Comparative Study Between Rezum and Tamsulosin

khaled Abdelsattar Gad Ibrahim

Status: Completed

Conditions: Prostate Hyperplasia

Treatments: Device: Rezum; Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT07169773

Rezum procedure for BPH

Details and patient eligibility

About

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

Full 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.

Enrollment: 94 patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Rezum group

Active Comparator group

Description:

47 patient underwent Rezum therapy

Treatment:

Device: Rezum

tamsulosin group

Active Comparator group

Description:

47 patients were given Tamsulosin medical treatment

Treatment:

Drug: Tamsulosin