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30 Benign Prostatic Hyperplasia Trials

Power is an online platform that helps thousands of Benign Prostatic Hyperplasia patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.

This trial aims to compare the safety of the iTind device with UroLift for men who have urinary problems because of an enlarged prostate. The iTind device temporarily reshapes the prostate tissue to help improve urine flow. iTIND is the second-generation version of a temporary implantable device, which is one of the latest minimally invasive surgeries available to treat bothersome lower urinary tract symptoms caused by benign prostate enlargement.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50 - 80
Sex:Male
206 Participants Needed
Benign prostatic hyperplasia (BPH) is the most common benign neoplasm in men. Almost 90% of men in their 70s report lower urinary tract symptoms related to BPH. These symptoms carry a significant negative impact on the patients' quality of life. Despite the wide availability of surgical offerings to relieve bladder outlet obstruction such as transurethral resection of the prostate (TURP), Holmium Laser Enucleation of the Prostate (HoLEP), and prostatectomy, many patients still suffer from persistent LUTS after undergoing these. A study describing postoperative outcomes following HoLEP revealed that patients with severe lower urinary tract symptoms, storage-positive sub-score, and high maximum urinary flow rate before the surgery were affected by a rebound of mainly storage symptoms 6-8 weeks after HoLEP and prolonged recovery from LUTS with 7.4% of them presenting for persistent urge complaints. Optimizing the management approach for these patients has been limited by lack of high level evidence-based recommendations and expert consensus. Intravesical botox injections are well-established therapeutic options for several urinary disorders. The current practice offers intravesical botox injections to patients who suffer from persistent urinary symptoms few months after their BPH procedure. This study aims to evaluate if giving botox injections at the time of the HoLEP surgery would yield a better outcome than performing the two procedures separately at different times (few months apart). The concomitant use of botox injection during bladder de-obstructing procedures has been previously studied in TURP and have showed a significant reduction of incontinence episodes and OAB symptoms in the group that were treated with botox injections after 36 weeks post TURP. This data may suggest promising potential of this intervention in managing persistent OAB symptoms in patients with BOO. However, the efficacy of combining HoLEP and bladder Botox injections has not been systematically studied and evaluated. The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms (LUTS) when administered during HoLEP surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB). The investigators are interested in comparing the postoperative outcome in terms of recovery and symptom relief in patients who performed HoLEP surgery with bladder Botox injections versus those who performed HoLEP surgery only at 2 weeks,1 month, 3 months, and 6 months postoperatively. The investigators hypothesize that administering bladder botox injections during HoLEP surgery is a combination treatment that will result in faster and more potent symptom relief compared to patients who received only a HoLEP surgery for their obstructive and irritative symptoms.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 4
Age:40+
Sex:Male
100 Participants Needed
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 75
Sex:Male
150 Participants Needed
The purpose of this study is to allow us to assess the effectiveness (or success) of starting pelvic floor physical therapy (i.e. exercises for your pelvic muscles) prior to HoLEP (holmium laser enucleation of the prostate) surgery for enlarged prostates in order to manage or prevent urinary incontinence (i.e. leaking) after surgery (i.e. post-operatively). Your pelvic floor refers to the muscles under your bladder along your pelvic bones that prevent you from leaking urine or stool. Traditionally, pelvic floor physical therapy is started after surgery and continued until urinary continence (i.e. no leaking of urine) is regained. We want to assess if beginning pelvic floor physical therapy prior to surgery (and continuing afterwards) reduces the time required to regain urinary continence following HoLEP.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:Male
36 Participants Needed
C.L.E.A.R. Study is poised to compare the patient experience post procedure, including catheterization needs as well as retreatment and BPH medication rates following treatment with either the UroLift® System or Rezūm™ System through 12 months.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:50+
Sex:Male
120 Participants Needed
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.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:45+
Sex:Male
215 Participants Needed
