QUAPELLA (QUAlity of Prostate Enucleation by LUMENIS - Laser)

Benign Prostatic Hyperplasia Clinical Trial

— QUAPELLA  

Official title:

Observational Study Evaluating the Quality of Laser Enucleation of the Prostate Using a LUMENIS Laser Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534793
• Other study ID #: K070301 / IC0709
• Secondary ID: 2008-A-00498-47
• Status: Completed
• Phase: N/A
• First received: January 25, 2012
• Last updated: February 24, 2015
• Start date: February 2012
• Est. completion date: July 2014

Study information

• Verified date: February 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	Service Urologie - Hôpital Tenon	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	participants will be followed for the duration of the intervention, an expected average of 1 hour	No
Secondary	I-PSS symptom score (15 days before operation, at 6 and 12 months postoperative)		15 days before operation, at 6 and 12 months postoperative)	No
Secondary	I-PSS bother score (15 days before operation, at 1, 6 and 12 months postoperative)		15 days before operation, at 1, 6 and 12 months postoperative	No
Secondary	DAN-PSSsex score (15 days before operation, at 6 and 12 months postoperative)		15 days before operation, at 6 and 12 months postoperative	No
Secondary	Global sexual satisfaction (15 days before operation, at 6 and 12 months postoperative)		15 days before operation, at 6 and 12 months postoperative	No
Secondary	Quality of life score QoL-Europe (15 days before operation, and at 12 months postoperative)		15 days before operation, and at 12 months postoperative	No
Secondary	Urinary flow rate I-PSS symptom score (15 days before operation, at day 0, and at 1, 6 and 12 months postoperative)		15 days before operation, at day 0, and at 1, 6 and 12 months postoperative	No
Secondary	Postvoid residual volume (15 days before operation, at day 0, and at 1, 6 and 12 months postoperative)		15 days before operation, at day 0, and at 1, 6 and 12 months postoperative	No
Secondary	Ultrasound examination of the prostate (15 days before operation, at 6 and 12 months postoperative)		15 days before operation, at 6 and 12 months postoperative	No
Secondary	PSA blood testing (15 days before operation, at 6 and 12 months postoperative)		15 days before operation, at 6 and 12 months postoperative	No
Secondary	One month post-operative questionnaire		at 1 month	No
Secondary	Evaluation of adverse events (the day of operation, at 1, 6 and 12 months postoperative)		the day of operation, at 1, 6 and 12 months postoperative	No
Secondary	Satisfaction of the intervention (at 1 and 12 months postoperative)		at 1 and 12 months postoperative	No
Secondary	Pathologic examination of the prostate tissue	Pathologic examination of the prostate tissue (at 1 month postoperative)	at 1 month postoperative	No
Secondary	Blood levels of sodium, haemoglobin, and haematocrit (15 days before intervention, immediately after intervention,)		15 days befor intervention, immediately after intervention	No
Secondary	Intervention duration		participants will be followed for the duration of the intervention, an expected average of 1 hour	No
Secondary	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	participants will be followed for the duration of the intervention, an expected average of 1 hour	No
Secondary	Laser data	Laser data (duration, Joules number number of fibers used, fibre type, morcellator ans nephroscope type)	participants will be followed for the duration of the intervention, an expected average of 1 hour	No
Secondary	Tissue weight		participants will be followed for the duration of the intervention, an expected average of 1 hour	No
Secondary	Irrigation volume		participants will be followed for the duration of hospital stay, an expected average of 1,5 days	No
Secondary	Need for coagulation with another device		participants will be followed for the duration of the intervention, an expected average of 1 hour	No
Secondary	Adverse events at the day of operation, at 1, 6,12 months post-operative		the day of operation, at 1, 6,12 months post-operative	No
Secondary	Type of catheter at the surgery		participants will be followed for the duration of the intervention, an expected average of 1 hour	No
Secondary	Duration of the catheterization		participants will be followed for the duration of hospital stay, an expected average of 1,5 days	No
Secondary	Post-operative irrigation (duration, volume, type)		participants will be followed for the duration of hospital stay, an expected average of 1,5 days	No
Secondary	Hospital stay		participants will be followed for the duration of hospital stay, an expected average of 1,5 days	No