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Benign Prostatic Hyperplasia (BPH)NCT02304549

A Prospective Investigation Using the Expired Breath Ethanol Test

An observational study of Benign Prostatic Hyperplasia (BPH), run by Daniel Stephan Engeler at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Benign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older than 60 years.In cases with moderate to severe lower urinary tract symptoms (LUTS) monopolar transurethral resection of the prostate (TUR-P) is the standard treatment. Read more about this study

Who is it for?
Ages 40 years and older, men only
Conditions the study is for
Benign Prostatic Hyperplasia (BPH)
How many people
57 participants
Where
1 siteSwitzerland
Study dates
Apr 2014to Feb 2016
Phase
Observational
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 40 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: patients with benign prostatic hyperplasia undergoing TUV-P

Who may be able to join

  • Men older than 40
  • Patient must be a candidate for TUV-P
  • Refractory to medical therapy or patient is not willing to consider (further) medical treatment
  • Written informed consent

Who cannot join

  • Mild symptoms (IPSS <8)
  • Urethral stenosis
  • Bladder diverticulum (>100ml)
  • Former alcoholic or chronic liver disease
  • Alcohol consumption 24h before operation

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Cantonal Hospital St. Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

About this study

Official title: Is Absorption of Irrigation Fluid a Problem in Thulium Laser Vaporization of the Prostate? A Prospective Investigation Using the Expired Breath Ethanol Test.

Benign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older than 60 years.In cases with moderate to severe lower urinary tract symptoms (LUTS) monopolar transurethral resection of the prostate (TUR-P) is the standard treatment. Especially in frail patients, conventional TUR-P is associated with relevant and potentially deleterious complications, e.g. TUR syndrome. Using isotonic saline, like in bipolar TUR-P and transurethral laser vaporization (TUV-P), TUR syndrome can be prevented.

The short-term complication rate with the Thulium laser is similar to the rate described after vaporisation with other laser systems18-23 and less than that with TUR-P.

Read more

Despite recent publications on the safety and complications with Thulium vaporisation of the prostate, to the investigators knowledge, until now, no prospective trial has directly assessed, whether absorption of irrigation fluid occurs and to what extent in Thulium Laser vaporisation of the prostate.

The investigators therefore aim to investigate if absorption of irrigation fluid occurs during Thulium Laser vaporisation of the prostate by expired breath ethanol test.

Read the detailed description

Benign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older than 60 years.3 The clinical picture of the disease includes lower urinary tract symptoms such as interrupted and weak urinary stream, nocturia, urgency and leaking and even sexual dysfunction in some individuals. Medical therapy is usually the first-line treatment. However, the efficacy of drugs like alpha-blockers is limited, and as disease progresses more invasive treatment options have to be taken into consideration.

In cases with moderate to severe lower urinary tract symptoms (LUTS) monopolar transurethral resection of the prostate (TUR-P) is the standard treatment. Especially in frail patients, conventional TUR-P is associated with relevant and potentially deleterious complications.

The proportion of elderly patients on anticoagulation or antiplatelet therapy with cardial comorbidities increases. Especially major bleeding and transurethral resection syndrome (TUR syndrome) put these high-risk patients at a relevant perioperative risk.

TUR syndrome is caused by absorption of electrolyte-free irrigating fluid (which has to be used in monopolar TUR-P), and consists of symptoms from the circulatory and nervous systems. Mild forms are common and often go undiagnosed, while severe forms of the TUR syndrome are potentially life-threatening.

Using isotonic saline, like in bipolar TUR-P and transurethral laser vaporization (TUV-P), TUR syndrome can be prevented. Moreover, these techniques were thought to completely prevent influx of irrigation fluid into the vascular system due to their excellent coagulation properties.

However, the Zürich study group has demonstrated that in bipolar resection of the prostate and with the Greenlight-Laser, significant intraoperative fluid absorption can occur. The authors emphasized, that care must be taken if using this procedures in patients with significant cardiovascular comorbidities, as large volume influx in patients with significant cardiac comorbidities could result in dangerous complications.

