Prostatic HyperplasiaNCT06116370
The Clinical Efficacy of Rezūm Therapy Versus Bipolar Trans-urethral Resection of the Prostate for Treatment Benign Prostatic Hyperplasia
A study testing Rezum procedure and B-TURP procedure in people with Prostatic Hyperplasia, run by Ain Shams University at 1 site in Egypt.
Trial summary
We aimed to compare the efficacy and safety of Rezūm therapy and bipolar transurethral resection of prostate (B-TURP) for the management of benign prostatic hyperplasia (BPH) of 50-120gm size. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Rezum procedure and B-TURP procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Sep 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
- Patients aged 50-80 years
- prostate volumes of 50-120 ml
- sexually active
- severe LUTS
- [Q max] of <10 ml/s
- [IPSS] of >20)
- failed medical treatment with alpha blockers
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: Two-Year Follow-Up Comparing Rezūm Therapy Versus Bipolar Transurethral Resection of the Prostate for Treating Benign Prostatic Hyperplasia. A Prospective Randomized Study.
We aimed to compare the efficacy and safety of Rezūm therapy and bipolar transurethral resection of prostate (B-TURP) for the management of benign prostatic hyperplasia (BPH) of 50-120gm size.
Read the detailed description
For decades, Transurethral resection of the prostate (TURP) was the gold standard surgical intervention for small and moderate prostates, however it has high morbidity and prolonged hospital stay. In contrast to monopolar TURP (M-TURP), where prolonged resection carries the risk of transurethral resection (TUR) syndrome, bipolar transurethral resection of prostate (B-TURP), especially in large prostates was a promising procedure for urologists, but unfortunately, the morbidity rate of B-TURP remains high [4]. Therefore, newer minimally invasive procedures have been introduced to provide alternative surgical options to TURP.
Rezūm is a radiofrequency made water vapour thermal treatment. It has recently been added to the international guidelines as a choice for medical treatment resistant lower urinary tract symptoms (LUTS). The AUA and Canadian Urological Association (CUA) guidelines now add water vapour therapy as a treatment option for BPH patients with small prostate size <80 gm and for those wishing to maintain antegrade ejaculation. While they still offer no clear recommendation to Rezūm use for those with large prostates. Early studies on this topic have found out promising results.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Rezum procedure, B-TURP procedure
- Keywords
- Rezum, LUTS, B-TURP
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rezum procedureProcedure or surgery
In Rezūm procedure, the Rezūm System (NxThera Inc., Maple Grove, MN, USA) consists of a radiofrequency (RF) power supply generator and single-use transurethral delivery device. Starting 1 cm distal to the bladder neck, injection was done at 3 and 9 o'clock sites. The needle was inserted for 9 s duration, retracted, and then delivered to another treatment site in 1 cm distance distal to the previous one.
B-TURP procedureProcedure or surgery
In B-TURP, Olympus SurgMaster™ UES-40 bipolar generator (Olympus Europe, Hamburg, Germany) was used. Current's settings used were cut/coag 200/120. Using continuous flow 26Fr resectoscope first resection of the median lobe from the level of the bladder neck to the apex of the prostate was done followed by resection of the lateral lobes. Using Ellic evacuator, Prostatic chips were extracted from the field. A 22 fr three-way silicon Foley catheter was placed with traction applied and the balloon inflated by normal saline of 30-80 cc according to the size of the prostate.
