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.
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.
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.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- 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 group | Role | What they receive |
|---|---|---|
| patients with BPH undergoing TUV-P | patients with Benign Prostatic Hyperplasia undergoing TUV-P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absorption volume of irrigation fluid during the Thulium laser TUV-P
Measured: shortly after Thulium laser TUV-P
Secondary outcomes (11)
Duration of surgery
Measured: at time of start and of end of surgery
Does absorption of irrigation fluid occur?
yes: any detection of alcohol in the expired breath
Measured: at time of surgery
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
Amount of laser energy used intraoperatively (kilojoules)
Measured: at time of end of surgery
Pre- to postoperative changes in serum biochemical and haematological variables (creatinin, sodium, potassium, chloride), venous pH, haemoglobin
Measured: 30 min after intervention
Pre- to postoperative changes in flow and residual urine
Measured: 12 weeks after intervention
Total irrigation volume and volume of all administered i.v. fluids
Measured: at time of end of surgery
Duration of hospitalization post procedure
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 week
Duration of post procedure catheterization
Measured: at time of end of catheterization, an expected average of 48 hrs
Pre- to postoperative changes in the IPSS
Measured: 12 weeks after intervention
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.
- First posted2 Dec 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2015
- Study completionFeb 2016
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 Hyperplasia (BPH)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Stephan Engeler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Stephan Engeler, Cantonal Hospital of St. Gallen
- Investigators
- Daniel Engeler, MD, Study chair, Cantonal Hospital of St. Gallen
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02304549
- Acronym / sponsor ID
- CTU 14.012
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Daniel Stephan EngelerUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 2 Dec 2014 (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.
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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with BPH undergoing TUV-P | – | –patients with Benign Prostatic Hyperplasia undergoing TUV-P |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with benign prostatic hyperplasia undergoing TUV-P
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Mild symptoms (IPSS <8)
- Urethral stenosis
- Bladder diverticulum (>100ml)
- Former alcoholic or chronic liver disease
- Alcohol consumption 24h before operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Absorption volume of irrigation fluid during the Thulium laser TUV-P
Time frame: shortly after Thulium laser TUV-P
11 secondary outcomes
Duration of surgery
Time frame: at time of start and of end of surgery
Does absorption of irrigation fluid occur?
Time frame: at time of surgery
Assessment of bleeding and relevant intraoperative events (capsular perforation, injury to prostatic sinuses or deep bladder neck incision) by the surgeon
Time frame: at time of surgery
Amount of laser energy used intraoperatively (kilojoules)
Time frame: at time of end of surgery
Pre- to postoperative changes in serum biochemical and haematological variables (creatinin, sodium, potassium, chloride), venous pH, haemoglobin
Time frame: 30 min after intervention
Pre- to postoperative changes in flow and residual urine
Time frame: 12 weeks after intervention
Total irrigation volume and volume of all administered i.v. fluids
Time frame: at time of end of surgery
Duration of hospitalization post procedure
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 week
Duration of post procedure catheterization
Time frame: at time of end of catheterization, an expected average of 48 hrs
Pre- to postoperative changes in the IPSS
Time frame: 12 weeks after intervention
Pre- to postoperative changes in bladder diary
Time frame: 12 weeks after intervention
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 2 Feb 2016.
- Background: PubMed 25903582Mordasini 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.
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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.
Daniel Engeler, MD study chair
Cantonal Hospital of St. Gallen
1 site in 1 country: see every site and its status.
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.