Benign Prostatic HyperplasiaNCT05784909
Outcomes of Water Vapor Thermal Therapy (REZUM) in Management of Symptomatic Patients With Benign Prostatic Enlargement
A study testing rezum in people with Benign Prostatic Hyperplasia, run by Assiut University.
Trial summary
new treatment modality for BPH , less invasive and more effective. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- rezum
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 May 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- any patient diagnosed with BPH
Who cannot join
- PATIENT REFUSING TO PARTICIPITATE
Trial locations and contacts
No sites are listed yet.
About this study
new treatment modality for BPH , less invasive and more effective.
Read the detailed description
Benign prostatic hyperplasia (BPH) is a common urological condition characterized by progressive increase in the size of the prostate gland. It is a disease of ageing, affecting 40% of men in their 50s and 90% of men over 90 years causing bladder outflow obstruction (BOO), which results in lower urinary tract symptoms (LUTS) which have a significant impact on quality of life (QoL).
The current management for LUTS caused by BOO secondary to BPH includes conservative approaches (watchful waiting and lifestyle modifications), pharmacotherapy and surgical intervention.
The Surgical interventions include open surgery (suprapubic and perineal approaches),transurethral resection of the prostate (TURP) which was a revolutionary step in the management of BPH, and was considered the first minimally invasive treatment for prostate enlargement and With the improvement of endoscopes, development and incorporation of new technologies into the medical field, minimally invasive procedures have been more and more introduced as surgical options to treat BPH .
Minimally invasive procedures include water vapor thermal therapy (REZUM), trans urethral needle ablation, trans urethral microwave thermotherapy, prostate urethral lift and prostate artery embolization.
REZUM (water vapor thermal therapy) is considered one of the advanced minimal invasive procedure that uses the principles of convective heat transfer that exploits the thermodynamic properties of water to remove the excess prostate tissue that is pressing on the urethra.
The therapy is targeted to a defined area because steam will travel only between cells until it encounters natural collagen barriers or the prostate capsule itself.
After the REZUM procedure, the body creates an inflammatory response, which takes two to four months to completely resolve. Initially, there will be swelling in the prostate, which can cause restriction of flow and cause more difficulty and frequency of urination.
In general, after the procedure symptoms will get worse before they get better and improved.
Erections are not affected by the REZUM procedure and there is 1% to 2% chance of retrograde ejaculation and his is a significantly lower percentage than in other prostate procedures.
Advantages of REZUM:
- Can be performed under sedation only
- Day case procedure
- Strong short-term safety profile
- No reports of de novo sexual dysfunction
- Suitable for patients with an obstructing median lobe
- Short procedure time
- Good improvement in subjective and objective outcome measures: IPSS, QoL, Qmax and PVR
- Cost effective
Disadvantages of REZUM:
- Limited long-term data available
- Not suitable for patients with history of recurrent urinary tract infections
- Not suitable for large prostate size (>120 cc)
- Not suitable for patients if prior invasive procedure for treatment of prostate or prior radiation on prostate
- >50% patients require catheter post procedure
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- rezum
- 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
Technique With the patient in a lithotomy position, after cystoscopy, an RF current is applied to. Water vapour is delivered through a retractable vapor needle via emitter holes in the transurethral device. This is done in 9-second bursts to the transition zone of the prostate, where, via convection, it diffuses evenly throughout the target tissue. The depth of the needle penetrating is approximately 10 mm.
Upon contact with body-temperature tissue, the water vapour then condenses. This phase shift to a liquid state dispenses concentrated energy onto the cell membranes of the target tissue, triggering instant cell necrosis. Overlapping injection sites can be established with repeated applications in order to fully target areas of hypertrophy. Saline flush irrigation is used to both cool the urethra and to promote visualization.
At the end of the procedure Urethral catheter is fixed for 1-3 days.
| Study group | Role | What they receive |
|---|---|---|
| patients diagnosed with bladder outlet obstruction due to BPH | Experimental | all symptomatic patients with BPH with failure medical management or prefer minimal invasive procedure from the start. Receives: Device: rezum |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the IPSS
to assess the success of treatment ,pre-operative and postoperative questionnaire will be done
Measured: 1 month after treatment
duration of the operation
minutes or hours needed for the procedure
Measured: intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Zamra, Assiut University
- Investigators
- Mohamed M Gadalmoulah, phd, Study director, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784909
- Sponsor's protocol ID
- REZUM in Assiut
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang SJ, Qian HN, Zhao Y, Sun K, Wang HQ, Liang GQ, Li FH, Li Z. Relationship between age and prostate size. Asian J Androl. 2013 Jan;15(1):116-20. doi: 10.1038/aja.2012.127. Epub 2012 Dec 10.
