Benign Prostatic Hyperplasia
Conditions
Brief summary
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
DEVICE22F Sheath Size
Participants in this group will have the 22F sheath size used in their procedure.
DEVICE26F Sheath Size
Participants in this group will have the 26F sheath size used in their procedure.
Sponsors
Thunder Bay Regional Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males over 50 years of age at the time of enrollment 2. Referred to urology for refractory LUTS secondary to BPH 3. Failed medical (non-surgical) treatment 4. Prostate size on preoperative TRUS of \> 80 ml 5. IPSS \>15, QOL score ≥3 and Qmax \<15 ml/sec 6. Written informed consent to participate in the study 7. Ability to comply with the requirements of the study procedures
Exclusion criteria
1. Previous surgical treatment for BPH 2. History of prostate cancer 3. Prostate size \< 80 mL 4. History of urethral stenosis or its management 5. Known or suspected neurogenic bladder 6. Participants with active urinary tract infection until appropriately treated 7. Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Operating Time | Intra-op | Operating time as measured during the procedure measured in minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | Within 6 hours of procedure completion | Time from end of procedure to participant discharge from the hospital in minutes. |
| Continence status | One year post-procedure | Self-report from the participant on their continence. |
| International Prostate Symptom Score | One year post-procedure | Eight questions (seven concerning urinary symptoms and one concerning quality of life), responses range from 0 (better outcome) to 5 (worse outcome), with total score ranging from 0 to 35. |
| Time to Catheter Removal | Within 6 hours of procedure completion | Time from end of procedure to the removal of catheter measured in minutes. |
| Peak flow rate | One year post-procedure | Measured as Qmax If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Response ranging from 'Delighted' to 'Terrible |
| Post-void residual | One year post-procedure | PVR If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Response ranging from 'Delighted' to 'Terrible |
| Rate of Complications | One year post-procedure | Occurrence of procedure-related complications |
| Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS) | One year post-procedure | Response to the last question on the IPSS: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Response ranging from 'Delighted' to 'Terrible |
Countries
Canada
Contacts
Primary ContactRabail Siddiqui
Backup ContactShalyn Littlefield
Outcome results
None listed