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Hyperplasia clinical trials

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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: NCT04760483 Active, not recruiting - Clinical trials for Prostatic Hyperplasia

Office Based Transperineal Laser Ablation for Benign Prostatic Hyperplasia HYPERPLASIA

Start date: November 20, 2020
Phase: Phase 1
Study type: Interventional

This study is set up as a phase I-II prospective, single center, interventional pilot study carried in Office setting under local anesthesia. It will assess the impact in quality of life and adverse events produced by transperineal laser ablation of the prostate (TPLA) in men 40 to 85 years of age with benign prostatic hypertrophy (BPH). BPH is currently managed with medications (ie, alpha-1 adrenergic medications) and/or invasive approaches such as transurethral resection of prostate or surgical excision of prostate - robotic or open lead to relaxation or excision of the bladder neck. Such alteration of the bladder neck function or anatomy portends a significant and noticeable change on a male lifestyle, represented by absence of antegrade ejaculation among others. This study aims to evaluate the use of TPLA in the office setting under local anesthesia - greatly decreasing patient perioperative surgical risk. Moreover, it aims to determine safety profile and outcomes from TPLA therapy The fundamental objective is to determine the feasibility and safety of TPLA in healthy men with LUTS due to BPH, successful performed in the outpatient office-based setting under local anesthesia. Secondary objectives include: 1-Uroflowmetry and Patient Reported Outcome Measures (PROMs) at three, six and 12 months; 2-Immediately spontaneous voiding post-TPLA; 3-Hematuria incidence after TPLA, measured by patient reporting; 4-LUTS after the treatment measured by IPSS; 5- Erectile function and presence of ejaculation after TPLA treatment and 6-Prostate volume changes using Transrectal ultrasound (TRUS) volume measurements

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: NCT04683237 Withdrawn - Obese Clinical Trials

Liraglutide Plus Megestrol Acetate in Endometrial Atypical Hyperplasia

Start date: March 20, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

To investigate the efficacy of liraglutide plus megestrol acetate in obesity patients with atypical endometrial hyperplasia (AEH)

NCT ID: NCT04681625 Completed - Overactive Bladder Clinical Trials

Evaluation of Silodosin and Pelvic Floor Muscle Training in Men With Benign Prostatic Hyperplasia and Overactive Bladder

SILODOSING
Start date: January 11, 2021
Phase: N/A
Study type: Interventional

This study will evaluate the efficacy of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder treated with Silodosin.

NCT ID: NCT04662151 Active, not recruiting - Clinical trials for Bronchopulmonary Dysplasia

A Clinical Safety Study of AT-100 (rhSP-D) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia (BPD)

Start date: September 1, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if an investigational drug, AT-100, can reduce the occurrence of Bronchopulmonary Dysplasia (BPD) in babies born premature, as compared to babies born premature who receive an air-sham alone.

NCT ID: NCT04658056 Not yet recruiting - Clinical trials for Benign Prostatic Hyperplasia

UK Post-market Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

Start date: January 2021
Phase:
Study type: Observational

A post-market, non-interventional, two-arm, long-term follow-up study of patients previously enrolled in the WATER Study (NCT02505919) - which was a prospective multi-centre randomized blinded study comparing Aquablation of the prostate with the AQUABEAM Robotic System with standard transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS).

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.

NCT ID: NCT04627701 Recruiting - Clinical trials for Benign Prostatic Hyperplasia

Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH

Start date: July 23, 2023
Phase: N/A
Study type: Interventional

The ProArc Medical Omega system is a prostatic reshaping device that is designed to treat Lower Urinary Tract Symptoms (LUTS) due to BPH. During the procedure an implant is delivered into the prostate tissue obstructing the urethra and restricting urine flow. The delivery system uses a static diathermy incision mechanism to make a circumferential incision in the tissue surrounding the prostatic urethra into which the Omega shaped permanent implant is placed. The implant expands the obstructed area, reducing the fluid obstruction through the prostatic urethra.