Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02429219
Other study ID # MD-URO-00033
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT02509975 - Safety and Efficacy of OCL 503 in Prostate Artery Embolization N/A
Completed NCT01177436 - Prostate Cancer Antigen 3 (PCA-3) Gene Project N/A
Completed NCT05082142 - Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP) Phase 4
Completed NCT01260129 - Safety and Efficacy of QD Versus BID Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH Phase 4
Completed NCT00771394 - Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia Phase 4
Active, not recruiting NCT03630926 - Evaluation of the NV-VPAC1 Prostate Cancer (PCa) Urine Diagnostic Test in Subjects With Biopsy-confirmed Prostate Cancer, Benign Prostatic Hypertrophy, or Bladder/Kidney Stones.
Completed NCT01342562 - The Effects of Intrathecal Dexmedetomidine on Spinal Anesthesia Using Diluted Low-Dose Bupivacaine for Transurethral Resection of Prostate in Elderly N/A
Completed NCT00382356 - Dutasteride After Failure of Finasteride In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H) N/A
Completed NCT00029822 - Clinical Trial in Males With BPH (Enlarged Prostate) Phase 3
Completed NCT05308017 - Wolf 24 F vs. Storz 28 F Laser Sheath Size for HoLEP N/A
Completed NCT00663858 - Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH) Phase 3
Completed NCT00670306 - Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH) Phase 3
Terminated NCT00449150 - Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH) Phase 3
Completed NCT00037141 - Safety/Tolerability Study of Alcohol Injection for Treatment of BPH (Enlarged Prostate) Phase 1/Phase 2
Suspended NCT02533687 - Comparison of Different Energy Sources During TUR-P N/A
Completed NCT00427219 - The Safety and Efficacy of Ozarelix to Treat Men With Lower Urinary Tract Symptoms Due to Enlargement of the Prostate Phase 2
Completed NCT04781049 - Transperineal Laser Ablation vs Transurethral Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial N/A
Completed NCT02051036 - Moxibustion as an Adjuvant for Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms: a Pilot Study N/A
Completed NCT00634608 - Integrating Targeted MedlinePlus Health Prescriptions Into Clinic Practice Workflow N/A
Completed NCT02401581 - Feasibility Study of Photovaporisation of Prostate With a Limitated Length of Catheterization of 3 Hours N/A