Benign Prostatic HyperplasiaQUAPELLANCT01534793
QUAPELLA (QUAlity of Prostate Enucleation by LUMENIS - Laser)
An observational study of Benign Prostatic Hyperplasia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This observational study aims at describing the learning curve of the Holmium Enucleation of the Prostate (HoLEP) technique using a LUMENIS laser device by senior attending urologists. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Holmium Laser Enucleation of the Prostate (HoLEP)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Jul 2014
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patient presenting low urinary tract symptoms due to benign prostatic hyperplasia
Who may be able to join
- Male patients over 50
- Classification of risk according to the American Society of Anesthesiologists (ASA) score: score 1, 2 or 3
- Protocol accepted by patient (signed informed consent)
- Patient presenting low urinary tract symptoms due to benign prostatic hyperplasia, since at least 3 months, with indication of surgical relief of bladder outlet obstruction , with International prostate symptom score (I-PSS)≥ 12 and a bother score ≥ 3, or full bladder retention, drained by a catheter or suprapubic catheter
- Patient with maximum urinary flow rate ≤ 12mL/s for a voiding volume ≥ 125mLat uroflowmetry, for patients who are not drained
- Prostate weight between 40 and 80 grams
Show all 15Show fewer
- Post void residual volume ≤ 300cc, for patients who are not drained
- Normal renal function
- Non suspect digital rectal examination
- PSA value et blood test £ 4 ng/ml, or negative prostatic biopsies if PSA comprised between 4 and 10 ng/ml for patients with age < 75 and life expectancy > 10 years
- Patient under oral anticoagulation therapy if a therapeutic switch is possible and validated by both the anaesthesiologist and the prescription of the anticoagulation therapy
- Patient under under antiplatelet agents if this treatment can be interrupted without replacement therapy 5 days prior to surgery without any increased risk for the patient safety
- Patient gave informed consent and is not opposed to the use of the data collected during the study for research purpose
- Patient treated by BPH drugs if the duration and type are known, and if the treatment has been stopped before the intervention (one week before surgery for plants and alpha-blockers, one week for 5-alpha reductase inhibitors)
- Patients has valid health insurance/coverage.
Who cannot join
- Patients with unstable known cardiac or pulmonary disease
- Patients with severe myasthenia, multiple sclerosis, Parkinson disease with known bladder or urinary sphincter dysfunction.
- Patient with history of severe pelvic injury having caused severe external urinary sphincter damage.
- Patient with active urinary tract infection
- Patient with urinary catheter or a suprapubic catheter for a reason other than acute urinary retention due to benign prostatic hyperplasia or experiencing no need to urinate after an event filling than 300cc
- Patient with neurogenic disease of the urinary tract
Show all 15Show fewer
- Patient with known or suspected malignant lesion of the bladder or the prostate
- Patient with history of previous prostatic surgery
- Patient with history of bladder stone, major hematuria, urethral stricture, bladder neck stenosis, bladder disease or diabetes with bladder impairment
- Patient with a prosthesis or material in the region potentially affected by the surgical procedure.
- Patient with ano-rectal disease
- Cases where the surgical indication is decided in an emergency context
- Patient with predictable incomplete follow-up
- Patient with coagulation disease or abnormalities not covered by the drugs belonging to the categories cited in inclusion criteria 11 and 12
- All patient condition that the investigator considers as an exclusion criterion
Trial locations and contacts
1 site in 1 country.
France1 site
Service Urologie - Hôpital Tenon
Paris, Île-de-France Region, 75020
About this study
Official title: Observational Study Evaluating the Quality of Laser Enucleation of the Prostate Using a LUMENIS Laser Device
This observational study aims at describing the learning curve of the Holmium Enucleation of the Prostate (HoLEP) technique using a LUMENIS laser device by senior attending urologists.
