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Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms

ConditionsUrinary IncontinenceOveractive Bladder SyndromeOveractive BladderUrologic Diseases
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexMale
Age18-89
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • OnabotulinumtoxinA

    Drug

    Intra-detrusor OnabotulinumtoxinA is commonly known as botox

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Intra-detrusor OnabotulinumtoxinA InjectionExperimental treatment 1 intervention
Group B: No intra-detrusor OnabotulinumtoxinA InjectionNo intervention 0 interventions

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

1

Difference in safety/ adverse effects

Identifying changes in post-op urinary retention, gross hematuria, UTI, ED visits and any additional complications.

Time frame
90 days
2

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

Identifying symptom resolution at different time points (1 month, 3 months, 6 months)

Time frame
6 months
3

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

Identifying efficacy endpoints as they relate to the use of anti-cholinergics, incontinence survey, post void residuals, continence pads requirements if any.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

University of Calgary

Collaborator

Ohio State University

Collaborator

University of Alberta

Collaborator

Source ClinicalTrials.gov
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