CompletedPhase 4

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

Canada108 participantsStarted 2012-01

Plain-language 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

Who can participate

SexMALE

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Inclusion criteria

✓. Ability to give informed consent.
✓. Lower urinary symptoms (LUTS) secondary to bladder outlet obstruction from BPH.
✓. Failed medical treatment of BPH.
✓. International prostate symptom scores (IPSS) \> 15.
✓. Peak urinary flow rate (Qmax) \< 15 ml/sec.
✓. Preoperative TRUS (transrectal ultrasound) size of the gland (from 40 to 150 cc).
✓. 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

✕. Inability to give informed consent.
✕. Patient who have a neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease.
✕. Active urinary tract infection.
✕. Presence of active bladder cancer (within the last 2 years).
✕. 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.

What they're measuring

change in urine flow parameters

Timeframe: one, 4 and 12 months postoperative

Trial details

NCT IDNCT01494337

SponsorRoyal Victoria Hospital, Canada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-03

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