Lower Urinary Tract Symptoms, Prostatic Hyperplasia, Transurethral Resection of Prostate
Conditions
Brief summary
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
Detailed description
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)
Interventions
Randomized allocation to M-TURP or PK-TURP
Sponsors
Hospital Universitario de Fuenlabrada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Sign the informed consent voluntarily and will be willing to follow-up * Prostate volume \<80 g * Meet any conditions (1) Diagnose of LUTS due to refractory to drugs BPH. (2) presenting complications derived from BPH (bladder calculi, recurrent haematuria, recurrent urinary tract infections, acute urinary retention) * The use of antiplatelet agents or anticoagulant drugs is allowed.
Exclusion criteria
* Previous history of pelvic surgery * Previous history of pelvic radiotherapy * Previous history of neurogenic bladder dysfunction * Documented or suspected prostate carcinoma * Patients with severe cardiopulmonary disease or severe mental disorders * Poor compliance, and can not be followed up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score (IPSS) | 12 months | 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 * Mild LUTS: 0-7 points * Moderate LUTS: 8-19 points * Severe LUTS: 20-35 points |
| Maximum Urinary Flow Rate (Qmax | 12 months | Maximum urinary flow rate (mL/s) at 1, 3, 6, and 12 months after surgery. |
| Postvoid Residual Urine (PVRU) Volume | 12 months | Postvoid residual urine volume (mL) was measured by abdominal ultrasound after urination at 1, 3, 6, and 12 months after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transfusion Rate | 1 month | Number of participants requiring blood transfusion during, expressed in % |
| Catheter Duration | 1 month | Catheter duration (days) |
| Hospital Stay | 1 month | Hospital stay (days) |
| Resected Tissue Weigh | Up to 24 hours | Resected tissue weigh (grams) |
| Resected Tissue Percentage | Up to 24 hours | Compared with the baseline, to demonstrate the % of tissue loss during operation |
| Speed Resection | Up to 24 hours | Speed resection (g/min) |
| Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire | 12 months | 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 * Good QoL: 0-2 points * Intermediate QoL: 3 points * Poor QoL: 4-6points |
| Number of Participants Reporting Sexual Activity in the Last Month | 12 months | 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. |
| International Index of Erectile Function (IIEF-5) | 12 months | 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 * Without erectile dysfunction: 22-25 points * Mild erectile dysfunction: 17-21 points * Mild to moderate erectile dysfunction: 12-16 points * Moderate erectile dysfunction: 8-11 points * Severe erectile dysfunction: 1-7 points |
| Prostate Volume (PV) | 12 months | Prostate volume was measured by transrectal ultrasound at 12 months after surgery |
| Operative Time | Up to 24 hours | Operative time (min) |
| Irrigation Volume | Up to 24 hours | Irrigation volume (L) |
| Early Reoperation Rate | 1 month | The ratio of patient who need reoperation because bleeding complications |
| Post-TURP Syndrome Rate | Up to 24 hours | Post-transurethral resection of the prostate syndrome rate was recorded. |
| Clavien Dindo System | 12 months | It is a system for evaluating surgical complications at 12 months after surgery. Clavien I * Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. * Acceptable therapeutic regimens are drugs as antiemetics, antipyretics, analgesics, diuretics and electrolytes, and physiotherapy. Clavien II * Requiring pharmacological treatment with drugs other than such allowed for grade I complications. * Blood transfusions and total parenteral nutrition are also included 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 |
| Bleeding Complications Rate | 1 month | Register the number of events of haematuria and acute urinary retention by clots |
| Urinary Tract Infections Rate | 12 months | Register the number of urinary tract infections at 1, 3, 6, and 12 months after surgery. |
