LUTS(Lower Urinary Tract Symptoms)

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Review clinical trials related to LUTS(Lower Urinary Tract Symptoms). Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Transurethral Thermodilatation vs. Prostatic Urethral Lift for Moderate-to-Severe BPH

This clinical trial aims to determine whether Prolieve® (microwave with balloon dilation) is as effective as UroLift® (prostate implants) for treating moderate-to-severe lower urinary tract symptoms in men aged 50-80 with enlarged prostates (BPH) who have failed oral medications. The main questions are: 1. Is Prolieve non-inferior to UroLift in improving IPSS symptom scores at 3 months? 2. Does Prolieve cause less pain and avoid the need for injected anaesthesia? Researchers will compare Prolieve (LA urethral gel only, no injections) against UroLift (LA urethral gel with or without local anaesthetic injection) to see if Prolieve offers similar relief with better tolerability. Participants will stop their BPH medications for 2-4 weeks, undergo one of the two same-day office procedures, and attend follow-ups at 1, 3, 6, and 12 months for symptom scores, flow tests, and bladder scans.

Participants needed: 150
Trial details
Age: 50-80Biological sex: MaleType: InterventionalSponsor: The University of Hong KongUpdated: Aug 12, 2026Locations: 1
Eligibility criteria

Male, aged ≥ 50 and ≤ 80 years [+7]

Intravesical prostatic protrusion > 10 mm on TRUS. [+15]

Status: Recruiting

MISTER Study: Minimally Invasive Steam Therapy - Russian Effectiveness Registry

Rezūm is a minimally invasive procedure that uses water vapor (steam) to treat urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia, BPH). It has been used in clinical practice since receiving FDA approval in 2015 and is recommended as a treatment option for men with moderate-to-severe urinary symptoms, including those who wish to preserve ejaculatory function. Clinical trials have shown that Rezūm improves urinary symptoms and flow rates, with benefits that last for at least five years, a low reoperation rate, and a low risk of sexual side effects. Despite this evidence, several important questions remain. It is not well understood which patients are more likely to experience temporary urinary retention after the procedure, need repeat treatment, or develop ejaculatory changes. Standardized criteria for defining overall treatment success are also lacking. The MISTER study is a multicenter registry designed to evaluate real-world outcomes of Rezūm therapy in patients treated in the Russian Federation. Using data from a large patient cohort, the study aims to identify factors associated with urinary retention after catheter removal, the need for repeat treatment or return to medication, and changes in ejaculatory function. The study will also develop and test combined criteria for defining treatment success.

Participants needed: 1,400
Trial details
Age: 18-85Biological sex: MaleType: InterventionalSponsor: Sechenov UniversityUpdated: Jul 23, 2026Locations: 1
Eligibility criteria

Lower urinary tract symptoms (IPSS ≥8 points; QoL ≥3 points) due to BPH [+8]

Patient refusal to allow use of medical data for scientific analysis [+1]

Status: Not yet recruiting

Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy

The goal of this clinical trial is to learn if the drug Tamsulosin Hydrochloride works to treat urination difficulties after a prostate biopsy in men.The main questions it aims to answer are: * Does Tamsulosin Hydrochloride lower the rate of Acute Urinary Retention (inability to urinate) after a prostate biopsy? * Does Tamsulosin Hydrochloride improve participants' urination symptoms, quality of life, urine flow rate, and post-void residual urine volume? Researchers will compare the drug group to a control group (receiving no preventive medication) to see if Tamsulosin Hydrochloride works to prevent urination problems. Participants will: * Be randomly assigned to either take Tamsulosin Hydrochloride or receive no preventive medication. * If in the drug group, take one capsule of Tamsulosin Hydrochloride every night, starting 3 days before the biopsy and continuing until 6 days after the biopsy (10 doses total). * Undergo a standard prostate biopsy procedure (either through the rectum or perineum). * Return to the clinic 7 days after the biopsy for a follow-up checkup, which will include questions about their symptoms (IPSS and QoL scores) and tests to measure urine flow and bladder emptying.

Participants needed: 1,844
Trial details
Phase: Phase 4Age: 40-85Biological sex: MaleType: InterventionalSponsor: Peking University First HospitalUpdated: Dec 23, 2025Locations: 1
Eligibility criteria

Male, aged 40 to 85 years (inclusive). [+2]

Previous prostate surgery, urinary diversion, or intermittent catheterization. [+9]

Status: Recruiting

Safety and Efficacy of MILEP Versus Standard EEP

Endoscopic enucleation of the prostate (EEP) is a standard treatment for benign prostatic hyperplasia (BPH), with modifications such as MiLEP that utilizes smaller instruments. The reduced resectoscope diameter in MiLEP may help decrease rates of stress urinary incontinence (SUI) and urethral strictures. Objective: to compare the efficacy and safety of MiLEP and standard EEP with a thulium fiber laser (TFL).

Participants needed: 340
Trial details
Age: 18-85Biological sex: MaleType: InterventionalSponsor: Sechenov UniversityUpdated: Feb 21, 2025Locations: 1
Eligibility criteria

IPSS questionnaire (Score >20); [+1]

Prostate volume > 120 cc [+5]

Status: Recruiting

Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH.

Benign prostatic hyperplasia (BPH) is one of the most prevalent human diseases and a major cause of lower urinary tract symptoms (LUTS). Some men respond to current medical treatment (mainly α-1 adrenoreceptor antagonists and 5 α-reductase inhibitors), but a large proportion of patients continues to need a surgical procedure to treat resistant LUTS or even more serious complications of BPH, creating the emerging necessity for novel pharmacological therapies. Oxitriptan may have a possible positive effect on BPH associated symptoms with probably no impact in sexual function (which is a common side effect of the current drugs for BPH associated symptoms). Also, improvement in symptoms could be higher than that of current drugs used for this condition. This is a single-center parallel group, randomized clinical trial. The study will take place in Hospital de Braga (Urology department). Eligible patients will be randomized to receive tamsulosin 0.4mg (once a day, q.d.) or 5-HTP (5-hidroxitriptophan) 100mg (three times a day, t.i.d.), for 6 months.

Participants needed: 70
Trial details
Phase: Phase 2Age: 50-74Biological sex: MaleType: InterventionalSponsor: Clinical Academic Center (2CA-Braga)Updated: Jan 6, 2025Locations: 1
Eligibility criteria

Written informed consent; [+4]

Patients with post-void bladder residual volume ≥250 ml; [+13]