Benign Prostatic HyperplasiaNCT05982444
Long Term Follow up of Water Vapor Thermal Therapy (Rezum) for Benign Prostatic Hyperplasia (BPH)
A study testing water vapor thermal therapy (Rezum) for prostate in people with Benign Prostatic Hyperplasia and Lower Urinary Track Symptoms, run by Helwan University at 1 site in Egypt.
Trial summary
This study aims to assess the effectiveness and morbidity of water vapor thermal therapy (Rezūm therapy) for benign prostatic hyperplasia (BPH). Data will be collected and analyzed from patients treated by Rezūm and followed up for 4 years prior to evaluating clinical outcomes. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Track Symptoms
- What is being tested?
- water vapor thermal therapy (Rezum) for prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 1 May 2025
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients underwent rezum procedure for benign prostatic hyperplasia from 2 to 4 years
Who cannot join
- previous prostatic intervention
- concurrent urological morbidity like urethral stricture
- neurological disease like parkinson's disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Helwan University
Helwan, Cairo Governorate, 11795
About this study
Official title: Long Term Post-operative Effectiveness and Morbidity of Rezum Therapy for Benign Prostatic Hyperplasia
This study aims to assess the effectiveness and morbidity of water vapor thermal therapy (Rezūm therapy) for benign prostatic hyperplasia (BPH). Data will be collected and analyzed from patients treated by Rezūm and followed up for 4 years prior to evaluating clinical outcomes.
Read the detailed description
The investigators will conduct a retrospective study evaluating patients treated with water vapor thermal therapy (Rezūm therapy) for BPH and followed up for4 years. The primary objectives are to assess the long-term effectiveness and morbidity rates associated with the procedure. Data collected will include urinary symptom scores, sexual function, and any treatment-related complications.
- Being tested
- water vapor thermal therapy (Rezum) for prostate
- Keywords
- water vapor thermal therapy
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water vapor thermal therapy (Rezum) for prostateProcedure or surgery
Also called Prostate steam treatment (Rezum) for benign prostatic hyperplasia (BPH)
all patients underwent rezum therapy for bph are evaluated for its effectiveness for long period
| Study group | Role | What they receive |
|---|---|---|
| patient treated by rezum procedure | Other | patients had benign prostatic hyperplasia and treated by rezum procedure from 2 to 4 years included in the study Receives: Procedure: water vapor thermal therapy (Rezum) for prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in prostate volume
Prostate volume will be measured via transrectal ultrasound.
Measured: 4 years
hange in International Prostate Symptom Score (IPSS)
IPSS is a questionnaire evaluating urinary symptoms. Scores ranging from 0 to 7 indicate mild symptoms, from 8 to 19 moderate symptoms, and from 20 to 35 severe symptoms.
Measured: 4 years
international index of erectile function (IIEF)
IIEF is a questionnaire evaluating sexual function. Scores ranging from 5 to 7 indicate severe symptoms, 8 to 11 moderate symptoms, 12 to 16 mild to moderate symptoms, 17 to 21 mild symptoms, and 22 to 25 no erectile dysfunction
Measured: 4 years
Change in Post-Void Residual Urine
Residual urine volume measured after urination using pelvic ultrasound.
Measured: 4 years
Secondary outcomes (2)
Retreatment Rate Following Rezūm Therapy
Number of participants requiring additional treatment for BPH after Rezūm therapy.
Measured: 4 years
complication rate
incidence of complications post procedure during follow-up
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Mar 2021
- Primary completion1 Mar 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohammed Elsaid Ali Elshahawy, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982444
- Sponsor's protocol ID
- 30-2023
- Status last verified
- Jun 2025
- First submitted
- 24 Jul 2023
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients are not permitted to post any of their personal information
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Post-operative Effectiveness and Morbidity of Rezum Therapy for Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT05982444
- Acronym / sponsor ID
- 30-2023
- Keywords
- water vapor thermal therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 8 Aug 2023 (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.
This study aims to assess the effectiveness and morbidity of water vapor thermal therapy (Rezūm therapy) for benign prostatic hyperplasia (BPH). Data will be collected and analyzed from patients treated by Rezūm and followed up for 4 years prior to evaluating clinical outcomes.
Detailed description
The investigators will conduct a retrospective study evaluating patients treated with water vapor thermal therapy (Rezūm therapy) for BPH and followed up for4 years. The primary objectives are to assess the long-term effectiveness and morbidity rates associated with the procedure. Data collected will include urinary symptom scores, sexual function, and any treatment-related complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient treated by rezum procedure | Other | Procedure: water vapor thermal therapy (Rezum) for prostatepatients had benign prostatic hyperplasia and treated by rezum procedure from 2 to 4 years included in the study |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients underwent rezum procedure for benign prostatic hyperplasia from 2 to 4 years
Key exclusion criteria (3 listed)
- previous prostatic intervention
- concurrent urological morbidity like urethral stricture
- neurological disease like parkinson's disease
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 |
|---|---|---|
| water vapor thermal therapy (Rezum) for prostateAlso: Prostate steam treatment (Rezum) for benign prostatic hyperplasia (BPH)all patients underwent rezum therapy for bph are evaluated for its effectiveness for long period | Procedure or surgery | patient treated by rezum procedure |
Primary outcome
change in prostate volume
Time frame: 4 years
Prostate volume will be measured via transrectal ultrasound.
hange in International Prostate Symptom Score (IPSS)
Time frame: 4 years
IPSS is a questionnaire evaluating urinary symptoms. Scores ranging from 0 to 7 indicate mild symptoms, from 8 to 19 moderate symptoms, and from 20 to 35 severe symptoms.
international index of erectile function (IIEF)
Time frame: 4 years
IIEF is a questionnaire evaluating sexual function. Scores ranging from 5 to 7 indicate severe symptoms, 8 to 11 moderate symptoms, 12 to 16 mild to moderate symptoms, 17 to 21 mild symptoms, and 22 to 25 no erectile dysfunction
Change in Post-Void Residual Urine
Time frame: 4 years
Residual urine volume measured after urination using pelvic ultrasound.
2 secondary outcomes
Retreatment Rate Following Rezūm Therapy
Time frame: 4 years
complication rate
Time frame: 4 years
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 27 Jun 2025.
- Individual participant dataSharing planned: No. Patients are not permitted to post any of their personal information
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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 water vapor thermal therapy (Rezum) for prostate in people with Benign Prostatic Hyperplasia and Lower Urinary Track Symptoms, run by Helwan 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 1 inclusion and 3 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 27 Jun 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?
change in prostate volume (time frame: 4 years). 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?
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 27 Jun 2025.