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Randomized controlled trial with one-year follow-up comparing intra, peri and postoperative outcomes for plasmakinetic transurethral resection of prostate (PK-TURP) and monopolar transurethral resection of prostate (M-TURP) in the treatment of LUTS due to BPH in a tertiary-care public institution
The study is a randomized controlled trial with one-year follow-up comparing intra, peri and postoperative outcomes (efficacy, complications and sequelae) for plasmakinetic transurethral resection of prostate (PK-TURP) and monopolar transurethral resection of prostate (M-TURP) in the treatment of LUTS due to BPH in a tertiary-care public institution (Madrid, Spain)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M-TURP | Active Comparator | The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator |
|
| PK-TURP | Experimental | The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transurethral Resection of the Prostate (TURP) | Device | Randomized allocation to M-TURP or PK-TURP |
|
| Measure | Description | Time Frame |
|---|---|---|
| International Prostate Symptom Score (IPSS) | International Prostate Symptom Score (with 7 questions) at 1, 3, 6, and 12 months after surgery. Results: the sum of the 7 items will range between 0 to 35 points Interpretation: allows categorizing the lower urinary tract symptoms (LUTS) in 3 categories
| 12 months |
| Maximum Urinary Flow Rate (Qmax | Maximum urinary flow rate (mL/s) at 1, 3, 6, and 12 months after surgery. | 12 months |
| Postvoid Residual Urine (PVRU) Volume | Postvoid residual urine volume (mL) was measured by abdominal ultrasound after urination at 1, 3, 6, and 12 months after surgery. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire | We use the bother score item of the IPSS questionnaire (question 8) at 1, 3, 6, and 12 months after surgery to assess the quality of life (QoL) due to lower urinary tract symptoms (LUTS) Results: will range between 0 to 6 points Interpretation: allows categorizing the QoL in 3 categories
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Álvarez Ardura, M.D. | Hospital Universitario de Fuenlabrada | Principal Investigator |
| Hugo Otaola Arca, M.D., Ph.D. | Hospital Universitario de Fuenlabrada | Principal Investigator |
| Álvaro Páez Borda, M.D., Ph.D. | Hospital Universitario de Fuenlabrada | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Fuenlabrada | Fuenlabrada | Madrid | 28942 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20825758 | Background | Ahyai SA, Gilling P, Kaplan SA, Kuntz RM, Madersbacher S, Montorsi F, Speakman MJ, Stief CG. Meta-analysis of functional outcomes and complications following transurethral procedures for lower urinary tract symptoms resulting from benign prostatic enlargement. Eur Urol. 2010 Sep;58(3):384-97. doi: 10.1016/j.eururo.2010.06.005. Epub 2010 Jun 11. | |
| 24972732 |
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| ID | Title | Description |
|---|---|---|
| FG000 | M-TURP | The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP |
| FG001 | PK-TURP | The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | M-TURP | The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | International Prostate Symptom Score (IPSS) | International Prostate Symptom Score (with 7 questions) at 1, 3, 6, and 12 months after surgery. Results: the sum of the 7 items will range between 0 to 35 points Interpretation: allows categorizing the lower urinary tract symptoms (LUTS) in 3 categories
| Posted | Mean | Standard Deviation | points | 12 months |
|
1 year
Clavien-Dindo classification
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | M-TURP | The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Need for reintervention | Renal and urinary disorders | Systematic Assessment | Need for surgery because of residual adenoma, urethral stenosis or bladder neck contracture |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stenotic events without the need for surgery | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hugo Otaola Arca | Hospital Universitario Fuenlabrada | +56 9 4108 9452 | hugotaolarca@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2019 | Jul 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D020728 | Transurethral Resection of Prostate |
| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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| 12 months |
