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

Sponsor
University of Magdeburg (Other)
Overall Status
Completed
CT.gov ID
NCT02429219
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
15
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Saline Irrigation with Ethanol
  • Procedure: transurethral resection of the prostate
  • Procedure: photoselective vaporisation of the prostate
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Feb 1, 2015
Actual Study Completion Date :
Feb 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients in which a TURiS or PVP to be performed
    Exclusion Criteria:

    • Alcoholics,

    • Patients with severe hepatic impairment,

    • Epilepsy,

    • Existing metabolic acidosis.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Urology University Hospital Otto-von-Guericke-University Magdeburg Magdeburg Sachsen-Anhalt Germany 39120

    Sponsors and Collaborators

    • University of Magdeburg

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johann J. Wendler, MD, Dr. med., University of Magdeburg
    ClinicalTrials.gov Identifier:
    NCT02429219
    Other Study ID Numbers:
    • MD-URO-00033
    First Posted:
    Apr 29, 2015
    Last Update Posted:
    Apr 29, 2015
    Last Verified:
    Apr 1, 2015
    Additional relevant MeSH terms:
    Prostatic Hyperplasia
    Hypertrophy
    Ethanol

    Study Results

    No Results Posted as of Apr 29, 2015