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 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 completion31 Oct 2026
- Study completionDec 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
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05878951
- Acronym / sponsor ID
- STU00218130
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Calgary, Ohio State University, University of Alberta
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 31 Oct 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-detrusor OnabotulinumtoxinA Injection | Experimental | Drug: OnabotulinumtoxinAInjection of intra-detrusor OnabotulinumtoxinA into the bladder will be performed. |
| No intra-detrusor OnabotulinumtoxinA Injection | No intervention | –Injection of intra-detrusor OnabotulinumtoxinA into the bladder will not be performed. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnabotulinumtoxinAAlso: BotoxIntra-detrusor OnabotulinumtoxinA is commonly known as botox | Drug | Intra-detrusor OnabotulinumtoxinA Injection |
Primary outcome
Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder.
Time frame: 12 months
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.
3 secondary outcomes
Difference in safety/ adverse effects
Time frame: 90 days
Difference in patient REDCap surveys (gross hematuria dysuria, incontinence)
Time frame: 6 months
Difference in efficacy endpoints (3-month clinic/telephone follow-up)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
Related trials for Urinary Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Krambeck, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.