Read the detailed description
This is a prospective, multicentre observational study studying the learning curve of the HoLEP procedure, through auto-evaluation of the quality of the surgery by senior attending urologists introducing HoLEP in their current clinical practice. This is a single arm, not comparative study. The primary outcome is the ability of each surgeon to perform 4 HoLEP procedures successfully, according to a pre-defined surgical performance scale [varying from 0 to 5]. To be successful, a procedure must be scored 5/5. Each procedure is evaluated at the end of the surgical act by the surgeon himself. As secondary outcomes, the short term efficacy and safety parameters of the HoLEP technique will be evaluated through the following data prospectively collected:
- I-PSS symptom score (15 days before operation, at 6 and 12 months postoperative)
- I-PSS bother score (15 days before operation, at 1, 6 and 12 months postoperative)
- DAN-PSSsex score (15 days before operation, at 6 and 12 months postoperative)Global sexual satisfaction (15 days before operation, at 6 and 12 months postoperative)
- Quality of life score QoL-Europe (15 days before operation, and at 12 months postoperative)
- Urinary flow rate I-PSS symptom score (15 days before operation, at day 0, and at 1, 6 and 12 months postoperative)
- Postvoid residual volume (15 days before operation, at day 0, and at 1, 6 and 12 months postoperative)
- Ultrasound examination of the prostate (15 days before operation, at 6 and 12 months postoperative)
- PSA blood testing (15 days before operation, at 6 and 12 months postoperative)One month post-operative questionnaire at one month post-operative
- Evaluation of adverse events (the day of operation, at 1, 6 and 12 months postoperative)
- Satisfaction of the intervention (at 1 and 12 months postoperative)
- Pathologic examination of the prostate tissue (at 1 months postoperative)
- Blood levels of sodium, haemoglobin, and haematocrit (15 days before intervention, immediately after intervention,)
Time needed for each step of the procedure:
- prostatic capsule contact
- enucleation of the median lobe
- enucleation of the lateral lobes
- hemostasis
- morcellation Laser data (duration, Joules number number of fibers used, fibre type, morcellator ans nephroscope type)
- Tissue weight
- Irrigation volume
- Need for coagulation with another device
- Adverse events during the procedure
- Type of catheter after surgery
- Duration of the catheterization
- Post-operative irrigation (duration, volume, type)
- Hospital stay. The indications of the surgery are the usual indications for bladder outlet obstruction relief in ta context of low urinary tract symptoms due to benign prostatic hyperplasia, as an alternative to the other level 1
- Grade A recommended surgical techniques. The profile of every surgeon will be recorded in terms of surgical experience with age, number of previous endoscopic prostatic surgical procedures, number of laser procedures.
The study design is scheduled as follows:
- Inclusion visit (between D-25 and D-5 before surgery), for inclusion written informed consent as assessment of baseline data
- Surgical intervention (D0): performed as previously described in the literature, with assessment of perioperative data
- One month visit: one month data
- Six month visit: six months data
- One year visit: one year data Statistical analysis will be conducted under SAS9.2 as descriptive analysis for all data, CUSUM technique for main outcome criterion (Altman et al. Stat Med 1988 7 : 629-637 and modelisation of the learning curve.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Holmium Laser Enucleation of the Prostate (HoLEP)
- Keywords
- Quality assessment, Benign Prostatic Hyperplasia, Enucleation of the prostate, LUMENIS, Laser, Learning Curve
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium Laser Enucleation of the Prostate (HoLEP)Procedure or surgery
Under regional or general anaesthesia Urethroscopy to check the location of the prostatic capsule Enucleation of the prostatic lobes (median if present, then lateral lobes)Hemostasis Morcellation Device : LUMENIS Laser
| Study group | Role | What they receive |
|---|---|---|
| HoLEP | Holmium Laser Enucleation of the Prostate Receives: Procedure: Holmium Laser Enucleation of the Prostate (HoLEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the ability of each surgeon to perform 4 HoLEP procedures successfully, according to a pre-defined surgical performance scale [varying from 0 to 5].
The primary outcome is the ability of each surgeon to perform 4 HoLEP procedures successfully, according to a pre-defined surgical performance scale [varying from 0 to 5]. To be successful, a procedure must be scored 5/5. Each procedure is evaluated at the end of the surgical act by the surgeon himself.
