Trial Outcomes & Findings for Urodynamic and Clinical Efficacy of Mirabegron for Neurogenic Bladder Patients (NCT NCT02044510)

Results Overview

Urodynamic bladder capacity

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

32 participants

Primary outcome timeframe

10 weeks

Results posted on

2019-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Mirabegron Patients randomised to this arm start with mirabegron 25mg PO daily for two weeks, and then at 2 weeks titrate to 50mg PO daily, and maintain that dose for the duration of the study (8 additional weeks). Mirabegron: Mirabegron 25mg PO daily for 2 weeks, with dose increase to Mirabegron 50mg PO daily for the remaining 8 weeks.	Placebo Inert placebo pill, matching active treatment pill. Placebo: Matched placebo capsules to the intervention arm
Overall Study STARTED	16	16
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Mirabegron Patients randomised to this arm start with mirabegron 25mg PO daily for two weeks, and then at 2 weeks titrate to 50mg PO daily, and maintain that dose for the duration of the study (8 additional weeks). Mirabegron: Mirabegron 25mg PO daily for 2 weeks, with dose increase to Mirabegron 50mg PO daily for the remaining 8 weeks.	Placebo Inert placebo pill, matching active treatment pill. Placebo: Matched placebo capsules to the intervention arm
Overall Study Adverse Event	1	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mirabegron n=16 Participants Patients randomised to this arm start with mirabegron 25mg PO daily for two weeks, and then at 2 weeks titrate to 50mg PO daily, and maintain that dose for the duration of the study (8 additional weeks). Mirabegron: Mirabegron 25mg PO daily for 2 weeks, with dose increase to Mirabegron 50mg PO daily for the remaining 8 weeks.	Placebo n=16 Participants Inert placebo pill, matching active treatment pill. Placebo: Matched placebo capsules to the intervention arm	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=16 Participants	0 Participants n=16 Participants	0 Participants n=32 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=16 Participants	1 Participants n=16 Participants	3 Participants n=32 Participants
Age, Categorical >=65 years	14 Participants n=16 Participants	15 Participants n=16 Participants	29 Participants n=32 Participants
Age, Continuous	50 years n=16 Participants	56 years n=16 Participants	54 years n=32 Participants
Sex: Female, Male Female	8 Participants n=16 Participants	7 Participants n=16 Participants	15 Participants n=32 Participants
Sex: Female, Male Male	8 Participants n=16 Participants	9 Participants n=16 Participants	17 Participants n=32 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Number of participants with a Spinal cord injury (SCI), n	9 Participants n=16 Participants	10 Participants n=16 Participants	19 Participants n=32 Participants
Number of participants with Mulitple sclerosis (MS), n	7 Participants n=16 Participants	6 Participants n=16 Participants	13 Participants n=32 Participants

PRIMARY outcome

Timeframe: 10 weeks

Urodynamic bladder capacity

Outcome measures

Outcome measures
Measure	Mirabegron n=16 Participants Patients randomised to this arm start with mirabegron 25mg PO daily for two weeks, and then at 2 weeks titrate to 50mg PO daily, and maintain that dose for the duration of the study (8 additional weeks). Mirabegron: Mirabegron 25mg PO daily for 2 weeks, with dose increase to Mirabegron 50mg PO daily for the remaining 8 weeks.	Placebo n=16 Participants Inert placebo pill, matching active treatment pill. Placebo: Matched placebo capsules to the intervention arm
Bladder Capacity	305 mL Interval 234.0 to 376.0	369 mL Interval 298.0 to 440.0

SECONDARY outcome

Timeframe: 10 weeks

The 3 day voiding diary is a simple patient maintained record of fluid intake, voided volume and incontinence episodes. This will be used to assess number of episodes of urgency incontinence, urinary frequency, longest time between voids, functional capacity, and mean voided volume

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 weeks

This will determine the amount of urinary incontinence that occurs over a 24hr period.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 weeks

The Short Form-Qualiveen is a urinary specific quality of life measure developed and studied specifically for neurogenic bladder patients; validity, reliability and responsiveness have been established.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 weeks

The I-QOL is an incontinence specific quality of life tool that has been shown to be a valid, reliable and responsive measurement among patients with neurogenic bladder dysfunction

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 weeks

The Neurogenic bladder symptom score (NBSS) is a symptom specific measure of urinary symptoms developed for patients with neurogenic bladder dysfunction with demonstrated validity and reliability. Minimum score is 0, maximum score is 74. Higher score is worse neurogenic bladder symptoms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 weeks

The patient perception of bladder condition is a commonly used measure in the assessment of oral medications for the treatment of overactive bladder symptoms

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 weeks

Adverse events will be monitored passively. They will be actively monitored for hypertension, tachycardia, and urinary retention.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 weeks

Outcome measures

Outcome data not reported

Adverse Events

Mirabegron

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mary McKibbon

Lawson Research Institute

Phone: 5196466367

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place