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Completed

NCT Number: NCT07169773

Comparative Study Between Rezum and Tamsulosin

the investigators aimed to compare the efficacy and safety of Rezūm therapy for the management of benign prostatic hyperplasia (BPH) with Tamsulosin.

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Key information

Conditions

Prostate Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Armed Forces College of Medicine (AFCM

Cairo, Nozha, 4470351, Egypt

About this study

So far, data from available studies point towards good clinical outcomes with a short-term risk of self-limiting minor complications. Its application has demonstrated clinical effectiveness and possesses specific benefits that distinguish it among other treatments. It is applicable to outpatient setting, is effective in preserving sexual function and is versatile in its ability to treat a variety of prostate gland morphology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • with prostate volumes of 30- 80 mL,
  • mild to mod LUTS
  • (maximum urinary flow rate [Q max] of <15 mL/s
  • International Prostate Symptom Score [IPSS] of >13)
  • PVR urine < 250 ml

Exclusion criteria

  • prostate cancer,
  • neurogenic bladder
  • urethral stricture,
  • urinary bladder stone
  • previous prostatic surgery

Treatment and study plan

Rezum

Device

Rezum procedure in Rezum group

Tamsulosin

Drug

Tamsulosin were given to Tamsulosin group

Primary outcomes

  1. The International Prostate Symptom score (IPSS)

    Time frame: Time Frame: for each case in both groups the investigator assess IPSS at 3, 6, 12 after procedures through study completion, an average of 1 year

    Measurement of The International Prostate Symptom score (IPSS) in both groups After 3, 6, 12 months of operation, the questioner is performed. Minimum :0 / Maximum : 35 Total score: 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic

  2. The Maximum Urinary flow rate (Qmax)

    Time frame: Time Frame: for each case in both groups the investigator assess Qmax at 3, 6, 12 months after procedures through study completion, an average of 1year

    Measurement of The Maximum Urinary flow rate (Qmax) in both groups After 3, 6, 12 months of operation, the procedure is performed. Qmax is measured by (ml/sec) Normal values are described as a Qmax above 15 ml/sec and below 10 ml/sec is considered abnormal

  3. The Quality of Life (QoL)

    Time frame: [Time Frame: for each case in both groups the investigator assess QoL at 3, 6, 12 months after procedures through study completion, an average of 1 year

    Measurement of The Quality of Life (QoL) in both groups After 3, 6, 12 months of operation, the questioner is performed. Minimum :0 means delighted / Maximum : 5 means unhappy

  4. The Prostate size

    Time frame: Time Frame: for each case in both groups the investigator assess prostate size at 3, 6, 12 months after procedures through study completion, an average of 1 year.

    the prostate size was measured by grams by Trans-rectal ultra sound

Secondary outcomes

  1. Incidence of complications

    Time frame: through 1 year

    For each case in both groups the investigator assess the safety using incidence of complications by The Clavien-Dindo system. It uses a 5-grade scale (I-V), to classify complications from minor issues not requiring intervention (Grade I) to death (Grade V).

Sponsors and collaborators

Lead sponsor

khaled Abdelsattar Gad Ibrahim

Other

Registry information

Official study title

Comparison Between Convective Radiofrequency Water Vapor Thermal Ablation (REZUM) Versus Tamsulosin in Management of Lower Urinary Tract Symptoms in Patients With Benign Prostatic Enlargement

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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