Benign Prostatic HypertrophySATURN-PNCT02429219
Saline With Alcohol in TransUrethral Resection aNd Photoselective Vaporisation of the Prostate
A study testing Saline Irrigation with Ethanol, transurethral resection of the prostate and photoselective vaporisation of the prostate in people with Benign Prostatic Hypertrophy, run by University of Magdeburg at 1 site in Germany.
Trial summary
Transurethral therapy (TURiS / PVP) of benign prostatic hyperplasia (BPH) using an ethanol-containing saline irrigating fluid, prospective detected by breath alcohol measurement. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Benign Prostatic Hypertrophy
- What is being tested?
- Saline Irrigation with Ethanol, transurethral resection of the prostate and photoselective vaporisation of the prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients in which a TURiS or PVP to be performed
Who cannot join
- Alcoholics,
- Patients with severe hepatic impairment,
- Epilepsy,
- Existing metabolic acidosis.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Urology University Hospital Otto-von-Guericke-University Magdeburg
Magdeburg, Saxony-Anhalt, 39120
About this study
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
Transurethral therapy (TURiS / PVP) of benign prostatic hyperplasia (BPH) using an ethanol-containing saline irrigating fluid, prospective detected by breath alcohol measurement.
Read the 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.
- Conditions
- Benign Prostatic Hypertrophy
- Being tested
- Saline Irrigation with Ethanol, transurethral resection of the prostate, photoselective vaporisation of the prostate
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline Irrigation with EthanolDrug
Also called ethanol containinge saline irrigation fluid
Saline Irrigation with Ethanol (alcohol)
transurethral resection of the prostateProcedure or surgery
Also called TURP
transurethral electro-resection of the prostate (TURP)
photoselective vaporisation of the prostateProcedure or surgery
Also called PVP
photoselective laser-vaporisation of the prostate (PVP)
| Study group | Role | What they receive |
|---|---|---|
| Transurethral Resection | Active comparator | Transurethral Resection of the Prostate in Saline irrigation with ethanol Receives: Drug: Saline Irrigation with Ethanol; Procedure: transurethral resection of the prostate |
| Photoselective vaporisation | Experimental | Photoselective vaporisation of the Prostate in Saline irrigation with ethanol Receives: Drug: Saline Irrigation with Ethanol; Procedure: photoselective vaporisation of the prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
Surgical abortion with significant Absorption of irrigation fluid
If a significant amount if Irrigation fluid is absorbed (>1,5l), the procedure will be aborted
Measured: Surgery will be last on average 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startNov 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johann J. Wendler, MD, University of Magdeburg
- Investigators
- Markus Porsch, MD, Principal investigator, Urologic Faculty University Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429219
- Sponsor's protocol ID
- MD-URO-00033
- Acronym
- SATURN-P
- Status last verified
- Apr 2015
- First submitted
- 19 Feb 2015
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hermanns T, Grossmann NC, Wettstein MS, Fankhauser CD, Capol JC, Poyet C, Hefermehl LJ, Zimmermann M, Sulser T, Muller A. Absorption of irrigation fluid occurs frequently during high power 532 nm laser vaporization of the prostate. J Urol. 2015 Jan;193(1):211-6. doi: 10.1016/j.juro.2014.07.117. Epub 2014 Aug 7.
PubMed 25108273
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02429219
- Acronym / sponsor ID
- SATURN-P / MD-URO-00033
- Conditions
- Benign Prostatic Hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transurethral therapy (TURiS / PVP) of benign prostatic hyperplasia (BPH) using an ethanol-containing saline irrigating fluid, prospective detected by breath alcohol measurement.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transurethral Resection | Active comparator | Drug: Saline Irrigation with Ethanol, Procedure: transurethral resection of the prostateTransurethral Resection of the Prostate in Saline irrigation with ethanol |
| Photoselective vaporisation | Experimental | Drug: Saline Irrigation with Ethanol, Procedure: photoselective vaporisation of the prostatePhotoselective vaporisation of the Prostate in Saline irrigation with ethanol |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in which a TURiS or PVP to be performed
Key exclusion criteria (4 listed)
- Alcoholics,
- Patients with severe hepatic impairment,
- Epilepsy,
- Existing metabolic acidosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline Irrigation with EthanolAlso: ethanol containinge saline irrigation fluidSaline Irrigation with Ethanol (alcohol) | Drug | Photoselective vaporisation, Transurethral Resection |
| transurethral resection of the prostateAlso: TURPtransurethral electro-resection of the prostate (TURP) | Procedure or surgery | Transurethral Resection |
| photoselective vaporisation of the prostateAlso: PVPphotoselective laser-vaporisation of the prostate (PVP) | Procedure or surgery | Photoselective vaporisation |
Primary outcome
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.
1 secondary outcome
Surgical abortion with significant Absorption of irrigation fluid
Time frame: Surgery will be last on average 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
- Results publication: PubMed 25108273Hermanns T, Grossmann NC, Wettstein MS, Fankhauser CD, Capol JC, Poyet C, Hefermehl LJ, Zimmermann M, Sulser T, Muller A. Absorption of irrigation fluid occurs frequently during high power 532 nm laser vaporization of the prostate. J Urol. 2015 Jan;193(1):211-6. doi: 10.1016/j.juro.2014.07.117. Epub 2014 Aug 7.
Related trials for Benign Prostatic Hypertrophy
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Porsch, MD principal investigator
Urologic Faculty University Magdeburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline Irrigation with Ethanol, transurethral resection of the prostate and photoselective vaporisation of the prostate in people with Benign Prostatic Hypertrophy, run by University of Magdeburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02429219, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.