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Prostatic Hyperplasia clinical trials

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NCT ID: NCT04579913 Terminated - Clinical trials for Benign Prostatic Hyperplasia (BPH)

A Multi-center, International Prospective Follow up Study

Start date: December 21, 2020
Phase:
Study type: Observational

The study objective is to assess the safety and efficacy of iTind three to five years following treatment.

NCT ID: NCT04398966 Terminated - Clinical trials for Prostatic Hyperplasia

Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia

Start date: September 23, 2020
Phase: N/A
Study type: Interventional

Purpose: The purpose of this study is to determine if prostatic artery embolization (PAE) is as effective as medication (non-inferiority) in reducing urinary symptoms due to benign prostatic hyperplasia (BPH) and to determine if PAE will result in less adverse events compared to medication in individual patients. Participants: Study subjects will be 30 men who have taken BPH medication for at least 6 months and planning to undergo PAE. Subjects will be enrolled across 3 sites. Procedures (methods): This will be a single arm, non-blinded study of PAE using HydroPearl Beads. Subjects will be compared to themselves. The study will involve 6 study visits: an enrollment/baseline visit, the PAE procedure, and 1 day, 3 month, 6 month, and 12 month follow-up visits. Subjects will complete questionnaires and uroflowmetry testing at baseline and each follow-up visit. Subjects will also obtain an MRI at baseline and their 6 month follow-up visit.

NCT ID: NCT04398420 Terminated - Clinical trials for Benign Prostatic Hypertrophy

Transurethral Vapor Enucleation Resection of the Prostate (TVERP), Bipolar TURis and HoLEP

Start date: August 27, 2020
Phase: N/A
Study type: Interventional

To verify the safety and efficacy of the use of the plasma vaporisation button in Transurethral Vapor Enucleation and Resection of the prostate (TVERP) for treatment of Benign prostatic hypertrophy (BPH) patients with prostate ˃30 and ≤80 ml compare to TURis or HoLEP surgery methods.

NCT ID: NCT04340934 Terminated - Clinical trials for Benign Prostatic Hyperplasia

The Use of REZUM System in Chinese Male Patients With LUTS Secondary to Benign Prostate Enlargement

Start date: May 13, 2020
Phase: N/A
Study type: Interventional

Men with enlarged prostates commonly experience lower urinary tract symptoms and may go on to develop complications such as acute urinary retention (AUR). Surgery is the standard treatment option required to remove the enlarged prostates and to rectify such complications. Transurethral resection of prostate (TURP) was first performed over 80 years ago and is still regarded as the "gold standard" for the treatment of benign prostatic enlargement (BPE) in prostates between 30 and 80ml. While TURP results in an improvement in symptoms, perioperative morbidity and long-term complications can include postoperative bleeding, urinary retention, incontinence, urethral strictures, erectile dysfunction, and ejaculatory dysfunction. Rezūm is a system uses water steam energy to remove the particular part of the prostate that enlarges and causes symptoms due to BPH. Rezum involves a radiofrequency (RF) generator system and an endoscopic device that is introduced into the body via the urethra. Radiofrequency energy from the generator will heat up a controlled amount of water inside the system and converting the water into vapour or steam. The thermal energy created outside the body is delivered into the prostate tissue through the tiny needle at the tip of the endoscopic device. Small amount of steam will then be injected into the tissue and energy will be released during the conversion of steam to water. The energy will heat up the prostate tissue and result in gradually removal of the targeted obstructive prostate tissue. The treatment procedure takes approximately 3-7 minutes and can be performed as day surgery. No radiofrequency energy is delivered into the body, other than the prostate. Throughout the procedure normal saline (salty water) is running into the urethra through the scope to help ensure better views and to prevent the urethra from overheating. Voiding symptom will gradually improve after the procedure. From clinical study based in Caucasian population, patients had improved urinary flow rate by on average 50% and also improvement in quality of life scores. The treatment results could last for at least 4 years. However, information regarding the use of Rezum in Chinese and Asian is lacking. This study is proposed to evaluate the efficacy and safety of Rezum in our population.

