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

Hospital Universitario de Fuenlabrada100 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Prostatic Hyperplasia Lower Urinary Tract Symptoms Transurethral Resection of Prostate

Interventions

Transurethral Resection of the Prostate (TURP)DEVICE

Randomized allocation to M-TURP or PK-TURP

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

Outcomes

Primary Outcomes

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

Maximum Urinary Flow Rate (Qmax

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

Time frame: 12 months

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

Secondary Outcomes

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

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

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

Data from ClinicalTrials.gov

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Time frame: 12 months

Prostate Volume (PV)

Prostate volume was measured by transrectal ultrasound at 12 months after surgery

Time frame: 12 months

Operative Time

Operative time (min)

Time frame: Up to 24 hours

Irrigation Volume

Irrigation volume (L)

Time frame: Up to 24 hours

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

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

Transfusion Rate

Number of participants requiring blood transfusion during, expressed in %

Time frame: 1 month

Catheter Duration

Catheter duration (days)

Time frame: 1 month

Hospital Stay

Hospital stay (days)

Time frame: 1 month

Resected Tissue Weigh

Resected tissue weigh (grams)

Time frame: Up to 24 hours

Resected Tissue Percentage

Compared with the baseline, to demonstrate the % of tissue loss during operation

Time frame: Up to 24 hours

Speed Resection

Speed resection (g/min)

Time frame: Up to 24 hours

Early Reoperation Rate

The ratio of patient who need reoperation because bleeding complications

Time frame: 1 month

Late Reoperation Rate

The ratio of patient who need reoperation because residual adenoma or complications

Time frame: 12 months

Post-TURP Syndrome Rate

Post-transurethral resection of the prostate syndrome rate was recorded.

Time frame: Up to 24 hours

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

Bleeding Complications Rate

Time frame: 1 month

Urinary Tract Infections Rate

Time frame: 12 months

Stenotic Complications Rate: Meatal Stenosis

Time frame: 12 months

Stenotic Complications Rate: Urethral Stricture

Time frame: 12 months

Stenotic Complications Rate: Bladder Neck Contracture

Time frame: 12 months

Stress Urinary Incontinence Rate

Time frame: 12 months

Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate

Time frame: 12 months

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

Sequelae Rate: Retrograde Ejaculation

Time frame: 12 months

Sequelae Rate: Dysuria

Time frame: 12 months