| Study group | Role | What they receive |
|---|---|---|
| BPH patients treated with Rezum procedure | Active comparator | Patients aged 50-80 years with prostate volumes of 50-120 ml, sexually active, and have severe LUTS treated with Rezum procedure Receives: Procedure: Rezum procedure |
| BPH patients treated with B-TURP procedure | Active comparator | Patients aged 50-80 years with prostate volumes of 50-120 ml, sexually active, and have severe LUTS treated with Rezum procedure Receives: Procedure: B-TURP procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of The International Prostate Symptom score (IPSS) in both groups
After 6, 12, and 24 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: for each case in both groups the investigator assess IPSS at 6, 12, and 24 months after procedures through study completion, an average of 2 years
Measurement of The Quality of Life (QoL) in both groups
After 6, 12, and 24 months of operation, the questioner is performed. Minimum :0 means delighted / Maximum : 5 means unhappy
Measured: for each case in both groups the investigator assess QoLat 6, 12, and 24 months after procedures through study completion, an average of 2 years
Measurement of The Maximum Urinary flow rate (Qmax) in both groups
After 6, 12, and 24 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: for each case in both groups the investigator assess Qmax at 6, 12, and 24 months after procedures through study completion, an average of 2 years
Concentration of The Prostatic specific antigen (PSA) in both groups
After 6, 12, and 24 months of operation, the procedure is performed. PSA is measured by ng/ml PSA levels of 4.0 ng/mL and lower were considered
Measured: for each case in both groups the investigator measures PSA at 6, 12, and 24 months after procedures through study completion, an average of 2 years
Measurement of The International Index of Erectile Function (IIEF) in both groups
After 6, 12, and 24 months of operation, the questioner is performed. The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction
Measured: for each case in both groups the investigator assess IIEF at 6, 12, and 24 months after procedures through study completion, an average of 2 years
Measurement of The Prostate size
the prostate size was measured by grams by Trans-rectal ultra sound
Measured: for each case in both groups the investigator assess prostate size at 24 months after procedures through study completion, an average of 2 years
The operative time of both groups
the operative time was measured by minutes in both groups.
Measured: for each case in both groups the investigator assess the time of operation from induction of anaesthesiatill the end of the operation through study completion, an average of 2 years
Post operative hospital stay time in both groups
the Post operative hospital stay time was measured by hours in both groups.
Measured: for each case in both groups the investigator assess the hospital time from the day of admission of the patient in hospital to do intervention till discharge from hospital through study completion, an average of 2 years
Incidence of The catheter duration post operative in both groups
The catheter duration was measured by days in both groups.
Measured: for each case in both groups the investigator assess the catheter duration from the end of the operation till removal through study completion, an average of 2 years
Measurement of Post operative residual urine (PVR)
PVR was measured by ml by pelvi abdominal ultra sound in both groups. Normal ranges are below 150 ml of urine.
Measured: for each case in both groups the investigator assess prostate size at 6, 12 and 24 months after procedures through study completion, an average of 2 years
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
Measured: through two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Jun 2021
- Primary completion1 Jun 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mohamed sa salem, MD, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116370
- Sponsor's protocol ID
- surgical treatments of BPH
- Status last verified
- Sep 2023
- First submitted
- 20 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dixon CM, Cedano ER, Pacik D, Vit V, Varga G, Wagrell L, Larson TR, Mynderse LA. Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia. Res Rep Urol. 2016 Nov 21;8:207-216. doi: 10.2147/RRU.S119596. eCollection 2016.
PubMed 27921028Elshal AM, Soltan M, El-Tabey NA, Laymon M, Nabeeh A. Randomised trial of bipolar resection vs holmium laser enucleation vs Greenlight laser vapo-enucleation of the prostate for treatment of large benign prostate obstruction: 3-years outcomes. BJU Int. 2020 Dec;126(6):731-738. doi: 10.1111/bju.15161. Epub 2020 Sep 30.
PubMed 32633020Samir M, Tawfick A, Mahmoud MA, Elawady H, Abuelnaga M, Shabayek M, Youssef AEH, Tawfeek AM. Two-year Follow-up in Bipolar Transurethral Enucleation and Resection of the Prostate in Comparison with Bipolar Transurethral Resection of the Prostate in Treatment of Large Prostates. Randomized Controlled Trial. Urology. 2019 Nov;133:192-198. doi: 10.1016/j.urology.2019.07.029. Epub 2019 Aug 9.
