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

Benign Prostatic Hypertrophy Clinical Trial

— SATURN-P  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02429219
• Other study ID #: MD-URO-00033
• Status: Completed
• Phase: N/A
• First received: February 19, 2015
• Last updated: April 28, 2015
• Start date: November 2013
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: University of Magdeburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients in which a TURiS or PVP to be performed

Exclusion Criteria:

• Alcoholics,

• Patients with severe hepatic impairment,

• Epilepsy,

• Existing metabolic acidosis.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hypertrophy
• Hypertrophy
• Prostatic Hyperplasia

Intervention

Drug:
• Saline Irrigation with Ethanol
Saline Irrigation with Ethanol (alcohol)

Procedure:
• transurethral resection of the prostate
transurethral electro-resection of the prostate (TURP)
• photoselective vaporisation of the prostate
photoselective laser-vaporisation of the prostate (PVP)

Locations

Country	Name	City	State
Germany	Department of Urology University Hospital Otto-von-Guericke-University Magdeburg	Magdeburg	Sachsen-Anhalt

Sponsors (1)

Lead Sponsor	Collaborator
University of Magdeburg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Hermanns T, Grossmann NC, Wettstein MS, Fankhauser CD, Capol JC, Poyet C, Hefermehl LJ, Zimmermann M, Sulser T, Müller A. Absorption of irrigation fluid occurs frequently during high power 532 nm laser vaporization of the prostate. J Urol. 2015 Jan;193(1) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No