Measured: participants will be followed for the duration of the intervention, an expected average of 1 hour
Secondary outcomes (25)
I-PSS symptom score (15 days before operation, at 6 and 12 months postoperative)
Measured: 15 days before operation, at 6 and 12 months postoperative)
I-PSS bother score (15 days before operation, at 1, 6 and 12 months postoperative)
Measured: 15 days before operation, at 1, 6 and 12 months postoperative
DAN-PSSsex score (15 days before operation, at 6 and 12 months postoperative)
Measured: 15 days before operation, at 6 and 12 months postoperative
Global sexual satisfaction (15 days before operation, at 6 and 12 months postoperative)
Measured: 15 days before operation, at 6 and 12 months postoperative
Quality of life score QoL-Europe (15 days before operation, and at 12 months postoperative)
Measured: 15 days before operation, and at 12 months postoperative
Urinary flow rate I-PSS symptom score (15 days before operation, at day 0, and at 1, 6 and 12 months postoperative)
Measured: 15 days before operation, at day 0, and at 1, 6 and 12 months postoperative
Postvoid residual volume (15 days before operation, at day 0, and at 1, 6 and 12 months postoperative)
Measured: 15 days before operation, at day 0, and at 1, 6 and 12 months postoperative
Ultrasound examination of the prostate (15 days before operation, at 6 and 12 months postoperative)
Measured: 15 days before operation, at 6 and 12 months postoperative
PSA blood testing (15 days before operation, at 6 and 12 months postoperative)
Measured: 15 days before operation, at 6 and 12 months postoperative
One month post-operative questionnaire
Measured: at 1 month
Evaluation of adverse events (the day of operation, at 1, 6 and 12 months postoperative)
Measured: the day of operation, at 1, 6 and 12 months postoperative
Satisfaction of the intervention (at 1 and 12 months postoperative)
Measured: at 1 and 12 months postoperative
Pathologic examination of the prostate tissue
Pathologic examination of the prostate tissue (at 1 month postoperative)
Measured: at 1 month postoperative
Blood levels of sodium, haemoglobin, and haematocrit (15 days before intervention, immediately after intervention,)
Measured: 15 days befor intervention, immediately after intervention
Intervention duration
Measured: participants will be followed for the duration of the intervention, an expected average of 1 hour
Time needed for each step of the procedure
Time needed for each step of the procedure:
- prostatic capsule contact
- enucleation of the median lobe
- enucleation of the lateral lobes
- hemostasis
- morcellation
Measured: participants will be followed for the duration of the intervention, an expected average of 1 hour
Laser data
Laser data (duration, Joules number number of fibers used, fibre type, morcellator ans nephroscope type)
Measured: participants will be followed for the duration of the intervention, an expected average of 1 hour
Tissue weight
Measured: participants will be followed for the duration of the intervention, an expected average of 1 hour
Irrigation volume
Measured: participants will be followed for the duration of hospital stay, an expected average of 1,5 days
Need for coagulation with another device
Measured: participants will be followed for the duration of the intervention, an expected average of 1 hour
Adverse events at the day of operation, at 1, 6,12 months post-operative
Measured: the day of operation, at 1, 6,12 months post-operative
Type of catheter at the surgery
Measured: participants will be followed for the duration of the intervention, an expected average of 1 hour
Duration of the catheterization
Measured: participants will be followed for the duration of hospital stay, an expected average of 1,5 days
Post-operative irrigation (duration, volume, type)
Measured: participants will be followed for the duration of hospital stay, an expected average of 1,5 days
Hospital stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 1,5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand LUKACS, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534793
- Sponsor's protocol ID
- K070301 / IC0709
- Other IDs
- 2008-A-00498-47
- Acronym
- QUAPELLA
- Status last verified
- Feb 2015
- First submitted
- 25 Jan 2012
- Last updated
- 25 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Evaluating the Quality of Laser Enucleation of the Prostate Using a LUMENIS Laser Device
- ClinicalTrials.gov ID
- NCT01534793
- Acronym / sponsor ID
- QUAPELLA / K070301 / IC0709
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Quality assessment, Benign Prostatic Hyperplasia, Enucleation of the prostate, LUMENIS, Laser, Learning Curve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 17 Feb 2012 (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.