PubMed 31404581McVary KT, Rogers T, Roehrborn CG. Rezum Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study. Urology. 2019 Apr;126:171-179. doi: 10.1016/j.urology.2018.12.041. Epub 2019 Jan 21.
PubMed 30677455Parsons JK, Dahm P, Kohler TS, Lerner LB, Wilt TJ. Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline Amendment 2020. J Urol. 2020 Oct;204(4):799-804. doi: 10.1097/JU.0000000000001298. Epub 2020 Jul 23.
PubMed 32698710Nickel JC, Aaron L, Barkin J, Elterman D, Nachabe M, Zorn KC. Canadian Urological Association guideline on male lower urinary tract symptoms/benign prostatic hyperplasia (MLUTS/BPH): 2018 update. Can Urol Assoc J. 2018 Oct;12(10):303-312. doi: 10.5489/cuaj.5616. No abstract available.
PubMed 30332601Bole R, Gopalakrishna A, Kuang R, Alamiri J, Yang DY, Helo S, Ziegelmann MJ, Kohler TS. Comparative Postoperative Outcomes of Rezum Prostate Ablation in Patients with Large Versus Small Glands. J Endourol. 2020 Jul;34(7):778-781. doi: 10.1089/end.2020.0177. Epub 2020 Jun 12.
PubMed 32408768Garden 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, Bhojani N, Vannabouathong C, Chughtai B, Zorn KC. Rezum therapy for >/=80-mL benign prostatic enlargement: a large, multicentre cohort study. BJU Int. 2022 Oct;130(4):522-527. doi: 10.1111/bju.15753. Epub 2022 May 7.
PubMed 35466513Samir M, Elaal AAA, Gad KAS, Basyony MW. Two-year follow-up comparing Rezum therapy versus bipolar transurethral resection of the prostate for treating benign prostatic hyperplasia. A prospective randomized study. Int J Urol. 2024 May;31(5):545-550. doi: 10.1111/iju.15410. Epub 2024 Jan 30.
PubMed 38291876
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Year Follow-Up Comparing Rezūm Therapy Versus Bipolar Transurethral Resection of the Prostate for Treating Benign Prostatic Hyperplasia. A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT06116370
- Acronym / sponsor ID
- surgical treatments of BPH
- Conditions
- Prostatic Hyperplasia
- Keywords
- Rezum, LUTS, B-TURP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 3 Nov 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.
We aimed to compare the efficacy and safety of Rezūm therapy and bipolar transurethral resection of prostate (B-TURP) for the management of benign prostatic hyperplasia (BPH) of 50-120gm size.
Detailed description
For decades, Transurethral resection of the prostate (TURP) was the gold standard surgical intervention for small and moderate prostates, however it has high morbidity and prolonged hospital stay. In contrast to monopolar TURP (M-TURP), where prolonged resection carries the risk of transurethral resection (TUR) syndrome, bipolar transurethral resection of prostate (B-TURP), especially in large prostates was a promising procedure for urologists, but unfortunately, the morbidity rate of B-TURP remains high [4]. Therefore, newer minimally invasive procedures have been introduced to provide alternative surgical options to TURP.
