Prostate HyperplasiaNCT07169773
Comparative Study Between Rezum and Tamsulosin
A study testing Rezum and Tamsulosin in people with Prostate Hyperplasia, run by khaled Abdelsattar Gad Ibrahim at 1 site in Egypt.
Trial summary
the investigators aimed to compare the efficacy and safety of Rezūm therapy for the management of benign prostatic hyperplasia (BPH) with Tamsulosin. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostate Hyperplasia
- What is being tested?
- Rezum and Tamsulosin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- prostate cancer,
- neurogenic bladder
- urethral stricture,
- urinary bladder stone
- previous prostatic surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Convective Radiofrequency Water Vapor Thermal Ablation (REZUM) Versus Tamsulosin in Management of Lower Urinary Tract Symptoms in Patients With Benign Prostatic Enlargement
the investigators aimed to compare the efficacy and safety of Rezūm therapy for the management of benign prostatic hyperplasia (BPH) with Tamsulosin.
Read the 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.
- Conditions
- Prostate Hyperplasia
- Being tested
- Rezum, Tamsulosin
- Keywords
- Rezum, tamsulosin
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RezumDevice
Rezum procedure in Rezum group
TamsulosinDrug
Tamsulosin were given to Tamsulosin group
| Study group | Role | What they receive |
|---|---|---|
| Rezum group | Active comparator | 47 patient underwent Rezum therapy Receives: Device: Rezum |
| tamsulosin group | Active comparator | 47 patients were given Tamsulosin medical treatment Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: [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
Measured: 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
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).
Measured: through 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 May 2022
- Primary completion1 May 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- khaled Abdelsattar Gad Ibrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, khaled Abdelsattar Gad Ibrahim, Armed Forces College of Medicine, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169773
- Sponsor's protocol ID
- Rezum procedure for BPH
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40676194
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Convective Radiofrequency Water Vapor Thermal Ablation (REZUM) Versus Tamsulosin in Management of Lower Urinary Tract Symptoms in Patients With Benign Prostatic Enlargement
- ClinicalTrials.gov ID
- NCT07169773
- Acronym / sponsor ID
- Rezum procedure for BPH
- Conditions
- Prostate Hyperplasia
- Keywords
- Rezum, tamsulosin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- khaled Abdelsattar Gad IbrahimUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rezum group | Active comparator | Device: Rezum47 patient underwent Rezum therapy |
| tamsulosin group | Active comparator | Drug: Tamsulosin47 patients were given Tamsulosin medical treatment |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- prostate cancer,
- neurogenic bladder
- urethral stricture,
- urinary bladder stone
- previous prostatic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RezumRezum procedure in Rezum group | Device | Rezum group |
| TamsulosinTamsulosin were given to Tamsulosin group | Drug | tamsulosin group |
Primary outcome
The International Prostate Symptom score (IPSS)
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
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: 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: [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: 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
1 secondary outcome
Incidence of complications
Time frame: through 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publication: PubMed 40676194Samir 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rezum and Tamsulosin in people with Prostate Hyperplasia, run by khaled Abdelsattar Gad Ibrahim at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The International Prostate Symptom score (IPSS) (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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07169773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.