as well.
The Safety of Dapoxetine/Tadalafil Combination Therapy
Premature EjaculationErectile Dysfunction1 moreThe purpose of this study is to evaluate the safety and efficacy of Dapoxetine/Tadalafil 30/20 mg film-coated tablet in the treatment of men with premature ejaculation and erectile dysfunction.
LI-ESWT Versus Sham Therapy in Men With ED
Erectile DysfunctionHong Kong has an aging population. By the year of 2036, more than 30% of our population will be older than 65 years old1. Aging in male has been shown to correlate with the risk of erectile dysfunction(ED). The demand in ED treatment is expected to increase. Several ED treatment options are available, ranging from oral or intracavernosal drug treatments, to vacuum erection therapy or even penile prosthesis implantation. However, none of these treatment are curative nor rectify the pathophysiology of ED. Low-intensity extra-corporeal shockwave therapy(LI-ESWT) has been introduced since 2010 for treatment of ED. The first randomized-controlled trial by Vardi et al. had proved the efficacy of ESWT in improving the International Index of Erectile Function(IIEF) score3. The International Index of Erectile Function-Erectile Function domain score(IIEF-EF) was significantly greater in the treatment group compared with the sham therapy group. The efficacy of LI-ESWT was also confirmed in meta-analyses. Nonetheless, the available studies were criticized for the variations in shockwave generators, energy parameters and treatment protocol. Most studies used focused electrohydraulic machines, did not include NPT as part of the outcomes assessment, and only reported the short-term outcomes. Currently LI-ESWT machine was used in few Hong Kong public hospitals for the treatment of erectile dysfunction. In KEC, few pilot cases have been done using the linear LI-ESWT machine. No adverse events were seen. Local published data is lacking. Yee et al. has published a double-blinded randomized placebo-controlled trial on LI-ESWT in 20144. Using an electrohydraulic machine with a focused shockwave source, they concluded no significant differences in IIEF-EF and Erectile Hardness Score(EHS) between treatment and sham therapy after 13 weeks of treatment. In subgroup analysis significant improvement was noted in men with severe baseline erectile dysfunction (LI-ESWT IIEF-EF improvement: 10.1 ± 4.1 vs sham therapy IIEF-ED domain improvement: 3.2 ± 3.3; P = 0.003). There were several limitations in this study. These include the small number of participants included in the subgroup analysis (ranges from 18 to 21 men in each subgroups), the lack of physical measurement of erectile function. The percentage of patients with 5 points or more IIEF-EF improvement and the Erection Hardness Score(EHS) were also not reported. They have also used an old design with focused energy source, instead of the linear energy source. In light of the limitations of the previous international and local studies, the investigators plan to investigate the efficacy of a linear electromagnetic LI-ESWT machine in men with moderate and severe ED. In addition, the intermediate-term outcomes would be studied, in terms of patients-reported erection scores and nocturnal tumescence and rigidity measurement.
LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment
Erectile DysfunctionWe designed a double blind randomized sham-controlled trial in order to investigate and compare the treatment efficacy of LiST plus PRP intracorporeal injection vs LiST plus placebo (normal saline intracorporeal injection) in men with moderate and mild to moderate vasculogenic ED, as measured by IIEF-EF.
Recalled International Index of Erectile Function-5 Collected Post Prostatectomy in Assessing Preop...
Erectile Dysfunction Following Radical ProstatectomyThe accurate assessment of erectile function before radical prostatectomy, using validated questionnaires like IIEF-5, is crucial to evaluate postoperative changes in erectile function, as the preoperative erectile function is a prognostic factor for the postoperative recovery of erectile function. In clinical practice, patients usually present at the urologist's office 3 months after the operation without a preoperative IIEF-5 score and at that time the doctors ask them about their preoperative erectile function. With this study, the investigators would like to evaluate the agreement between a real-time preoperative IIEF-5 and a recalled one 3 months after radical prostatectomy.
Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction...
Erectile Dysfunction Following Radical ProstatectomyThe goal of this clinical trial is to assess if a new device is safe to use as a potential treatment for erectile dysfunction following radical prostatectomy. The main questions it aims to answer are: Is the device safe? Does the device works well? Are the participants satisfied with the device? Participants will be implanted with the device during the ongoing prostatectomy surgery and will be asked to complete the following tasks during 6 months follow-up: Come to the hospital for follow-up visits, Complete questionnaires, Activate the device every day, Measure erection hardness. Researchers will compare an implanted group (participants having the device) with a control group (participants not having the device) to see if the device works well.
A New Sildenafil Oral Film in Patients With Erectile Dysfunction
Erectile DysfunctionThis is a Phase III, prospective, interventional, multi-center, randomized, double-blind, flexible-dose, placebo-controlled, parallel group clinical study required by FDA to demonstrate the efficacy and safety of Sildenafil oral film 25 mg, 50 mg, 75 mg and 100 mg as compared to placebo in approximately 488 men clinically diagnosed with erectile dysfunction (ED).
Selution Sirolimus-eluting Balloon for Internal Pudendal-penile Artery Disease-related Erectile...
Erectile DysfunctionPeripheral Arterial Disease1 moreAccording to epidemiological surveys in various countries around the world, the prevalence of erectile dysfunction in men over the age of 40 is about 40%. Previous angiography studies have shown that nearly 70% of erectile dysfunction patients do have pelvic arterial stenosis. Our team leads the world in the use of percutaneous angioplasty combined with drug-eluting stents or paclitaxel-coated balloons to delineate the stenosis of the pelvic pudendal artery and penile artery The successful report of erectile dysfunction shows that the 12-month erectile function improvement rate is nearly 60%, and the vascular restenosis rate is also about 40% to 50%, obviously there is room for improvement. This study aims to observe the clinical efficacy, safety and lower restenosis rate of the newly developed "Selution SLR™ sirolimus drug sustained-release coated balloon" in patients with distal internal pudendal artery and penile artery stenosis complicated with erectile dysfunction . Compared with drug-eluting stents and paclitaxel drug-coated balloons, the Sirolimus drug-coated balloon has two advantages: one is that the clinical performance of sirolimus is much better than that of paclitaxel when used in drug-eluting stents; the other is that there is no indwelling stent in the Therefore, it can reduce the local stimulation of blood vessels and maintain the biological activity of blood vessels. Selution SLR™ sirolimus drug sustained-release coated balloon has obtained European Union approval for marketing, and has also been granted four Breakthrough Device Designation Status by the U.S. Food and Drug Administration (FDA): coronary artery disease, coronary artery disease In-stent restenosis, infra-knee artery disease, and arteriovenous canals.
Genital Nerves Stimulation for Treatment for Erectile Dysfunction
Erectile DysfunctionObjectives: To perform pilot study using unilateral transcutaneous electrical stimulation (TENS) on thegenital nerves (dorsal nerve penis and cavernous nerves) for improving of the intracorpereal pressure and full penil erection in men after exclusion neurogenic, endrogenic and earteriogenic disorders. The investigators hypothesize that this therapy will be effective at improving erectile dysfunction (ED). Material and methods: The study will comprised 20 patients with ED randomized in two groups. Two adhesive skin electrodes are placed, one at the root of the penis and near the pubic symphysis as a cathode, and a second 2-3cm lateral to the penis. Stimulation is delivered for 30 min at the maximal tolerable stimulation amplitude at 210μs pulse width and in one group with a pulse rate at 20Hz, the second group at 60Hz. The penile tumescence and rigidity observed during stimulation are recorded in both groups of patients. Erection Harness Score (EHS) and Quality of Erection Questionnaire (QEQ) are assessed at baseline, immediately after stimulation and 2 weeks after stimulation.
Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis
Multiple SclerosisErectile Dysfunction1 moreThe 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.