Benign Prostatic HyperplasiaNCT06546865
Slim Sheath 22F Holmium Laser Enucleation of the Prostate (HoLEP) vs 26 F Sheath HoLEP for BPH: RCT
A study testing 22F Sheath Size and 26F Sheath Size in people with Benign Prostatic Hyperplasia, run by Thunder Bay Regional Health Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- 22F Sheath Size and 26F Sheath Size
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteCanada
- Study dates
- 16 Apr 2024to 16 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
Rabail Siddiqui, (807) 684-6000, rabail.siddiqui@tbh.net
Hazem Elmansy
About this study
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
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
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- 22F Sheath Size, 26F Sheath Size
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
22F Sheath SizeDevice
Participants in this group will have the 22F sheath size used in their procedure.
26F Sheath SizeDevice
Participants in this group will have the 26F sheath size used in their procedure.
| Study group | Role | What they receive |
|---|---|---|
| 22F Sheath Size | Active comparator | Comparator arm for procedures using 22F sheath size Receives: Device: 22F Sheath Size |
| 26F Sheath Size | Active comparator | Comparator arm for procedures using 26F sheath size Receives: Device: 26F Sheath Size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Operating Time
Operating time as measured during the procedure measured in minutes.
Measured: Intra-op
Secondary outcomes (8)
Time to Catheter Removal
Time from end of procedure to the removal of catheter measured in minutes.
Measured: Within 6 hours of procedure completion
Length of Hospital Stay
Time from end of procedure to participant discharge from the hospital in minutes.
Measured: Within 6 hours of procedure completion
Continence status
Self-report from the participant on their continence.
Measured: One year post-procedure
International Prostate Symptom Score
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.
Measured: One year post-procedure
Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS)
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
Measured: One year post-procedure
Peak flow rate
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
Measured: One year post-procedure
Post-void residual
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
Measured: One year post-procedure
Rate of Complications
Occurrence of procedure-related complications
Measured: One year post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start16 Apr 2024
- Primary completion16 Apr 2025 (estimated)
- Study completion16 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thunder Bay Regional Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hazem Elmansy, Principal investigator, Thunder Bay Regional Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546865
- Sponsor's protocol ID
- RP-1064
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06546865
- Acronym / sponsor ID
- RP-1064
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Thunder Bay Regional Health Research InstituteUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 16 Apr 2025 (estimated)
- Study completion
- 16 Apr 2025 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 22F Sheath Size | Active comparator | Device: 22F Sheath SizeComparator arm for procedures using 22F sheath size |
| 26F Sheath Size | Active comparator | Device: 26F Sheath SizeComparator arm for procedures using 26F sheath size |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 22F Sheath SizeParticipants in this group will have the 22F sheath size used in their procedure. | Device | 22F Sheath Size |
| 26F Sheath SizeParticipants in this group will have the 26F sheath size used in their procedure. | Device | 26F Sheath Size |
Primary outcome
Comparison of Operating Time
Time frame: Intra-op
Operating time as measured during the procedure measured in minutes.
8 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hazem Elmansy principal investigator
Thunder Bay Regional Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 22F Sheath Size and 26F Sheath Size in people with Benign Prostatic Hyperplasia, run by Thunder Bay Regional Health Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rabail Siddiqui ((807) 684-6000, rabail.siddiqui@tbh.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Operating Time (time frame: Intra-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.