This trial is testing a new device called the Urocross Expander System/Retrieval Sheath. It is designed to help men with an enlarged prostate (BPH) who have trouble urinating. The device works by widening the urinary passage to make it easier to urinate.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:45+
Sex:Male
240 Participants Needed
Specific Aim 1. To evaluate the efficacy of TNF antagonist action in BPH/LUTS Specific Aim 2. Define the consequences of TNF antagonist therapy on prostate tissue Specific Aim 3. Identify genetic predictors to stratify patients with differential response to TNF-antagonist therapy.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:45 - 80
Sex:Male
70 Participants Needed
This trial is testing the Zenflow Spring System, a small device that helps men with urinary problems due to an enlarged prostate. It works by keeping the urinary pathway open, making it easier to urinate. The Zenflow Spring System is a novel device designed to alleviate lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH).
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:45+
Sex:Male
279 Participants Needed
The goal of this clinical trial is to assess the performance and safety of the AQUABEAM Robotic System for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS) and are diagnosed with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:< 80
Sex:Male
125 Participants Needed
This trial is testing a new device called the ProVee Urethral Expander System. It aims to help men who have trouble urinating because of an enlarged prostate. The device works by widening the urethra, making it easier for urine to pass through.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:45+
Sex:Male
221 Participants Needed
This trial is testing a special catheter designed to treat men with an enlarged prostate. The device helps to open up the urinary passage, making it easier to urinate. The goal is to see if this treatment is safe and effective for these patients.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:50 - 80
Sex:Male
162 Participants Needed
This trial aims to test the safety and effectiveness of the Zenflow Spring System, a device designed to help men with an enlarged prostate urinate more easily. The spring is placed in the urinary tract to keep it open, reducing symptoms with minimal side effects. The target group is men who suffer from urinary problems due to an enlarged prostate.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:45+
Sex:Male
40 Participants Needed
Background: Men who are treated for prostate cancer often develop urinary leakage (incontinence). An experimental device that uses electrical impulses to stimulate pelvic floor muscles and surrounding tissues may help. Objective: To see if the Elidah device can reduce urinary incontinence after prostate treatment. Eligibility: Men aged 18 years and older who have had moderate urinary incontinence for at least 6 months after treatment for prostate cancer. Design: Participants will be in the study for about 9 weeks. They will be screened. They will have a physical exam with urine tests. The Elidah device consists of a Controller and a GelPad. The Controller sets the strength of electrical impulses. The GelPad is placed against the skin under the pelvis. Participants will be given an Elidah device and taught how to use it at home. They will use the device once a day for 20 minutes at a time; they will do this 5 days a week for 6 weeks. Participants will complete a daily log. They will record the strength of electrical impulses (0-35); the number of incontinence episodes; the type of incontinence episode; and the number of used pads. Participants will do a pad weight test. For 3 days before and 3 days after using the Elidah device, they will collect all of their used pads for each 24-hour period into a sealed plastic bag. They will also collect a second set of bags that contain dry versions of each product used. Participants will have clinic visits after using the device for 3 weeks and after finishing the 6 weeks of treatment. Participants will complete 15-minute questionnaires.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:Male
41 Participants Needed
A prospective, multicenter, blind randomized (2:1) controlled study comparing the International Prostate Symptom Score (IPSS) of the Active arm to the IPSS of the control arm at the 3 months follow-up and active arm IPSS score change from time zero to 12 months. Patients in the active arm undergo Butterfly device treatment. Patients in the control arm undergo a sham rigid cystoscopy procedure
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:50+
Sex:Male
245 Participants Needed