PubMed 23223031Vuichoud C, Loughlin KR. Benign prostatic hyperplasia: epidemiology, economics and evaluation. Can J Urol. 2015 Oct;22 Suppl 1:1-6.
PubMed 26497338Kim EH, Larson JA, Andriole GL. Management of Benign Prostatic Hyperplasia. Annu Rev Med. 2016;67:137-51. doi: 10.1146/annurev-med-063014-123902. Epub 2015 Sep 2.
PubMed 26331999Magistro G, Chapple CR, Elhilali M, Gilling P, McVary KT, Roehrborn CG, Stief CG, Woo HH, Gratzke C. Emerging Minimally Invasive Treatment Options for Male Lower Urinary Tract Symptoms. Eur Urol. 2017 Dec;72(6):986-997. doi: 10.1016/j.eururo.2017.07.005. Epub 2017 Jul 19.
PubMed 28734706Garden EB, Shukla D, Ravivarapu KT, Kaplan SA, Reddy AK, Small AC, Palese MA. Rezum therapy for patients with large prostates (>/= 80 g): initial clinical experience and postoperative outcomes. World J Urol. 2021 Aug;39(8):3041-3048. doi: 10.1007/s00345-020-03548-7. Epub 2021 Jan 3.
PubMed 33392646Elterman D, Shepherd S, Saadat SH, Alshak MN, Bhojani N, Zorn KC, Rijo E, Misrai V, Lajkosz K, Chughtai B. Prostatic urethral lift (UroLift) versus convective water vapor ablation (Rezum) for minimally invasive treatment of BPH: a comparison of improvements and durability in 3-year clinical outcomes. Can J Urol. 2021 Oct;28(5):10824-10833.
PubMed 34657655
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Water Vapor Thermal Therapy (REZUM) in Management of Symptomatic Patients With Benign Prostatic Enlargement
- ClinicalTrials.gov ID
- NCT05784909
- Acronym / sponsor ID
- REZUM in Assiut
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 27 Mar 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.
new treatment modality for BPH , less invasive and more effective.
Detailed description
Benign prostatic hyperplasia (BPH) is a common urological condition characterized by progressive increase in the size of the prostate gland. It is a disease of ageing, affecting 40% of men in their 50s and 90% of men over 90 years causing bladder outflow obstruction (BOO), which results in lower urinary tract symptoms (LUTS) which have a significant impact on quality of life (QoL).
The current management for LUTS caused by BOO secondary to BPH includes conservative approaches (watchful waiting and lifestyle modifications), pharmacotherapy and surgical intervention.
The Surgical interventions include open surgery (suprapubic and perineal approaches),transurethral resection of the prostate (TURP) which was a revolutionary step in the management of BPH, and was considered the first minimally invasive treatment for prostate enlargement and With the improvement of endoscopes, development and incorporation of new technologies into the medical field, minimally invasive procedures have been more and more introduced as surgical options to treat BPH .
Minimally invasive procedures include water vapor thermal therapy (REZUM), trans urethral needle ablation, trans urethral microwave thermotherapy, prostate urethral lift and prostate artery embolization.
REZUM (water vapor thermal therapy) is considered one of the advanced minimal invasive procedure that uses the principles of convective heat transfer that exploits the thermodynamic properties of water to remove the excess prostate tissue that is pressing on the urethra.
The therapy is targeted to a defined area because steam will travel only between cells until it encounters natural collagen barriers or the prostate capsule itself.
After the REZUM procedure, the body creates an inflammatory response, which takes two to four months to completely resolve. Initially, there will be swelling in the prostate, which can cause restriction of flow and cause more difficulty and frequency of urination.
In general, after the procedure symptoms will get worse before they get better and improved.
Erections are not affected by the REZUM procedure and there is 1% to 2% chance of retrograde ejaculation and his is a significantly lower percentage than in other prostate procedures.
