Bipolar Plasmakinetic TURP Vs Monopolar TURP in the Treatment of Lower Urinary Tract Symptoms
NCT ID: NCT03936244
Last Updated: 2020-11-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2014-12-05
2019-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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
Interventions
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Transurethral Resection of the Prostate (TURP)
Randomized allocation to M-TURP or PK-TURP
Eligibility Criteria
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Inclusion Criteria
* 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 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.
MALE
No
Sponsors
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Hospital Universitario de Fuenlabrada
OTHER
Responsible Party
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Carolina Alonso
Attending physician
Principal Investigators
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Manuel Álvarez Ardura, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario de Fuenlabrada
Hugo Otaola Arca, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario de Fuenlabrada
Álvaro Páez Borda, M.D., Ph.D.
Role: STUDY_CHAIR
Hospital Universitario de Fuenlabrada
Locations
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Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HUF
Identifier Type: -
Identifier Source: org_study_id