Stress Urinary IncontinenceEarly Phase 1NCT04984317
Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence
A Early Phase 1 study testing onabotulinumtoxin A in people with Stress Urinary Incontinence, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of onabotulinumtoxin A (BOTOX) injection into the detrusor muscle on increasing bladder compliance to reduce urinary leakage in women suffering from stress urinary incontinence (SUI). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- onabotulinumtoxin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2022to Aug 2027
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be female sex and at least 18 years of age.
- Must be willing and able to complete all procedures and follow-up visits indicated in the protocol.
- Must have confirmed stress urinary incontinence (SUI) through urodynamic studies.
- Must have failed two non-invasive incontinence therapies (such as behavior modification, Kegel exercises, etc) for > 3 months.
Who cannot join
- Currently suffering from active urogenital infection.
- Has incontinence due to neurogenic causes (such as multiple sclerosis, cerebrovascular accident, spinal cord/brain injury, Parkinson Disease, detrusor-external sphincter dyssynergia, or similar conditions).
- Having concomitant pelvic floor or cystoscopic procedure.
- Has had prior surgical SUI treatment.
- Has had prior radiation therapy or brachy therapy.
- Has an atonic bladder or post-void residual (PVR) above 100cc on two or more occasions.
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- Is pregnant or planning to become pregnant during the study duration.
- Has a contraindication to therapeutic BOTOX injections or cystoscopic procedures.
- Is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect urinary continence or bladder function without the sponsor's approval.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Onabotulinumtoxin A Injection on Improving Female Stress Urinary Incontinence
The purpose of this study is to assess the effect of onabotulinumtoxin A (BOTOX) injection into the detrusor muscle on increasing bladder compliance to reduce urinary leakage in women suffering from stress urinary incontinence (SUI).
Read the detailed description
The study involves a single-time injection of 100 units of onabotulinumtoxin A into the detrusor muscle of the bladder. Cystoscopy, which is the insertion of a scope with a small camera inside a tube into the participant's urethra. Then the doctor fills the participant's bladder with water or saline and sees detailed images of the injection site in the bladder while administrating the injection.
- Conditions
- Stress Urinary Incontinence
- Being tested
- onabotulinumtoxin A
- Keywords
- Urinary Incontinence, Incontinence
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onabotulinumtoxin ADrug
Also called BOTOX
One-time injection of 100U BOTOX
| Study group | Role | What they receive |
|---|---|---|
| Botox Injection | Experimental | One-time injection of 100U BOTOX (onabotulinumtoxin A) into the fundus of the bladder under direct visualization via cystoscopy. Receives: Drug: onabotulinumtoxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the amount of urinary leakage post-treatment compared to baseline.
1-hour pad weight, in grams
Measured: Baseline, 1-month, 3-month, 6-month
Secondary outcomes (9)
Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.
Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems
Measured: Time of Procedure
Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.
Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems
Measured: 1-month
Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.
Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems
Measured: 3-month
Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.
Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems
Measured: 6-month
Change in patient-reported symptoms of stress incontinence symptoms via PGI-I.
The Patient Global Impression of Improvement (PGI-I) scale is a scale that measures improvement in symptoms and ranges from 1-7, with 1 indicating very much improvement and higher scores indicating less improvement.
Measured: 1-month, 3-month, 6-month
Change in quality of life impacted by urinary incontinence via UDI-6.
The Urinary Distress Inventory (UDI-6) is an inventory that assess symptoms and urinary incontinence and its severity on a scale of 0 to 3, with higher scores indicating greater symptom severity. IIQ-7 is a 30-item self-report questionnaire on the impact of urinary incontinence on activities roles and emotional states. Assigned values of the questionnaire are 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly.
Measured: Baseline, 1-month, 3-month, 6-month
Change in quality of life impacted by urinary incontinence via IIQ-7.
The Incontinence Impact Questionnaire (IIQ-7) is a 30-item self-report questionnaire on the impact of urinary incontinence on activities roles and emotional states. Assigned values of the questionnaire are 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly.
