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出境医 / 临床实验 / Bipolar Plasmakinetic TURP Vs Monopolar TURP in the Treatment of Lower Urinary Tract Symptoms

Bipolar Plasmakinetic TURP Vs Monopolar TURP in the Treatment of Lower Urinary Tract Symptoms

Study Description
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

Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Lower Urinary Tract Symptoms Transurethral Resection of Prostate Device: Transurethral Resection of the Prostate (TURP) Not Applicable

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)
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Bipolar Plasmakinetic Transurethral Resection of the Prostate With Monopolar Transurethral Resection of the Prostate in the Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Actual Study Start Date : December 5, 2014
Actual Primary Completion Date : December 12, 2017
Actual Study Completion Date : December 12, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: 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
 Device: Transurethral Resection of the Prostate (TURP)
Randomized allocation to M-TURP or PK-TURP
Experimental: 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
 Device: Transurethral Resection of the Prostate (TURP)
Randomized allocation to M-TURP or PK-TURP
Outcome Measures
Primary Outcome Measures :
  1. International Prostate Symptom Score (IPSS) [ Time Frame: 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

  2. Maximum Urinary Flow Rate (Qmax [ Time Frame: 12 months ]
    Maximum urinary flow rate (mL/s) at 1, 3, 6, and 12 months after surgery.

  3. Postvoid Residual Urine (PVRU) Volume [ Time Frame: 12 months ]
    Postvoid residual urine volume (mL) was measured by abdominal ultrasound after urination at 1, 3, 6, and 12 months after surgery.


Secondary Outcome Measures :
  1. Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire [ Time Frame: 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

  2. Number of Participants Reporting Sexual Activity in the Last Month [ Time Frame: 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.


  3. International Index of Erectile Function (IIEF-5) [ Time Frame: 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

  4. Prostate Volume (PV) [ Time Frame: 12 months ]
    Prostate volume was measured by transrectal ultrasound at 12 months after surgery

  5. Operative Time [ Time Frame: Up to 24 hours ]
    Operative time (min)

  6. Irrigation Volume [ Time Frame: Up to 24 hours ]
    Irrigation volume (L)

  7. Change in Plasmatic Sodium in 24 Hours Post-operation [ Time Frame: 24 hours after surgery ]
    Compared with the baseline, to demonstrate the sodium loss during operation

  8. Change in Haemoglobin in 24 Hours Post-operation [ Time Frame: 24 hours after surgery ]
    Compared with the baseline, to demonstrate the blood loss during operation

  9. Transfusion Rate [ Time Frame: 1 month ]
    Number of participants requiring blood transfusion during, expressed in %

  10. Catheter Duration [ Time Frame: 1 month ]
    Catheter duration (days)

  11. Hospital Stay [ Time Frame: 1 month ]
    Hospital stay (days)

  12. Resected Tissue Weigh [ Time Frame: Up to 24 hours ]
    Resected tissue weigh (grams)

  13. Resected Tissue Percentage [ Time Frame: Up to 24 hours ]
    Compared with the baseline, to demonstrate the % of tissue loss during operation

  14. Speed Resection [ Time Frame: Up to 24 hours ]
    Speed resection (g/min)

  15. Early Reoperation Rate [ Time Frame: 1 month ]
    The ratio of patient who need reoperation because bleeding complications

  16. Late Reoperation Rate [ Time Frame: 12 months ]
    The ratio of patient who need reoperation because residual adenoma or complications

  17. Post-TURP Syndrome Rate [ Time Frame: Up to 24 hours ]
    Post-transurethral resection of the prostate syndrome rate was recorded.

  18. Clavien Dindo System [ Time Frame: 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


  19. Bleeding Complications Rate [ Time Frame: 1 month ]
    Register the number of events of haematuria and acute urinary retention by clots

  20. Urinary Tract Infections Rate [ Time Frame: 12 months ]
    Register the number of urinary tract infections at 1, 3, 6, and 12 months after surgery.

  21. Stenotic Complications Rate: Meatal Stenosis [ Time Frame: 12 months ]
    Register the number of meatal stenosis at 1, 3, 6, and 12 after surgery.

  22. Stenotic Complications Rate: Urethral Stricture [ Time Frame: 12 months ]
    Register the number of urethral stricture at 1, 3, 6, and 12 after surgery.

  23. Stenotic Complications Rate: Bladder Neck Contracture [ Time Frame: 12 months ]
    Register the number of bladder neck contracture at 1, 3, 6, and 12 after surgery.

  24. Stress Urinary Incontinence Rate [ Time Frame: 12 months ]
    Register the number of patients with stress urinary incontinence at 1, 3, 6, and 12 after surgery.

  25. Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate [ Time Frame: 12 months ]
    Register the number of patients with urge urinary incontinence with need for drug use at 1, 3, 6, and 12 after surgery.

  26. Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate [ Time Frame: 12 months ]
    Register the number of patients with urge urinary incontinence without need for drug use at 1, 3, 6, and 12 after surgery.

  27. Sequelae Rate: Retrograde Ejaculation [ Time Frame: 12 months ]
    register the number of retrograde ejaculation at 1, 3, 6, and 12 after surgery.

  28. Sequelae Rate: Dysuria [ Time Frame: 12 months ]
    register the number of dysuria at 1, 3, 6, and 12 after surgery.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Locations
Layout table for location information
Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain, 28942
Sponsors and Collaborators
Hospital Universitario de Fuenlabrada
Investigators
Layout table for investigator information
Principal Investigator: Manuel Álvarez Ardura, M.D. Hospital Universitario de Fuenlabrada
Principal Investigator: Hugo Otaola Arca, M.D., Ph.D. Hospital Universitario de Fuenlabrada
Study Chair: Álvaro Páez Borda, M.D., Ph.D. Hospital Universitario de Fuenlabrada
Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE May 3, 2019
Results First Submitted Date  ICMJE July 2, 2020
Results First Posted Date  ICMJE October 19, 2020
Last Update Posted Date November 12, 2020
Actual Study Start Date  ICMJE December 5, 2014
Actual Primary Completion Date December 12, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2020)
  • International Prostate Symptom Score (IPSS) [ Time Frame: 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 [ Time Frame: 12 months ]
    Maximum urinary flow rate (mL/s) at 1, 3, 6, and 12 months after surgery.
  • Postvoid Residual Urine (PVRU) Volume [ Time Frame: 12 months ]
    Postvoid residual urine volume (mL) was measured by abdominal ultrasound after urination at 1, 3, 6, and 12 months after surgery.
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • International Prostate Symptom Score (IPSS) [ Time Frame: 36 months ]
    International Prostate Symptom Score (with 7 questions) was measured at the baseline and at 1, 3, 6, 12, 18, 24 and 36-month postoperatively. Results: the sum of the 7 items will range between 0 to 35 points Interpretation: allows to categorize 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 [ Time Frame: 36 months ]
    Maximum urinary flow rate (mL/s) was measured at the baseline and at 1, 3, 6, 12, 18, 24 and 36-month postoperatively
  • Postvoid Residual Urine (PVRU) Volume [ Time Frame: 36 months ]
    Postvoid residual urine volume (mL) was measured by abdominal ultrasound after urination at the baseline and at 1, 3, 6, 12, 18, 24 and 36-month postoperatively
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2020)
  • Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 12 months ]
    Prostate volume was measured by transrectal ultrasound at 12 months after surgery
  • Operative Time [ Time Frame: Up to 24 hours ]
    Operative time (min)
  • Irrigation Volume [ Time Frame: Up to 24 hours ]
    Irrigation volume (L)
  • Change in Plasmatic Sodium in 24 Hours Post-operation [ Time Frame: 24 hours after surgery ]
    Compared with the baseline, to demonstrate the sodium loss during operation
  • Change in Haemoglobin in 24 Hours Post-operation [ Time Frame: 24 hours after surgery ]
    Compared with the baseline, to demonstrate the blood loss during operation
  • Transfusion Rate [ Time Frame: 1 month ]
    Number of participants requiring blood transfusion during, expressed in %
  • Catheter Duration [ Time Frame: 1 month ]
    Catheter duration (days)
  • Hospital Stay [ Time Frame: 1 month ]
    Hospital stay (days)
  • Resected Tissue Weigh [ Time Frame: Up to 24 hours ]
    Resected tissue weigh (grams)
  • Resected Tissue Percentage [ Time Frame: Up to 24 hours ]
    Compared with the baseline, to demonstrate the % of tissue loss during operation
  • Speed Resection [ Time Frame: Up to 24 hours ]
    Speed resection (g/min)
  • Early Reoperation Rate [ Time Frame: 1 month ]
    The ratio of patient who need reoperation because bleeding complications
  • Late Reoperation Rate [ Time Frame: 12 months ]
    The ratio of patient who need reoperation because residual adenoma or complications
  • Post-TURP Syndrome Rate [ Time Frame: Up to 24 hours ]
    Post-transurethral resection of the prostate syndrome rate was recorded.
  • Clavien Dindo System [ Time Frame: 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 [ Time Frame: 1 month ]
    Register the number of events of haematuria and acute urinary retention by clots
  • Urinary Tract Infections Rate [ Time Frame: 12 months ]
    Register the number of urinary tract infections at 1, 3, 6, and 12 months after surgery.
  • Stenotic Complications Rate: Meatal Stenosis [ Time Frame: 12 months ]
    Register the number of meatal stenosis at 1, 3, 6, and 12 after surgery.
  • Stenotic Complications Rate: Urethral Stricture [ Time Frame: 12 months ]
    Register the number of urethral stricture at 1, 3, 6, and 12 after surgery.
  • Stenotic Complications Rate: Bladder Neck Contracture [ Time Frame: 12 months ]
    Register the number of bladder neck contracture at 1, 3, 6, and 12 after surgery.
  • Stress Urinary Incontinence Rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]
    register the number of retrograde ejaculation at 1, 3, 6, and 12 after surgery.
  • Sequelae Rate: Dysuria [ Time Frame: 12 months ]
    register the number of dysuria at 1, 3, 6, and 12 after surgery.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire [ Time Frame: 36 months ]
    We use the bother score item of the IPSS questionnaire (question 8) measured at the baseline and in 1, 3, 6, 12, 18, 24 and 36 months after the operation to assess the quality of life (QoL) due to lower urinary tract symptoms (LUTS) Results: will range between 0 to 6 points Interpretation: allows to categorize the QoL in 3 categories
    • Good QoL: 0-2 points
    • Intermediate QoL: 3 points
    • Poor QoL: 4-6points
  • Sexual activity [ Time Frame: 36 months ]
    Sexual activity was measured (with yes/no questions) at at the baseline and at 1, 3, 6, 12, 18, 24 and 36-month postoperatively
  • International Index of Erectile Function (IIEF-5) [ Time Frame: 36 months ]
    International Index of Erectile Function (with 5 questions) was measured at the baseline and at 1, 3, 6, 12, 18, 24 and 36-month postoperatively. Results: the sum of the 5 items will range between 1 to 25 points Interpretation: allows to categorize 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) [ Time Frame: 36 months ]
    Prostate volumen was measured by transrectal ultrasound at the baseline and at 12-month postoperatively
  • Operative Time [ Time Frame: Up to 24 hours ]
    Operative time (min)
  • Irrigation Volume [ Time Frame: Up to 24 hours ]
    Irrigation volume (L)
  • Change in Plasmatic Sodium in 24 Hours Post-operation [ Time Frame: 24 hours after surgery ]
    Compared with the baseline, to demonstrate the sodium loss during operation
  • Change in Haemoglobin in 24 Hours Post-operation [ Time Frame: 24 hours after surgery ]
    Compared with the baseline, to demonstrate the blood loss during operation
  • Transfusion Rate [ Time Frame: 1 month ]
    Transfusion rate (%)
  • Catheter Duration [ Time Frame: 1 month ]
    Catheter duration (days)
  • Hospital Stay [ Time Frame: 1 month ]
    Hospital stay (days)
  • Resected Tissue Weigh [ Time Frame: Up to 24 hours ]
    Resected tissue weigh (grams)
  • Resected Tissue Percentage [ Time Frame: Up to 24 hours ]
    Compared with the baseline, to demonstrate the % of tissue loss during operation
  • Speed Resection [ Time Frame: Up to 24 hours ]
    Speed resection (g/min)
  • Early Reoperation Rate [ Time Frame: 1 month ]
    The ratio of patient who need reoperation because bleeding complications
  • Late Reoperation Rate [ Time Frame: 36 months ]
    The ratio of patient who need reoperation because residual adenoma, complications
  • Post-TURP Syndrome Rate [ Time Frame: Up to 24 hours ]
    Post-transurethral resection of the prostate syndrome rate was recorded.
  • Clavien Dindo System [ Time Frame: 36 months ]
    It is a system for evaluating surgical complications at 1, 3, 6, 12, 18, 24 and 36-month postoperatively
  • Bleeding Complications Rate [ Time Frame: 1 month ]
    Register the number of events of haematuria and acute urinary retention by clots
  • Urinary Tract Infections Rate [ Time Frame: 36 months ]
    Register the number of urinary tract infections at baseline and at 1, 3, 6, 12, 18, 24 and 36-month postoperatively
  • Stenotic complications rate [ Time Frame: 36 months ]
    Register the number of stenotic complications (meatal stenosis, urethral stricture and bladder neck contracture) at 1, 3, 6, 12, 18, 24 and 36-month postoperatively
  • Urinary incontinence rate [ Time Frame: 36 months ]
    Register the number of patientes with urinary incontinence (stress and urge incontinence) at baseline and at 1, 3, 6, 12, 18, 24 and 36-month postoperatively
  • Sequelae rate [ Time Frame: 36 months ]
    register the number of sequelas (retrograde ejaculation, dysuria) at 1, 3, 6, 12, 18, 24 and 36-month postoperatively
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bipolar Plasmakinetic TURP Vs Monopolar TURP in the Treatment of Lower Urinary Tract Symptoms
Official Title  ICMJE Randomized Controlled Trial Comparing Bipolar Plasmakinetic Transurethral Resection of the Prostate With Monopolar Transurethral Resection of the Prostate in the Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostatic Hyperplasia
  • Lower Urinary Tract Symptoms
  • Transurethral Resection of Prostate
Intervention  ICMJE Device: Transurethral Resection of the Prostate (TURP)
Randomized allocation to M-TURP or PK-TURP
Study Arms  ICMJE
  • Active Comparator: 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
    Intervention: Device: Transurethral Resection of the Prostate (TURP)
  • Experimental: 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
    Intervention: Device: Transurethral Resection of the Prostate (TURP)
Publications *
  • 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. Review.
  • 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. Review.
  • Otaola-Arca H, Álvarez-Ardura M, Molina-Escudero R, Fernández MI, Páez-Borda Á. 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 12, 2019
Actual Primary Completion Date December 12, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03936244
Other Study ID Numbers  ICMJE HUF
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Carolina Alonso, Hospital Universitario de Fuenlabrada
Study Sponsor  ICMJE Hospital Universitario de Fuenlabrada
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manuel Álvarez Ardura, M.D. Hospital Universitario de Fuenlabrada
Principal Investigator: Hugo Otaola Arca, M.D., Ph.D. Hospital Universitario de Fuenlabrada
Study Chair: Álvaro Páez Borda, M.D., Ph.D. Hospital Universitario de Fuenlabrada
PRS Account Hospital Universitario de Fuenlabrada
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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