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NCT Number: NCT06546865

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

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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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location status: Recruiting

Location contact

Hazem Elmansy

PRINCIPAL_INVESTIGATOR

Rabail Siddiqui

CONTACT

[email protected]

(807) 684-6000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

22F Sheath Size

Device

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

26F Sheath Size

Device

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

Primary outcomes

  1. Comparison of Operating Time

    Time frame: Intra-op

    Operating time as measured during the procedure measured in minutes.

Secondary outcomes

  1. Time to Catheter Removal

    Time frame: Within 6 hours of procedure completion

    Time from end of procedure to the removal of catheter measured in minutes.

  2. Length of Hospital Stay

    Time frame: Within 6 hours of procedure completion

    Time from end of procedure to participant discharge from the hospital in minutes.

  3. Continence status

    Time frame: One year post-procedure

    Self-report from the participant on their continence.

  4. International Prostate Symptom Score

    Time frame: 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.

  5. Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS)

    Time frame: 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

  6. Peak flow rate

    Time frame: 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

  7. Post-void residual

    Time frame: 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

  8. Rate of Complications

    Time frame: One year post-procedure

    Occurrence of procedure-related complications

Study contacts

Contact information is provided by the study sponsor or research team.

Rabail Siddiqui

CONTACT

[email protected]

(807) 684-6000

Shalyn Littlefield

CONTACT

[email protected]

(807) 684-6000

Sponsors and collaborators

Lead sponsor

Thunder Bay Regional Health Research Institute

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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