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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Benign Prostatic Hypertrophy

Intervention / Treatment
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* Drug: Saline Irrigation with Ethanol
* Procedure: transurethral resection of the prostate
* Procedure: photoselective vaporisation of the prostate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in which a TURiS or PVP to be performed Exclusion Criteria: Alcoholics, Patients with severe hepatic impairment, Epilepsy, Existing metabolic acidosis.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transurethral Resection<br>Transurethral Resection of the Prostate in Saline irrigation with ethanol | Drug: Saline Irrigation with Ethanol<br>* Saline Irrigation with Ethanol (alcohol)<br>* Other names: ethanol containinge saline irrigation fluid;Procedure: transurethral resection of the prostate<br>* transurethral electro-resection of the prostate (TURP)<br>* Other names: TURP;|
| Experimental: Photoselective vaporisation<br>Photoselective vaporisation of the Prostate in Saline irrigation with ethanol | Drug: Saline Irrigation with Ethanol<br>* Saline Irrigation with Ethanol (alcohol)<br>* Other names: ethanol containinge saline irrigation fluid;Procedure: photoselective vaporisation of the prostate<br>* photoselective laser-vaporisation of the prostate (PVP)<br>* Other names: PVP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Outcome Measures

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