Lower urinary symptoms (LUTS) affect older men and their frequency and severity increase with age. According to Berry et al., the histological diagnosis of benign prostatic hyperplasia (BPH) increases from 25% in the group age between 40 to 49 years to 80% in the group age between 70 to 79 years (1). However, this hyperplasia can lead to a bladder outlet obstruction (BOO) secondary to benign prostatic enlargement (BPE), causing storage and voiding symptoms, associated with a considerable impairment of the quality of life (2). Surgical therapy of BPH has continuously evolved in recent years. The current gold standard for the endoscopic treatment of BPH is the transurethral resection of the prostate (TURP). Other innovative techniques were developed including Urolift, transurethral laser enucleation (holmium, thulium) and Aquablation therapy. One of the latest technologies for the management of BPH are Optilume BPH Catheter System (Optilume®, Urotronic Inc, Minneapolis, USA) and Rezum Water Vapor Therapy (Rezum System, Bostocn Scientific, Marlborough, MA). The purpose of the present study is to compare between patient experience, symptom relief and functional improvement when using the Optilume BPH Catheter System (Optilume®, Urotronic Inc, Minneapolis, USA) and Rezum Water Vapor Therapy (Rezum System, Boston Scientific, Marlborough, MA).
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18+
Sex:Male
100 Participants Needed
This trial is testing a new device called the Mercury Expander system, which aims to help men who have trouble urinating because of an enlarged prostate. The device works by opening up the blocked area in the urinary tract, making it easier for urine to pass through. The Mercury Expander System is a novel implantable device designed to treat lower urinary tract symptoms due to benign prostatic hyperplasia.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:50+
Sex:Male
45 Participants Needed
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50+
Sex:Male
92 Participants Needed
To determine if use of Moses 2.0 results in improved ablation efficiency during holmium laser vaporization of the prostate. To determine if use of Moses 2.0 results in less char, improved visibility, and improved hemostasis in prostate vaporization.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:Male
124 Participants Needed
The study is being conducted to learn why some patients with Benign Prostatic Hyperplasia (BPH) do not respond to a commonly used treatment drug, Finasteride. The hope is to find ways to predict which patients will not respond to Finasteride so that, in the future, these patients can be identified prior to offering this treatment and they can be offered alternative treatment strategies in its place. The aim is to see if noninvasive techniques such as MRI can detect inflammation of the prostate to assist with early detection of those who will and who will not respond to Finasteride.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50+
Sex:Male
120 Participants Needed
Holmium laser enucleation of the prostate (HoLEP) is routinely performed with 24F, 26F, and 28F laser scopes. Proponents of larger caliber scopes suggest that the larger scope size allows for improved visualization, hemostasis, and operative efficiencies. Proponents of a smaller scope diameter suggest that by eliminating the need for pre-HoLEP urethral dilation to accommodate a larger scope. It has also been proposed that a smaller caliber scope is less traumatic to the urethra resulting in lower rates of bladder neck contracture and urethral stricture disease. Currently, to our knowledge, there are no level one evaluation examining scope size 22F versus 26F sheath in laser enucleation outcomes. The aim of our study is to determine if a smaller diameter scope is associated with improved laser enucleation time, post-operative recovery, rates of same-day discharge, or increasing intra-operative or postoperative complication rates
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50+
Sex:Male
142 Participants Needed
This trial compares two laser treatments for men with an enlarged prostate. These treatments aim to remove excess prostate tissue with less bleeding and faster recovery than traditional methods. One treatment uses a Thulium laser, while the other uses a Holmium laser.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50+
Sex:Male
104 Participants Needed
Benign prostatic hyperplasia (BPH), the non-malignant enlargement of the prostate gland, places pressure on the urethra and causes urination difficulties and bladder problems. Lower Urinary Tract Symptoms (LUTS) secondary to BPH is a common condition in aging men, with an overall prevalence of more than 50% in those older than 50 years of age. Men with LUTS often experience sexual dysfunction including ejaculatory loss, painful ejaculation, and erectile dysfunction, which among other complications can also lead to a decreased quality of life. Holmium laser enucleation of the prostate (HoLEP), first reported by Fraundorfer et al in 1998, is a more recent step in the evolution of holmium laser prostatectomy. HOLEP offers patients the alternative of being treated endoscopically with minimal blood loss, short catheterization time, and decreased hospital stay. One noted drawback to HoLEP, and the primary reason why it has yet to become the new standard for treatment of symptomatic BPH, is the complexity of this procedure, with a prolonged learning curve. Modifications to the procedure have thus been explored in order to address this limitation. The "Top-Down" HoLEP technique is a novel technique which offers potential benefits to the Traditional HoLEP procedure, including decreased complexity, a reduced learning curve, with anticipated improved continence. This study will compare the operating time between the Top-Down Holmium Laser Enucleation of the prostate (HoLEP) and the Traditional HoLEP for the treatment of patients with symptomatic bladder outlet obstruction due to BPH in Northwestern Ontario.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:50+
