NCT07169773

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 4, 2025

Last Update Submit

September 10, 2025

Conditions

Prostate Hyperplasia

Keywords

Rezumtamsulosin

Outcome Measures

Primary Outcomes (4)

  • 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: 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: 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: 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: 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 (1)

  • Incidence of complications

    through 1 year

Study Arms (2)

Rezum group

ACTIVE COMPARATOR

47 patient underwent Rezum therapy

Device: Rezum

tamsulosin group

ACTIVE COMPARATOR

47 patients were given Tamsulosin medical treatment

Drug: Tamsulosin

Interventions

RezumDEVICE

Rezum procedure in Rezum group

Rezum group
TamsulosinDRUG

Tamsulosin were given to Tamsulosin group

tamsulosin group

Eligibility Criteria

Age50 Years - 80 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Armed Forces College of Medicine (AFCM

Cairo, Nozha, 4470351, Egypt

Location

Related Publications (1)

  • Samir M, Mahmoud MA, Abdelmonem HA, Elrefaie M, Gad KA. A comparative analysis of the outcomes of Rezum therapy based on prostate size: a four-year retrospective analysis. World J Urol. 2025 Jul 17;43(1):443. doi: 10.1007/s00345-025-05793-0.

    PMID: 40676194BACKGROUND

Related Links

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
consultatnt doctor

Study Record Dates

First Submitted

September 4, 2025

First Posted

September 12, 2025

Study Start

May 1, 2022

Primary Completion

May 1, 2023

Study Completion

June 1, 2023

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)