This observational study aims at describing the learning curve of the Holmium Enucleation of the Prostate (HoLEP) technique using a LUMENIS laser device by senior attending urologists.
Detailed description
This is a prospective, multicentre observational study studying the learning curve of the HoLEP procedure, through auto-evaluation of the quality of the surgery by senior attending urologists introducing HoLEP in their current clinical practice. This is a single arm, not comparative study. The primary outcome is the ability of each surgeon to perform 4 HoLEP procedures successfully, according to a pre-defined surgical performance scale [varying from 0 to 5]. To be successful, a procedure must be scored 5/5. Each procedure is evaluated at the end of the surgical act by the surgeon himself. As secondary outcomes, the short term efficacy and safety parameters of the HoLEP technique will be evaluated through the following data prospectively collected:
- I-PSS symptom score (15 days before operation, at 6 and 12 months postoperative)
- I-PSS bother score (15 days before operation, at 1, 6 and 12 months postoperative)
- DAN-PSSsex score (15 days before operation, at 6 and 12 months postoperative)Global sexual satisfaction (15 days before operation, at 6 and 12 months postoperative)
- Quality of life score QoL-Europe (15 days before operation, and at 12 months postoperative)
- Urinary flow rate I-PSS symptom score (15 days before operation, at day 0, and at 1, 6 and 12 months postoperative)
- Postvoid residual volume (15 days before operation, at day 0, and at 1, 6 and 12 months postoperative)
- Ultrasound examination of the prostate (15 days before operation, at 6 and 12 months postoperative)
- PSA blood testing (15 days before operation, at 6 and 12 months postoperative)One month post-operative questionnaire at one month post-operative
- Evaluation of adverse events (the day of operation, at 1, 6 and 12 months postoperative)
- Satisfaction of the intervention (at 1 and 12 months postoperative)
- Pathologic examination of the prostate tissue (at 1 months postoperative)
- Blood levels of sodium, haemoglobin, and haematocrit (15 days before intervention, immediately after intervention,)
Time needed for each step of the procedure:
- prostatic capsule contact
- enucleation of the median lobe
- enucleation of the lateral lobes
- hemostasis
- morcellation Laser data (duration, Joules number number of fibers used, fibre type, morcellator ans nephroscope type)
- Tissue weight
- Irrigation volume
- Need for coagulation with another device
- Adverse events during the procedure
- Type of catheter after surgery
- Duration of the catheterization
- Post-operative irrigation (duration, volume, type)
- Hospital stay. The indications of the surgery are the usual indications for bladder outlet obstruction relief in ta context of low urinary tract symptoms due to benign prostatic hyperplasia, as an alternative to the other level 1
- Grade A recommended surgical techniques. The profile of every surgeon will be recorded in terms of surgical experience with age, number of previous endoscopic prostatic surgical procedures, number of laser procedures.
The study design is scheduled as follows:
- Inclusion visit (between D-25 and D-5 before surgery), for inclusion written informed consent as assessment of baseline data
- Surgical intervention (D0): performed as previously described in the literature, with assessment of perioperative data
- One month visit: one month data
- Six month visit: six months data
- One year visit: one year data Statistical analysis will be conducted under SAS9.2 as descriptive analysis for all data, CUSUM technique for main outcome criterion (Altman et al. Stat Med 1988 7 : 629-637 and modelisation of the learning curve.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HoLEP | – | Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)Holmium Laser Enucleation of the Prostate |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient presenting low urinary tract symptoms due to benign prostatic hyperplasia
Key inclusion criteria (15 listed)
- Male patients over 50
- Classification of risk according to the American Society of Anesthesiologists (ASA) score: score 1, 2 or 3
- Protocol accepted by patient (signed informed consent)
- Patient presenting low urinary tract symptoms due to benign prostatic hyperplasia, since at least 3 months, with indication of surgical relief of bladder outlet obstruction , with International prostate symptom score (I-PSS)≥ 12 and a bother score ≥ 3, or full bladder retention, drained by a catheter or suprapubic catheter
- Patient with maximum urinary flow rate ≤ 12mL/s for a voiding volume ≥ 125mLat uroflowmetry, for patients who are not drained
Key exclusion criteria (15 listed)
- Patients with unstable known cardiac or pulmonary disease
- Patients with severe myasthenia, multiple sclerosis, Parkinson disease with known bladder or urinary sphincter dysfunction.
