Comparative Study Between Rezum and Tamsulosin

khaled Abdelsattar Gad Ibrahim94 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Hyperplasia

Interventions

RezumDEVICE

Rezum procedure in Rezum group

TamsulosinDRUG

Tamsulosin were given to Tamsulosin group

Eligibility

Sex: MALEMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

The Armed Forces College of Medicine (AFCM

Cairo, Nozha, Egypt

Outcomes

Primary Outcomes

The International Prostate Symptom score (IPSS)

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

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

The Maximum Urinary flow rate (Qmax)

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

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

The Quality of Life (QoL)

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

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

The Prostate size

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

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.

Secondary Outcomes

Incidence of complications

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).

Data from ClinicalTrials.gov

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