Benign Prostatic HypertrophyPRECOCENCT02401581
Feasibility Study of Photovaporisation of Prostate With a Limitated Length of Catheterization of 3 Hours
A study testing Catheter in people with Benign Prostatic Hypertrophy, run by Centre Hospitalier Universitaire de Nice at 12 sites in France.
Trial summary
Benign hypertrophy of the prostate (BPH) is the most frequent pathology in the urinary tract of middle-aged men. In recent years, to enable BPH treatment with larger volumes and to reduce the risk of hemorrhage known to be associated to the transurethral resection of prostate treatment, transurethral photovaporisation… Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hypertrophy
- What is being tested?
- Catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 12 sitesFrance
- Study dates
- 2 Feb 2015to 8 Jun 2021
- 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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with lower urinary tract symptoms (LUTS )
- IPSS≥ 15 despite medical treatment > 1 month if monotherapy or > 3 months if bitherapie OR acute urinary retention ( RAU ) non-medical after the 1st failure to remove the catheter OR acute prostatitis OR macroscopic haematuria of prostatic origin
- prostate volume > 30 cc by transrectal ultrasonography ;
- IPSS Qol ≥ 3 has at inclusion ;
- PSA ≤ 4 ng / ml ;
- if PSA between 4 and 10 then PSA L/T ≥25 % or negative PBP <6 months .
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- Accommodation <50 km;
- company available for the return at home and monitoring first post- operative night .
- patient sign the informed consent
- patient covered by social security or other health insurance
Who cannot join
- post- voiding residue > 250 cc by suprapubic ultrasound not older than < 45 days
- prostate volume > 100 cc by transrectal ultrasound not older than 45 days
- urological antecedents : o urethral stenosis or cervical disease
- UTI in progress
- SAD patient or self-catheterization
- obstructive hydronephrosis + / - renal failure
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- vesical calculi
- cancer of the prostate treated or untreated
- bladder tumor associated
- Interstitial cystitis ( symptom or biopsy)
- antecedent of the prostate surgery
- neurologic bladder ( parkinsonian syndrome , multiple sclerosis , lupus, neuropathy, Diabetic, cauda equina syndrome )
- criteria related concomitant medications that can not be stopped at least < 48 hours before PVP with GL XPS 180 W
- contra indication for outpatient care for medical reason
- contra indication of a product analgesic according to protocol
- patient inability to understand and sign the informed consent as well as completing the questionnaires
- ASA Score > 3 .
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
CHU Brest Urologie
Brest, 2609
CH Grasse - urologie
Grasse, Alpes-maritimes, 06130
CHU Grenoble
Grenoble, 38043
CHU Limoges -Urologie - Hôpital Dupuytren
Limoges, 87042
APHM - Urologie - Hôpital Conception
Marseille, PACA, 13005
CHU de Nice - Urologie
Nice, Alpes-Maritimes, 06200
AP-HP - Urologie Hôpital Tenon
Paris, Île-de-France Region, 75020
Institut Mutualiste Monsouris urologie
Paris, Île-de-France Region, 75674
Polyclinique les Bleuets
Reims, 51726
CHU Rennes
Rennes, 51726
CH privé St Brieuc
Saint-Brieuc, Cote D'armor, 22003
CHRU Tours
Tours, Vendée, 37 044
About this study
Official title: Study ¨PRECOCE Feasibility Study of Photovaporisation of Prostate With a Limitated Length of Catheterization of 3 Hours
Benign hypertrophy of the prostate (BPH) is the most frequent pathology in the urinary tract of middle-aged men. In recent years, to enable BPH treatment with larger volumes and to reduce the risk of hemorrhage known to be associated to the transurethral resection of prostate treatment, transurethral photovaporisation of the prostate (PVP ) with the GreenLight (GL) XPS 180 W was developed. Therefore, the question arises to maximally reduce the length of catheterization to facilitate outpatient surgical management of prostate adenoma.
In the investigators study, the investigators propose to evaluate the failure rate of an early removal of the catheter 3 hours post-operative after a PVP procedure with GL 180 W/XPS in selected patients on general anesthesia or spinal anesthesia. To this end, the investigators realize a national multicenter prospective study including 300 patients. The effectiveness of this model of management is defined by absence of a need for re-catheterization in the post -operative period of 24 hours.
- Conditions
- Benign Prostatic Hypertrophy
- Being tested
- Catheter
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CatheterOther
The effectiveness of this model of management is defined by absence of a need for re-catheterization in the post -operative period of 24 hours, indications for resondage being cases of acute urinary retention (AUR ) or macroscopic hematuria necessitating a washes with drainage . Patients are followed for a period of 3 months with a post-operative visit at 30 days and a last follow-up visit at 90 days during which the effectiveness is evaluated by conventional means of clinical indicators ( flowmetry , postvoid residue, volumetry of the prostate , IPSS scores , QoL , EVA, IIEF ... ).
| Study group | Role | What they receive |
|---|---|---|
| rate of early removal of the catheter | Experimental | In our study, we propose to evaluate the failure rate of an early removal of the catheter 3 hours post-operative after a PVP procedure with GL 180 W/XPS in selected patients on general anesthesia or spinal anesthesia for limiting autonomic effects on the bladder and ensure fastest possible recovery of voiding . Receives: Other: Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure rate of a limited catheterization duration of 3 hours post- operative
- The failure rate of a limited catheterization duration of 3 hours post- operative is defined by a need of recatheterizatrion within 24 hours post- GL with PVP XPS 180W . The catheterization remains indicated in case of macroscopic hematuria RAU or if no natural urination is possible
Measured: at three hours post surgery
Secondary outcomes (2)
Total dose of energy
The total dose of energy delivered to the tissue induring the intervention will be expressed and collected by means of the instrumentation of the GL-XPS console.
Measured: during 24 hours hospitalisation
The duration of recatherization
The duration of recatherization is regarded as the total cumulative duration of catheterization regardless of the number of attempts for removale when it is a failure. The average duration of resondage counts only recatheterizations occurring in the first week which may be considered as due to PVP with GL XPS 180W followed by a shortened catheterization of 3 hours post- operatively . The duration of recatherization is defined from the time when it was done in thefirst week post- operative until urinary recovery
Measured: during 24 hours hospitalisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study start2 Feb 2015
- Primary completion21 Aug 2019
- Study completion8 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HypertrophyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DURAND Matthieu, Ph, Principal investigator, Service d'Urologie, CHU de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401581
- Sponsor's protocol ID
- 14-PP-07
- Acronym
- PRECOCE
- Status last verified
- Sep 2021
- First submitted
- 1 Dec 2014
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study ¨PRECOCE Feasibility Study of Photovaporisation of Prostate With a Limitated Length of Catheterization of 3 Hours
- ClinicalTrials.gov ID
- NCT02401581
- Acronym / sponsor ID
- PRECOCE / 14-PP-07
- Conditions
- Benign Prostatic Hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- 21 Aug 2019 (actual)
- Study completion
- 8 Jun 2021 (actual)
- First posted
- 30 Mar 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.
Benign hypertrophy of the prostate (BPH) is the most frequent pathology in the urinary tract of middle-aged men. In recent years, to enable BPH treatment with larger volumes and to reduce the risk of hemorrhage known to be associated to the transurethral resection of prostate treatment, transurethral photovaporisation of the prostate (PVP ) with the GreenLight (GL) XPS 180 W was developed. Therefore, the question arises to maximally reduce the length of catheterization to facilitate outpatient surgical management of prostate adenoma.
In the investigators study, the investigators propose to evaluate the failure rate of an early removal of the catheter 3 hours post-operative after a PVP procedure with GL 180 W/XPS in selected patients on general anesthesia or spinal anesthesia. To this end, the investigators realize a national multicenter prospective study including 300 patients. The effectiveness of this model of management is defined by absence of a need for re-catheterization in the post -operative period of 24 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rate of early removal of the catheter | Experimental | Other: CatheterIn our study, we propose to evaluate the failure rate of an early removal of the catheter 3 hours post-operative after a PVP procedure with GL 180 W/XPS in selected patients on general anesthesia or spinal anesthesia for limiting autonomic effects on the bladder and ensure fastest possible recovery of voiding . |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- patients with lower urinary tract symptoms (LUTS )
- IPSS≥ 15 despite medical treatment > 1 month if monotherapy or > 3 months if bitherapie OR acute urinary retention ( RAU ) non-medical after the 1st failure to remove the catheter OR acute prostatitis OR macroscopic haematuria of prostatic origin
- prostate volume > 30 cc by transrectal ultrasonography ;
- IPSS Qol ≥ 3 has at inclusion ;
- PSA ≤ 4 ng / ml ;
Key exclusion criteria (17 listed)
- post- voiding residue > 250 cc by suprapubic ultrasound not older than < 45 days
- prostate volume > 100 cc by transrectal ultrasound not older than 45 days
- urological antecedents : o urethral stenosis or cervical disease
- antecedent of the prostate surgery
- neurologic bladder ( parkinsonian syndrome , multiple sclerosis , lupus, neuropathy, Diabetic, cauda equina syndrome )
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 |
|---|---|---|
| CatheterThe effectiveness of this model of management is defined by absence of a need for re-catheterization in the post -operative period of 24 hours, indications for resondage being cases of acute urinary retention (AUR ) or macroscopic hematuria necessitating a washes with drainage . Patients are followed for a period of 3 months with a post-operative visit at 30 days and a last follow-up visit at 90 days during which the effectiveness is evaluated by conventional means of clinical indicators ( flowmetry , postvoid residue, volumetry of the prostate , IPSS scores , QoL , EVA, IIEF ... ). | Other | rate of early removal of the catheter |
Primary outcome
failure rate of a limited catheterization duration of 3 hours post- operative
Time frame: at three hours post surgery
• The failure rate of a limited catheterization duration of 3 hours post- operative is defined by a need of recatheterizatrion within 24 hours post- GL with PVP XPS 180W . The catheterization remains indicated in case of macroscopic hematuria RAU or if no natural urination is possible
2 secondary outcomes
Total dose of energy
Time frame: during 24 hours hospitalisation
The duration of recatherization
Time frame: during 24 hours hospitalisation
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 17 Sep 2021.
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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.
DURAND Matthieu, Ph principal investigator
Service d'Urologie, CHU de Nice
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter in people with Benign Prostatic Hypertrophy, run by Centre Hospitalier Universitaire de Nice at 12 sites 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 10 inclusion and 17 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 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
failure rate of a limited catheterization duration of 3 hours post- operative (time frame: at three hours post surgery). 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 17 Sep 2021.