| Stenotic Complications Rate: Meatal Stenosis | 12 months | Register the number of meatal stenosis at 1, 3, 6, and 12 after surgery. |
| Stenotic Complications Rate: Urethral Stricture | 12 months | Register the number of urethral stricture at 1, 3, 6, and 12 after surgery. |
| Stenotic Complications Rate: Bladder Neck Contracture | 12 months | Register the number of bladder neck contracture at 1, 3, 6, and 12 after surgery. |
| Stress Urinary Incontinence Rate | 12 months | Register the number of patients with stress urinary incontinence at 1, 3, 6, and 12 after surgery. |
| Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate | 12 months | Register the number of patients with urge urinary incontinence with need for drug use at 1, 3, 6, and 12 after surgery. |
| Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate | 12 months | Register the number of patients with urge urinary incontinence without need for drug use at 1, 3, 6, and 12 after surgery. |
| Sequelae Rate: Retrograde Ejaculation | 12 months | register the number of retrograde ejaculation at 1, 3, 6, and 12 after surgery. |
| Sequelae Rate: Dysuria | 12 months | register the number of dysuria at 1, 3, 6, and 12 after surgery. |
| Late Reoperation Rate | 12 months | The ratio of patient who need reoperation because residual adenoma or complications |
| Change in Plasmatic Sodium in 24 Hours Post-operation | 24 hours after surgery | Compared with the baseline, to demonstrate the sodium loss during operation |
| Change in Haemoglobin in 24 Hours Post-operation | 24 hours after surgery | Compared with the baseline, to demonstrate the blood loss during operation |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 45 |
| 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 | 39 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 1 |
| Overall Study | Physician Decision | 7 | 3 |
Baseline characteristics
| Characteristic | M-TURP | PK-TURP | Total |
|---|---|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 7.2 | 66.2 years STANDARD_DEVIATION 7.1 | 65.5 years STANDARD_DEVIATION 7.2 |
| ASA classification ASA I | 1 Participants | 1 Participants | 2 Participants |
| ASA classification ASA II | 38 Participants | 33 Participants | 71 Participants |
| ASA classification ASA III | 6 Participants | 5 Participants | 11 Participants |
| Body mass index (BMI) | 27.9 kg/m^2 STANDARD_DEVIATION 4.2 | 26.8 kg/m^2 STANDARD_DEVIATION 4.2 | 27.4 kg/m^2 STANDARD_DEVIATION 4.2 |
| Creatinine | 0.9 mg/dL STANDARD_DEVIATION 0.3 | 0.9 mg/dL STANDARD_DEVIATION 0.1 | 0.9 mg/dL STANDARD_DEVIATION 0.3 |
| Diabetes mellitus | 7 Participants | 6 Participants | 13 Participants |
| Drugs for hemostasis Antiaggregants | 12 Participants | 5 Participants | 17 Participants |
| Drugs for hemostasis Anticoagulants | 2 Participants | 4 Participants | 6 Participants |
| Drugs for hemostasis None | 31 Participants | 30 Participants | 61 Participants |
| Drugs for LUTS None | 1 Participants | 1 Participants | 2 Participants |
| Drugs for LUTS Storage symptoms | 1 Participants | 2 Participants | 3 Participants |
| Drugs for LUTS Voiding symptoms | 43 Participants | 36 Participants | 79 Participants |
| Dysuria | 5 Participants | 6 Participants | 11 Participants |
| Hemoglobin | 14.7 g/dL STANDARD_DEVIATION 1.3 | 15.1 g/dL STANDARD_DEVIATION 1.1 | 14.9 g/dL STANDARD_DEVIATION 1.2 |
| Hypertension | 27 Participants | 18 Participants | 45 Participants |
| IIEF score | 11.7 units on a scale STANDARD_DEVIATION 7.1 | 10.5 units on a scale STANDARD_DEVIATION 7.9 | 11.2 units on a scale STANDARD_DEVIATION 7.5 |
| Indication of surgery Acute urinary retention (AUR) | 9 Participants | 10 Participants | 19 Participants |
| Indication of surgery Drug failure | 35 Participants | 28 Participants | 63 Participants |
| Indication of surgery Vesical calculi | 1 Participants | 1 Participants | 2 Participants |
| IPSS | 24.7 units on a scale STANDARD_DEVIATION 6.1 | 23.8 units on a scale STANDARD_DEVIATION 4.8 | 24.3 units on a scale STANDARD_DEVIATION 6.1 |
| Number of Participants Reporting Sexual Activity in the Last Month | 37 Participants | 28 Participants | 65 Participants |
