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

NCT ID: NCT02429219

Last Updated: 2015-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-02-28

Brief Summary

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

Detailed Description

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.

Conditions

Benign Prostatic Hypertrophy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transurethral Resection

Transurethral Resection of the Prostate in Saline irrigation with ethanol

Group Type: ACTIVE_COMPARATOR

Saline Irrigation with Ethanol

Intervention Type: DRUG

Saline Irrigation with Ethanol (alcohol)

transurethral resection of the prostate

Intervention Type: PROCEDURE

transurethral electro-resection of the prostate (TURP)

Photoselective vaporisation

Photoselective vaporisation of the Prostate in Saline irrigation with ethanol

Group Type: EXPERIMENTAL

Saline Irrigation with Ethanol

Intervention Type: DRUG

Saline Irrigation with Ethanol (alcohol)

photoselective vaporisation of the prostate

Intervention Type: PROCEDURE

photoselective laser-vaporisation of the prostate (PVP)

Interventions

Saline Irrigation with Ethanol

Saline Irrigation with Ethanol (alcohol)

Intervention Type: DRUG

transurethral resection of the prostate

transurethral electro-resection of the prostate (TURP)

Intervention Type: PROCEDURE

photoselective vaporisation of the prostate

photoselective laser-vaporisation of the prostate (PVP)

Intervention Type: PROCEDURE

Other Intervention Names

ethanol containinge saline irrigation fluid; TURP; PVP

Eligibility Criteria

Inclusion Criteria

• Patients in which a TURiS or PVP to be performed

Exclusion Criteria

• Alcoholics,
• Patients with severe hepatic impairment,
• Epilepsy,
• Existing metabolic acidosis.

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Magdeburg

OTHER

Sponsor Role: lead

Responsible Party

Johann J. Wendler, MD

Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Markus Porsch, MD

Role: PRINCIPAL_INVESTIGATOR

Urologic Faculty University Magdeburg

Locations

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

Magdeburg, Saxony-Anhalt, Germany

Countries

Germany

References

Hermanns T, Grossmann NC, Wettstein MS, Fankhauser CD, Capol JC, Poyet C, Hefermehl LJ, Zimmermann M, Sulser T, Muller A. Absorption of irrigation fluid occurs frequently during high power 532 nm laser vaporization of the prostate. J Urol. 2015 Jan;193(1):211-6. doi: 10.1016/j.juro.2014.07.117. Epub 2014 Aug 7.

Reference Type: RESULT

PMID: 25108273 (View on PubMed)

Other Identifiers

MD-URO-00033

Identifier Type: -

Identifier Source: org_study_id