Saline With Alcohol in TransUrethral Resection aNd Photoselective Vaporisation of the Prostate (SATURN-P)

University of Magdeburg

Status: Completed

Conditions: Benign Prostatic Hypertrophy

Treatments: Procedure: transurethral resection of the prostate; Drug: Saline Irrigation with Ethanol; Procedure: photoselective vaporisation of the prostate

Study type: Interventional

Funder types: Other

Identifiers

NCT02429219

MD-URO-00033

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients in which a TURiS or PVP to be performed

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Transurethral Resection

Active Comparator group

Description:

Transurethral Resection of the Prostate in Saline irrigation with ethanol

Treatment:

Drug: Saline Irrigation with Ethanol

Procedure: transurethral resection of the prostate

Photoselective vaporisation

Experimental group

Description:

Photoselective vaporisation of the Prostate in Saline irrigation with ethanol

Treatment:

Procedure: photoselective vaporisation of the prostate

Drug: Saline Irrigation with Ethanol