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NCT06968494
The 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.
NCT06768177
Patients are randomized into 2 groups (A and B), subsequently group A is subjected to a cycle of 6 weekly injections of 3 ml of autologous PRP while group B is subjected to 6 weekly injections of 1 ml of caverject (alprostadil) 20 mcg. After 4 (four) weeks the groups will be crossed, so group A will be subjected to 6 weekly injections of 1 ml of caverject (alprostadil) 20 mcg while group B will be subjected to a cycle of 6 weekly injections of 3 ml of autologous PRP.
NCT07172854
Post-prostatectomy urinary incontinence (PP-UI) and erectile dysfunction (ED) are common complications after radical prostatectomy, negatively affecting quality of life. Pelvic floor muscle training (PFMT) is widely recommended as the first-line conservative treatment, but recent evidence suggests that multimodal, structured rehabilitation may further improve recovery. This randomized controlled trial will investigate the additional effects of aerobic exercise and relaxation training combined with PFMT in men following nerve-sparing robotic-assisted radical prostatectomy. Forty-eight participants aged 40-65 years, within one year post-surgery, who demonstrate voluntary pelvic floor muscle contraction and sufficient cognitive function (MoCA), will be randomly assigned (1:1) to intervention or control groups. All participants will receive standardized education and a 12-week supervised PFMT program with biofeedback and home-based exercises. The intervention group will additionally perform treadmill-based aerobic exercise three times per week and structured relaxation training once per week. Primary outcomes include urinary symptoms (ICIQ-MLUTS), erectile function (IIEF-15), and prostate cancer-specific quality of life (EPIC). Secondary outcomes include pad test, ICIQ-SF, 6-minute walk test, MoCA, HADS, and adherence. This non-commercial study aims to provide high-quality evidence supporting physiotherapy-based multimodal rehabilitation for improved pelvic health and quality of life in men after prostate cancer surgery.
NCT06605508
The goal of this prospective observational study is to evaluate whether injections of stem cells derived from the patient's own fat tissue (adipose tissue) can improve erectile function in men aged 30 to 75 who have erectile dysfunction (ED) and have not responded well to standard treatments like PDE-5 inhibitors (e.g., Viagra). The main questions the study aims to answer are: Will the stem cell injections improve erectile function, as measured by the International Index of Erectile Function (IIEF) score? Are there any changes in blood flow to the penis, which will be measured using a Doppler ultrasound? Participants will: Receive injections of their own stem cells (obtained from a biopsy of fat) directly into the penis. Undergo assessments to check erectile function before and after treatment. Have follow-up visits at 3, 6, 9, and 12 months to monitor long-term effects. The study will also look for any possible side effects or complications and evaluate biological markers in the penis that may indicate the effectiveness of the treatment. Participants will be recruited from clinic where they are already receiving care for ED. To take part, they must be in good overall health, with no severe heart disease, uncontrolled diabetes, cancer, or other conditions that could make stem cell therapy unsafe for them.
NCT06458855
A single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing a somatic to autonomic nerve grafting procedure for restoration of erectile function in patients who have lost erectile function following radical prostatectomy for prostate cancer. During this study a total of 10 patients who have persistent erectile dysfunction for more than 18 months post prostatectomy will undergo a post radical prostatectomy nerve restoration procedure (PRP-NR).
NCT06875258
The PEHAB-II study is prospective, randomized trial designed to assess the effect of two different rehabilitation strategies on the recovery of erectile function in nerve sparing prostatectomy patients. The two rehabilitation strategies consist of 1)12 months daily doses of 100 mg Sildenafil combined with vacuum device (VED) therapy for 10 minutes a day, five times a week or 2) Standard of care: monotherapy with an on-demand dosage of 100mg Sildenafil. The study will be performed in multiple centers in the Netherlands.
NCT06743048
A surgical technique using laser assisted penile prosthesis implantation
NCT05558007
To determine efficacy, safety and tolerabiltiy of topically applied BZ371A in patients that experienced RP, in combination with daily tadalafil compared to placebo.
NCT06219785
This research study is trying to determine if Low-Intensity shock wave therapy (LiSWT) is safe and effective in patients with symptoms of erectile dysfunction (ED) after radical prostatectomy.
NCT05363644
The purpose of this study is to assess functional outcomes post operatively after the use of BioDFence® G3 during robotic radical prostatectomy.
NCT03862599
Erectile dysfunction (ED) is reported in up to 85% of men who have undergone a radical prostatectomy for prostate cancer. A few small studies have recently shown that low-intensity shockwave therapy may improve sexual performance in men with ED. However, the optimal dosage and length of treatment is yet to be determined. The investigators propose a randomised trial evaluating the efficacy and safety of low-intensity shockwave therapy in men with ED following prostatectomy surgery.
NCT05578157
Nocturnal erection detection with the outdated RigiScan is the golden standard for erectile dysfunction (ED) nature differentiation. The Staying Hot and Feeling Hot study have shown that nocturnal erection detection is feasible with patient-friendly overnight penile temperature measurements. The question has arisen whether the penile temperature methodology is also capable to detect the absence of nocturnal erections, which is essential for clinical implementation in erectile dysfunction diagnostics. The objective of the MENDiP-study is to determine the feasibility to detect the absence of nocturnal erections with overnight penile temperature sensors. Furthermore, the MENDiP study functions as a first pilot trial to investigate the effect of age on the penile temperature during nocturnal erections in test subjects with normal erectile functioning. This is done in an observational study with a longitudinal design in which pre- and postoperative ambulatory overnight measurements are performed in patients, aged 55 - 70 years with preoperative normal sexual functioning, undergoing a non- or unilateral nerve-sparing robot assisted radical prostatectomy.
NCT05531877
This is a chart of penile size measurements where penile length and width are recorded intra-operatively prior to penile prosthesis implantation to guide the surgeon to the correct and adequate post-operative penile size
NCT05272995
The 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.
NCT05118607
Erectile dysfunction (ED) affects up to 20% of men and is a growing problem with advancing age. There are many causes that contribute to ED, including the concomitant use of prescription drugs for health problems, including hypertension, or diseases such as diabetes. causes an up-regulation or increased local tissue expression of these proteins. This study follows the demonstration of the effectiveness of using BES in the treatment of ED. The aim of this study will be to examine the potentially additive effect of adding a third arm to the previous protocol to include the addition of 4 new target proteins to VEGF, including endothelial nitric oxide (eNOS), stromal-derived factor 1 (SDF-1), insulin-like growth factor (IGF) and follistatin.
NCT04164355
This study evaluates the retinal and choriocapillary vascular features in patients under the effects of Tadalafil 20mg using optical coherence tomography angiography.
NCT01996852
This is a research study of erectile dysfunction (ED) in men diagnosed with prostate cancer. 144 patients and partners will participate in the study. The purpose of this study is to test a new treatment that combines a cognitive-behavioral intervention with medication and a vacuum constrictive device to treat ED. This new treatment consists of multiple therapeutic elements that enhance compliance with medical treatment and increase sexual activity through enhancement of the sensual pleasure of sex and partner support.
NCT03241758
A study designed to evaluate vascular changes after radical laparoscopic prostatectomy using Doppler ultrasound and the impact of such changes on erectile function and quality of life of patients. The baseline study will be compared with the study one year after surgery.