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This study was created to determine the safety and efficacy of treating prostatic hyperplasia with or without prominent median lobe enlargement with the REZUM technique. The systematic implementation of decisions for the location, vapor time, and the number of injections contributes to the Rezum procedure configuration for the median lobe treatment being safer and standardizer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A, 5 seconds | Experimental | Patients with benign prostatic hyperplasia featuring a small median lobe enlargement will be allocated to the 5-second Rezum therapy group. |
|
| Group B, 9 seconds | Experimental | Patients with benign prostatic hyperplasia featuring a big prominent median lobe enlargement will be allocated to the 9-second Rezum therapy group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rezum® | Device | Rezum® Water vaporization device |
|
| Measure | Description | Time Frame |
|---|---|---|
| age | patient's records | prior to procedure |
| Gender | patient's records | prior to procedure |
| height | meters | prior to procedure |
| weight | kilograms | prior to procedure |
| Medical history | patient's records | prior to procedure |
| Surgical history | patient's records | prior to procedure |
| Date of consent | patient's records | prior to procedure |
| Eastern Cooperative Oncology Group | 0 Fully active, able to carry on all pre-disease performance without restriction
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 110-744 | South Korea |
The datasets used during the current study are available from the corresponding author on request.
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| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| prior to procedure |
| complications | patient's records | prior to procedure |
| medications used at the time of pre-consent | patient's records | prior to procedure |
| drug allergies | patient's records | prior to procedure |
| prostate specific antigen | patient's records, ng/ml | prior to procedure, 3 month after surgery |
| Protein | Urinalysis, mg/dl | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| pH | Urinalysis | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| occult blood | Urinalysis, Negative or positive | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| white blood cell : Urinalysis | Urinalysis, Quantity | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| glucose | Urinalysis, mg/dl | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| red blood cell | Urinalysis, Quantity | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| Bacteria | Urinalysis, Quantity | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| Sodium | Blood tests, mEq/L | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| Chloride | Blood tests, mEq/L | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| calcium | Blood tests, mg/dL | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| Phosphorus | Blood tests, mg/dL | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| uric acid | Blood tests, mg/dl | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| blood urea nitrogen | Blood tests, mg/dl | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| creatinine | Blood tests, mg/dL | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| C-reactive protein | Blood tests, mg/dl | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| White blood cell : Blood tests | Blood tests, quantity | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| Hemoglobin | Blood tests, g/dl | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| Platelet | Blood tests, 10^3/μL | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| Prostate specific antigen | Blood tests, ng/ml | prior to procedure, 1-2 weeks after injection, 3 month after surgery |
| Prostate Ultrasound | patient's records | prior to procedure, 3 month after surgery |
| Uroflowmetry | patient's records, ml/sec | prior to procedure, 3 month after surgery |
| International Prostate Symptom Score | 0 to 7 points: Mild symptoms 8 to 19 points: Moderate symptoms 20 to 35 points: Severe symptoms | prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery |
| Incontinence Severity Index | Slight (1-2) Moderate (3-6) Severe (8-9) Very severe (12) | prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery |
| Overactive Bladder Symptom Score | 1. How many times do you typically urinate from waking in the morning until sleeping at night? 7 or less 8 to 14 15 or more 2. How many times do you typically wake up to urinate from sleeping at night until waking in the morning? 0 1 2 3 or more 3. How often do you have a sudden desire to urinate, which is difficult to defer? Not at All less than once a week once a week or more about once a day 2 to 4 times per day 5 times a day or more 4. How often do you leak urine, because you cannot defer the sudden desire to urinate? Not at All less than once a week once a week or more about once a day 2 to 4 times per day 5 times a day or more | prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery |
| Male Sexual Health for assessing ejaculatory dysfunction |
| prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery |
| International Index of Erectile Function | The IIEF-5 Questionnaire (SHIM)Score for Erectile Dysfunction1-7: Severe8-11: Moderate12-16: Mild-moderate17-21: Mild22-25: No Erectile Dysfunction Survey. | prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery |
| McGill Pain Questionnaire | The interpretation of the questionnaire is pretty basic: the higher the score, the higher the pain level. The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. | prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery |
| Brief Pain Inventory | Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain. | prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery |
| Treatment Satisfaction-Visual Analogue Scale | 0. No, not at all satisfied. 10. Yes, completely satisfied. | 1-2 weeks after injection, 3 month after surgery |
| Patient Global Impression of Improvement | Very much better 1 Much better 2 A little better 3 No change 4 A little worse 5 Much worse 6 Very much worse 7 | 1-2 weeks after injection, 3 month after surgery |
| transrectal sonography of the prostate | Ultrasound examination | prior to procedure, 3 month after surgery |
| transrectal ultrasound | Ultrasound examination | prior to procedure |
| Postvoiding Residual | uroflowmetry | prior to procedure, 3 month after surgery |
| Post-surgery complications | patient's records | 1-2 weeks after injection, 3 month after surgery |