Urinary IncontinencePhase 2/3NCT05878951
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
A Phase 2/3 study testing OnabotulinumtoxinA in people with Urinary Incontinence and Overactive Bladder Syndrome, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years, men only
- Conditions the study is for
- Urinary Incontinence, Overactive Bladder Syndrome, Overactive Bladder
- What is being tested?
- OnabotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2023to Nov 2026
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Randomized Controlled Trial Examining the Effects of Intra-detrusor Botulinum Toxin at Time of Holmium Laser Enucleation of the Prostate (HoLEP) in Men With Overactive Bladder (OAB) Symptoms
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.
Read the detailed description
Patients with significant preoperative urgency and/or urge urinary incontinence (UUI) along with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) may require post-HoLEP anticholinergic, B-3 agonist, or intravesical OnabotulinumtoxinA administration. This injection is a guideline recommended for treatment in patients with severe irritative LUTS (urgency, UUI) and overactive bladder.
- Being tested
- OnabotulinumtoxinA
- Medical subject headings
- Urinary Incontinence, Urinary Bladder, Overactive, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinADrug
Also called Botox
Intra-detrusor OnabotulinumtoxinA is commonly known as botox
| Study group | Role | What they receive |
|---|---|---|
| Intra-detrusor OnabotulinumtoxinA Injection | Experimental | Injection of intra-detrusor OnabotulinumtoxinA into the bladder will be performed. Receives: Drug: OnabotulinumtoxinA |
| No intra-detrusor OnabotulinumtoxinA Injection | No intervention | Injection of intra-detrusor OnabotulinumtoxinA into the bladder will not be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Difference in safety/ adverse effects
Identifying changes in post-op urinary retention, gross hematuria, UTI, ED visits and any additional complications.
Measured: 90 days
Difference in patient REDCap surveys (gross hematuria dysuria, incontinence)
Identifying symptom resolution at different time points (1 month, 3 months, 6 months)
Measured: 6 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start13 Jul 2023
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, Ohio State University, University of Alberta
- Responsible party
- Principal investigator, Amy Krambeck, Northwestern University
- Investigators
- Amy Krambeck, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878951
- Sponsor's protocol ID
- STU00218130
- Status last verified
- May 2026
- First submitted
- 4 May 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No