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CompletedNCT01534793QUAPELLAUpdated Feb 25, 2015

QUAPELLA (QUAlity of Prostate Enucleation by LUMENIS - Laser)

An observational study in Benign Prostatic Hyperplasia, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2015-02-25.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
50 Years and older
Sex
Male
01

Study 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 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.
02

Conditions studied

  • Benign Prostatic Hyperplasia

Keywords

  • Quality assessment
  • Benign Prostatic Hyperplasia
  • Enucleation of the prostate
  • LUMENIS
  • Laser
  • Learning Curve
03

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 100 is below the median of 214 across 167 observational studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient presenting low urinary tract symptoms due to benign prostatic hyperplasia

Inclusion criteria

  1. Male patients over 50
  2. Classification of risk according to the American Society of Anesthesiologists (ASA) score: score 1, 2 or 3
  3. Protocol accepted by patient (signed informed consent)
  4. 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
  5. Patient with maximum urinary flow rate ≤ 12mL/s for a voiding volume ≥ 125mLat uroflowmetry, for patients who are not drained
  6. Prostate weight between 40 and 80 grams
  7. Post void residual volume ≤ 300cc, for patients who are not drained
  8. Normal renal function
  9. Non suspect digital rectal examination
  10. 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
  11. Patient under oral anticoagulation therapy if a therapeutic switch is possible and validated by both the anaesthesiologist and the prescription of the anticoagulation therapy
  12. 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
  13. Patient gave informed consent and is not opposed to the use of the data collected during the study for research purpose
  14. 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)
  15. Patients has valid health insurance/coverage.

Exclusion criteria

Exclusion Criteria:

  1. Patients with unstable known cardiac or pulmonary disease
  2. Patients with severe myasthenia, multiple sclerosis, Parkinson disease with known bladder or urinary sphincter dysfunction.
  3. Patient with history of severe pelvic injury having caused severe external urinary sphincter damage.
  4. Patient with active urinary tract infection
  5. 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
  6. Patient with neurogenic disease of the urinary tract
  7. Patient with known or suspected malignant lesion of the bladder or the prostate
  8. Patient with history of previous prostatic surgery
  9. Patient with history of bladder stone, major hematuria, urethral stricture, bladder neck stenosis, bladder disease or diabetes with bladder impairment
  10. Patient with a prosthesis or material in the region potentially affected by the surgical procedure.
  11. Patient with ano-rectal disease
  12. Cases where the surgical indication is decided in an emergency context
  13. Patient with predictable incomplete follow-up
  14. Patient with coagulation disease or abnormalities not covered by the drugs belonging to the categories cited in inclusion criteria 11 and 12
  15. All patient condition that the investigator considers as an exclusion criterion
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)

Groups and cohorts

  • HoLEP

    Holmium Laser Enucleation of the Prostate

    Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)

Interventions

  • ProcedureHolmium 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. One month post-operative questionnaire

    Time frame: at 1 month

  11. 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

  12. Satisfaction of the intervention (at 1 and 12 months postoperative)

    Time frame: at 1 and 12 months postoperative

  13. Pathologic examination of the prostate tissue

    Pathologic examination of the prostate tissue (at 1 month postoperative)

    Time frame: at 1 month postoperative

  14. Blood levels of sodium, haemoglobin, and haematocrit (15 days before intervention, immediately after intervention,)

    Time frame: 15 days befor intervention, immediately after intervention

  15. Intervention duration

    Time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour

  16. 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

    Time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour

  17. Laser data

    Laser data (duration, Joules number number of fibers used, fibre type, morcellator ans nephroscope type)

    Time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour

  18. Tissue weight

    Time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour

  19. Irrigation volume

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days

  20. Need for coagulation with another device

    Time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour

  21. 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

  22. Type of catheter at the surgery

    Time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour

  23. Duration of the catheterization

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days

  24. 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

  25. Hospital stay

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days

07

Study locations

1 site
  • Service Urologie - Hôpital Tenon
    Paris, Ile de France 75020, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01534793
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Feb 17, 2012
Start date
Feb 2012
Primary completion
May 2013
Completion
Jul 2014
Last update
Feb 25, 2015

Study contacts

Bertrand LUKACS, MD,PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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