| Number of Participants Reporting Sexual Activity in the Last Month | Measure Description: All patients were asked, Did you have sexual activity in the last month? Possible answers were yes or no. Possible answers: yes or no. Measurement moment: at 1, 3, 6 and 12 months after surgery. | 12 months |
| International Index of Erectile Function (IIEF-5) | International Index of Erectile Function (with 5 questions) at 1, 3, 6, and 12 months after surgery. Results: the sum of the 5 items will range between 1 to 25 points Interpretation: allows categorizing the erectile function of patients
| 12 months |
| Prostate Volume (PV) | Prostate volume was measured by transrectal ultrasound at 12 months after surgery | 12 months |
| Operative Time | Operative time (min) | Up to 24 hours |
| Irrigation Volume | Irrigation volume (L) | Up to 24 hours |
| Change in Plasmatic Sodium in 24 Hours Post-operation | Compared with the baseline, to demonstrate the sodium loss during operation | 24 hours after surgery |
| Change in Haemoglobin in 24 Hours Post-operation | Compared with the baseline, to demonstrate the blood loss during operation | 24 hours after surgery |
| Transfusion Rate | Number of participants requiring blood transfusion during, expressed in % | 1 month |
| Catheter Duration | Catheter duration (days) | 1 month |
| Hospital Stay | Hospital stay (days) | 1 month |
| Resected Tissue Weigh | Resected tissue weigh (grams) | Up to 24 hours |
| Resected Tissue Percentage | Compared with the baseline, to demonstrate the % of tissue loss during operation | Up to 24 hours |
| Speed Resection | Speed resection (g/min) | Up to 24 hours |
| Early Reoperation Rate | The ratio of patient who need reoperation because bleeding complications | 1 month |
| Late Reoperation Rate | The ratio of patient who need reoperation because residual adenoma or complications | 12 months |
| Post-TURP Syndrome Rate | Post-transurethral resection of the prostate syndrome rate was recorded. | Up to 24 hours |
| Clavien Dindo System | It is a system for evaluating surgical complications at 12 months after surgery. Clavien I
Clavien II
Clavien III - Requiring surgical, endoscopic or radiological intervention Clavien IV - Life-threatening complication (including central nervous system complications) requiring intensive care unit management Clavien V - Death of a patient | 12 months |
| Bleeding Complications Rate | Register the number of events of haematuria and acute urinary retention by clots | 1 month |
| Urinary Tract Infections Rate | Register the number of urinary tract infections at 1, 3, 6, and 12 months after surgery. | 12 months |
| Stenotic Complications Rate: Meatal Stenosis | Register the number of meatal stenosis at 1, 3, 6, and 12 after surgery. | 12 months |
| Stenotic Complications Rate: Urethral Stricture | Register the number of urethral stricture at 1, 3, 6, and 12 after surgery. | 12 months |
| Stenotic Complications Rate: Bladder Neck Contracture | Register the number of bladder neck contracture at 1, 3, 6, and 12 after surgery. | 12 months |
| Stress Urinary Incontinence Rate | Register the number of patients with stress urinary incontinence at 1, 3, 6, and 12 after surgery. | 12 months |
| Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate | Register the number of patients with urge urinary incontinence with need for drug use at 1, 3, 6, and 12 after surgery. | 12 months |
| Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate | Register the number of patients with urge urinary incontinence without need for drug use at 1, 3, 6, and 12 after surgery. | 12 months |
| Sequelae Rate: Retrograde Ejaculation | register the number of retrograde ejaculation at 1, 3, 6, and 12 after surgery. | 12 months |
| Sequelae Rate: Dysuria | register the number of dysuria at 1, 3, 6, and 12 after surgery. | 12 months |
| Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25. |
| 33047918 | Result | Otaola-Arca H, Alvarez-Ardura M, Molina-Escudero R, Fernandez MI, Paez-Borda A. A prospective randomized study comparing bipolar plasmakinetic transurethral resection of the prostate and monopolar transurethral resection of the prostate for the treatment of Benign Prostatic Hyperplasia: efficacy, sexual function, Quality of Life, and complications. Int Braz J Urol. 2021 Jan-Feb;47(1):131-144. doi: 10.1590/S1677-5538.IBJU.2019.0766. |