- Patient with history of severe pelvic injury having caused severe external urinary sphincter damage.
- Patient with active urinary tract infection
- Patient with urinary catheter or a suprapubic catheter for a reason other than acute urinary retention due to benign prostatic hyperplasia or experiencing no need to urinate after an event filling than 300cc
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 |
|---|---|---|
| Holmium Laser Enucleation of the Prostate (HoLEP)Under regional or general anaesthesia Urethroscopy to check the location of the prostatic capsule Enucleation of the prostatic lobes (median if present, then lateral lobes)Hemostasis Morcellation Device : LUMENIS Laser | Procedure or surgery | HoLEP |
Primary outcome
The primary outcome is the ability of each surgeon to perform 4 HoLEP procedures successfully, according to a pre-defined surgical performance scale [varying from 0 to 5].
Time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour
The primary outcome is the ability of each surgeon to perform 4 HoLEP procedures successfully, according to a pre-defined surgical performance scale [varying from 0 to 5]. To be successful, a procedure must be scored 5/5. Each procedure is evaluated at the end of the surgical act by the surgeon himself.
25 secondary outcomes
I-PSS symptom score (15 days before operation, at 6 and 12 months postoperative)
Time frame: 15 days before operation, at 6 and 12 months postoperative)
I-PSS bother score (15 days before operation, at 1, 6 and 12 months postoperative)
Time frame: 15 days before operation, at 1, 6 and 12 months postoperative
DAN-PSSsex score (15 days before operation, at 6 and 12 months postoperative)
Time frame: 15 days before operation, at 6 and 12 months postoperative
Global sexual satisfaction (15 days before operation, at 6 and 12 months postoperative)
Time frame: 15 days before operation, at 6 and 12 months postoperative
Quality of life score QoL-Europe (15 days before operation, and at 12 months postoperative)
Time frame: 15 days before operation, and at 12 months postoperative
Urinary flow rate I-PSS symptom score (15 days before operation, at day 0, and at 1, 6 and 12 months postoperative)
Time frame: 15 days before operation, at day 0, and at 1, 6 and 12 months postoperative
Postvoid residual volume (15 days before operation, at day 0, and at 1, 6 and 12 months postoperative)
Time frame: 15 days before operation, at day 0, and at 1, 6 and 12 months postoperative
Ultrasound examination of the prostate (15 days before operation, at 6 and 12 months postoperative)
Time frame: 15 days before operation, at 6 and 12 months postoperative
PSA blood testing (15 days before operation, at 6 and 12 months postoperative)
Time frame: 15 days before operation, at 6 and 12 months postoperative
One month post-operative questionnaire
Time frame: at 1 month
Evaluation of adverse events (the day of operation, at 1, 6 and 12 months postoperative)
Time frame: the day of operation, at 1, 6 and 12 months postoperative
Satisfaction of the intervention (at 1 and 12 months postoperative)
Time frame: at 1 and 12 months postoperative
Pathologic examination of the prostate tissue
Time frame: at 1 month postoperative
Blood levels of sodium, haemoglobin, and haematocrit (15 days before intervention, immediately after intervention,)
Time frame: 15 days befor intervention, immediately after intervention
Intervention duration
Time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour
Time needed for each step of the procedure
Time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour
Laser data
Time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour
Tissue weight
Time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour
Irrigation volume
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days
Need for coagulation with another device
Time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour
Adverse events at the day of operation, at 1, 6,12 months post-operative
Time frame: the day of operation, at 1, 6,12 months post-operative
Type of catheter at the surgery
Time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour
Duration of the catheterization
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days
Post-operative irrigation (duration, volume, type)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days
Hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days
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 25 Feb 2015.
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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.
Bertrand LUKACS, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 15 inclusion and 15 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 25 Feb 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 France. 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?
The primary outcome is the ability of each surgeon to perform 4 HoLEP procedures successfully, according to a pre-defined surgical performance scale [varying from 0 to 5]. (time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2015.