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Completed

NCT Number: NCT03936244

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

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

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Signs and Symptoms Transurethral Resection of Prostate Urogenital Diseases Urological Manifestations

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transurethral Resection of the Prostate (TURP)

Device

Randomized allocation to M-TURP or PK-TURP

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Fuenlabrada

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
May 3, 2019
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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