Ongoing Clinical Trials for Benign Prostatic Hyperplasia
There are currently 2 ongoing clinical trials investigating new approaches to managing benign prostatic hyperplasia, a common condition in older men where the enlarged prostate gland causes urinary problems. These studies are exploring the use of tryptophan supplements and antibiotic strategies to improve symptoms and surgical outcomes for patients. (Also known as: BPH, Enlarged Prostate)
Clinical trial locations
- France
- Portugal
Study on the Safety and Effectiveness of Oxitriptan and Tamsulosin Hydrochloride for Patients with Benign Prostatic Hyperplasia
This trial is investigating whether tryptophan, an essential amino acid, can help improve urinary symptoms when added to standard treatment. The study combines tryptophan (in the form of oxitriptan) with tamsulosin hydrochloride, a commonly prescribed medication for enlarged prostate. The research aims to understand if tryptophan supplementation can enhance symptom relief and improve quality of life for men dealing with urinary difficulties caused by prostate enlargement.
Main inclusion criteria: Participants must be men between 50 and 74 years of age who have been diagnosed with an enlarged prostate. The prostate must measure at least 30 cubic centimeters in volume, and participants must have moderate to severe urinary symptoms with a score of 13 or more on the International Prostate Symptom Score questionnaire. The standard recommended treatment should be tamsulosin. All participants must provide written informed consent after understanding the study details.
Main exclusion criteria: The study excludes anyone who is not male, does not have benign prostatic hyperplasia, or belongs to a vulnerable population group requiring special protection.
Focus and goal: The trial monitors participants over six months to evaluate changes in urinary symptoms using the International Prostate Symptom Score. Researchers will also measure urine flow rate, erectile function, prostate volume, and overall quality of life related to urinary health. The study is expected to continue until December 2026.
Investigational drug: The main substance being studied is tryptophan, administered orally as Cincofarm 100 mg hard capsules. Tryptophan serves as a precursor to serotonin and may influence urinary function. Participants also receive tamsulosin hydrochloride (Omnic 0.4 mg) as prolonged-release tablets alongside the experimental treatment.
Study on Antibiotic Treatment Before Surgery for Benign Prostate Hyperplasia: Fosfomycin Calcium, Bromhexine Hydrochloride, Sulfamethoxazole, and Trimethoprim
This trial is examining whether giving antibiotics before surgery is necessary to prevent urinary tract infections in men undergoing procedures for prostate enlargement. Researchers are comparing the use of specific antibiotics against no antibiotic treatment to determine if the standard practice of prescribing antibiotics is actually beneficial, particularly when multiple types of bacteria are present in the urine before surgery.
Main inclusion criteria: Participants must be adult men aged 18 or older who are affiliated with the French social security system. They must be scheduled for endoscopic surgery to treat urinary symptoms caused by prostate enlargement, including procedures such as Urolift, Rezum, Aquabeam, transurethral resection, prostate enucleation, or simple prostatectomy. Importantly, participants must have a urine culture showing three or more different types of bacteria before surgery. All participants must provide written informed consent and be able to follow study requirements.
Main exclusion criteria: The study excludes anyone who is not male or who belongs to a vulnerable population requiring special protection.
Focus and goal: The primary objective is to determine whether avoiding antibiotics before surgery is as effective as using them in preventing urinary tract infections within one month after the procedure. Participants are randomly assigned to receive either antibiotics or no antibiotics before their scheduled surgery. After the procedure, they are monitored for infection symptoms such as burning during urination, fever, and urgency. The study also evaluates economic factors, including treatment costs and the number of surgeries that need to be canceled due to infections.
Investigational drugs: The antibiotics being evaluated include fosfomycin calcium and a combination of bromhexine hydrochloride, sulfamethoxazole, and trimethoprim. These medications are administered orally according to the study protocol. The research aims to provide insights into whether these antibiotics are truly necessary for preventing post-surgical infections and could potentially influence future prescribing practices.
Summary
The two ongoing clinical trials for benign prostatic hyperplasia represent distinct approaches to managing this common condition in older men. One study, conducted in Portugal, explores a novel treatment avenue using tryptophan supplementation combined with standard medication to address urinary symptoms. The other, taking place in France, questions current surgical practices by examining whether routine antibiotic use before prostate surgery is necessary.
These trials highlight the diversity of research approaches in managing prostate enlargement, from symptom management with supplements to infection prevention strategies around surgical procedures. Both studies require specific patient populations and aim to provide evidence that could change clinical practice. The French trial is particularly notable for its focus on antibiotic stewardship, addressing concerns about unnecessary antibiotic use and associated costs. Meanwhile, the Portuguese study represents an innovative approach to symptom relief using an amino acid supplement that may work through serotonin pathways.
Patients interested in participating should carefully review the eligibility criteria and discuss with their healthcare providers whether these trials might be appropriate for their situation. Each trial has specific requirements regarding age, prostate size, symptom severity, or surgical planning that must be met for participation.
