Urgency Urinary IncontinencePhase 4NCT04227184
Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence
A Phase 4 study testing Trospium in people with Urgency Urinary Incontinence, run by Becky Clarkson at 1 site in United States.
Trial summary
This is a randomized double-blind crossover trial of trospium and placebo in women with urgency urinary incontinence, with evaluation (history, physical, incontinence evaluation and brain MRI) at baseline, and after each course of therapy. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Urgency Urinary Incontinence
- What is being tested?
- Trospium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2020to 30 Oct 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60+ years old
- Has UUI or urge-predominant mixed incontinence at least 5 times/ week for > 3 months despite treatment for reversible causes
Who cannot join
- conditions/medications contraindicating trospium
- If currently taking anticholinergic medications (participant must refrain from anticholinergic medications for 4 weeks prior enrollment in order to be eligible)
- Impaired mobility or cognition sufficient to preclude following study procedures; MoCA test score <24/30; a clinically-apparent neurological condition
- Prolapse beyond the hymen
- Interstitial cystitis
- Spinal cord injury
Show all 15Show fewer
- History of pelvic radiation or advanced uterine/bladder cancer
- Urethral obstruction (uroflow); PVR >200 ml
- Medical instability
- Prior UUI treatment with onabotulinum toxin or neuromodulation
- Drug interaction or expected medication change during the study
- Conditions requiring IV antibacterial prophylaxis
- New incontinence treatment < 3 months prior to enrollment
- Fecal incontinence, and symptomatic colitis/IBS
- Contraindications to MRI.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
This is a randomized double-blind crossover trial of trospium and placebo in women with urgency urinary incontinence, with evaluation (history, physical, incontinence evaluation and brain MRI) at baseline, and after each course of therapy. The investigators will evaluate functional brain changes in relation to bladder improvement in order to improve our knowledge of the brain's role in the continence mechanism.
Read the detailed description
Urgency urinary incontinence (UUI) costs the US $83 billion/year, owing in large part to its increased prevalence with age, particularly in women: 9% of those over age 18 and 36% of those over age 65. UUI also impairs quality of life, social interaction, and independence; contributes to functional decline; and increases risk for falls, hip fractures, UTIs, urosepsis, anxiety, depression, and institutionalization.The cause of UUI is unknown. Its urgency and leakage are usually ascribed to detrusor overactivity (DO, involuntary detrusor contraction), suggesting that the cause is intrinsic to the bladder even though DO is not always confirmed on testing. Because of this assumption, most therapies target the bladder albeit with only moderate success: e.g., anticholinergics reduce incontinence episodes but their benefit and tolerability (especially for older adults) are sufficiently low that 75% of patients discontinue them within a year. By contrast, therapies such as biofeedback-assisted pelvic muscle therapy (BFB) tackle behaviors. Moreover, the use of biofeedback to retrain the brain shows that the central control mechanism can be targeted and improved. Thus, the present proposal is designed to further elucidate this mechanism, thereby paving the way for discovery of new and more effective ways to control UUI. These could transform current treatment and either complement or supplant current therapy.
Explanation for change in study outcomes: This study was designed as a mechanistic study, using the study drug as a probe, to develop a more comprehensive qualitative model of the brain's role in bladder control. We present the primary outcome of response to drug/placebo as a cross-over drug study which allows evaluation of the study drug in a clinical population, as reported in our IRB approval document STUDY19090167. The synthesis of the groups of responders and non-responders to drug or placebo is crucial to allow in depth analysis of changes in brain structure and function which will provide insight into how the brain controls the bladder. However, such analysis is necessarily qualitative, complex and challenging to convey in a context-free numerical format, such as this site. Thus, the initially entered primary outcomes of brain structure and function will be reported with full context in upcoming manuscripts.
