Comparative Study Between Rezum and Tamsulosin

Not Applicable

Completed

• Conditions: Prostate Hyperplasia
• Interventions: Device: Rezum; Drug: Tamsulosin

• Registration Number: NCT07169773
• Lead Sponsor: khaled Abdelsattar Gad Ibrahim

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-06-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-04
• Study First Submitted QC: 2025-09-10
• Last Update Submitted: 2025-09-10
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 94

Inclusion Criteria

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

Exclusion Criteria

1. prostate cancer,
2. neurogenic bladder
3. urethral stricture,
4. urinary bladder stone
5. previous prostatic surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rezum group	Rezum	47 patient underwent Rezum therapy
tamsulosin group	Tamsulosin	47 patients were given Tamsulosin medical treatment

Primary Outcome Measures

Name	Time	Method
The International Prostate Symptom score (IPSS)	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
The Maximum Urinary flow rate (Qmax)	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
The Quality of Life (QoL)	[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
The Prostate size	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 Outcome Measures

Name	Time	Method
Incidence of complications	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).

Trial Locations

Locations (1)

The Armed Forces College of Medicine (AFCM; 🇪🇬 Cairo, Nozha, Egypt