Holmium Laser Enucleation of Prostate(HOLEP) vs Greenlight(XPS) Laser Photoselective Vapo-Enucleation of Prostate(PVEP)

Benign Prostate Hyperplasia Clinical Trial

Official title:

Randomized Study Comparing Holmium Laser Enucleation of the Prostate (HOLEP) Versus Greenlight (XPS) Laser Photoselective Vapo-Enucleation of Prostate(PVEP) in the Management of Infravesical Obstruction Secondary to BPH

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01494337
• Other study ID #: 11-171-SDR
• Status: Completed
• Phase: Phase 4
• First received: December 5, 2011
• Last updated: August 25, 2014
• Start date: January 2012
• Est. completion date: April 2014

Study information

• Verified date: August 2014
• Source: Royal Victoria Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The investigators are now proposing to compare two laser techniques for treating Benign prostate hyperplasia (BPH); Holmium Laser Enucleation of the Prostate (HOLEP) versus (greenlight) XPS which is a recently available technology in our center and is more efficient hence our choice to include patients with any size prostate. This will confirm whether the two techniques are equivalent in efficacy and safety independent of size as well as cost. The two techniques are available world wide as standard of care

Description:

Patients with lower urinary tract symptoms (LUTS) secondary to bladder outlet obstruction from BPH seen through the outpatient clinic in the urology department will be assessed to see if the patient satisfies all inclusion and exclusion criteria. Patients who are meeting these criteria will be asked to participate in this randomized comparison study. If they agree they will be provided with an informed consent form which they can take home with them. The randomization process will be performed using computer-generated simple random tables in a 1:1 ratio. Study participants will be enrolled randomized, and the appropriate surgery scheduled. Procedures will be performed on an outpatient basis whenever possible.

All surgeries will be performed under a spinal or general anaesthesia. In case of coexisting vesical stone, Holmium laser cystolithotripsy will be done first regardless the type of next procedure for the prostate. Both HOLEP and greenLight (XPS) laser vaporization of the prostate begins with the insertion of a resectoscope transurethrally. Examination of the lower urinary tract is performed and holmium laser fiber is used to enucleate (HOLEP) or to vaporize [greenLight (XPS)] the obstructing prostatic tissue using the Moxy fibre until the surgical capsule is reached. After treatment, the prostatic fossa will be examined for hemostasis and if adequate, a 22 french Foley catheter will be inserted. Patients will then be sent to the post-anaesthetic recovery room.

Once awake, the patient could have the catheter removed with a voiding trial if the urine is judged to be sufficiently clear and the surgeon is comfortable about early catheter removal. Those patients able to void will be sent home without catheter. Those patients unable to void or the surgeon decides to keep the catheter for 24 hours will be either sent home with a catheter to be removed the next day or hospitalized overnight.

Finally, those patients with multiple medical problems or with postoperative bleeding requiring bladder irrigation will be kept overnight with a trial of voiding attempted the next morning if the urine is clear.

Intraoperative and early postoperative parameters of interest will be recorded and compared between groups. These parameters include the total procedure time, total laser energy used, cost of disposables including the number of laser fibers per case, number of bags of irrigant per case, urethral catheterization time, length of hospital stay, subjective assessment of hemostasis during each laser procedure, objective assessment of changes in serum electrolytes and hematocrit and thorough recording of all complications.

Patients will be seen in follow-up at 2 weeks, 1, 3, 6, and 12 months. The parameters to be assessed at each time point are listed below. As can be seen from the table, the most important parameters will be changes in voiding symptoms and uroflowmetry over time. Some validated questionnaires will be utilized to assess the patients` sexual function both at base line and at different follow-up visits. Different aspects of the sexual function will be analysed, partner`s feedback will be addressed by a special questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Ability to give informed consent.

2. Lower urinary symptoms (LUTS) secondary to bladder outlet obstruction from BPH.

3. Failed medical treatment of BPH.

4. International prostate symptom scores (IPSS) > 15.

5. Peak urinary flow rate (Qmax) < 15 ml/sec.

6. Preoperative TRUS (transrectal ultrasound) size of the gland (from 40 to 150 cc).

7. Patients in retention secondary to BPH (with cystometrogram (CMG) confirming adequate detrusor pressure if the bladder capacity at time of catheterization is in excess of 1000 ml).

Exclusion Criteria:

1. Inability to give informed consent.

2. Patient who have a neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease.

3. Active urinary tract infection.

4. Presence of active bladder cancer (within the last 2 years).

5. Known cancer prostate patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• HOLEP
USING HOLMIUM LASER, the prostate adenoma will be enucleated and removed into small pieces
• PVEP-XPS
Greenlight laser will be used with high power setting for selective vaporization of the prostate adenoma, using 180 watt XPS laser machine

Locations

Country	Name	City	State
Canada	Royal victoria hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Royal Victoria Hospital, Canada	McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in urine flow parameters	change in urine flow parameters; IPSS= international prostate symptom score QOL= quality of life score PVR= post voiding residual urine Q-MAX= maximal flow rate	one, 4 and 12 months postoperative	Yes
Secondary	TIME TO CATHETER REMOVAL, HOSPITAL STAY	At first postoperative day; the catheter will be removed for trial voiding Patient will be discharged from the hospital as soon as possible (same day or once urine color is normalized)	1 day post operative	Yes
Secondary	the need for redo surgery	The need for re-operation in the fist year will be assessed	1 year	Yes