25 Clinical Trials for Various Conditions
This completed study evaluated the safety and efficacy of two dose levels of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) versus finasteride.
Benign Prostatic Hyperplasia (BPH), Enlarged Prostate
The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). All participants will undergo a flexible cystoscopy and those randomized to the treatment arm will receive the FloStent, while those randomized to the sham arm will not receive the FloStent.
Benign Prostatic Hyperplasia
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
Male Urogenital Diseases, Genital Diseases, Male, Prostatic Disease, Prostatic Hyperplasia
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.
BPH, Enlarged Prostate (BPH), Prostatic Hyperplasia
Investigator-initiated study to evaluate the safety and efficacy of prostate artery embolization for the treatment lower urinary tract symptoms in patients with benign prostatic hyperplasia
Prostatic Hyperplasia, Benign, Enlarged Prostate With Lower Urinary Tract Symptoms
For ageing men, Health related quality of life ( HRQoL) is challenged by two common issues: the onset of bothersome urinary symptoms attributable to prostate enlargement and diminishing ability to maintain normal sexual activity and function; both issues are important to men, yet often the treatment of the former has adverse effects on the latter. Current medical and surgical treatments offer symptomatic improvement of urinary symptoms. However long recovery times, degradation of sexual function and incontinence may negatively affect a patient's QoL. Prostatic urethral lift (PUL) and prostate artery embolization (PAE) represent two evolving techniques with contrasting mechanisms of action (mechanical decompression vs angiographic embolization). Both are minimally invasive, yield relief of urinary symptoms and have similar safety profiles. More importantly neither causes degradation of sexual function or urinary continence. Although multiple studies are being reported on PUL and PAE alike, currently there are no prospective clinical trials comparing these two technologies. We aim to prospectively evaluate and compare HRQol outcomes of PUL and PAE. Results of this study could have a great impact on patient outcomes in men opting for minimally invasive, sexual function sparing treatment options for symptom relief from prostate enlargement.
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia, Urinary Frequency/Urgency, Urinary Incontinence, Urge, Incontinence, Urinary, Nocturia
The purpose of the study is to evaluate improvement in symptoms related to benign prostatic hyperplasia (BPH) in men treated with prostate artery embolization (PAE) using Embosphere Microspheres.
Prostatic Hyperplasia
To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH).
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptom
The purpose of this study is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for prostatic artery embolization (PAE) using Embosphere Microspheres compared to conventional transurethral resection of the prostate (TURP).
Benign Prostatic Hyperplasia
This is a pilot study examining biological endpoints in men with localized prostate cancer who are scheduled to have radical prostatectomies and men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (BPH/LUTS) following botulinum toxin type A (BoNT-A) injection. Patients will serve as their own controls by receiving BoNT-A injections into the right peripheral and transition zones and sham saline injections into the left peripheral and transition zones.
Prostate Cancer, Benign Prostatic Hyperplasia, Enlarged Prostate With Lower Urinary Tract Symptoms (LUTS)
This is a Phase 4, prospective, open-label, randomized study of Greenlight XPS Laser versus BiVAP Saline Vaporization of the prostate in men with symptomatic Benign Prostatic Hyperplasia (BPH). The study consists of a screening phase, treatment, followed by follow-up visits at 1 week, 4 weeks, 3 months, 6 months, and 12 months.
Benign Prostatic Hyperplasia (BPH)
The purpose of this study is to evaluate the safety, tolerability and efficacy of a single treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.
Benign Prostatic Hyperplasia
This study is designed to demonstrate the safety and efficacy of a second transrectal intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH) who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.
Benign Prostatic Hyperplasia
The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.
Benign Prostatic Hyperplasia, Enlarged Prostate
This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) as compared to placebo.
Benign Prostatic Hyperplasia (BPH)
This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) as compared to placebo.
Benign Prostatic Hyperplasia
To gain clinical experience with the GreenLight HPS System, a system designed to vaporize and coagulate tissue in the treatment of benign prostatic hyperplasia to reduce lower urinary tract symptoms.
