Trial Outcomes & Findings for URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence (NCT NCT04211831)

Last Updated: 2023-04-20

Results Overview

Average daily number of urgency episodes was calculated as the total number of urgency episodes recorded on a completed diary day within the visit window divided by the number of days the Bladder Diary was filled out. An urgency episode was defined as when a participant answered "Yes" to the question "Need to urinate immediately" on the bladder diary electronic case report form (eCRF). If a participant had more than 1 bladder diary filled out on the same day, then all the urgency episodes were summed together. The denominator used for calculating the average number only counted the days in which there was at least 1 completed bladder diary day within the visit window. Baseline was defined as the last non-missing measurement prior to the study treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

Baseline (Day 1) and at Week 12

Results posted on

2023-04-20

Participant Flow

This multicenter, randomized, double-blind, placebo-controlled, single-treatment, 2-cohort, dose escalation study evaluated the efficacy and safety of URO-902 in females with overactive bladder (OAB) and Urge Urinary Incontinence (UUI).

A total of 80 participants were randomized into the study.

Participant milestones

Participant milestones
Measure	Placebo Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 milligrams (mg) or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.	URO-902 24 mg Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.	URO-902 48 mg Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 48 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.
Overall Study STARTED	27	26	27
Overall Study COMPLETED	23	22	22
Overall Study NOT COMPLETED	4	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 milligrams (mg) or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.	URO-902 24 mg Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.	URO-902 48 mg Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 48 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.
Overall Study Withdrawal by Subject	4	1	1
Overall Study Protocol Violation	0	0	1
Overall Study Adverse Event	0	1	0
Overall Study Lack of Efficacy	0	0	1
Overall Study Lost to Follow-up	0	0	2
Overall Study Unable to Complete the Procedures Successfully	0	1	0
Overall Study Other	0	1	0

Baseline Characteristics

URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=26 Participants Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 milligrams (mg) or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.	URO-902 24 mg n=22 Participants Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.	URO-902 48 mg n=26 Participants Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 48 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.	Total n=74 Participants Total of all reporting groups
Age, Continuous	65.6 years STANDARD_DEVIATION 7.05 • n=5 Participants	65.7 years STANDARD_DEVIATION 7.39 • n=7 Participants	62.8 years STANDARD_DEVIATION 6.75 • n=5 Participants	64.7 years STANDARD_DEVIATION 7.09 • n=4 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	22 Participants n=7 Participants	26 Participants n=5 Participants	74 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	18 Participants n=7 Participants	25 Participants n=5 Participants	67 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	17 Participants n=4 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	17 Participants n=7 Participants	19 Participants n=5 Participants	56 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and at Week 12

Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 milligrams (mg) or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.	URO-902 24 mg n=22 Participants Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.	URO-902 48 mg n=21 Participants Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 48 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.
Change From Baseline at Week 12 in Average Daily Number of Urgency Episodes	-1.13 Urgency episodes per day Standard Error 0.740	-2.43 Urgency episodes per day Standard Error 0.777	-3.37 Urgency episodes per day Standard Error 0.738

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Population comprises of all participants who were randomized and received study drug.

An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant, administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize participant and may require medical or surgical intervention to prevent any of outcomes listed above. TEAEs/TESAEs are defined as any event that began or worsened in severity after initial exposure of study treatment through 48 weeks after treatment administration or the date of the initiation of another overactive bladder medication, investigational agent, or surgical intervention, whichever occurred first.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 milligrams (mg) or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.	URO-902 24 mg n=22 Participants Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.	URO-902 48 mg n=26 Participants Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 48 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) Any TEAE	14 Participants	10 Participants	14 Participants
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) Any TESAE	3 Participants	1 Participants	2 Participants

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

URO-902 24 mg

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

URO-902 48 mg

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=26 participants at risk Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 milligrams (mg) or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.	URO-902 24 mg n=22 participants at risk Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.	URO-902 48 mg n=26 participants at risk Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 48 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.
Nervous system disorders Cervical radiculopathy	3.8% 1/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	0.00% 0/22 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	0.00% 0/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	0.00% 0/22 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	3.8% 1/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	0.00% 0/22 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	3.8% 1/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.
Infections and infestations COVID-19 pneumonia	0.00% 0/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	4.5% 1/22 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	0.00% 0/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	0.00% 0/22 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	3.8% 1/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.
General disorders Non-cardiac chest pain	0.00% 0/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	0.00% 0/22 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	3.8% 1/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.8% 1/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	0.00% 0/22 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	0.00% 0/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.
General disorders Hypertension	3.8% 1/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	0.00% 0/22 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	0.00% 0/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.
Nervous system disorders Migraine	3.8% 1/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	0.00% 0/22 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	0.00% 0/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.
Nervous system disorders Transient ischaemic attack	3.8% 1/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	0.00% 0/22 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.	0.00% 0/26 • Up to 48 Weeks Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.

Other adverse events

Additional Information

Information, Clinical Trial Results

Urovant Sciences

Phone: 949-226-6029

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor does not object to publication by Institution or Principal Investigator (PI) of results of the Trial based on information collected or generated by the Institution or PI. However, the Institution and PI are required to provide the Sponsor with an opportunity to review any proposed publication or other type of disclosure before it is submitted or otherwise disclosed to ensure against any inadvertent disclosure of Sponsor Confidential Information or unprotected Sponsor Inventions.
Publication restrictions are in place

Restriction type: OTHER