NCT05878951

Brief Summary

The objective of our multi-center randomized single-blind study is to examine the safety and effect of intra-detrusor OnabotulinumtoxinA injections at the time of holium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
6mo left

Started Jul 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
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 Progress84%
Jul 2023Dec 2026

First Submitted

Initial submission to the registry

May 4, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 13, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

3.1 years

First QC Date

May 4, 2023

Last Update Submit

June 2, 2026

Conditions

Overactive Bladder SyndromeOveractive BladderUrinary IncontinenceUrologic Diseases

Outcome Measures

Primary Outcomes (1)

  • Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder.

    Examine the safety and effect of intra-detrusor botulinum toxin injections at the time of helium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.

    12 months

Secondary Outcomes (3)

  • Difference in safety/ adverse effects

    90 days

  • Difference in patient REDCap surveys (gross hematuria dysuria, incontinence)

    6 months

  • Difference in efficacy endpoints (3-month clinic/telephone follow-up)

    3 months

Study Arms (2)

Intra-detrusor OnabotulinumtoxinA Injection

EXPERIMENTAL

Injection of intra-detrusor OnabotulinumtoxinA into the bladder will be performed.

Drug: OnabotulinumtoxinA

No intra-detrusor OnabotulinumtoxinA Injection

NO INTERVENTION

Injection of intra-detrusor OnabotulinumtoxinA into the bladder will not be performed.

Interventions

OnabotulinumtoxinADRUG

Intra-detrusor OnabotulinumtoxinA is commonly known as botox

Also known as: Botox
Intra-detrusor OnabotulinumtoxinA Injection

Eligibility Criteria

Age18 Years - 89 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMen experiencing overactive bladder symptoms
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males 18 -89 undergoing HoLEP
  • Component of OAB symptoms including frequency, nocturia, urgency, and/or urge related incontinence
  • Willing to sign the Informed Consent Form
  • Able to read, understand, and complete patient questionnaires.

You may not qualify if:

  • Allergy or hypersensitivity to OnabotulinumtoxinA injections
  • Patients having a concurrent ureteroscopy +/- laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at the time of their HoLEP
  • Anticipated need for perineal urethrostomy at the time of HoLEP
  • Prior pelvic radiation or patients with a history of bladder cancer with or without BCG therapy
  • Patients who lack decisional capacity
  • Active urinary tract infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Urinary IncontinenceUrinary Bladder, OveractiveUrologic Diseases

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urination DisordersFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Amy Krambeck, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyssa McDonald

CONTACT

312-695-8146Alyssa.McDonald@northwestern.edu

Allaa Fadl-Alla

CONTACT

312-695-8146Allaa.Fadlalla@northwestern.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Urology

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 30, 2023

Study Start

July 13, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 4, 2026

Record last verified: 2026-05

Locations

US(1)