| PV by TRUS | 38.3 mL STANDARD_DEVIATION 17.4 | 41.4 mL STANDARD_DEVIATION 17.1 | 39.7 mL STANDARD_DEVIATION 17.2 |
| PVRU volume | 60.6 mL STANDARD_DEVIATION 83.4 | 93.1 mL STANDARD_DEVIATION 91.1 | 75.9 mL STANDARD_DEVIATION 88 |
| Qmax | 10.9 mL/s STANDARD_DEVIATION 5.5 | 9.3 mL/s STANDARD_DEVIATION 4 | 10.1 mL/s STANDARD_DEVIATION 4.9 |
| QoL score | 5.2 units on a scale STANDARD_DEVIATION 0.8 | 4.8 units on a scale STANDARD_DEVIATION 1.3 | 5.1 units on a scale STANDARD_DEVIATION 1.1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Retrograde ejaculation | 5 Participants | 3 Participants | 8 Participants |
| Serum PSA | 2 ng/mL STANDARD_DEVIATION 3 | 1.3 ng/mL STANDARD_DEVIATION 0.9 | 1.7 ng/mL STANDARD_DEVIATION 2.2 |
| Serum sodium | 140.8 mEq/L STANDARD_DEVIATION 2.3 | 140.5 mEq/L STANDARD_DEVIATION 2.5 | 140.7 mEq/L STANDARD_DEVIATION 2.4 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 45 Participants | 39 Participants | 84 Participants |
| Smoker | 7 Participants | 6 Participants | 13 Participants |
| Stress urinary incontinence | 0 Participants | 0 Participants | 0 Participants |
| Urge urinary incontinence with need for drug use (UUIND) | 1 Participants | 2 Participants | 3 Participants |
| urge Urinary incontinence without the need for drug use (UUIWND) | 13 Participants | 9 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 39 |
| other Total, other adverse events | 4 / 45 | 4 / 39 |
| serious Total, serious adverse events | 2 / 45 | 1 / 39 |
Outcome results
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 * Mild LUTS: 0-7 points * Moderate LUTS: 8-19 points * Severe LUTS: 20-35 points
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| M-TURP | International Prostate Symptom Score (IPSS) | 1 month | 14.6 points | Standard Deviation 7.4 |
| M-TURP | International Prostate Symptom Score (IPSS) | 3 months | 12.2 points | Standard Deviation 8.2 |
| M-TURP | International Prostate Symptom Score (IPSS) | 6 months | 9.7 points | Standard Deviation 7.7 |
| M-TURP | International Prostate Symptom Score (IPSS) | 12 months | 9.7 points | Standard Deviation 8 |
| PK-TURP | International Prostate Symptom Score (IPSS) | 12 months | 7.4 points | Standard Deviation 4.7 |
| PK-TURP | International Prostate Symptom Score (IPSS) | 1 month | 12.7 points | Standard Deviation 7.4 |
| PK-TURP | International Prostate Symptom Score (IPSS) | 6 months | 9.4 points | Standard Deviation 5.9 |
| PK-TURP | International Prostate Symptom Score (IPSS) | 3 months | 11.3 points | Standard Deviation 7.8 |
Primary
Maximum Urinary Flow Rate (Qmax
Maximum urinary flow rate (mL/s) at 1, 3, 6, and 12 months after surgery.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| M-TURP | Maximum Urinary Flow Rate (Qmax | 1 months | 17.5 mL/s | Standard Deviation 9 |
| M-TURP | Maximum Urinary Flow Rate (Qmax | 3 months | 18.2 mL/s | Standard Deviation 8.9 |
| M-TURP | Maximum Urinary Flow Rate (Qmax | 6 months | 21 mL/s | Standard Deviation 10.1 |
| M-TURP | Maximum Urinary Flow Rate (Qmax | 12 months | 21.2 mL/s | Standard Deviation 9.5 |
| PK-TURP | Maximum Urinary Flow Rate (Qmax | 12 months | 19.2 mL/s | Standard Deviation 7.2 |
| PK-TURP | Maximum Urinary Flow Rate (Qmax | 1 months | 18.9 mL/s | Standard Deviation 8.3 |
| PK-TURP | Maximum Urinary Flow Rate (Qmax | 6 months | 18.7 mL/s | Standard Deviation 8.1 |
| PK-TURP | Maximum Urinary Flow Rate (Qmax | 3 months | 16.8 mL/s | Standard Deviation 9 |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| M-TURP | Postvoid Residual Urine (PVRU) Volume | 1 month | 14.2 mL | Standard Deviation 28.8 |
| M-TURP | Postvoid Residual Urine (PVRU) Volume | 3 months | 22.8 mL | Standard Deviation 44.9 |
| M-TURP | Postvoid Residual Urine (PVRU) Volume | 6 months | 15.3 mL | Standard Deviation 28.9 |
| M-TURP | Postvoid Residual Urine (PVRU) Volume | 12 months | 14 mL | Standard Deviation 28.3 |
| PK-TURP | Postvoid Residual Urine (PVRU) Volume | 12 months | 8.3 mL | Standard Deviation 17.7 |
| PK-TURP | Postvoid Residual Urine (PVRU) Volume | 1 month | 13 mL | Standard Deviation 22.3 |
