NCT06758466

Brief Summary

To compare the surgical outcomes at 12 months post-surgery between Bipolar TURP and BipoLEP in men with BPH and prostate volumes between 30-80 grams.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Jan 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Jan 2025Mar 2028

First Submitted

Initial submission to the registry

December 27, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2028

Last Updated

January 3, 2025

Status Verified

January 1, 2025

Enrollment Period

2.9 years

First QC Date

December 27, 2024

Last Update Submit

January 2, 2025

Conditions

Benign Prostatic Hyperplasia

Keywords

BPH - Bipolar- TURP - Enucleation

Outcome Measures

Primary Outcomes (2)

  • International Prostate Symptom Score (IPSS)

    12 months

  • Qmax

    12 months

Secondary Outcomes (2)

  • PVR

    12 months

  • Complications

    12 months

Study Arms (2)

Bipolar enucleation

ACTIVE COMPARATOR
Procedure: Prostate surgery

Bipolar resection

ACTIVE COMPARATOR
Procedure: Prostate surgery

Interventions

Prostate surgeryPROCEDURE

Prostate removal

Bipolar enucleationBipolar resection

Eligibility Criteria

Age45 Years - 80 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsBPH
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients aged 45-80 years diagnosed with symptomatic BPH.
  • Prostate volume between 30-80 grams as determined by transrectal ultrasound (TRUS) performed within 4 weeks before randomization.
  • Moderate to severe LUTS with an IPSS of ≥ 8.
  • Failure of medical management.
  • Patients able to provide written informed consent.

You may not qualify if:

  • History of prostate cancer.
  • History of previous prostate surgery (including any procedure for BPH or prostate cancer).
  • History of urethral stricture or bladder neck contracture.
  • Neurogenic bladder dysfunction.
  • Significant coagulopathy.
  • Uncontrolled urinary tract infection.
  • Patient on anticoagulant medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 27, 2024

First Posted

January 3, 2025

Study Start

January 15, 2025

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

March 15, 2028

Last Updated

January 3, 2025

Record last verified: 2025-01