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

Lower Urinary Tract Symptoms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03936244
• Other study ID #: HUF
• Status: Completed
• Phase: N/A
• Start date: December 5, 2014
• Est. completion date: December 12, 2019

Study information

• Verified date: October 2020
• Source: Hospital Universitario de Fuenlabrada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 12, 2019
• Est. primary completion date: December 12, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Transurethral Resection of the Prostate (TURP)
Randomized allocation to M-TURP or PK-TURP

Locations

Country	Name	City	State
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario de Fuenlabrada

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. Review. — View 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. Review. — View Citation

Otaola-Arca H, Álvarez-Ardura M, Molina-Escudero R, Fernández MI, Páez-Borda Á. A prospective randomized study comparing bipolar plasmakinetic transurethral resection of the prostate and monopolar transurethral resection of the prostate for the treatment — View Citation

Outcome

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