| PK-TURP | Postvoid Residual Urine (PVRU) Volume | 6 months | 14.7 mL | Standard Deviation 25 |
| PK-TURP | Postvoid Residual Urine (PVRU) Volume | 3 months | 18.2 mL | Standard Deviation 26.5 |
Secondary
Bleeding Complications Rate
Register the number of events of haematuria and acute urinary retention by clots
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| M-TURP | Bleeding Complications Rate | 8 Participants |
| PK-TURP | Bleeding Complications Rate | 7 Participants |
Secondary
Catheter Duration
Catheter duration (days)
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| M-TURP | Catheter Duration | 3.6 days | Standard Deviation 1.4 |
| PK-TURP | Catheter Duration | 3.5 days | Standard Deviation 0.8 |
Secondary
Change in Haemoglobin in 24 Hours Post-operation
Compared with the baseline, to demonstrate the blood loss during operation
Time frame: 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| M-TURP | Change in Haemoglobin in 24 Hours Post-operation | 0.9 mg/dL | Standard Deviation 1.1 |
| PK-TURP | Change in Haemoglobin in 24 Hours Post-operation | 1 mg/dL | Standard Deviation 1.1 |
Secondary
Change in Plasmatic Sodium in 24 Hours Post-operation
Compared with the baseline, to demonstrate the sodium loss during operation
Time frame: 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| M-TURP | Change in Plasmatic Sodium in 24 Hours Post-operation | 3.3 mEq/L | Standard Deviation 4.1 |
| PK-TURP | Change in Plasmatic Sodium in 24 Hours Post-operation | 2.2 mEq/L | Standard Deviation 3.6 |
Secondary
Clavien Dindo System
It is a system for evaluating surgical complications at 12 months after surgery. Clavien I * Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. * Acceptable therapeutic regimens are drugs as antiemetics, antipyretics, analgesics, diuretics and electrolytes, and physiotherapy. Clavien II * Requiring pharmacological treatment with drugs other than such allowed for grade I complications. * Blood transfusions and total parenteral nutrition are also included 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
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-TURP | Clavien Dindo System | Clavien I | 2 Participants |
| M-TURP | Clavien Dindo System | Clavien IV | 0 Participants |
| M-TURP | Clavien Dindo System | Clavien V | 0 Participants |
| M-TURP | Clavien Dindo System | Clavien II | 2 Participants |
| M-TURP | Clavien Dindo System | Clavien III | 2 Participants |
| PK-TURP | Clavien Dindo System | Clavien III | 1 Participants |
| PK-TURP | Clavien Dindo System | Clavien I | 2 Participants |
| PK-TURP | Clavien Dindo System | Clavien II | 2 Participants |
| PK-TURP | Clavien Dindo System | Clavien IV | 0 Participants |
| PK-TURP | Clavien Dindo System | Clavien V | 0 Participants |
Secondary
Early Reoperation Rate
The ratio of patient who need reoperation because bleeding complications
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| M-TURP | Early Reoperation Rate | 2 Participants |
| PK-TURP | Early Reoperation Rate | 1 Participants |
Secondary
Hospital Stay
Hospital stay (days)
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| M-TURP | Hospital Stay | 1.1 days | Standard Deviation 0.4 |
| PK-TURP | Hospital Stay | 1.1 days | Standard Deviation 0.8 |
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 * Without erectile dysfunction: 22-25 points * Mild erectile dysfunction: 17-21 points * Mild to moderate erectile dysfunction: 12-16 points * Moderate erectile dysfunction: 8-11 points * Severe erectile dysfunction: 1-7 points
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| M-TURP | International Index of Erectile Function (IIEF-5) | 1 month | 8.5 points | Standard Deviation 7.9 |
| M-TURP | International Index of Erectile Function (IIEF-5) | 3 months | 9.9 points | Standard Deviation 8.2 |
| M-TURP | International Index of Erectile Function (IIEF-5) | 6 months | 10.7 points | Standard Deviation 8.5 |
| M-TURP | International Index of Erectile Function (IIEF-5) | 12 months | 9.7 points | Standard Deviation 8.6 |