Sex:Male
107 Participants Needed
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
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:50+
Sex:Male
26 Participants Needed
The investigators wish to perform a prospective study at the Men's Health Clinic in Winnipeg, Manitoba to accomplish two goals: 1) Prospectively describe 1 year outcomes for MIST therapies performed at the clinic 2) perform a head to head comparison of Rezum water vapor therapy vs the iTind device in respect to symptom score improvement, uroflow parameters and side effect profile.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:18 - 65
Sex:Male
20 Participants Needed
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
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:40 - 85
Sex:Male
20 Participants Needed
This trial is evaluating two methods for addressing prostate issues to determine which one better improves symptoms in patients.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:50+
Sex:Male
45 Participants Needed
This study aims to find out if tranexamic acid (TXA), a medication, works to decrease blood loss during a specific surgery called Aquablation therapy, which is a treatment for men with Benign Prostatic Hyperplasia (BPH). BPH is a common condition in men over the age of 45 that involves enlargement of the prostate gland and can lead to problems or discomfort with urination. The main goal of this research is to see if TXA can help reduce the amount of blood loss during surgery compared to not using the drug. This is important because losing less blood during surgery can help patients recover faster and more safely. Researchers will monitor the safety of TXA and its effects on other outcomes, like the length of hospital stay and any possible changes in blood tests that check how well blood clots. Participants in this study will: * Be males diagnosed with BPH who are already scheduled to undergo Aquablation therapy. * Be randomly assigned to either receive TXA or a placebo (a look-alike substance that contains no drug) right before their surgery. * Not know which treatment they are receiving to make sure the results are unbiased. Researchers hope to engage participants who meet the health criteria of the study. They will be carefully monitored before, during, and after the surgery for any health changes, and their blood loss during surgery will be measured. This study does not require any additional time commitment outside of the standard surgical process, and all treatments will be provided at no additional cost to the participants. The researchers will ensure that all participants understand the procedure and support their safety throughout the research.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 4
Age:45+
Sex:Male
56 Participants Needed
This prospective, multicenter, two-arm, 1:1 randomized controlled trial (RCT) will enroll approximately 250 males at approximately 25 sites located within the United States. All enrolled subjects will be 45 years of age or older diagnosed with symptomatic benign prostatic hyperplasia (BPH). They will be randomized to one of two readily available, marketed BPH therapies; Prostatic Urethral Lift procedure with the UroLift System (PUL Arm) or 0.4mg tamsulosin HCl (MED Arm).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:45+
Sex:Male
250 Participants Needed
Image of trial facility.

Exercise for Enlarged Prostate

San Francisco, California
This is a single-center pilot randomized controlled trial among 68 physically "inactive" older men with lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (LUTS/BPH) assessing a 12-week remote exercise intervention versus health education control.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:60+
Sex:Male
68 Participants Needed
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Frequently Asked Questions

How much do Benign Prostatic Hyperplasia clinical trials pay?

Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.

How do Benign Prostatic Hyperplasia clinical trials work?

After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Benign Prostatic Hyperplasia trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Benign Prostatic Hyperplasia is 12 months.

How do I participate in a study as a "healthy volunteer"?

Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.

What does the "phase" of a clinical trial mean?

The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.

Do I need to be insured to participate in a Benign Prostatic Hyperplasia medical study ?

Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.

What are the newest Benign Prostatic Hyperplasia clinical trials ?

Most recently, we added Botox + HoLEP for Enlarged Prostate and Overactive Bladder, FloStent for Enlarged Prostate and Optilume vs Rezum for Enlarged Prostate to the Power online platform.