| BG001 | PK-TURP | The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Smoker | Count of Participants | Participants |
|
| ASA classification | Count of Participants | Participants |
|
| Serum PSA | Mean | Standard Deviation | ng/mL |
|
| Creatinine | Mean | Standard Deviation | mg/dL |
|
| Serum sodium | Mean | Standard Deviation | mEq/L |
|
| Hemoglobin | Mean | Standard Deviation | g/dL |
|
| IPSS | IPSS = International Prostate Symptom Score Interpretation:
| Mean | Standard Deviation | units on a scale |
|
| QoL score | QoL = Quality of Life Interpretation:
| Mean | Standard Deviation | units on a scale |
|
| Number of Participants Reporting Sexual Activity in the Last Month | All patients were asked, Did you have sexual activity in the last month? Possible answers: yes/no | Count of Participants | Participants |
|
| IIEF score | IIEF = International Index of Erectile Function Interpretation:
| Mean | Standard Deviation | units on a scale |
|
| Qmax | Maximum urinary flow rate (mL/s) in free uroflowmetry | Mean | Standard Deviation | mL/s |
|
| PVRU volume | PVRU = postvoid residual urine Postvoid residual urine in the bladder after urination, measured with transvesical ultrasound | Mean | Standard Deviation | mL |
|
| PV by TRUS | Mean | Standard Deviation | mL |
|
| Stress urinary incontinence | Count of Participants | Participants |
|
| Urge urinary incontinence with need for drug use (UUIND) | Count of Participants | Participants |
|
| urge Urinary incontinence without the need for drug use (UUIWND) | Count of Participants | Participants |
|
| Retrograde ejaculation | Count of Participants | Participants |
|
| Dysuria | Count of Participants | Participants |
|
| Drugs for hemostasis | Count of Participants | Participants |
|
| Drugs for LUTS | Count of Participants | Participants |
|
| Indication of surgery | Count of Participants | Participants |
|
| OG001 | PK-TURP | The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP |
|
|
| Primary | Maximum Urinary Flow Rate (Qmax | Maximum urinary flow rate (mL/s) at 1, 3, 6, and 12 months after surgery. | Posted | Mean | Standard Deviation | mL/s | 12 months |
|
|
|
| Primary | Postvoid Residual Urine (PVRU) Volume | Postvoid residual urine volume (mL) was measured by abdominal ultrasound after urination at 1, 3, 6, and 12 months after surgery. | Posted | Mean | Standard Deviation | mL | 12 months |
|
|
|
| Secondary | Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire | We use the bother score item of the IPSS questionnaire (question 8) at 1, 3, 6, and 12 months after surgery to assess the quality of life (QoL) due to lower urinary tract symptoms (LUTS) Results: will range between 0 to 6 points Interpretation: allows categorizing the QoL in 3 categories
| Posted | Mean | Standard Deviation | points | 12 months |
|
|
|
| Secondary | Number of Participants Reporting Sexual Activity in the Last Month | Measure Description: All patients were asked, Did you have sexual activity in the last month? Possible answers were yes or no. Possible answers: yes or no. Measurement moment: at 1, 3, 6 and 12 months after surgery. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | International Index of Erectile Function (IIEF-5) | International Index of Erectile Function (with 5 questions) at 1, 3, 6, and 12 months after surgery. Results: the sum of the 5 items will range between 1 to 25 points Interpretation: allows categorizing the erectile function of patients
| Posted | Mean | Standard Deviation | points | 12 months |
|
|
|
| Secondary | Prostate Volume (PV) | Prostate volume was measured by transrectal ultrasound at 12 months after surgery | Posted | Mean | Standard Deviation | mL | 12 months |
|
|
|
| Secondary | Operative Time | Operative time (min) | Posted | Mean | Standard Deviation | minutes | Up to 24 hours |
|
|
|
| Secondary | Irrigation Volume | Irrigation volume (L) | Posted | Mean | Standard Deviation | L | Up to 24 hours |
|
|
|
| Secondary | Change in Plasmatic Sodium in 24 Hours Post-operation | Compared with the baseline, to demonstrate the sodium loss during operation | Posted | Mean | Standard Deviation | mEq/L | 24 hours after surgery |
|
|
|
| Secondary | Change in Haemoglobin in 24 Hours Post-operation | Compared with the baseline, to demonstrate the blood loss during operation | Posted | Mean | Standard Deviation | mg/dL | 24 hours after surgery |
|
|
|