| PK-TURP | International Index of Erectile Function (IIEF-5) | 12 months | 11 points | Standard Deviation 8.1 |
| PK-TURP | International Index of Erectile Function (IIEF-5) | 1 month | 9.5 points | Standard Deviation 8 |
| PK-TURP | International Index of Erectile Function (IIEF-5) | 6 months | 12.4 points | Standard Deviation 8.2 |
| PK-TURP | International Index of Erectile Function (IIEF-5) | 3 months | 10.7 points | Standard Deviation 8.1 |
Secondary
Irrigation Volume
Irrigation volume (L)
Time frame: Up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| M-TURP | Irrigation Volume | 16 L | Standard Deviation 6.8 |
| PK-TURP | Irrigation Volume | 20.2 L | Standard Deviation 11.8 |
Secondary
Late Reoperation Rate
The ratio of patient who need reoperation because residual adenoma or complications
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| M-TURP | Late Reoperation Rate | 2 Participants |
| PK-TURP | Late Reoperation Rate | 1 Participants |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-TURP | Number of Participants Reporting Sexual Activity in the Last Month | 1 month | 23 Participants |
| M-TURP | Number of Participants Reporting Sexual Activity in the Last Month | 6 months | 30 Participants |
| M-TURP | Number of Participants Reporting Sexual Activity in the Last Month | 3 months | 33 Participants |
| M-TURP | Number of Participants Reporting Sexual Activity in the Last Month | 12 months | 29 Participants |
| PK-TURP | Number of Participants Reporting Sexual Activity in the Last Month | 12 months | 30 Participants |
| PK-TURP | Number of Participants Reporting Sexual Activity in the Last Month | 1 month | 22 Participants |
| PK-TURP | Number of Participants Reporting Sexual Activity in the Last Month | 3 months | 28 Participants |
| PK-TURP | Number of Participants Reporting Sexual Activity in the Last Month | 6 months | 29 Participants |
Secondary
Operative Time
Operative time (min)
Time frame: Up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| M-TURP | Operative Time | 39.7 minutes | Standard Deviation 14.1 |
| PK-TURP | Operative Time | 47.7 minutes | Standard Deviation 21.4 |
Secondary
Post-TURP Syndrome Rate
Post-transurethral resection of the prostate syndrome rate was recorded.
Time frame: Up to 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| M-TURP | Post-TURP Syndrome Rate | 1 Participants |
| PK-TURP | Post-TURP Syndrome Rate | 0 Participants |
Secondary
Prostate Volume (PV)
Prostate volume was measured by transrectal ultrasound at 12 months after surgery
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| M-TURP | Prostate Volume (PV) | 22.3 mL | Standard Deviation 13 |
| PK-TURP | Prostate Volume (PV) | 22.5 mL | Standard Deviation 12.2 |
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 * Good QoL: 0-2 points * Intermediate QoL: 3 points * Poor QoL: 4-6points
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| M-TURP | Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire | 1 month | 3.7 points | Standard Deviation 1.9 |
| M-TURP | Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire | 3 months | 2.9 points | Standard Deviation 1.8 |
| M-TURP | Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire | 6 months | 2.3 points | Standard Deviation 1.9 |
| M-TURP | Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire | 12 months | 2.4 points | Standard Deviation 1.9 |
| PK-TURP | Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire | 12 months | 1.5 points | Standard Deviation 1.2 |
| PK-TURP | Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire | 1 month | 2.9 points | Standard Deviation 2.1 |
| PK-TURP | Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire | 6 months | 1.6 points | Standard Deviation 1.6 |
| PK-TURP | Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire | 3 months | 2.6 points | Standard Deviation 1.9 |
Secondary
Resected Tissue Percentage
Compared with the baseline, to demonstrate the % of tissue loss during operation
Time frame: Up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| M-TURP | Resected Tissue Percentage | 33.5 % of resected tissue | Standard Deviation 17 |