Ethanol monitoring was first used in the late 1980's as an alternative to traditional methods of measuring fluid absorption (i.e. measuring volumetric fluid balance and serum sodium concentration). These techniques, however, are bothersome and must be carried out meticulously to yield a valid figure of absorption. If a tracer amount of ethanol is added to the irrigation fluid, the volume of fluid absorbed can be estimated from the amount of ethanol measured in the patients' exhaled breath.

The expired-breath ethanol technique is an established method of investigating intra operative absorption of irrigation fluid. Ethanol 1% is added to conventional isotonic 0.9% saline for use as intra-operative irrigation. The absorption of irrigation fluid can be estimated by measuring the end-expiratory ethanol concentrations with an alcometer.

During the last years, the Thulium laser has emerged as an alternative to other types of lasers, combining the best features for performing vaporisation techniques: Thulium laser has a wavelength of 2013 nm, and its target chromophore is water. The energy of the Thulium laser has a high tissue absorption rate, producing effective vaporisation with scant depth in the remaining tissue. As the properties of water remain unaltered until it reaches boiling point, the effect of the laser on the tissue remains constant throughout the surgical procedure.

The short-term complication rate with the Thulium laser is similar to the rate described after vaporisation with other laser systems and less than that with TUR-P. Thus, Thulium vaporisation of prostate has established as a standard procedure in many urological departments including ours.

Despite recent publications on the safety and complications with Thulium vaporisation of the prostate, to the investigators knowledge, until now, no prospective trial has directly assessed, whether absorption of irrigation fluid occurs and to what extent in Thulium Laser vaporisation of the prostate.

The investigators therefore aim to investigate if absorption of irrigation fluid occurs during Thulium Laser vaporisation of the prostate by expired breath ethanol test.

Medical subject headings
Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02304549
Study groupRoleWhat they receive
patients with BPH undergoing TUV-Ppatients with Benign Prostatic Hyperplasia undergoing TUV-P

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absorption volume of irrigation fluid during the Thulium laser TUV-P

    Measured: shortly after Thulium laser TUV-P

Secondary outcomes (11)
  1. Duration of surgery

    Measured: at time of start and of end of surgery

  2. Does absorption of irrigation fluid occur?

    yes: any detection of alcohol in the expired breath

    Measured: at time of surgery

  3. Assessment of bleeding and relevant intraoperative events (capsular perforation, injury to prostatic sinuses or deep bladder neck incision) by the surgeon

    Measured: at time of surgery

  4. Amount of laser energy used intraoperatively (kilojoules)

    Measured: at time of end of surgery

  5. Pre- to postoperative changes in serum biochemical and haematological variables (creatinin, sodium, potassium, chloride), venous pH, haemoglobin

    Measured: 30 min after intervention

  6. Pre- to postoperative changes in flow and residual urine

    Measured: 12 weeks after intervention

  7. Total irrigation volume and volume of all administered i.v. fluids

    Measured: at time of end of surgery

  8. Duration of hospitalization post procedure

    Measured: participants will be followed for the duration of hospital stay, an expected average of 1 week

  9. Duration of post procedure catheterization

    Measured: at time of end of catheterization, an expected average of 48 hrs

  10. Pre- to postoperative changes in the IPSS

    Measured: 12 weeks after intervention

  11. Pre- to postoperative changes in bladder diary

    Measured: 12 weeks after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionNov 2015
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02304549
Sponsor's protocol ID
CTU 14.012
Status last verified
Feb 2016
First submitted
17 Nov 2014
Last updated
2 Feb 2016
Results posted
No
Data monitoring committee
No

Publications

  • Mordasini L, Abt D, Mullhaupt G, Engeler DS, Luthi A, Schmid HP, Schwab C. Is absorption of irrigation fluid a problem in Thulium laser vaporization of the prostate? A prospective investigation using the expired breath ethanol test. BMC Urol. 2015 Apr 24;15:35. doi: 10.1186/s12894-015-0029-2.

    PubMed 25903582

Questions about this trial

What is this clinical trial studying?

An observational study of Benign Prostatic Hyperplasia (BPH), run by Daniel Stephan Engeler at 1 site in Switzerland.

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 4 inclusion and 5 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 2 Feb 2016. 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 Switzerland. 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?

Absorption volume of irrigation fluid during the Thulium laser TUV-P (time frame: shortly after Thulium laser TUV-P). 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 NCT02304549, 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 2 Feb 2016.

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