Trial Outcomes & Findings for Effect of Botulinum Toxin A on Detrusor Overactivity and Renal Function in Chronic Spinal Cord Injured Patients (NCT NCT01682603)

NCT ID: NCT01682603

Last Updated: 2017-03-20

Results Overview

Efficacy: Net change of the UrinaryDdistress Inventory (UDI-6) from baseline and 12 months. The UDI-6 is a 6-item short forms on a 4-point scale ranging from 0 "Not at all" to 3 "Greatly". The total UDI-6 score can therefore range from 0 to 18 (asymptomatic to very symptomatic). Safety: Systemic adverse events

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 34 participants
• Primary outcome timeframe: Baseline and 12 months
• Results posted on: 2017-03-20

Participant Flow

The chronic SCI patients with urinary incontinence in Hualien Tzu Chi General Hospital were consecutively recruited into this study.

Patients were excluded if they had an active urinary tract infection, urinary tract cancer, history of lower urinary tract surgery or chronic systemic diseases. If patients fulfilled the inclusion criteria, they were enrolled in this study.

Participant milestones

Measure	Botulinum Toxin A Botulinum toxin A (BoNT-A) (BOTOX 300U)
Overall Study STARTED	37
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Botulinum Toxin A Botulinum toxin A (BoNT-A) (BOTOX 300U)
Overall Study Lost to Follow-up	3

Baseline Characteristics

Effect of Botulinum Toxin A on Detrusor Overactivity and Renal Function in Chronic Spinal Cord Injured Patients

Baseline characteristics by cohort

Measure	Botulinum Toxin A n=34 Participants BoNT-A (BOTOX 300U) Botulinum toxin A: BoNT-A (BOTOX 300U)
Age, Continuous	41.5 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment Taiwan	34 participants n=5 Participants
Injury Level Cervical	13 participants n=5 Participants
Injury Level Thoracic	21 participants n=5 Participants
ASIA Classification A	27 participants n=5 Participants
ASIA Classification B	3 participants n=5 Participants
ASIA Classification C	2 participants n=5 Participants
ASIA Classification D	2 participants n=5 Participants
Autonomic dysreflexia Autonomic dysreflexia	11 participants n=5 Participants
Autonomic dysreflexia Non-Autonomic dysreflexia	23 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Efficacy:

Net change of the UrinaryDdistress Inventory (UDI-6) from baseline and 12 months.

The UDI-6 is a 6-item short forms on a 4-point scale ranging from 0 "Not at all" to 3 "Greatly".

The total UDI-6 score can therefore range from 0 to 18 (asymptomatic to very symptomatic).

Safety:

Systemic adverse events

Outcome measures

Measure	Botulinum Toxin A n=34 Participants BoNT-A (BOTOX 300U) Botulinum toxin A: BoNT-A (BOTOX 300U)	Pre-Non Autonomic Dysreflexia Baseline Non autonomic dysreflexia
Net Change of the Urinary Distress Inventory (UDI-6) Baseline	10.4 units on a scale Standard Deviation 4.13	—
Net Change of the Urinary Distress Inventory (UDI-6) 12 months	7.43 units on a scale Standard Deviation 2.24	—

PRIMARY outcome

Timeframe: Baseline and 12 months

Efficacy:

Net change of the Incontinence Impact Questionnaire (IIQ-7) from baseline and 12 months.

The IIQ-7 is a 7-item short forms on a 4-point scale ranging from 0 "Not at all" to 3 "Greatly".

Total IIQ-7 score ranges = 0 to 21 The total IIQ-7 score can therefore range from 0 to 21 (asymptomatic to very symptomatic).

Safety:

Systemic adverse events

Outcome measures

Measure	Botulinum Toxin A n=34 Participants BoNT-A (BOTOX 300U) Botulinum toxin A: BoNT-A (BOTOX 300U)	Pre-Non Autonomic Dysreflexia Baseline Non autonomic dysreflexia
Net Change of the Incontinence Impact Questionnaire (IIQ-7) Baseline	11.9 units on a scale Standard Deviation 5.22	—
Net Change of the Incontinence Impact Questionnaire (IIQ-7) 12 months	5.57 units on a scale Standard Deviation 4.97	—

PRIMARY outcome

Timeframe: Baseline and 12 months

Efficacy:

Net change of the quality of life index (QoL-I) from baseline and 12 months. The QoL-I on a 7-point scale ranging from 0 "Delighted" to 6 "Terrible". The QoL-I ranges 0 to 6

Safety:

Systemic adverse events

Outcome measures

Measure	Botulinum Toxin A n=34 Participants BoNT-A (BOTOX 300U) Botulinum toxin A: BoNT-A (BOTOX 300U)	Pre-Non Autonomic Dysreflexia Baseline Non autonomic dysreflexia
Net Change of the Quality of Life Index (QoL-I) Baseline	4.00 units on a scale Standard Deviation 1.24	—
Net Change of the Quality of Life Index (QoL-I) 12 months	2.21 units on a scale Standard Deviation 1.48	—

SECONDARY outcome

Timeframe: Baseline and 12 months

Efficacy:

Net change of the cystometric bladder capacity (CBC) from baseline and 12 months

Safety:

Systemic adverse events

Outcome measures

Measure	Botulinum Toxin A n=34 Participants BoNT-A (BOTOX 300U) Botulinum toxin A: BoNT-A (BOTOX 300U)	Pre-Non Autonomic Dysreflexia Baseline Non autonomic dysreflexia
Net Change of the Cystometric Bladder Capacity (CBC) 12 months	437.6 mL Standard Deviation 114.3	—
Net Change of the Cystometric Bladder Capacity (CBC) Baseline	305.9 mL Standard Deviation 167.7	—

SECONDARY outcome

Timeframe: Baseline and 12 months

Bladder compliance is the result of a mathematical calculation of the volume required for a unit rise of pressure measured during a cystometric filling.

