Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 11:04 AM
Study NCT ID:
NCT07416227
Status:
RECRUITING
Last Update Posted:
2026-02-18
First Post:
2025-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Water Vapor Thermal Therapy and Prostatic Artery Embolization in Treatment of Benign Prostatic Hyperplasia
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Comparison Between Water Vapor Thermal Therapy and Prostatic Artery Embolization in Treatment of Benign Prostatic Hyperplasia
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to compare the effectiveness of Rezum therapy versus Prostatic Artery Embolization in managing moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), with the primary endpoint being the improvement in the International Prostate Symptom Score (IPSS) over a 6-month follow-up period. Secondary endpoints include changes in post-void residual urine (PVR), maximum urinary flow rate (Qmax), patient-reported quality of life (QoL), and the preservation of ejaculatory and overall sexual function as assessed by validated questionnaires. This study aims to provide evidence-based guidance for optimizing treatment strategies for men with BPH, particularly those seeking alternatives to pharmacological therapy.
Detailed Description:
The aim of this study is to compare the effectiveness of Rezum therapy versus Prostatic Artery Embolization in managing moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), with the primary endpoint being the improvement in the International Prostate Symptom Score (IPSS) over a 6-month follow-up period. Secondary endpoints include changes in post-void residual urine (PVR), maximum urinary flow rate (Qmax), patient-reported quality of life (QoL), and the preservation of ejaculatory and overall sexual function as assessed by validated questionnaires. This study aims to provide evidence-based guidance for optimizing treatment strategies for men with BPH, particularly those seeking alternatives to pharmacological therapy.
A RCT will be conducted, including a minimum of 30 patients (15/group), will be enrolled over a two-year period with the final sample size depending on the number of eligible patients available during the study period, to compare the effectiveness of Rezum therapy versus Prostatic Artery Embolization in managing moderate-to-severe lower urinary tract symptoms due to benign prostatic hyperplasia (BPH).
Participants will be assigned in a 1:1 ratio to either Rezum group or the prostatic artery embolization group by randomization using closed envelope technique.
All patients will be subjected to full history taking and physical examination. Radiology investigation will include pelvi-abdominal ultrasonography. Laboratory investigation will include urine analysis, urine culture and sensitivity if indicated, Serum Prostatic specific antigen (serum PSA). Routine preoperative laboratories included serum creatinine, serum urea, CBC, liver function tests and coagulation profile in both groups. The total amount of withdrawn blood for these routine laboratory investigations will be about 10-15 ml of venous blood from each patient.
Diagnosis of BPH patients who are eligible for the study will be confirmed by physical examination (including enlarged prostate with smooth surface, firm consistency with no suspicious nodules, preserved median sulcus and good anal tone) , PAUS with prostate size over 30 gram with no suspicious lesions , serum PSA below 4 ng/mL or suspicious psa but confirmed to be benign by Multiparametric MRI prostate protocol and/or transrectal ultrasound guided prostate biopsy.
The patients will be allocated into two equal groups by randomization. Group A (Rezum group), group B (prostatic artery embolization group). As regard Rezum group all procedures will be performed with only sedation or under general anathesia according to the patient preference and anathesiologist recommendations in a lithotomy position.
A single-use transurethral delivery device with an 18-gauge retractable needle is used to inject steam into the targeted area with a fixed depth of 10.25 mm via 12 emitter holes spaced at the needle tip with an angle of 120°.
The procedure is visualized using an integrated cystoscope with a standard 4 mm 30° lens.
Saline irrigation is used to improve visualization and to cool down the urethral surface during the procedure.
Injection starts 1 cm distal to the bladder neck at 3 and 9 o'clock positions. Each injection deploys 0.5 ml of steam over 9 s at 103 °C raising the tissue temperature to 70 °C and it is recommended to wait for a couple of seconds postinjection to avoid loss of vapor through the puncture site.
After each injection, the needle is retracted and reinserted 1 cm distal to the previous injection until the proximal edge of the verumontanum creating tissue ablation along the prostatic urethra. \[5\] As regard Prostatic artery embolization group patients will undergo the procedure under local anathesia.
The Patients will lie in supine position wearing the hospital gown. Sterilization of the groin will be done then puncture of the right femoral and/or left femoral artery will be done using puncture set after local anathesia.
6F vascular sheath, then a 5F cobra head catheter will be introduced in right and/or left femoral artery to catheterize one of the internal iliac artery then catheterizing its anterior division.
An ipsilateral oblique view (30-40 degrees) and/or cranio-caudal view (10 degrees) will be obtained for differentiation of prostatic artery from other branches of anterior division \& for identification of prostatic artery origin.