Advantages of REZUM:
- Can be performed under sedation only
- Day case procedure
- Strong short-term safety profile
- No reports of de novo sexual dysfunction
- Suitable for patients with an obstructing median lobe
- Short procedure time
- Good improvement in subjective and objective outcome measures: IPSS, QoL, Qmax and PVR
- Cost effective
Disadvantages of REZUM:
- Limited long-term data available
- Not suitable for patients with history of recurrent urinary tract infections
- Not suitable for large prostate size (>120 cc)
- Not suitable for patients if prior invasive procedure for treatment of prostate or prior radiation on prostate
- >50% patients require catheter post procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients diagnosed with bladder outlet obstruction due to BPH | Experimental | Device: rezumall symptomatic patients with BPH with failure medical management or prefer minimal invasive procedure from the start. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any patient diagnosed with BPH
Key exclusion criteria (1 listed)
- PATIENT REFUSING TO PARTICIPITATE
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 |
|---|---|---|
| rezumTechnique With the patient in a lithotomy position, after cystoscopy, an RF current is applied to. Water vapour is delivered through a retractable vapor needle via emitter holes in the transurethral device. This is done in 9-second bursts to the transition zone of the prostate, where, via convection, it diffuses evenly throughout the target tissue. The depth of the needle penetrating is approximately 10 mm. Upon contact with body-temperature tissue, the water vapour then condenses. This phase shift to a liquid state dispenses concentrated energy onto the cell membranes of the target tissue, triggering instant cell necrosis. Overlapping injection sites can be established with repeated applications in order to fully target areas of hypertrophy. Saline flush irrigation is used to both cool the urethra and to promote visualization. At the end of the procedure Urethral catheter is fixed for 1-3 days. | Device | patients diagnosed with bladder outlet obstruction due to BPH |
Primary outcome
evaluation of the IPSS
Time frame: 1 month after treatment
to assess the success of treatment ,pre-operative and postoperative questionnaire will be done
duration of the operation
Time frame: intra-operative
minutes or hours needed for the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Background: PubMed 23223031Zhang SJ, Qian HN, Zhao Y, Sun K, Wang HQ, Liang GQ, Li FH, Li Z. Relationship between age and prostate size. Asian J Androl. 2013 Jan;15(1):116-20. doi: 10.1038/aja.2012.127. Epub 2012 Dec 10.
- Background: PubMed 26497338Vuichoud C, Loughlin KR. Benign prostatic hyperplasia: epidemiology, economics and evaluation. Can J Urol. 2015 Oct;22 Suppl 1:1-6.
- Background: PubMed 26331999Kim EH, Larson JA, Andriole GL. Management of Benign Prostatic Hyperplasia. Annu Rev Med. 2016;67:137-51. doi: 10.1146/annurev-med-063014-123902. Epub 2015 Sep 2.
- Background: PubMed 28734706Magistro G, Chapple CR, Elhilali M, Gilling P, McVary KT, Roehrborn CG, Stief CG, Woo HH, Gratzke C. Emerging Minimally Invasive Treatment Options for Male Lower Urinary Tract Symptoms. Eur Urol. 2017 Dec;72(6):986-997. doi: 10.1016/j.eururo.2017.07.005. Epub 2017 Jul 19.
- Background: PubMed 33392646Garden EB, Shukla D, Ravivarapu KT, Kaplan SA, Reddy AK, Small AC, Palese MA. Rezum therapy for patients with large prostates (>/= 80 g): initial clinical experience and postoperative outcomes. World J Urol. 2021 Aug;39(8):3041-3048. doi: 10.1007/s00345-020-03548-7. Epub 2021 Jan 3.
- Background: PubMed 34657655Elterman D, Shepherd S, Saadat SH, Alshak MN, Bhojani N, Zorn KC, Rijo E, Misrai V, Lajkosz K, Chughtai B. Prostatic urethral lift (UroLift) versus convective water vapor ablation (Rezum) for minimally invasive treatment of BPH: a comparison of improvements and durability in 3-year clinical outcomes. Can J Urol. 2021 Oct;28(5):10824-10833.
- 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.
Mohamed M Gadalmoulah, phd study director
professor
Questions about this trial
What is this clinical trial studying?
A study testing rezum in people with Benign Prostatic Hyperplasia, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A Zamra, Msc (+971508079718, mohamedzomrah@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of the IPSS (time frame: 1 month after treatment). The study lists 2 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 NCT05784909, which also lists 6 linked publications.
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 Mar 2023.