Benign Prostatic Hyperplasia
To determine whether pomegranate tablets have a therapeutic effect on Benign Prostatic Hyperplasia.
Benign Prostatic Hyperplasia
The purpose of this trial is to evaluate the dose response relationship of lonidamine and the primary efficacy endpoint, International Prostate Symptom Score (IPSS), in subjects with symptomatic benign prostatic hyperplasia (BPH).
Benign Prostatic Hyperplasia
Patients who are currently symptomatic and have been diagnosed with BPH by a physician may qualify for this 20-week study. Patients must not be diabetic, must not have prostate cancer and must not have had any surgery to repair your prostate or treat your BPH. Patients will first undergo a phone screening to confirm their eligibility and interest and to rule out any exclusionary history or medications. Eligible patients will be scheduled to come in to the clinic to sign an Informed Consent Form. Patients will then undergo blood and urine tests, a complete physical examination and history and answer several questionnaires to determine their eligibility. Patients will have a total of at least 7-8 visits over 20 weeks to the clinic during this study.Qualified patients receive free study medication, free medical care (physical examinations, EKG, laboratory tests) for the duration of the study.
Prostatic Hyperplasia
A study to determine the effect on prevention of Acute Urinary Retention (inability to urinate) in males with an enlarged prostate, also known as BPH. * Free study-related medical care provided.
Urinary Retention, Prostatic Hyperplasia, Benign Prostatic Hypertrophy
The purpose of this study is to evaluate the safety and efficacy of a single treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.
Benign Prostatic Hyperplasia
This study is to compare the efficacy and safety of ozarelix 15 mg given intramuscular (IM) 2 weeks apart on the improvement of symptoms and the duration of improvement for up to 6 months in men with Benign Prostatic Hypertrophy (BPH) who are over 50 years of age.
Benign Prostatic Hypertrophy
Many options currently exist to relieve the symptoms caused by benign prostatic hyperplasia (BPH). At present, transurethral resection of the prostate (TURP) serves as the surgical standard to which all other operative treatments are compared. Although TURP provides excellent short and long-term results, this procedure has many potential risks and complications. The desire to avoid the potential risks of TURP and still achieve results of comparable durability has led to the development of alternative surgical procedures. One such surgical alternative in the treatment of BPH is holmium laser ablation of the prostate (HoLAP). HoLAP has been compared to TURP in a randomized clinical trial with comparable outcomes in both uroflow rate and symptom score improvements (Mottet, et al 1999). Use of the holmium laser in treating BPH provides specific advantages over TURP. The risk of dilutional hyponatremia is eliminated, as the holmium laser can be used in conjunction with a normal saline irrigant. In addition, the hemostatic properties of the holmium laser results in superior hemostasis, thus minimizing the risk of bleeding. HoLAP has been utilized for prostate glands up to 60 grams in volume, as larger glands become more inefficient to treat using a tissue vaporization technique. Recently, another laser technology has been introduced for the surgical treatment of BPH, the potassium titanyl-phosphate (KTP) laser. This modality can also be used to vaporize obstructive prostate tissue, and has been studied through single arm clinical studies. Short-term results are promising, with significant improvements in voiding symptoms and urine flow rates as well as minimal associated morbidity. However, to date a randomized comparison study between HoLAP and KTP laser vaporization of the prostate has not been reported. A group of investigators with extensive experience with both procedures intends to objectively compare these two procedures in a randomized clinical trial.
Benign Prostatic Hyperplasia
STATEMENT OF PURPOSE: Transurethral resection of the prostate (TURP) is the standard surgical intervention for obstructive benign prostatic hyperplasia (BPH) in all but the largest of glands, which are typically treated with open simple prostatectomy. Recently, new generation lasers (holmium and potassium titanyl phosphate \[KTP\]) have been utilized for BPH treatment. Long-term follow-up of laser prostatectomy outcomes must be documented to fully characterize the degree of voiding improvement achievable by these new techniques, the durability of these outcomes, and the safety profiles of these procedures.
Benign Prostatic Hyperplasia, Enlarged Prostate