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Recruiting NCT06546865

Slim Sheath 22F Holmium Laser Enucleation of the Prostate (HoLEP) vs 26 F Sheath HoLEP for BPH: RCT

No phase Interventional Benign Prostatic Hyperplasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 22F Sheath Size, 26F Sheath Size.
Who it may be relevant to
Registry conditions: Benign Prostatic Hyperplasia. Basic parameters: from 50 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Slim Sheath 22F Holmium Laser Enucleation of the Prostate (HoLEP) Technique vs 26 F Sheath HoLEP for Treatment of Benign Prostatic Hyperplasia (BPH): A Randomized Prospective Comparative Study

Overview

Holmium laser enucleation of the prostate (HoLEP) is routinely performed with 24F, 26F, and 28F laser scopes. Proponents of larger caliber scopes suggest that the larger scope size allows for improved visualization, hemostasis, and operative efficiencies. Proponents of a smaller scope diameter suggest that by eliminating the need for pre-HoLEP urethral dilation to accommodate a larger scope. It has also been proposed that a smaller caliber scope is less traumatic to the urethra resulting in lower rates of bladder neck contracture and urethral stricture disease. Currently, to our knowledge, there are no level one evaluation examining scope size 22F versus 26F sheath in laser enucleation outcomes. The aim of our study is to determine if a smaller diameter scope is associated with improved laser enucleation time, post-operative recovery, rates of same-day discharge, or increasing intra-operative or postoperative complication rates

Interventions

  • Device 22F Sheath Size
    Participants in this group will have the 22F sheath size used in their procedure.
  • Device 26F Sheath Size
    Participants in this group will have the 26F sheath size used in their procedure.

Primary outcome measures

  • Comparison of Operating Time [Time frame: Intra-op]
Secondary outcome measures (8)
  • Time to Catheter Removal [Time frame: Within 6 hours of procedure completion]
  • Length of Hospital Stay [Time frame: Within 6 hours of procedure completion]
  • Continence status [Time frame: One year post-procedure]
  • International Prostate Symptom Score [Time frame: One year post-procedure]
  • Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS) [Time frame: One year post-procedure]
  • Peak flow rate [Time frame: One year post-procedure]
  • Post-void residual [Time frame: One year post-procedure]
  • Rate of Complications [Time frame: One year post-procedure]

Eligibility criteria

Inclusion criteria

  • Males over 50 years of age at the time of enrollment
  • Referred to urology for refractory LUTS secondary to BPH
  • Failed medical (non-surgical) treatment
  • Prostate size on preoperative TRUS of > 80 ml
  • IPSS >15, QOL score ≥3 and Qmax <15 ml/sec
  • Written informed consent to participate in the study
  • Ability to comply with the requirements of the study procedures

Exclusion criteria

  • Previous surgical treatment for BPH
  • History of prostate cancer
  • Prostate size < 80 mL
  • History of urethral stenosis or its management
  • Known or suspected neurogenic bladder
  • Participants with active urinary tract infection until appropriately treated
  • Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Thunder Bay Regional Health Sciences Centre — Thunder Bay

Identifiers

NCT: NCT06546865 · RP-1064

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