NCT ID: NCT03938194 Terminated - Clinical trials for Benign Prostatic Hyperplasia

Waterjet Prostate Ablation

Start date: April 25, 2019
Phase: N/A
Study type: Interventional

Introduction Men with enlarged prostates commonly experience lower urinary tract symptoms and may go on to develop complications such as acute urinary retention (AUR). Surgery is the standard treatment option required to remove the enlarged prostates and to rectify such complications. Transurethral resection of prostate (TURP) was first performed over 80 years ago and is still regarded as the "gold standard" for the treatment of benign prostatic enlargement (BPE) in prostates between 30 and 80ml. While TURP results in an improvement in symptoms, perioperative morbidity and long-term complications can include postoperative bleeding, urinary retention, incontinence, urethral strictures, erectile dysfunction, and ejaculatory dysfunction. Aquablation, a novel minimally invasive water ablation therapy combining image guidance and robotics (AQUABEAM®, Procept BioRobotics, Redwood Shores, CA, USA) for the targeted and heatfree removal of prostate tissue is one of the efforts in the development of new technology in recent years to replicate the effectiveness of TURP and at the same time with an improved safety profile. In this study, investigators plan to evaluate the feasibility and safety of Aquablation in the management of AUR secondary to BPE. Method 20 participants are expected in this study. After patients consent to participate in the study, they will go through Aquablation under general anaesthesia or spinal anaesthesia. The ablation is delivered by transurethral means. After the procedure, subject is expected to go home on the following day. Subject will be assessed 3 months and 6 months after the procedure. Follow-up assessment includes blood tests, prostate ultrasound and urodynamic study.

NCT ID: NCT03297398 Terminated - Clinical trials for Benign Prostatic Hyperplasia

Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)

Start date: February 21, 2018
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and effectiveness of different doses of OPK-88004 compared to placebo on serum PSA compared to placebo in men with benign prostatic hyperplasia (BPH).

NCT ID: NCT03062111 Terminated - Clinical trials for Benign Prostatic Hyperplasia

Laser Enucleation of Prostate (LEP) Versus Transurethral Resection of Prostate (TURP)

Start date: October 23, 2017
Phase: N/A
Study type: Interventional

Benign prostatic hyperplasia (BPH) refers to the proliferation of smooth muscle and epithelial cells of the prostate gland. The enlarged gland has the potential to result in lower urinary tract symptoms (LUTS) secondary to either bladder outlet obstruction or increased muscle tone and resistance, or both. For decades transurethral resection of the prostate (TURP) has been the gold standard for treatment of symptomatic BPH that is refractory to nonoperative management. This is a surgical intervention aimed to reduce the size of the prostate gland. However, over the past fifteen years, many alternative therapies have been introduced including laser enucleation of the prostate (LEP). LEP has numerous advantages including decreased blood loss and length of hospital stay as well as increased effectiveness and safety for large prostate gland sizes (>80g).

NCT ID: NCT02962674 Terminated - Clinical trials for Benign Prostatic Hyperplasia

To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.

Start date: September 19, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and performance of the ProstaCare System in relieving symptoms of urinary outflow obstruction secondary to benign prostatic hyperplasia.

NCT ID: NCT02918227 Terminated - Clinical trials for Benign Prostatic Hyperplasia

Exploration of Ejaculation Changing Mechanism After Surgery for Benign Prostatic Hyperplasia

EMMECH
Start date: December 8, 2016
Phase: N/A
Study type: Interventional

Every year in France, more than 60 000 people are operated for benign prostatic hyperplasia (BPH). This surgery is accompanied by a change or even a loss of ejaculations externalized what constitutes the main constraint for patients. Empirically, the investigators talk to the patient "retrograde ejaculation" to explain a possible loss of ejaculation. Yet the underlying mechanism of this modification or loss of ejaculation remains completely unknown. Yet the underlying mechanism of this modification or loss of ejaculation remains completely unknown. No study could not determine whether the predominant mechanism was a real retrograde ejaculation or aspermia. Moreover, technical changes are sometimes tempted to preserve antegrade ejaculation but no scientific rationale can not validate.

NCT ID: NCT02676544 Terminated - Clinical trials for Lower Urinary Tract Symptoms

Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)

Start date: December 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This is a prospective, open label single center feasibility study to demonstrate basic safety and effectiveness of prostate artery embolization for the treatment of symptomatic benign prostatic Hyperplasia (BPH) in a small series of patients with large (≥90 grams) glands.