| PK-TURP | Resected Tissue Percentage | 28.8 % of resected tissue | Standard Deviation 19 |
Secondary
Resected Tissue Weigh
Resected tissue weigh (grams)
Time frame: Up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| M-TURP | Resected Tissue Weigh | 12.7 grams | Standard Deviation 8.2 |
| PK-TURP | Resected Tissue Weigh | 12.4 grams | Standard Deviation 9.9 |
Secondary
Sequelae Rate: Dysuria
register the number of dysuria at 1, 3, 6, and 12 after surgery.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-TURP | Sequelae Rate: Dysuria | 1 month | 5 Participants |
| M-TURP | Sequelae Rate: Dysuria | 3 months | 0 Participants |
| M-TURP | Sequelae Rate: Dysuria | 6 months | 0 Participants |
| M-TURP | Sequelae Rate: Dysuria | 12 months | 0 Participants |
| PK-TURP | Sequelae Rate: Dysuria | 12 months | 0 Participants |
| PK-TURP | Sequelae Rate: Dysuria | 1 month | 0 Participants |
| PK-TURP | Sequelae Rate: Dysuria | 6 months | 0 Participants |
| PK-TURP | Sequelae Rate: Dysuria | 3 months | 0 Participants |
Secondary
Sequelae Rate: Retrograde Ejaculation
register the number of retrograde ejaculation at 1, 3, 6, and 12 after surgery.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-TURP | Sequelae Rate: Retrograde Ejaculation | 1 month | 17 Participants |
| M-TURP | Sequelae Rate: Retrograde Ejaculation | 3 months | 24 Participants |
| M-TURP | Sequelae Rate: Retrograde Ejaculation | 6 months | 21 Participants |
| M-TURP | Sequelae Rate: Retrograde Ejaculation | 12 months | 23 Participants |
| PK-TURP | Sequelae Rate: Retrograde Ejaculation | 12 months | 18 Participants |
| PK-TURP | Sequelae Rate: Retrograde Ejaculation | 1 month | 13 Participants |
| PK-TURP | Sequelae Rate: Retrograde Ejaculation | 6 months | 17 Participants |
| PK-TURP | Sequelae Rate: Retrograde Ejaculation | 3 months | 18 Participants |
Secondary
Speed Resection
Speed resection (g/min)
Time frame: Up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| M-TURP | Speed Resection | 0.9 g/min | Standard Deviation 0.3 |
| PK-TURP | Speed Resection | 0.9 g/min | Standard Deviation 0.3 |
Secondary
Stenotic Complications Rate: Bladder Neck Contracture
Register the number of bladder neck contracture at 1, 3, 6, and 12 after surgery.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-TURP | Stenotic Complications Rate: Bladder Neck Contracture | 1 month | 0 Participants |
| M-TURP | Stenotic Complications Rate: Bladder Neck Contracture | 3 months | 1 Participants |
| M-TURP | Stenotic Complications Rate: Bladder Neck Contracture | 6 months | 2 Participants |
| M-TURP | Stenotic Complications Rate: Bladder Neck Contracture | 12 months | 1 Participants |
| PK-TURP | Stenotic Complications Rate: Bladder Neck Contracture | 12 months | 0 Participants |
| PK-TURP | Stenotic Complications Rate: Bladder Neck Contracture | 1 month | 0 Participants |
| PK-TURP | Stenotic Complications Rate: Bladder Neck Contracture | 6 months | 0 Participants |
| PK-TURP | Stenotic Complications Rate: Bladder Neck Contracture | 3 months | 0 Participants |
Secondary
Stenotic Complications Rate: Meatal Stenosis
Register the number of meatal stenosis at 1, 3, 6, and 12 after surgery.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-TURP | Stenotic Complications Rate: Meatal Stenosis | 1 month | 2 Participants |
| M-TURP | Stenotic Complications Rate: Meatal Stenosis | 3 months | 5 Participants |
| M-TURP | Stenotic Complications Rate: Meatal Stenosis | 6 months | 2 Participants |
| M-TURP | Stenotic Complications Rate: Meatal Stenosis | 12 months | 4 Participants |
| PK-TURP | Stenotic Complications Rate: Meatal Stenosis | 12 months | 2 Participants |
| PK-TURP | Stenotic Complications Rate: Meatal Stenosis | 1 month | 2 Participants |
| PK-TURP | Stenotic Complications Rate: Meatal Stenosis | 6 months | 0 Participants |
| PK-TURP | Stenotic Complications Rate: Meatal Stenosis | 3 months | 2 Participants |
Secondary
Stenotic Complications Rate: Urethral Stricture
Register the number of urethral stricture at 1, 3, 6, and 12 after surgery.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-TURP | Stenotic Complications Rate: Urethral Stricture | 1 month | 0 Participants |
