Effect of Botulinum Toxin A on Neurogenic Detrusor Overactivity in Chronic Spinal Cord Injured Patients

NCT03063827 | Completed DMC FDA Drug

• 1 other identifier: BuddhistTCGH 098-53
• Study Type: observational
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study investigated the changes in urothelial dysfunction and sensory protein expression in the bladder urothelium with time after onabotulinumtoxin injection in spinal cord injured (SCI) patients. The investigators planned to enroll 30 chronic SCI patient with neurogenic detrusor overactivity and urinary incontinence were treated with a single injection of 200 U onabotulinumtoxinA at the detrusor. Video urodynamic studies and bladder mucosal biopsies were performed at baseline, 3 months, and 6 months after treatment. Bladder tissues will be investigated for urothelial barrier and inflammation proteins as well as sensory proteins by Western blotting, between SCI patients and 10 controls, as well as successful and failed treatment groups. This study will explore the therapeutic efficacy of a single injection of 200 U onabotulinumtoxinA on neurogenic detrusor overactivity and the changes of urothelial sensory proteins in SCI patients with successful and failed treatment outcome.

Conditions

Neurogenic Bladder

Outcome Measures

Primary Outcomes (1)

• Bladder capacity

  The maximal cystometric or functional bladder capacity

  from baseline to 6 months after treatment

Secondary Outcomes (3)

• IIQ-7

  from baseline to 6 months after treatment

• UDI-6

  from baseline to 6 months after treatment

• Sensory protein assessment

  from baseline to 6 months after treatment

Study Arms (2)

Treatment group

Patients with chronic SCI causing NDO and urinary incontinence

Drug: OnabotulinumtoxinA 200 UNT; Diagnostic Test: Urothelial sensory protein levels

Control group

Female patients who underwent anti-incontinence suregery without lower urinary tract symptoms

Diagnostic Test: Urothelial sensory protein levels

Interventions

OnabotulinumtoxinA 200 UNT DRUG

Patient in the treatment arm received a single injection of onabotulinumtoxinA 200 UNT to the detrusor muscle at 20 sites of the bladder body.

Also known as: OnabotulinumtoxinA (Botox) 200 UNT

Treatment group

Urothelial sensory protein levels DIAGNOSTIC_TEST

Bladder tissues were investigated for urothelial barrier and inflammation proteins as well as urothelial sensory protein levels by Western blotting, between SCI patients and 10 controls, as well as successful and failed treatment groups.

Also known as: Sensory proteins

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients with chronic spinal cord injury causing neurogenic detrusor overactivity and urinary incontinence were treated with a single injection of 200 U onabotulinumtoxinA to the detrusor muscle. All patients presented with urinary incontinence with or without difficult bladder emptying. In patients who received detrusor injections, clean intermittent catheterization was suggested as a possible mode of urinary management after treatment.

You may qualify if:

• patients with chronic SCI causing NDO and urinary incontinence

You may not qualify if:

• patients did not present with urinary incontinence
• patients are known to be allergic to onabotulinumtoxinA
• patients cannot be followed up regularly
• active urinary tract infection

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Hann-Chorng Kuo, M.D.

  Department of Urology, Buddhist Tzu Chi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Urology

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 13, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share