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Prostatic Hyperplasia clinical trials

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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: NCT03936244 Completed - Clinical trials for Lower Urinary Tract Symptoms

Bipolar Plasmakinetic TURP Vs Monopolar TURP in the Treatment of Lower Urinary Tract Symptoms

Start date: December 5, 2014
Phase: N/A
Study type: Interventional

Randomized controlled trial with one-year follow-up comparing intra, peri and postoperative outcomes for plasmakinetic transurethral resection of prostate (PK-TURP) and monopolar transurethral resection of prostate (M-TURP) in the treatment of LUTS due to BPH in a tertiary-care public institution

NCT ID: NCT03916536 Completed - Clinical trials for Prostate Hypertrophy

Holmium Laser Versus Thulium Laser Versus Bipolar Enucleation of the Prostate.

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Because of the diversity of the studies and deficiency of those comparing various techniques of EEP for treatment of LUTs secondary to BPO in patients with large sized prostate, we aim in this study at testing the non-inferiority of PKEP and ThuLEP to HoLEP in relieving LUTs secondary to BPO in patients prostate size >80ml. Our hypothesis is to present an evidence that enucleation is a technique rather than a power dependent procedure through a RCT.

NCT ID: NCT03912766 Completed - Clinical trials for Benign Prostatic Hyperplasia

Serum Copeptin as a Predictor of the Risk of Hyponatremia After Transurethral Prostatectomy

Start date: February 1, 2016
Phase:
Study type: Observational

Hyponatremic hypovolemia is a frequent complication of transurethral resection of the prostate gland (TURP). Copeptin has been established as is a surrogate marker of vasopressin and is measured useful for thea clinical assessment of various sodium and water disturbances. The aim of our the study was to assess the utility of serum concentration of copeptin (CPP) and brain natriuretic peptide (NT-proBNP) for the prediction of postoperative alterations of serum sodium concentration. Study population comprised 43 patients with benign prostatic hyperplasia (BPH) undergoing transurethral resection of the prostate gland. In a forward stepwise multiple regression only serum copeptin before the surgery and the duration of TURP significantly explained the variation of sodium concentration for 12 hours from the start of the surgery. Serum NT-proBNP before the surgery did not predict hyponatremia 12 hours after TURP.Conclusion Serum copeptin before TURP surgery but not NT-proBNP may be a clinically useful marker of a decrease of serum sodium after TURP surgery.

NCT ID: NCT03902080 Completed - Overactive Bladder Clinical Trials

Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

Start date: March 26, 2019
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy of vibegron compared with placebo in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH) as defined by micturition and urgency episodes.

NCT ID: NCT03887871 Completed - Clinical trials for Benign Prostatic Hyperplasia

Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers After Meal

Start date: March 11, 2019
Phase: Phase 1
Study type: Interventional

This study is an open-label, randomized, fed, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc. "Harnal-D" in healthy volunteers

NCT ID: NCT03887858 Completed - Clinical trials for Benign Prostatic Hyperplasia

Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers

Start date: March 11, 2019
Phase: Phase 1
Study type: Interventional

This study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc. "Harnal-D" in healthy volunteers

NCT ID: NCT03856242 Completed - Clinical trials for Benign Prostatic Hyperplasia (BPH)

Benign Prostatic Hyperplasia and Ischemic Heart DIsease

Start date: September 1, 2015
Phase: Phase 4
Study type: Interventional

To examine the dynamics of 24 - hours ECG monitoring parameters (Holter monitoring) in patients with ischaemic heart disease (IHD) before and after treatment of voiding dysfunctions resulted from benign prostatic hyperplasia (BPH) with the indications for either conservative or operative treatment. A total of eighty-three 57-to-81-year-old (mean age 70.4±5.75 years) patients with BPH and accompanying IHD were examined at the Institute of Urology and Human Reproductive Health and Clinic of Cardiology of the Sechenov University.

NCT ID: NCT03846700 Recruiting - Clinical trials for Benign Prostatic Hyperplasia (BPH)

Urodynamic Evaluation of Disobstrucitve Power of Aquablation VS Laser Techniques

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

in the last decade, lots of attemps have been done to identify new technologies able to reply the efficacy of gold standard technique for treating BPH, but with a better safety profile. The introduction of laser techniques allowed to reduce complication rates. Among these, considerable importance had Holep and PVP. Aquablation is a recent technique for LUTS treatment. It is minimally invasive, robot-assisted and ultrasound-guided to ablate the prostate in targeted way and in "heat-free" way. It works with high pression water jet. However, in literature informations about disobstructive capacity of minimally invasive techniques, evaluated with invasive urodynamic tests, are low. The enrolled subjects will undergo surgical treatment with one of the techniques under study: Aquablation, HoLEP or PVP. Outpatient visits will be performed at 1, 3 and 6 months after the surgical treatment. During the sixth month visit an invasive urodynamic examination will be performed

NCT ID: NCT03831321 Recruiting - Pain Clinical Trials

The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy

Start date: December 11, 2018
Phase: Phase 4
Study type: Interventional

The study was designed as a prospective, randomized double-blind placebo controlled trial. According to power analysis in regards of previous studies in the literature with diclofenac sodium, using a total of 144 patients are needed for Power: 80% and Efficacy: 0.05. diclofenac (20 mg) and placebo drugs to be used in the study will be numbered 1 and 2 individually. Patient randomization was performed using random.org in 144 patients. On the day of cystoscopy, the patient randomized according to inclusion criteria will be given a medication package corresponding to the number given in randomization. It will not be known by the staff and cystoscopy will be performed by the physician who does not know which package is an effective drug. Parameters: 1. Visual Pain Score during cystoscopy 2. Cystoscopy comfort - a questionnaire to be filled by the doctor 1. Excellent 2. Very good 3. Good 4. Bad 5. Too bad 3. Cystoscopy: Is it efficient? Not efficient? - Will be answered by the doctor. Post-Op: 1. 1st hour Visual Analog Pain Scale inquiry, dysuria, frequency 2. 24th Hour dysuria, Frequency, A total of 144 patients, we plan to arrive at the end of 1 month.