| M-TURP | Stenotic Complications Rate: Urethral Stricture | 3 months | 2 Participants |
| M-TURP | Stenotic Complications Rate: Urethral Stricture | 6 months | 2 Participants |
| M-TURP | Stenotic Complications Rate: Urethral Stricture | 12 months | 1 Participants |
| PK-TURP | Stenotic Complications Rate: Urethral Stricture | 12 months | 2 Participants |
| PK-TURP | Stenotic Complications Rate: Urethral Stricture | 1 month | 0 Participants |
| PK-TURP | Stenotic Complications Rate: Urethral Stricture | 6 months | 2 Participants |
| PK-TURP | Stenotic Complications Rate: Urethral Stricture | 3 months | 1 Participants |
Secondary
Stress Urinary Incontinence Rate
Register the number of patients with stress urinary incontinence at 1, 3, 6, and 12 after surgery.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-TURP | Stress Urinary Incontinence Rate | 1 month | 18 Participants |
| M-TURP | Stress Urinary Incontinence Rate | 3 months | 12 Participants |
| M-TURP | Stress Urinary Incontinence Rate | 6 months | 7 Participants |
| M-TURP | Stress Urinary Incontinence Rate | 12 months | 3 Participants |
| PK-TURP | Stress Urinary Incontinence Rate | 12 months | 0 Participants |
| PK-TURP | Stress Urinary Incontinence Rate | 1 month | 12 Participants |
| PK-TURP | Stress Urinary Incontinence Rate | 6 months | 3 Participants |
| PK-TURP | Stress Urinary Incontinence Rate | 3 months | 9 Participants |
Secondary
Transfusion Rate
Number of participants requiring blood transfusion during, expressed in %
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| M-TURP | Transfusion Rate | 0 Participants |
| PK-TURP | Transfusion Rate | 0 Participants |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-TURP | Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate | 1 month | 9 Participants |
| M-TURP | Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate | 3 months | 3 Participants |
| M-TURP | Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate | 6 months | 3 Participants |
| M-TURP | Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate | 12 months | 0 Participants |
| PK-TURP | Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate | 12 months | 0 Participants |
| PK-TURP | Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate | 1 month | 3 Participants |
| PK-TURP | Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate | 6 months | 2 Participants |
| PK-TURP | Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate | 3 months | 3 Participants |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-TURP | Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate | 1 month | 8 Participants |
| M-TURP | Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate | 3 months | 6 Participants |
| M-TURP | Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate | 6 months | 6 Participants |
| M-TURP | Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate | 12 months | 1 Participants |
| PK-TURP | Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate | 12 months | 0 Participants |
| PK-TURP | Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate | 1 month | 4 Participants |
| PK-TURP | Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate | 6 months | 4 Participants |
| PK-TURP | Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate | 3 months | 3 Participants |
Secondary
Urinary Tract Infections Rate
Register the number of urinary tract infections at 1, 3, 6, and 12 months after surgery.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-TURP | Urinary Tract Infections Rate | 1 month | 5 Participants |
| M-TURP | Urinary Tract Infections Rate | 3 months | 0 Participants |
| M-TURP | Urinary Tract Infections Rate | 6 months | 0 Participants |
| M-TURP | Urinary Tract Infections Rate | 12 months | 0 Participants |
| PK-TURP | Urinary Tract Infections Rate | 12 months | 0 Participants |
| PK-TURP | Urinary Tract Infections Rate | 1 month | 1 Participants |
| PK-TURP | Urinary Tract Infections Rate | 6 months | 0 Participants |
| PK-TURP | Urinary Tract Infections Rate | 3 months | 0 Participants |