Rezūm is a radiofrequency made water vapour thermal treatment. It has recently been added to the international guidelines as a choice for medical treatment resistant lower urinary tract symptoms (LUTS). The AUA and Canadian Urological Association (CUA) guidelines now add water vapour therapy as a treatment option for BPH patients with small prostate size <80 gm and for those wishing to maintain antegrade ejaculation. While they still offer no clear recommendation to Rezūm use for those with large prostates. Early studies on this topic have found out promising results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPH patients treated with Rezum procedure | Active comparator | Procedure: Rezum procedurePatients aged 50-80 years with prostate volumes of 50-120 ml, sexually active, and have severe LUTS treated with Rezum procedure |
| BPH patients treated with B-TURP procedure | Active comparator | Procedure: B-TURP procedurePatients aged 50-80 years with prostate volumes of 50-120 ml, sexually active, and have severe LUTS treated with Rezum procedure |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 50-80 years
- prostate volumes of 50-120 ml
- sexually active
- severe LUTS
- [Q max] of <10 ml/s
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 |
|---|---|---|
| Rezum procedureIn Rezūm procedure, the Rezūm System (NxThera Inc., Maple Grove, MN, USA) consists of a radiofrequency (RF) power supply generator and single-use transurethral delivery device. Starting 1 cm distal to the bladder neck, injection was done at 3 and 9 o'clock sites. The needle was inserted for 9 s duration, retracted, and then delivered to another treatment site in 1 cm distance distal to the previous one. | Procedure or surgery | BPH patients treated with Rezum procedure |
| B-TURP procedureIn B-TURP, Olympus SurgMaster™ UES-40 bipolar generator (Olympus Europe, Hamburg, Germany) was used. Current's settings used were cut/coag 200/120. Using continuous flow 26Fr resectoscope first resection of the median lobe from the level of the bladder neck to the apex of the prostate was done followed by resection of the lateral lobes. Using Ellic evacuator, Prostatic chips were extracted from the field. A 22 fr three-way silicon Foley catheter was placed with traction applied and the balloon inflated by normal saline of 30-80 cc according to the size of the prostate. | Procedure or surgery | BPH patients treated with B-TURP procedure |
Primary outcome
Measurement of The International Prostate Symptom score (IPSS) in both groups
Time frame: for each case in both groups the investigator assess IPSS at 6, 12, and 24 months after procedures through study completion, an average of 2 years
After 6, 12, and 24 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
Measurement of The Quality of Life (QoL) in both groups
Time frame: for each case in both groups the investigator assess QoLat 6, 12, and 24 months after procedures through study completion, an average of 2 years
After 6, 12, and 24 months of operation, the questioner is performed. Minimum :0 means delighted / Maximum : 5 means unhappy
Measurement of The Maximum Urinary flow rate (Qmax) in both groups
Time frame: for each case in both groups the investigator assess Qmax at 6, 12, and 24 months after procedures through study completion, an average of 2 years
After 6, 12, and 24 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
Concentration of The Prostatic specific antigen (PSA) in both groups
Time frame: for each case in both groups the investigator measures PSA at 6, 12, and 24 months after procedures through study completion, an average of 2 years
After 6, 12, and 24 months of operation, the procedure is performed. PSA is measured by ng/ml PSA levels of 4.0 ng/mL and lower were considered
Measurement of The International Index of Erectile Function (IIEF) in both groups
Time frame: for each case in both groups the investigator assess IIEF at 6, 12, and 24 months after procedures through study completion, an average of 2 years
After 6, 12, and 24 months of operation, the questioner is performed. The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction
Measurement of The Prostate size
Time frame: for each case in both groups the investigator assess prostate size at 24 months after procedures through study completion, an average of 2 years
the prostate size was measured by grams by Trans-rectal ultra sound
The operative time of both groups
Time frame: for each case in both groups the investigator assess the time of operation from induction of anaesthesiatill the end of the operation through study completion, an average of 2 years
the operative time was measured by minutes in both groups.
Post operative hospital stay time in both groups
Time frame: for each case in both groups the investigator assess the hospital time from the day of admission of the patient in hospital to do intervention till discharge from hospital through study completion, an average of 2 years
the Post operative hospital stay time was measured by hours in both groups.
Incidence of The catheter duration post operative in both groups
Time frame: for each case in both groups the investigator assess the catheter duration from the end of the operation till removal through study completion, an average of 2 years
The catheter duration was measured by days in both groups.
Measurement of Post operative residual urine (PVR)
Time frame: for each case in both groups the investigator assess prostate size at 6, 12 and 24 months after procedures through study completion, an average of 2 years
PVR was measured by ml by pelvi abdominal ultra sound in both groups. Normal ranges are below 150 ml of urine.
