BPH (Benign Prostatic Hyperplasia)NCT07587333
Convective Radio-frequency Water Vapor Energy Verses Trans-urethral Enucleation of Prostate for Management of Benign Prostatic Hyperplasia
A study testing Rezum and TUEP in people with BPH (Benign Prostatic Hyperplasia), run by Beni-Suef University at 1 site in Egypt.
Trial summary
Convective RF water vapor energy was introduced as a minimally invasive, radio-frequency thermal energy-based treatment, designed to convectively deliver sterile water vapor, or steam for targeted ablation limited to the transition and central zones in men with clinical BPH. Thus. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia)
- What is being tested?
- Rezum and TUEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 May 2026
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male aged > 50 yrs.
- International Prostate Symptom Score (IPSS) >12
- Maximum flow rate ( Qmax ) < 15 ml/s for 125ml voided volume
- Post-void residual volume <350 ml
- Prostate volume 80-120 g
Who cannot join
- Active urinary tract infection at time of treatment.
- Prostate-specific antigen (PSA) more than 10 ng/l.
- history of prostate or bladder cancer.
- Anticoagulants within 3d of the index procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study Comparing Convective Radio-frequency Water Vapor Energy With Trans-urethral Enucleation of Prostate for Management of Benign Prostatic Hyperplasia
Convective RF water vapor energy was introduced as a minimally invasive, radio-frequency thermal energy-based treatment, designed to convectively deliver sterile water vapor, or steam for targeted ablation limited to the transition and central zones in men with clinical BPH. Thus. the aim of the study is to compare Convective RF water vapor energy (Rezum) with trans-urethral enucleation of the prostate (TUEP) regarding efficacy in terms of lower urinary tract symptoms (LUTS) improvement, international prostatic symptoms score (IPSS), improving of the maximum flow rate (Qmax), worsening of erectile and ejaculatory function, and safety regarding post operative complications \& hospital stay.
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Being tested
- Rezum, TUEP
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RezumProcedure or surgery
Convective RF water vapor energy (Rezum)
TUEPProcedure or surgery
transurethral enucleation of prostate (TUEP)
| Study group | Role | What they receive |
|---|---|---|
| Convective RF water vapor energy (Rezum) | Active comparator | Not described Receives: Procedure: Rezum |
| Transurethral enucleation of prostate (TUEP) | Active comparator | Not described Receives: Procedure: TUEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (IPSS)
The total score ranges from 0 to 35, where 0 indicates no symptoms and 35 indicates the most severe symptoms. Higher scores represent worse urinary symptoms and poorer clinical status.
Measured: 1, 6, 12 months
Secondary outcomes (4)
International Index of Erectile Function (IIEF-EF)
The erectile function domain score ranges from 1 to 30, where lower scores indicate more severe erectile dysfunction and higher scores indicate better erectile function. Higher scores represent better clinical outcomes.
Measured: 1, 6, 12 months
four-item version of Male Sexual Health Questionnaire (MSHQ-EjD Short Form)
The total score ranges from 1 to 15 for the ejaculatory function domain, with higher scores indicating better ejaculatory function. In the bother item, scores range from 0 to 5, where higher scores indicate greater bother or distress related to ejaculatory dysfunction.
Measured: 1, 6, 12 months
Qmax maximum urinary flow rate
Maximum urinary flow rate (Qmax) will be assessed using uroflowmetry, a non-invasive urodynamic test that measures the maximum flow rate of urine during voiding. Qmax is reported in milliliters per second (mL/s). Higher values indicate better urinary flow and improved urinary function.
Measured: 1, 6, 12 months
Post Void Residual volume (PVR)
Post-Void Residual urine volume (PVR) will be assessed using bladder ultrasound immediately after voiding to determine the amount of urine remaining in the bladder. PVR is reported in milliliters (mL). Higher values indicate worse bladder emptying and poorer urinary function.
Measured: 1, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Mar 2025
- Primary completion1 Mar 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH (Benign Prostatic Hyperplasia)Studies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Fathy Badawy, MD, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587333
- Sponsor's protocol ID
- FMBSUREC/04062024/ Mohamed
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Comparing Convective Radio-frequency Water Vapor Energy With Trans-urethral Enucleation of Prostate for Management of Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT07587333
- Acronym / sponsor ID
- FMBSUREC/04062024/ Mohamed
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 14 May 2026 (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.
Convective RF water vapor energy was introduced as a minimally invasive, radio-frequency thermal energy-based treatment, designed to convectively deliver sterile water vapor, or steam for targeted ablation limited to the transition and central zones in men with clinical BPH. Thus. the aim of the study is to compare Convective RF water vapor energy (Rezum) with trans-urethral enucleation of the prostate (TUEP) regarding efficacy in terms of lower urinary tract symptoms (LUTS) improvement, international prostatic symptoms score (IPSS), improving of the maximum flow rate (Qmax), worsening of erectile and ejaculatory function, and safety regarding post operative complications \& hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Convective RF water vapor energy (Rezum) | Active comparator | Procedure: Rezum |
| Transurethral enucleation of prostate (TUEP) | Active comparator | Procedure: TUEP |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male aged > 50 yrs.
- International Prostate Symptom Score (IPSS) >12
- Maximum flow rate ( Qmax ) < 15 ml/s for 125ml voided volume
- Post-void residual volume <350 ml
- Prostate volume 80-120 g
Key exclusion criteria (4 listed)
- Active urinary tract infection at time of treatment.
- Prostate-specific antigen (PSA) more than 10 ng/l.
- history of prostate or bladder cancer.
- Anticoagulants within 3d of the index procedure
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 |
|---|---|---|
| RezumConvective RF water vapor energy (Rezum) | Procedure or surgery | Convective RF water vapor energy (Rezum) |
| TUEPtransurethral enucleation of prostate (TUEP) | Procedure or surgery | Transurethral enucleation of prostate (TUEP) |
Primary outcome
International Prostate Symptom Score (IPSS)
Time frame: 1, 6, 12 months
The total score ranges from 0 to 35, where 0 indicates no symptoms and 35 indicates the most severe symptoms. Higher scores represent worse urinary symptoms and poorer clinical status.
4 secondary outcomes
International Index of Erectile Function (IIEF-EF)
Time frame: 1, 6, 12 months
four-item version of Male Sexual Health Questionnaire (MSHQ-EjD Short Form)
Time frame: 1, 6, 12 months
Qmax maximum urinary flow rate
Time frame: 1, 6, 12 months
Post Void Residual volume (PVR)
Time frame: 1, 6, 12 months
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 19 May 2026.
- Individual participant dataSharing planned: Undecided
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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 TUEP in people with BPH (Benign Prostatic Hyperplasia), run by Beni-Suef University 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 4 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 19 May 2026. 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?
International Prostate Symptom Score (IPSS) (time frame: 1, 6, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2026.