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Prostatic Hyperplasia clinical trials

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NCT ID: NCT04879940 Recruiting - Clinical trials for Benign Prostatic Hyperplasia

Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization

Start date: February 23, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase II prospective clinical trial in which patients with prostate carcinoma and obstructive lower urinary tract symptoms electing for radiation therapy will undergo Prostatic Artery Embolization (PAE) prior to treatment. PAE will be administered by Interventional Radiology. Patients will be seen for follow-up at 6 weeks and 12 weeks following PAE after which they will start definitive radiotherapy. After completion of radiotherapy the patient will be seen at 12 weeks

NCT ID: NCT04853914 Recruiting - Clinical trials for Benign Prostatic Hyperplasia

Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.

Start date: September 13, 2021
Phase: N/A
Study type: Interventional

Prostate adenoma or benign prostatic hypertrophy (BPH) is a benign disease of the prostate gland. It results in an increase in the volume of the prostate area located in contact with the urethra. Compression of the prostatic urethra by the adenoma can cause lower urinary tract disorders. The classic treatments in case of failure of medical treatment are endoscopic resection of the prostate and adenomectomy, but these techniques are characterized by a significant hemorrhagic risk that may require transfusions and prolonged hospitalization. Minimally invasive treatments with low morbidity have been developed to overcome these drawbacks. They allow to propose a therapeutic solution adapted to patients: not tolerating their medical treatment, wishing to keep antegrade ejaculation, elderly and/or frail, at risk of bleeding, wishing an ambulatory treatment, refusing the conventional surgical techniques. The Focal One® device was developed to treat prostate cancer using ultrasound energy. This energy is delivered through a probe placed in your rectum. Connected to this probe, an ultrasound machine will allow your doctor to see precisely which part of your prostate is being treated. By heating the prostate tissue to a very high temperature in one treatment session, the energy delivered will then destroy the tissue. Ultrasound guidance coupled with the localized nature of the treatment allows the targeted area to be treated while respecting the prostate tissue and structures adjacent to the prostate and thus reducing side effects. Treatment of prostate adenoma with HIFU would allow for localized destruction to reduce prostate volume. The reduction of the compression of the prostatic urethra thus obtained would allow an improvement of the urinary disorders. The treatment is performed transrectally under real-time ultrasound control, which allows the adjacent structures to be respected, thus preserving antegrade ejaculation and limiting the side effects.

NCT ID: NCT04838769 Recruiting - Clinical trials for Benign Prostatic Hyperplasia (BPH)

REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men

VAPEUR RCT
Start date: September 15, 2021
Phase: N/A
Study type: Interventional

The study objective is to compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy in sexually active men.

NCT ID: NCT04807296 Recruiting - Clinical trials for Benign Prostatic Hyperplasia

Thulium Fiber Laser Enucleation of the Prostate (TFLEP) vs HoLEP With Moses Technology (m-HoLEP)

Start date: September 8, 2021
Phase: N/A
Study type: Interventional

Enucleation of the prostate equips technology (usually laser) to effectively treat lower urinary tract symptoms associated with benign prostate hyperplasia (BPH). The holmium: yttrium-aluminum-garnet (Ho: YAG) laser is considered the gold standard laser used to perform enucleation of the prostate. Holmium laser enucleation of the prostate (HoLEP) reduces hospital stay and hemoglobin drop while improving International Prostate Symptom Score (IPSS) and quality of life, as well as other postoperative outcomes. HoLEP has been found to have a better enucleation efficiency rate and may have better hemostatic properties when combined with the modulated pulsed laser energy featured associated with Moses technology (m-HoLEP). A novel laser technology called thulium fiber laser (TFL) delivers a pulsed laser at a more optimal wavelength and a shallower depth of tissue penetration leading to better hemostatic properties. However, the differences in clinical outcomes between TFL enucleation of the prostate (TFLEP) and m-HoLEP have yet to be described. This prospective study aims to compare the safety profile and clinical outcomes, peri-operatively up to one year post-operatively, between m-HoLEP and TFLEP with BPH and evidence of bladder obstruction.

NCT ID: NCT04802252 Recruiting - Clinical trials for Benign Prostatic Hyperplasia

A Diagnostic Study of Abnormal Acoustic Waves in Modern Pulse in Benign Prostatic Hyperplasia