1 secondary outcome
Incidence of complications
Time frame: through two 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 7 Nov 2023.
- Background: PubMed 27921028Dixon CM, Cedano ER, Pacik D, Vit V, Varga G, Wagrell L, Larson TR, Mynderse LA. Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia. Res Rep Urol. 2016 Nov 21;8:207-216. doi: 10.2147/RRU.S119596. eCollection 2016.
- Background: PubMed 32633020Elshal AM, Soltan M, El-Tabey NA, Laymon M, Nabeeh A. Randomised trial of bipolar resection vs holmium laser enucleation vs Greenlight laser vapo-enucleation of the prostate for treatment of large benign prostate obstruction: 3-years outcomes. BJU Int. 2020 Dec;126(6):731-738. doi: 10.1111/bju.15161. Epub 2020 Sep 30.
- Background: PubMed 31404581Samir M, Tawfick A, Mahmoud MA, Elawady H, Abuelnaga M, Shabayek M, Youssef AEH, Tawfeek AM. Two-year Follow-up in Bipolar Transurethral Enucleation and Resection of the Prostate in Comparison with Bipolar Transurethral Resection of the Prostate in Treatment of Large Prostates. Randomized Controlled Trial. Urology. 2019 Nov;133:192-198. doi: 10.1016/j.urology.2019.07.029. Epub 2019 Aug 9.
- Background: PubMed 30677455McVary KT, Rogers T, Roehrborn CG. Rezum Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study. Urology. 2019 Apr;126:171-179. doi: 10.1016/j.urology.2018.12.041. Epub 2019 Jan 21.
- Background: PubMed 32698710Parsons JK, Dahm P, Kohler TS, Lerner LB, Wilt TJ. Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline Amendment 2020. J Urol. 2020 Oct;204(4):799-804. doi: 10.1097/JU.0000000000001298. Epub 2020 Jul 23.
- Background: PubMed 30332601Nickel JC, Aaron L, Barkin J, Elterman D, Nachabe M, Zorn KC. Canadian Urological Association guideline on male lower urinary tract symptoms/benign prostatic hyperplasia (MLUTS/BPH): 2018 update. Can Urol Assoc J. 2018 Oct;12(10):303-312. doi: 10.5489/cuaj.5616. No abstract available.
- Background: PubMed 32408768Bole R, Gopalakrishna A, Kuang R, Alamiri J, Yang DY, Helo S, Ziegelmann MJ, Kohler TS. Comparative Postoperative Outcomes of Rezum Prostate Ablation in Patients with Large Versus Small Glands. J Endourol. 2020 Jul;34(7):778-781. doi: 10.1089/end.2020.0177. Epub 2020 Jun 12.
- 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 35466513Elterman D, Bhojani N, Vannabouathong C, Chughtai B, Zorn KC. Rezum therapy for >/=80-mL benign prostatic enlargement: a large, multicentre cohort study. BJU Int. 2022 Oct;130(4):522-527. doi: 10.1111/bju.15753. Epub 2022 May 7.
- Derived from this study: PubMed 38291876Samir M, Elaal AAA, Gad KAS, Basyony MW. Two-year follow-up comparing Rezum therapy versus bipolar transurethral resection of the prostate for treating benign prostatic hyperplasia. A prospective randomized study. Int J Urol. 2024 May;31(5):545-550. doi: 10.1111/iju.15410. Epub 2024 Jan 30.
- 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 sa salem, MD study chair
Ain Shams University
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 procedure and B-TURP procedure in people with Prostatic Hyperplasia, run by Ain Shams 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 7 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 7 Nov 2023. 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?
Measurement of The International Prostate Symptom score (IPSS) in both groups (time frame: for each case in both groups the investigator assess IPSS at 6, 12, and 24 months after procedures through study completion, an average of 2 years). The study lists 10 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 NCT06116370, which also lists 10 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 7 Nov 2023.