Efficacy and Safety of Longidaze in the Treatment of Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
NCT Number: NCT06568718
Acronym: ADAM
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lower Urinary Tract Symptoms|Prostatic Hyperplasia
Interventions: DRUG: bovhyaluronidase azoximer|DRUG: tamsulosin
Sponsor: NPO Petrovax
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 229
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-03-20
Completion Date: 2024-02-09
Locations: LLC "Krasnodar Medical and Biological Center", Krasnodar, 350000, Russian Federation|First Saint Petersburg State Medical University named after academician I.P. Pavlov, Saint Petersburg, 197022, Russian Federation|LLC "Clinic of Modern Medicine of Dr. Bogorodskaya", Yaroslavl, 150001, Russian Federation

Summary:
The goal of this clinical trial is to learn if Longidaze works to treat lower urinary tract symptoms in adult males with benign prostatic hyperplasia. It will also learn about the safety of Longidaze. The main question it aims to answer is:

* Does addition of Longidaze to tamsulosin lower the severity of symptoms assessed by International Prostate Symptom Score?
* What medical problems do participants have under the combined treatment by Longidaze and tamsulosin?

Researchers will compare combined therapy (Longidaze + tamsulosin) with monotherapy (tamsulosin only) to see if the combination works better.

Participants will:

* Take tamsulosin (0.4mg) every day for 130 days
* In combined therapy arm -- make intramuscular injections of Longidaze every 5 days (5 injections); then apply Longidaze rectal suppositories every 3 days (10 applications); then apply Longidaze rectal suppositories every 7 days (10 applications)
* Visit the clinic on day 1, 26±1, 60±1, 130±3 for checkups and tests

Primary Outcome Measures: Change from Baseline in IPSS on Day 60 and 130, Change in symptom severity assessed by the patient using the International Prostate Symptom Score (IPSS) relative to baseline on days 60 and 130 of therapy., Day 0, Day 60, Day 130
Secondary Outcome Measures: Change from Baseline in IPSS on Day 26, Change in symptom severity assessed by the patient using the International Prostate Symptom Score (IPSS) relative to baseline on day 26 of therapy., Day 0, Day 26|Change from Baseline in Qmax, Change in maximum urine flow rate (Qmax) according to uroflowmetry relative to baseline, Day 0, Day 26, Day 60, Day 130|Change from Baseline in Prostate Volume, Change in prostate volume relative to baseline, Day 0, Day 26, Day 60, Day 130|Number of Participants with 4 Points and/or 25% Decrease in IPSS, Proportion of patients showing a decrease in symptom severity as assessed by the IPSS questionnaire by 4 or more points and/or by 25% from the baseline., Day 0, Day 26, Day 60, Day 130|Change from Baseline in QoL, Change in quality of life assessed by the patient using the International Prostate Symptom Score (IPSS, QoL domain) relative to baseline, Day 0, Day 26, Day 60, Day 130|Change from Baseline in IPSS-V, Change in voiding symptom severity assessed by the patient using the IPSS questionnaire (IPSS-V subscore) relative to baseline, Day 0, Day 26, Day 60, Day 130|Change from Baseline in IPSS-S, Change in storage symptom severity assessed by the patient using the IPSS questionnaire (IPSS-S subscore) relative to baseline, Day 0, Day 26, Day 60, Day 130|Change from Baseline in Residual Urine Volume, Change in residual urine volume based on ultrasound data relative to baseline, Day 0, Day 26, Day 60, Day 130|Change from Baseline in NIH-CPSI, Change in symptom severity according to the NIH Chronic Prostatitis Symptom index (NIH-CPSI) questionnaire relative to the baseline, Day 0, Day 26, Day 60, Day 130
Other Outcome Measures: Number of Participants with Treatment-Related Adverse Events, Safety assessment based on laboratory test data, evaluation of the vital signs, physical examination, and registration of adverse events., From enrollment to the end of treatment on Day 130