- Conditions
- Urgency Urinary Incontinence
- Being tested
- Trospium, Placebo oral tablet
- Keywords
- Urinary Incontinence, Urgency urinary incontinence, Trospium
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrospiumDrug
Also called Sanctura
Drug to treat overactive bladder
Placebo oral tabletDrug
Also called Placebo
Placebo tablet containing no active drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo/Trospium | Experimental | Placebo first for 12 weeks followed by Trospium for 12 weeks. Receives: Drug: Trospium; Drug: Placebo oral tablet |
| Trospium/Placebo | Experimental | Trospium first for 12 weeks followed by Placebo for 12 weeks Receives: Drug: Trospium; Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder (Yes/no)
Whether reduction in number of leaks on 3-day bladder diary is at least 50%
Measured: Baseline to 12 weeks and baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start13 Feb 2020
- Primary completion28 Feb 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urgency Urinary IncontinenceStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becky Clarkson
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Becky Clarkson, University of Pittsburgh
- Investigators
- Becky Clarkson, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227184
- Sponsor's protocol ID
- STUDY19090167
- Other IDs
- R01AG064251
- Status last verified
- Nov 2025
- First submitted
- 9 Jan 2020
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after de-identification may be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04227184
- Acronym / sponsor ID
- STUDY19090167
- Conditions
- Urgency Urinary Incontinence
- Keywords
- Urinary Incontinence, Urgency urinary incontinence, Trospium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Becky ClarksonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Posted 24 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized double-blind crossover trial of trospium and placebo in women with urgency urinary incontinence, with evaluation (history, physical, incontinence evaluation and brain MRI) at baseline, and after each course of therapy. The investigators will evaluate functional brain changes in relation to bladder improvement in order to improve our knowledge of the brain's role in the continence mechanism.
Detailed description
Urgency urinary incontinence (UUI) costs the US $83 billion/year, owing in large part to its increased prevalence with age, particularly in women: 9% of those over age 18 and 36% of those over age 65. UUI also impairs quality of life, social interaction, and independence; contributes to functional decline; and increases risk for falls, hip fractures, UTIs, urosepsis, anxiety, depression, and institutionalization.The cause of UUI is unknown. Its urgency and leakage are usually ascribed to detrusor overactivity (DO, involuntary detrusor contraction), suggesting that the cause is intrinsic to the bladder even though DO is not always confirmed on testing. Because of this assumption, most therapies target the bladder albeit with only moderate success: e.g., anticholinergics reduce incontinence episodes but their benefit and tolerability (especially for older adults) are sufficiently low that 75% of patients discontinue them within a year. By contrast, therapies such as biofeedback-assisted pelvic muscle therapy (BFB) tackle behaviors. Moreover, the use of biofeedback to retrain the brain shows that the central control mechanism can be targeted and improved. Thus, the present proposal is designed to further elucidate this mechanism, thereby paving the way for discovery of new and more effective ways to control UUI. These could transform current treatment and either complement or supplant current therapy.
Explanation for change in study outcomes: This study was designed as a mechanistic study, using the study drug as a probe, to develop a more comprehensive qualitative model of the brain's role in bladder control. We present the primary outcome of response to drug/placebo as a cross-over drug study which allows evaluation of the study drug in a clinical population, as reported in our IRB approval document STUDY19090167. The synthesis of the groups of responders and non-responders to drug or placebo is crucial to allow in depth analysis of changes in brain structure and function which will provide insight into how the brain controls the bladder. However, such analysis is necessarily qualitative, complex and challenging to convey in a context-free numerical format, such as this site. Thus, the initially entered primary outcomes of brain structure and function will be reported with full context in upcoming manuscripts.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo/Trospium | Experimental | Drug: Trospium, Drug: Placebo oral tabletPlacebo first for 12 weeks followed by Trospium for 12 weeks. |
| Trospium/Placebo | Experimental | Drug: Trospium, Drug: Placebo oral tabletTrospium first for 12 weeks followed by Placebo for 12 weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 60+ years old
- Has UUI or urge-predominant mixed incontinence at least 5 times/ week for > 3 months despite treatment for reversible causes
Key exclusion criteria (15 listed)
- conditions/medications contraindicating trospium
- If currently taking anticholinergic medications (participant must refrain from anticholinergic medications for 4 weeks prior enrollment in order to be eligible)
- Impaired mobility or cognition sufficient to preclude following study procedures; MoCA test score <24/30; a clinically-apparent neurological condition
- Prolapse beyond the hymen
- Interstitial cystitis
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 |
|---|---|---|
| TrospiumAlso: SancturaDrug to treat overactive bladder | Drug | Placebo/Trospium, Trospium/Placebo |
| Placebo oral tabletAlso: PlaceboPlacebo tablet containing no active drug | Drug | Placebo/Trospium, Trospium/Placebo |
Primary outcome
Responder (Yes/no)
Time frame: Baseline to 12 weeks and baseline to 24 weeks
Whether reduction in number of leaks on 3-day bladder diary is at least 50%
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after de-identification may be shared with other researchers.
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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.
Becky Clarkson, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trospium in people with Urgency Urinary Incontinence, run by Becky Clarkson 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 2 inclusion and 15 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: finished, as of the sponsor's last update on 24 Apr 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Responder (Yes/no) (time frame: Baseline to 12 weeks and baseline to 24 weeks). 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 24 Apr 2026.