Bladder compliance is calculated by dividing the volume change by the change in bladder pressure (mL/cmH2O).

Efficacy:

Net change of the bladder compliance from baseline and 12 months

Safety:

Systemic adverse events

Outcome measures

Measure	Botulinum Toxin A n=34 Participants BoNT-A (BOTOX 300U) Botulinum toxin A: BoNT-A (BOTOX 300U)	Pre-Non Autonomic Dysreflexia Baseline Non autonomic dysreflexia
Net Change of the Bladder Compliance Baseline	30.6 mL/cmH2O Standard Deviation 29.1	—
Net Change of the Bladder Compliance 12 months	29.0 mL/cmH2O Standard Deviation 19.6	—

SECONDARY outcome

Timeframe: Baseline and 12 months

Efficacy:

Net change of the maximum flow rate (Qmax) from baseline and 12 months

Safety:

Systemic adverse events

Outcome measures

Measure	Botulinum Toxin A n=34 Participants BoNT-A (BOTOX 300U) Botulinum toxin A: BoNT-A (BOTOX 300U)	Pre-Non Autonomic Dysreflexia Baseline Non autonomic dysreflexia
Net Change of the Maximum Flow Rate (Qmax) Baseline	4.56 mL/s Standard Deviation 4.75	—
Net Change of the Maximum Flow Rate (Qmax) 12 months	3.54 mL/s Standard Deviation 8.85	—

SECONDARY outcome

Timeframe: Baseline and 12 months

Efficacy:

Net change of the void volume from baseline and 12 months

Safety:

Systemic adverse events

Outcome measures

Measure	Botulinum Toxin A n=34 Participants BoNT-A (BOTOX 300U) Botulinum toxin A: BoNT-A (BOTOX 300U)	Pre-Non Autonomic Dysreflexia Baseline Non autonomic dysreflexia
Net Change of the Void Volume Baseline	79.6 mL Standard Deviation 95.1	—
Net Change of the Void Volume 12 months	59.2 mL Standard Deviation 125.1	—

SECONDARY outcome

Timeframe: Baseline and 12 months

Efficacy:

Net change of the detrusor pressure (Pdet) from baseline and 12 months

Safety:

Systemic adverse events

Outcome measures

Measure	Botulinum Toxin A n=34 Participants BoNT-A (BOTOX 300U) Botulinum toxin A: BoNT-A (BOTOX 300U)	Pre-Non Autonomic Dysreflexia Baseline Non autonomic dysreflexia
Net Change of the Detrusor Pressure (Pdet) Baseline	36.1 cmH2O Standard Deviation 22.2	—
Net Change of the Detrusor Pressure (Pdet) 12 months	12.9 cmH2O Standard Deviation 16.9	—

SECONDARY outcome

Timeframe: Baseline and 12 months

Efficacy:

Net change of the postvoid residual volume (PVR) from baseline and 12 months

Results:

Botulinum toxin A injection have increased postvoid residual urine volume in patients treated for bladder dysfunction.

Treat only patients who are willing and able to initiate catheterization post-treatment, if required, for urinary retention.

Safety:

Systemic adverse events

Outcome measures

Measure	Botulinum Toxin A n=34 Participants BoNT-A (BOTOX 300U) Botulinum toxin A: BoNT-A (BOTOX 300U)	Pre-Non Autonomic Dysreflexia Baseline Non autonomic dysreflexia
Net Change of the Postvoid Residual Volume (PVR) Baseline	226.3 mL Standard Deviation 138.2	—
Net Change of the Postvoid Residual Volume (PVR) 12 months	378.5 mL Standard Deviation 142.1	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12 months

Outcome measures

Measure	Botulinum Toxin A n=11 Participants BoNT-A (BOTOX 300U) Botulinum toxin A: BoNT-A (BOTOX 300U)	Pre-Non Autonomic Dysreflexia n=23 Participants Baseline Non autonomic dysreflexia
Autonomic Dysreflexia Post-Autonomic dysreflexia	5 participants	1 participants
Autonomic Dysreflexia Post-Non Autonomic dysreflexia	6 participants	22 participants

Adverse Events

Botulinum Toxin A

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Botulinum Toxin A n=34 participants at risk BoNT-A (BOTOX 300U) Botulinum toxin A: BoNT-A (BOTOX 300U)
Nervous system disorders De nove autonomic dysreflexia	17.6% 6/34 • 12 months
Renal and urinary disorders Difficult urination	2.9% 1/34 • 12 months
Renal and urinary disorders Hematuria	14.7% 5/34 • 12 months
Renal and urinary disorders Urinary tract infection	29.4% 10/34 • 12 months

Additional Information

Dr. Hann-Chorng Kuo

Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University

Phone: 886-3-8561825

Email: hck@tzuchi.com.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place