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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-16

Study Completion Date

2025-04-16

Brief Summary

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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

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Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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22F Sheath Size

Comparator arm for procedures using 22F sheath size

Group Type ACTIVE_COMPARATOR

22F Sheath Size

Intervention Type DEVICE

Participants in this group will have the 22F sheath size used in their procedure.

26F Sheath Size

Comparator arm for procedures using 26F sheath size

Group Type ACTIVE_COMPARATOR

26F Sheath Size

Intervention Type DEVICE

Participants in this group will have the 26F sheath size used in their procedure.

Interventions

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22F Sheath Size

Participants in this group will have the 22F sheath size used in their procedure.

Intervention Type DEVICE

26F Sheath Size

Participants in this group will have the 26F sheath size used in their procedure.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No