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

April 28, 2015 updated by: Johann J. Wendler, MD, University of Magdeburg

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
        • Department of Urology University Hospital Otto-von-Guericke-University Magdeburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
last breath alcohol measurement
Time Frame: 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.
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
Time Frame: Surgery will be last on average 1 hour
If a significant amount if Irrigation fluid is absorbed (>1,5l), the procedure will be aborted
Surgery will be last on average 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Magdeburg

Investigators

  • Principal Investigator: Markus Porsch, MD, Urologic Faculty University Magdeburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-URO-00033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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