Measured: Baseline, 1-month, 3-month, 6-month
Assessment of patient satisfaction post-treatment via SSQ-8.
The Surgical Satisfaction Questionnaire (SSQ-8) is a questionnaire about patient satisfaction after a surgery/procedure. Responses range from "Very unsatisfied" to "Very Satisfied".
Measured: 1-month
Change in pain post-treatment compared to baseline via VAS.
Scores are measured on a 100mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 with 0 indicating no pain and higher scores indicating greater pain.
Measured: Baseline, Time of Procedure, 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start14 Feb 2022
- Primary completionDec 2026 (estimated)
- Study completionAug 2027 (estimated)
Why it stopped: Principal Investigator changing locations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Bilal Chughtai, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984317
- Sponsor's protocol ID
- 20-04021756
- Status last verified
- Jan 2026
- First submitted
- 29 Jul 2021
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Onabotulinumtoxin A Injection on Improving Female Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04984317
- Acronym / sponsor ID
- 20-04021756
- Conditions
- Stress Urinary Incontinence
- Keywords
- Urinary Incontinence, Incontinence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Principal Investigator changing locations.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 30 Jul 2021 (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 purpose of this study is to assess the effect of onabotulinumtoxin A (BOTOX) injection into the detrusor muscle on increasing bladder compliance to reduce urinary leakage in women suffering from stress urinary incontinence (SUI).
Detailed description
The study involves a single-time injection of 100 units of onabotulinumtoxin A into the detrusor muscle of the bladder. Cystoscopy, which is the insertion of a scope with a small camera inside a tube into the participant's urethra. Then the doctor fills the participant's bladder with water or saline and sees detailed images of the injection site in the bladder while administrating the injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botox Injection | Experimental | Drug: onabotulinumtoxin AOne-time injection of 100U BOTOX (onabotulinumtoxin A) into the fundus of the bladder under direct visualization via cystoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be female sex and at least 18 years of age.
- Must be willing and able to complete all procedures and follow-up visits indicated in the protocol.
- Must have confirmed stress urinary incontinence (SUI) through urodynamic studies.
- Must have failed two non-invasive incontinence therapies (such as behavior modification, Kegel exercises, etc) for > 3 months.
Key exclusion criteria (9 listed)
- Currently suffering from active urogenital infection.
- Has incontinence due to neurogenic causes (such as multiple sclerosis, cerebrovascular accident, spinal cord/brain injury, Parkinson Disease, detrusor-external sphincter dyssynergia, or similar conditions).
- Having concomitant pelvic floor or cystoscopic procedure.
- Has had prior surgical SUI treatment.
- Has had prior radiation therapy or brachy therapy.
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 |
|---|---|---|
| onabotulinumtoxin AAlso: BOTOXOne-time injection of 100U BOTOX | Drug | Botox Injection |
Primary outcome
Change in the amount of urinary leakage post-treatment compared to baseline.
Time frame: Baseline, 1-month, 3-month, 6-month
1-hour pad weight, in grams
9 secondary outcomes
Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.
Time frame: Time of Procedure
Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.
Time frame: 1-month
Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.
Time frame: 3-month
Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.
Time frame: 6-month
Change in patient-reported symptoms of stress incontinence symptoms via PGI-I.
Time frame: 1-month, 3-month, 6-month
Change in quality of life impacted by urinary incontinence via UDI-6.
Time frame: Baseline, 1-month, 3-month, 6-month
Change in quality of life impacted by urinary incontinence via IIQ-7.
Time frame: Baseline, 1-month, 3-month, 6-month
Assessment of patient satisfaction post-treatment via SSQ-8.
Time frame: 1-month
Change in pain post-treatment compared to baseline via VAS.
Time frame: Baseline, Time of Procedure, 1-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Bilal Chughtai, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing onabotulinumtoxin A in people with Stress Urinary Incontinence, run by Northwell Health 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 9 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: paused, as of the sponsor's last update on 26 Jan 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change in the amount of urinary leakage post-treatment compared to baseline. (time frame: Baseline, 1-month, 3-month, 6-month). 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 26 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.