Clinical trial NCT03936244: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Transurethral Resection of Prostate
Lead sponsor: Hospital Universitario de Fuenlabrada
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 100
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: 12 months
measure: Maximum Urinary Flow Rate (Qmax
timeFrame: 12 months
measure: Postvoid Residual Urine (PVRU) Volume
timeFrame: 12 months
Secondary outcomes:
measure: Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire
timeFrame: 12 months
measure: Number of Participants Reporting Sexual Activity in the Last Month
timeFrame: 12 months
measure: International Index of Erectile Function (IIEF-5)
timeFrame: 12 months
measure: Prostate Volume (PV)
timeFrame: 12 months
measure: Operative Time
timeFrame: Up to 24 hours
measure: Irrigation Volume
timeFrame: Up to 24 hours
measure: Change in Plasmatic Sodium in 24 Hours Post-operation
timeFrame: 24 hours after surgery
measure: Change in Haemoglobin in 24 Hours Post-operation
timeFrame: 24 hours after surgery
measure: Transfusion Rate
timeFrame: 1 month
measure: Catheter Duration
timeFrame: 1 month
measure: Hospital Stay
timeFrame: 1 month
measure: Resected Tissue Weigh
timeFrame: Up to 24 hours
measure: Resected Tissue Percentage
timeFrame: Up to 24 hours
measure: Speed Resection
timeFrame: Up to 24 hours
measure: Early Reoperation Rate
timeFrame: 1 month
measure: Late Reoperation Rate
timeFrame: 12 months
measure: Post-TURP Syndrome Rate
timeFrame: Up to 24 hours
measure: Clavien Dindo System
timeFrame: 12 months
measure: Bleeding Complications Rate
timeFrame: 1 month
measure: Urinary Tract Infections Rate
timeFrame: 12 months
measure: Stenotic Complications Rate: Meatal Stenosis
timeFrame: 12 months
measure: Stenotic Complications Rate: Urethral Stricture
timeFrame: 12 months
measure: Stenotic Complications Rate: Bladder Neck Contracture
timeFrame: 12 months
measure: Stress Urinary Incontinence Rate
timeFrame: 12 months
measure: Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate
timeFrame: 12 months
measure: Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate
timeFrame: 12 months
measure: Sequelae Rate: Retrograde Ejaculation
timeFrame: 12 months
measure: Sequelae Rate: Dysuria
timeFrame: 12 months
Other outcomes:
Locations:
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
Study officials:
affiliation: Hospital Universitario de Fuenlabrada
name: Manuel Álvarez Ardura, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Fuenlabrada
name: Hugo Otaola Arca, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Fuenlabrada
name: Álvaro Páez Borda, M.D., Ph.D.
role: STUDY_CHAIR
References:
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.
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.
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.