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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparison between Water Vapor Thermal Therapy and Prostatic Artery Embolization in treatment of Benign Prostatic Hyperplasia'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-14', 'studyFirstSubmitDate': '2025-12-05', 'studyFirstSubmitQcDate': '2026-02-14', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in the International Prostate Symptom Score (IPSS) over a 6-month follow-up period.', 'timeFrame': '6 months follow up for each patient following the procedure', 'description': 'Changes in a International Prostate Symptom Score (IPSS) will be measured to assess the degree of improvement after each procedure. Reduction of the score more than that it was before the procedure means better results and vice versa.\n\n(0-7) means mild symptoms , (8-19) means moderate symptoms and (20-35) means severe symptoms.\n\nThe Unit of measure is a score .'}], 'secondaryOutcomes': [{'measure': '1-Changes in post-voiding residual urine (PVR) assed by pelviabdomenal ultrasound in (mL) 2-Maximum urinary flow rate (Qmax) assessed by Uroflowmetry in (mL/s) 3-The preservation of ejaculatory function assessed by a validated questionnaire (MSHQ-EJD).', 'timeFrame': '6 months follow up for each patient following the procedure', 'description': '1. Post voiding residual urine will be assessed by PelviAbdomenal ultrasonography and the lower post voiding residual urine the more improvement and unit of measure is milliliter (mL).\n2. maximum urinary flow rate will be assessed by uroflowmetry and the higher the maximum flow rate the more improvement and the unit of measure is milliliter(s)/second (mL/s).\n3. Preservation of ejaculatory function will be assessed by asking the patient him self to compare his ejaculatory function pre and post procedure by a validated questionnaire (Male sexual health questionnaire) \\[MSHQ-EjD\\] and the unit of measure for this is a questionnaire.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Comparison between Water Vapor Thermal Therapy and Prostatic Artery Embolization in treatment of Benign Prostatic Hyperplasia', 'Rezum vs Prostatic artery embolization in the treatment of Benign prostatic hyperplasia with lower urinary tract symptoms'], 'conditions': ['Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nA 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).\n\nParticipants will be assigned in a 1:1 ratio to either Rezum group or the prostatic artery embolization group by randomization using closed envelope technique.\n\nAll 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.\n\nDiagnosis 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.\n\nThe 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.\n\nA 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°.\n\nThe procedure is visualized using an integrated cystoscope with a standard 4 mm 30° lens.\n\nSaline irrigation is used to improve visualization and to cool down the urethral surface during the procedure.\n\nInjection 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.\n\nAfter 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.\n\nThe 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.\n\n6F 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.\n\nAn 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.\n\nSelective catheterization of prostatic artery with suitable type of micro catheter and adjusted microwire angle.\n\nInjection of 3ml of contrast through micro catheter to ensure the micro catheter position and no reflux occurs.\n\nEmbolizing material (400-500 micron microspheres) will be injected slowly and cautiously to avoid reflux under fluoroscopy guidance.\n\nIntraoperative data:\n\nOperative time, bleeding and any intraoperative events will be recorded.\n\nPostoperative:\n\nHospitalization time and early post-operative complication will be recorded.\n\nFollow up:\n\nPatients 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.\n\nResults" All intra, post-operative data and follow up results will be analyzed and assessed by the surgeon.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': 'Only males are eligible to participate as the study is directed to assess the improvement of lower urinary tract symptoms due to Benign prostatic hyperplasia which is a male accessory sexual gland.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥50 years.\n* IPSS ≥13.\n* Prostate volume between 30-80 mL.\n* Maximum urinary flow rate (Qmax) ≤15 mL/sec in patients with voiding LUTs.\n* Patients not responding to medical treatment.\n\nExclusion Criteria:\n\n* History or suspicion of prostate cancer.\n* Previous prostate surgery or minimally invasive BPH intervention.\n* Neurological bladder dysfunction.\n* Active urinary tract infection.'}, 'identificationModule': {'nctId': 'NCT07416227', 'briefTitle': 'Comparison Between Water Vapor Thermal Therapy and Prostatic Artery Embolization in Treatment of Benign Prostatic Hyperplasia', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Comparison Between Water Vapor Thermal Therapy and Prostatic Artery Embolization in Treatment of Benign Prostatic Hyperplasia', 'orgStudyIdInfo': {'id': 'FMASU MD295/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A - Water Vapor Thermal Therapy (Rezum) group', 'description': "procedures will be performed with only sedation or under general anathesia according to the patient preference and anathesiologist recommendations in a lithotomy position.\n\nA single-use transurethral delivery device with an 18-gauge retractable needle is used to inject steam into the targeted area.\n\nThe procedure is visualized using an integrated cystoscope with a standard 4 mm 30° lens.\n\nSaline irrigation is used to improve visualization and to cool down the urethral surface during the procedure.\n\nInjection 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.\n\nAfter 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.", 'interventionNames': ['Procedure: Rezum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B - Prostatic Artery Embolization (PAE)', 'description': 'Patients will undergo the procedure under local anathesia. The Patients will lie in supine position and 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.\n\n6F 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.\n\nAn 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.\n\nSelective catheterization of prostatic artery with suitable type of micro catheter and adjusted microwire angle.\n\nEmbolizing material (400-500 micron microspheres) will be injected slowly and cautiously to avoid reflux under fluoroscopy guidance.', 'interventionNames': ['Procedure: Prostatic Artery Embolization']}], 'interventions': [{'name': 'Rezum', 'type': 'PROCEDURE', 'description': "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°.\n\nThe procedure is visualized using an integrated cystoscope with a standard 4 mm 30° lens.\n\nSaline irrigation is used to improve visualization and to cool down the urethral surface during the procedure.\n\nInjection 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.\n\nAfter 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.", 'armGroupLabels': ['Arm A - Water Vapor Thermal Therapy (Rezum) group']}, {'name': 'Prostatic Artery Embolization', 'type': 'PROCEDURE', 'description': '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.\n\n6F 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.\n\nAn 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.\n\nSelective catheterization of prostatic artery with suitable type of micro catheter and adjusted microwire angle.\n\nEmbolizing material (400-500 micron microspheres) will be injected slowly and cautiously to avoid reflux under fluoroscopy guidance.', 'armGroupLabels': ['Arm B - Prostatic Artery Embolization (PAE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00202', 'city': 'Cairo', 'state': 'Abbassia', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Seif AbdElmomen Yosef, MBBCh, MSc Faculty of Medicine', 'role': 'CONTACT', 'email': 'siefabdelmomen@gmail.com', 'phone': '01093390291'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}