| Secondary | Transfusion Rate | Number of participants requiring blood transfusion during, expressed in % | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Catheter Duration | Catheter duration (days) | Posted | Mean | Standard Deviation | days | 1 month |
|
|
|
| Secondary | Hospital Stay | Hospital stay (days) | Posted | Mean | Standard Deviation | days | 1 month |
|
|
|
| Secondary | Resected Tissue Weigh | Resected tissue weigh (grams) | Posted | Mean | Standard Deviation | grams | Up to 24 hours |
|
|
|
| Secondary | Resected Tissue Percentage | Compared with the baseline, to demonstrate the % of tissue loss during operation | Posted | Mean | Standard Deviation | % of resected tissue | Up to 24 hours |
|
|
|
| Secondary | Speed Resection | Speed resection (g/min) | Posted | Mean | Standard Deviation | g/min | Up to 24 hours |
|
|
|
| Secondary | Early Reoperation Rate | The ratio of patient who need reoperation because bleeding complications | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Late Reoperation Rate | The ratio of patient who need reoperation because residual adenoma or complications | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Post-TURP Syndrome Rate | Post-transurethral resection of the prostate syndrome rate was recorded. | Posted | Count of Participants | Participants | Up to 24 hours |
|
|
|
| Secondary | Clavien Dindo System | It is a system for evaluating surgical complications at 12 months after surgery. Clavien I
Clavien II
Clavien III - Requiring surgical, endoscopic or radiological intervention Clavien IV - Life-threatening complication (including central nervous system complications) requiring intensive care unit management Clavien V - Death of a patient | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Bleeding Complications Rate | Register the number of events of haematuria and acute urinary retention by clots | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Urinary Tract Infections Rate | Register the number of urinary tract infections at 1, 3, 6, and 12 months after surgery. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Stenotic Complications Rate: Meatal Stenosis | Register the number of meatal stenosis at 1, 3, 6, and 12 after surgery. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Stenotic Complications Rate: Urethral Stricture | Register the number of urethral stricture at 1, 3, 6, and 12 after surgery. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Stenotic Complications Rate: Bladder Neck Contracture | Register the number of bladder neck contracture at 1, 3, 6, and 12 after surgery. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Stress Urinary Incontinence Rate | Register the number of patients with stress urinary incontinence at 1, 3, 6, and 12 after surgery. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate | Register the number of patients with urge urinary incontinence with need for drug use at 1, 3, 6, and 12 after surgery. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate | Register the number of patients with urge urinary incontinence without need for drug use at 1, 3, 6, and 12 after surgery. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Sequelae Rate: Retrograde Ejaculation | register the number of retrograde ejaculation at 1, 3, 6, and 12 after surgery. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Sequelae Rate: Dysuria | register the number of dysuria at 1, 3, 6, and 12 after surgery. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 45 |
| 2 |
| 45 |
| 4 |
| 45 |
| EG001 | PK-TURP | The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP | 0 | 39 | 1 | 39 | 4 | 39 |
|
Not provided
Not provided
Not provided
| D052801 |
| Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 | Surgical Procedures, Operative |
| ASA III |
|
| Anticoagulants |
|
| Voiding symptoms |
|
| Vesical calculi |
|
| 6 months |
|
| 12 months |
|
| 6 months |
|
| 12 months |
|
| 6 months |
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| 12 months |
|
| 6 months |
|
| 12 months |
|
| 6 months |
|
| 12 months |
|
| Clavien III |
|
| Clavien IV |
|
| Clavien V |
|
| 6 months |
|
| 12 months |
|
| 6 months |
|
| 12 months |
|
| 6 months |
|
| 12 months |
|
| 6 months |
|
| 12 months |
|
| 6 months |
|
| 12 months |
|
| 6 months |
|
| 12 months |
|
| 6 months |
|
| 12 months |
|
| 6 months |
|
| 12 months |
|
| 6 months |
|
| 12 months |
|