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

Prospective Study of Monitoring the Alcohol Concentration in Breathing Air During Transurethral Prostate Resection of Benign Prostate Hyperplasia (BPH) Assessing the Uptake of Irrigation Fluids

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02429219

Acronym

SATURN-P

Enrollment

Registered

2015-04-29

Start date

2013-11-30

Completion date

2015-02-28

Last updated

2015-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hypertrophy

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.

Interventions

PROCEDUREphotoselective vaporisation of the prostate

photoselective laser-vaporisation of the prostate (PVP)

DRUGSaline Irrigation with Ethanol

Saline Irrigation with Ethanol (alcohol)

PROCEDUREtransurethral resection of the prostate

transurethral electro-resection of the prostate (TURP)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

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.

Design outcomes

Primary

Measure	Time frame	Description
last breath alcohol measurement	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.	Measurement will be done using a breath Alcohol device (Alcomed 3011, Envitec-Wismar Inc., Germany). The unit will be mg/l.

Secondary

Measure	Time frame	Description
Surgical abortion with significant Absorption of irrigation fluid	Surgery will be last on average 1 hour	If a significant amount if Irrigation fluid is absorbed (\>1,5l), the procedure will be aborted

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026