Comparative Study Between Rezum and Tamsulosin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-06-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Prostate Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rezum group

47 patient underwent Rezum therapy

Group Type ACTIVE_COMPARATOR

Rezum

Intervention Type DEVICE

Rezum procedure in Rezum group

tamsulosin group

47 patients were given Tamsulosin medical treatment

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

Tamsulosin were given to Tamsulosin group

Interventions

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Rezum

Rezum procedure in Rezum group

Intervention Type DEVICE

Tamsulosin

Tamsulosin were given to Tamsulosin group

Intervention Type DRUG

Eligibility Criteria

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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