Saline With Alcohol in TransUrethral Resection aNd Photoselective Vaporisation of the Prostate

University of Magdeburg60 enrolled

Overview

Transurethral therapy (TURiS / PVP) of benign prostatic hyperplasia (BPH) using an ethanol-containing saline irrigating fluid, prospective detected by breath alcohol measurement.

Aim was to evaluate the amount of absorbed saline irrigation fluid during transurethral therapy of benign prostatic hyperplasia (BPH). We want to differentiate two different methods of the surgical therapy: the TransUrethral Resection in Saline (TURiS) and the Photoselective Vaporisation of the Prostate (PVP). Both methods using saline irrigation. To measure the amount of absorbed saline irrigation fluid, we added pure Ethanol to the Irrigation fluid resulting in am 0,02% ethanol containing saline irrigation fluid. The conventional TransUrethral Resection of the Prostate (TUR) method is using electrolyte free irrigation. In the literature this method is well known for the occurence of the transurethral resection syndrome ("TUR syndrome"). This is caused by absorption of electrolyte-free irrigating fluid, followed by a hyponatraemic hyperhydration, and consists of symptoms from the circulatory and nervous Systems.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Benign Prostatic Hypertrophy

Interventions

Saline Irrigation with EthanolDRUG

Saline Irrigation with Ethanol (alcohol)

transurethral resection of the prostatePROCEDURE

transurethral electro-resection of the prostate (TURP)

photoselective vaporisation of the prostatePROCEDURE

photoselective laser-vaporisation of the prostate (PVP)

Eligibility

Sex: MALE

Medical Language ↔ Plain English

Inclusion Criteria: * Patients in which a TURiS or PVP to be performed Exclusion Criteria: * Alcoholics, * Patients with severe hepatic impairment, * Epilepsy, * Existing metabolic acidosis.

Locations (1)

Department of Urology University Hospital Otto-von-Guericke-University Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Outcomes

Primary Outcomes

last breath alcohol measurement

Measurement will be done using a breath Alcohol device (Alcomed 3011, Envitec-Wismar Inc., Germany). The unit will be mg/l.

Time frame: Every 10 minutes, the breath alcohol is measured to 2 hours after the operation. Of these unnoticed, the intervention (surgery) is carried out until the end. It's all about the detection; the patient's treatment does not change.

Secondary Outcomes

Surgical abortion with significant Absorption of irrigation fluid

If a significant amount if Irrigation fluid is absorbed (\>1,5l), the procedure will be aborted

Time frame: Surgery will be last on average 1 hour

Data from ClinicalTrials.gov

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