Start date: March 1, 2021
Phase:
Study type: Observational

Pulse diagnosis is one of the traditional diagnostic methods of traditional Chinese medicine, which is of great significance in the process of disease diagnosis.Pulse diagnosis is the diagnosis of disease by touching the pulse of the radial artery at the wrist. Different diseases reflect different pulse characteristics.What we've found in long-term clinical observation is that patients with benign prostatic hyperplasia have something different in their pulse,the abnormal pulse we called "astringent pulse".There is no modern physiologic and pathological description on the occurrence of "astringent pulse" in traditional pulse science, so we study it from acoustics perspective.Our team thinks that every beat of the heart produces a vibration, which produces sound waves,the sound waves travel through the blood and eventually reflect off the arterial walls.When an organ(such as the prostate),develops hyperplasia, local blood flow changes,the flow of blood, which should be laminar, changes and becomes turbulent,the conduction of sound waves in turbulence is disordered,so we end up with pulse features that are different from normal people that are reflected on the arterial wall. We have previously studied the pulse characteristics of chronic gastritis, coronary heart disease, cirrhosis and some other diseases,different pulse sounds were collected and analyzed using an independently developed Acoustic Pulse Detection System,the ideal results have been obtained.We found that most of the abnormal sound waves were between 20Hz and 500Hz, so we classified this sound wave as low frequency and audible sound wave.Based on the above analysis, this study will use the acoustic pulse detection system to collect the pulse images of patients with benign prostatic hyperplasia(BPH).We expected to collect the pulse waves of 62 patients and 62 relatively healthy people without BPH, and use Fourier transform, wavelet analysis and other analysis methods to study the characteristics of the collected sound waves, and observe the pulse characteristics of BPH disease.Then diagnostic tests were carried out to calculate the sensitivity and specificity of the acoustic pulse detection system in the diagnosis of BPH. This experiment will further verify the effectiveness of pulse diagnosis of diseases, and finally lay a foundation for the development of pulse diagnostic instrument can diagnose a variety of diseases.

NCT ID: NCT04801381 Recruiting - Clinical trials for BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80 - 180mL) in Benign Prostatic Hyperplasia

WATER III
Start date: December 16, 2020
Phase: N/A
Study type: Interventional

Comparative analysis of efficacy and safety of Aquablation (AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA) and transurethral laser enucleation as surgical therapy for benign prostatic hyperplasia with large prostates (80-180ml).

NCT ID: NCT04766268 Recruiting - Clinical trials for Lower Urinary Tract Symptoms

Prostate Artery Embolization: Single Center Experience

Start date: March 17, 2021
Phase: N/A
Study type: Interventional

Benign prostatic hyperplasia (BPH) is an enlarged prostate gland from smooth muscle and glandular hyperplasia seen in the aging population with a prevalence of upto 90% in patients in the ninth decade. Lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO) are the most common presenting symptoms of BPH. Patients are initially evaluated with a complete history and physical exam to rule out other causes of LUTS and assess the severity of LUTS with scoring systems such as the American Urologic Association Symptom Index (AUASI) or the International Prostate Symptom Score (IPSS). Patients with mild or no symptoms are treated with watchful waiting. Surgical procedure such as transurethral resection of the prostate and minimally invasive procedures such as microwave ablation and prostate artery embolization are performed in patients with failed medical management or patients who are not able to tolerate the side effects of the medications. Prostate artery embolization is a safe minimally invasive procedure shown to improve IPSS and quality of life with none or potential risk of minor complications shown in short, intermediate, and long term follow up.

NCT ID: NCT04757116 Recruiting - Clinical trials for Benign Prostatic Hyperplasia (BPH)

Post-Market Study to Assess iTind Safety in Comparison to UroLift

MT-08
Start date: September 26, 2022
Phase: N/A
Study type: Interventional

The study objective is to evaluate the safety of the iTind device comparied to UroLift.

NCT ID: NCT04726748 Recruiting - Clinical trials for Benign Prostatic Hyperplasia

Economic Evaluation of Prostatic Urethral Lift

ECOLIFT
Start date: April 8, 2021
Phase:
Study type: Observational

Prostatic urethral lift (Urolift) has been developed as a minimally invasive alternative to transurethral resection of the prostate with no need of general anaesthesia, less need of urinary catheter and less exposure to post-operative complication. Its efficacy and safety have been assessed by 2 clinical randomized trials with evidence of urinary symptom improvement remaining inferior to TURP but durable for 5 years. Urolift preserved overall quality of life better than TURP. Urolift has been recommended by the European Association of Urology guidelines and recognized by French authorities but cannot be financed by the hospital itself. Reimbursement of the implants by healthcare system is therefore needed for the distribution of Urolift in France. The additional cost of the implants could be compensated by a reduced length of hospital stay and a lower rate of post-operative complications inducing healthcare expenditures. This study aims to assess if Urolift could be a cost-effective therapeutic strategy compared to transurethral surgery with 2 phases design: a field study comparing patients treated with Urolift to those treated with TURP/laser during 1 year follow-up, and an additional study comparing healthcare consumptions during 3 years follow-up between each group using data of the French National Claims Database (SNDS database).

NCT ID: NCT04648176 Recruiting - Clinical trials for Lower Urinary Tract Symptoms

Application of MOSES Technology in BPH

Start date: March 6, 2020
Phase: N/A
Study type: Interventional

In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation.