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

Primary Purpose

Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Transurethral Resection of Prostate

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Transurethral Resection of the Prostate (TURP)
Sponsored by
Hospital Universitario de Fuenlabrada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario de Fuenlabrada

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

M-TURP

PK-TURP

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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
Prostate Volume (PV)
Prostate volume was measured by transrectal ultrasound at 12 months after surgery
Operative Time
Operative time (min)
Irrigation Volume
Irrigation volume (L)
Change in Plasmatic Sodium in 24 Hours Post-operation
Compared with the baseline, to demonstrate the sodium loss during operation
Change in Haemoglobin in 24 Hours Post-operation
Compared with the baseline, to demonstrate the blood loss during operation
Transfusion Rate
Number of participants requiring blood transfusion during, expressed in %
Catheter Duration
Catheter duration (days)
Hospital Stay
Hospital stay (days)
Resected Tissue Weigh
Resected tissue weigh (grams)
Resected Tissue Percentage
Compared with the baseline, to demonstrate the % of tissue loss during operation
Speed Resection
Speed resection (g/min)
Early Reoperation Rate
The ratio of patient who need reoperation because bleeding complications
Late Reoperation Rate
The ratio of patient who need reoperation because residual adenoma or complications
Post-TURP Syndrome Rate
Post-transurethral resection of the prostate syndrome rate was recorded.
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
Bleeding Complications Rate
Register the number of events of haematuria and acute urinary retention by clots
Urinary Tract Infections Rate
Register the number of urinary tract infections at 1, 3, 6, and 12 months after surgery.
Stenotic Complications Rate: Meatal Stenosis
Register the number of meatal stenosis at 1, 3, 6, and 12 after surgery.
Stenotic Complications Rate: Urethral Stricture
Register the number of urethral stricture at 1, 3, 6, and 12 after surgery.
Stenotic Complications Rate: Bladder Neck Contracture
Register the number of bladder neck contracture at 1, 3, 6, and 12 after surgery.
Stress Urinary Incontinence Rate
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
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
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
register the number of retrograde ejaculation at 1, 3, 6, and 12 after surgery.
Sequelae Rate: Dysuria
register the number of dysuria at 1, 3, 6, and 12 after surgery.

Full Information

First Posted
April 24, 2019
Last Updated
October 19, 2020
Sponsor
Hospital Universitario de Fuenlabrada
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1. Study Identification

Unique Protocol Identification Number
NCT03936244
Brief Title
Bipolar Plasmakinetic TURP Vs Monopolar TURP in the Treatment of Lower Urinary Tract Symptoms
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 5, 2014 (Actual)
Primary Completion Date
December 12, 2017 (Actual)
Study Completion Date
December 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario de Fuenlabrada

4. Oversight

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
Data Monitoring Committee
No

5. 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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Transurethral Resection of Prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
M-TURP
Arm Type
Active Comparator
Arm Description
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
Arm Title
PK-TURP
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Transurethral Resection of the Prostate (TURP)
Intervention Description
Randomized allocation to M-TURP or PK-TURP
Primary Outcome Measure Information:
Title
International Prostate Symptom Score (IPSS)
Description
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
Title
Maximum Urinary Flow Rate (Qmax
Description
Maximum urinary flow rate (mL/s) at 1, 3, 6, and 12 months after surgery.
Time Frame
12 months
Title
Postvoid Residual Urine (PVRU) Volume
Description
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
Secondary Outcome Measure Information:
Title
Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire
Description
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
Title
Number of Participants Reporting Sexual Activity in the Last Month
Description
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
Title
International Index of Erectile Function (IIEF-5)
Description
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
Title
Prostate Volume (PV)
Description
Prostate volume was measured by transrectal ultrasound at 12 months after surgery
Time Frame
12 months
Title
Operative Time
Description
Operative time (min)
Time Frame
Up to 24 hours
Title
Irrigation Volume
Description
Irrigation volume (L)
Time Frame
Up to 24 hours
Title
Change in Plasmatic Sodium in 24 Hours Post-operation
Description
Compared with the baseline, to demonstrate the sodium loss during operation
Time Frame
24 hours after surgery
Title
Change in Haemoglobin in 24 Hours Post-operation
Description
Compared with the baseline, to demonstrate the blood loss during operation
Time Frame
24 hours after surgery
Title
Transfusion Rate
Description
Number of participants requiring blood transfusion during, expressed in %
Time Frame
1 month
Title
Catheter Duration
Description
Catheter duration (days)
Time Frame
1 month
Title
Hospital Stay
Description
Hospital stay (days)
Time Frame
1 month
Title
Resected Tissue Weigh
Description
Resected tissue weigh (grams)
Time Frame
Up to 24 hours
Title
Resected Tissue Percentage
Description
Compared with the baseline, to demonstrate the % of tissue loss during operation
Time Frame
Up to 24 hours
Title
Speed Resection
Description
Speed resection (g/min)
Time Frame
Up to 24 hours
Title
Early Reoperation Rate
Description
The ratio of patient who need reoperation because bleeding complications
Time Frame
1 month
Title
Late Reoperation Rate
Description
The ratio of patient who need reoperation because residual adenoma or complications
Time Frame
12 months
Title
Post-TURP Syndrome Rate
Description
Post-transurethral resection of the prostate syndrome rate was recorded.
Time Frame
Up to 24 hours
Title
Clavien Dindo System
Description
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
Title
Bleeding Complications Rate
Description
Register the number of events of haematuria and acute urinary retention by clots
Time Frame
1 month
Title
Urinary Tract Infections Rate
Description
Register the number of urinary tract infections at 1, 3, 6, and 12 months after surgery.
Time Frame
12 months
Title
Stenotic Complications Rate: Meatal Stenosis
Description
Register the number of meatal stenosis at 1, 3, 6, and 12 after surgery.
Time Frame
12 months
Title
Stenotic Complications Rate: Urethral Stricture
Description
Register the number of urethral stricture at 1, 3, 6, and 12 after surgery.
Time Frame
12 months
Title
Stenotic Complications Rate: Bladder Neck Contracture
Description
Register the number of bladder neck contracture at 1, 3, 6, and 12 after surgery.
Time Frame
12 months
Title
Stress Urinary Incontinence Rate
Description
Register the number of patients with stress urinary incontinence at 1, 3, 6, and 12 after surgery.
Time Frame
12 months
Title
Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate
Description
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
Title
Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate
Description
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
Title
Sequelae Rate: Retrograde Ejaculation
Description
register the number of retrograde ejaculation at 1, 3, 6, and 12 after surgery.
Time Frame
12 months
Title
Sequelae Rate: Dysuria
Description
register the number of dysuria at 1, 3, 6, and 12 after surgery.
Time Frame
12 months

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Álvarez Ardura, M.D.
Organizational Affiliation
Hospital Universitario de Fuenlabrada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hugo Otaola Arca, M.D., Ph.D.
Organizational Affiliation
Hospital Universitario de Fuenlabrada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Álvaro Páez Borda, M.D., Ph.D.
Organizational Affiliation
Hospital Universitario de Fuenlabrada
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario de Fuenlabrada
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20825758
Citation
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.
Results Reference
background
PubMed Identifier
24972732
Citation
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.
Results Reference
background
PubMed Identifier
33047918
Citation
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.
Results Reference
result

Learn more about this trial

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

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