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

NCT ID: NCT01494337

Last Updated: 2014-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-04-30

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.

Conditions

Benign Prostate Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HOLEP

HOLEP In the first arm, holmium laser enucleation of the prostate will be done

Group Type: ACTIVE_COMPARATOR

HOLEP

Intervention Type: PROCEDURE

USING HOLMIUM LASER, the prostate adenoma will be enucleated and removed into small pieces

PVEP/XPS

PVEP/XPS green light photoselective Vapo-Enucleation of prostate using XPS 180W machine will be used in the second arm

Group Type: ACTIVE_COMPARATOR

PVEP-XPS

Intervention Type: PROCEDURE

Greenlight laser will be used with high power setting for selective vaporization of the prostate adenoma, using 180 watt XPS laser machine

Interventions

HOLEP

USING HOLMIUM LASER, the prostate adenoma will be enucleated and removed into small pieces

Intervention Type: PROCEDURE

PVEP-XPS

Greenlight laser will be used with high power setting for selective vaporization of the prostate adenoma, using 180 watt XPS laser machine

Intervention Type: PROCEDURE

Other Intervention Names

Holmium Laser Enucleation of The Prostate; Photoselective Vapo-Enucleation of prostate(PVEP)

Eligibility Criteria

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.

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

McGill University

OTHER

Sponsor Role: collaborator

Royal Victoria Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Elhilali

clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mostafa M Elhilali, Professor

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

Royal victoria hospital

Montreal, Quebec, Canada

Countries

Canada

References

Elshal AM, Elkoushy MA, El-Nahas AR, Shoma AM, Nabeeh A, Carrier S, Elhilali MM. GreenLight laser (XPS) photoselective vapo-enucleation versus holmium laser enucleation of the prostate for the treatment of symptomatic benign prostatic hyperplasia: a randomized controlled study. J Urol. 2015 Mar;193(3):927-34. doi: 10.1016/j.juro.2014.09.097. Epub 2014 Sep 28.

Reference Type: DERIVED

PMID: 25261801 (View on PubMed)

Other Identifiers

11-171-SDR

Identifier Type: -

Identifier Source: org_study_id