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

Phase 4

Completed

• Conditions: Benign Prostate Hyperplasia
• Interventions: Procedure: PVEP-XPS; Procedure: HOLEP

• Registration Number: NCT01494337
• Lead Sponsor: Royal Victoria Hospital, Canada

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-16
• Study First Posted: 2011-12-19
• Study Start: 2012-01
• Primary Completion: 2014-03
• Study Completion: 2014-04
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-25
• Last Update Posted: 2014-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 108

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVEP/XPS	PVEP-XPS	PVEP/XPS green light photoselective Vapo-Enucleation of prostate using XPS 180W machine will be used in the second arm
HOLEP	HOLEP	HOLEP In the first arm, holmium laser enucleation of the prostate will be done

Primary Outcome Measures

Name	Time	Method
change in urine flow parameters	one, 4 and 12 months postoperative	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

Secondary Outcome Measures

Name	Time	Method
TIME TO CATHETER REMOVAL, HOSPITAL STAY	1 day post operative	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)
the need for redo surgery	1 year	The need for re-operation in the fist year will be assessed

Trial Locations

Locations (1)

Royal victoria hospital; 🇨🇦 Montreal, Quebec, Canada