Selective catheterization of prostatic artery with suitable type of micro catheter and adjusted microwire angle.
Injection of 3ml of contrast through micro catheter to ensure the micro catheter position and no reflux occurs.
Embolizing material (400-500 micron microspheres) will be injected slowly and cautiously to avoid reflux under fluoroscopy guidance.
Intraoperative data:
Operative time, bleeding and any intraoperative events will be recorded.
Postoperative:
Hospitalization time and early post-operative complication will be recorded.
Follow up:
Patients will be followed at 1, 3, 6 months post-initiation of treatment. Assessments at each visit will include IPSS and QoL questionnaire, uroflowmetry and pelvic ultrasound to assess the prostate volume and post voiding residual urine.
Results" All intra, post-operative data and follow up results will be analyzed and assessed by the surgeon.
A RCT will be conducted, including a minimum of 30 patients (15/group), will be enrolled over a two-year period with the final sample size depending on the number of eligible patients available during the study period, to compare the effectiveness of Rezum therapy versus Prostatic Artery Embolization in managing moderate-to-severe lower urinary tract symptoms due to benign prostatic hyperplasia (BPH).
Participants will be assigned in a 1:1 ratio to either Rezum group or the prostatic artery embolization group by randomization using closed envelope technique.
All patients will be subjected to full history taking and physical examination. Radiology investigation will include pelvi-abdominal ultrasonography. Laboratory investigation will include urine analysis, urine culture and sensitivity if indicated, Serum Prostatic specific antigen (serum PSA). Routine preoperative laboratories included serum creatinine, serum urea, CBC, liver function tests and coagulation profile in both groups. The total amount of withdrawn blood for these routine laboratory investigations will be about 10-15 ml of venous blood from each patient.
Diagnosis of BPH patients who are eligible for the study will be confirmed by physical examination (including enlarged prostate with smooth surface, firm consistency with no suspicious nodules, preserved median sulcus and good anal tone) , PAUS with prostate size over 30 gram with no suspicious lesions , serum PSA below 4 ng/mL or suspicious psa but confirmed to be benign by Multiparametric MRI prostate protocol and/or transrectal ultrasound guided prostate biopsy.
The patients will be allocated into two equal groups by randomization. Group A (Rezum group), group B (prostatic artery embolization group). As regard Rezum group all procedures will be performed with only sedation or under general anathesia according to the patient preference and anathesiologist recommendations in a lithotomy position.
A single-use transurethral delivery device with an 18-gauge retractable needle is used to inject steam into the targeted area with a fixed depth of 10.25 mm via 12 emitter holes spaced at the needle tip with an angle of 120°.
The procedure is visualized using an integrated cystoscope with a standard 4 mm 30° lens.
Saline irrigation is used to improve visualization and to cool down the urethral surface during the procedure.
Injection starts 1 cm distal to the bladder neck at 3 and 9 o'clock positions. Each injection deploys 0.5 ml of steam over 9 s at 103 °C raising the tissue temperature to 70 °C and it is recommended to wait for a couple of seconds postinjection to avoid loss of vapor through the puncture site.
After each injection, the needle is retracted and reinserted 1 cm distal to the previous injection until the proximal edge of the verumontanum creating tissue ablation along the prostatic urethra. \[5\] As regard Prostatic artery embolization group patients will undergo the procedure under local anathesia.
The Patients will lie in supine position wearing the hospital gown. Sterilization of the groin will be done then puncture of the right femoral and/or left femoral artery will be done using puncture set after local anathesia.
6F vascular sheath, then a 5F cobra head catheter will be introduced in right and/or left femoral artery to catheterize one of the internal iliac artery then catheterizing its anterior division.
An ipsilateral oblique view (30-40 degrees) and/or cranio-caudal view (10 degrees) will be obtained for differentiation of prostatic artery from other branches of anterior division \& for identification of prostatic artery origin.
Selective catheterization of prostatic artery with suitable type of micro catheter and adjusted microwire angle.
Injection of 3ml of contrast through micro catheter to ensure the micro catheter position and no reflux occurs.
Embolizing material (400-500 micron microspheres) will be injected slowly and cautiously to avoid reflux under fluoroscopy guidance.
Intraoperative data:
Operative time, bleeding and any intraoperative events will be recorded.
Postoperative:
Hospitalization time and early post-operative complication will be recorded.
Follow up:
Patients will be followed at 1, 3, 6 months post-initiation of treatment. Assessments at each visit will include IPSS and QoL questionnaire, uroflowmetry and pelvic ultrasound to assess the prostate volume and post voiding residual urine.
Results" All intra, post-operative data and follow up results will be analyzed and assessed by the surgeon.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: