Skip to main content
Clinical Trials/NCT02009540
NCT02009540
Unknown
Phase 4

Efficacy of Peri-trigonal Onabotulinumtoxin Injections in the Treatment of Refractory Idiopathic Detrusor Overactivity (IDO): A Single-blind, Randomised Controlled Trial Comparing Peri-trigonal Injections vs Injection of the Bladder Body.

Mr HD Flood1 site in 1 country60 target enrollmentDecember 2013

Overview

Phase
Phase 4
Intervention
Botulinum toxin injected to bladder body
Conditions
Overactive Detrusor
Sponsor
Mr HD Flood
Enrollment
60
Locations
1
Primary Endpoint
Global Response Assessment
Last Updated
12 years ago

Overview

Brief Summary

Overactive Bladder (OAB) is a chronic condition caused by instability of the detrusor or bladder muscle, which gives rise to symptoms of urinary urgency and often urinary incontinence. Idiopathic Detrusor Overactivity (IDO) is a subset of OAB where the cause for the bladder muscle instability is unknown.

OAB is usually treated by conservative measures or with oral medications eg. anticholinergics. Injection of onabotulinum toxin A (onaBoNT-A) into the bladder wall is licenced in the treatment of refractory IDO where oral medications fail. The injected toxin paralyses the bladder by blocking the ability of certain (motor) nerves to communicate with the bladder muscle. As these nerves are mainly concentrated in what is known as the "body" of the bladder this is traditionally where the injections are given.

In addition to its action on motor nerves, onaBoNT-A also affects sensory nerve pathways. Recent studies show that IDO is caused by both motor and sensory nerve dysfunction, therefore injecting the "trigone", a part of the bladder where sensory nerves are particularly dense, may be of clinical benefit. Three studies comparing trigone versus trigone-sparing injection of botulinum toxin in the treatment of IDO have been carried out. One of these indicated a significant benefit in targeting the trigone and the other two did not show any difference.

Our study aims to examine if injection of onaBoNT-A into the trigone alone will provide symptom and functional improvement in patients with IDO by comparing peritrigonal injection of onaBoNT-A with the traditional method of injection which spares the trigone.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
January 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Mr HD Flood
Responsible Party
Sponsor Investigator
Principal Investigator

Mr HD Flood

Consultant Urologist

University Hospital of Limerick

Eligibility Criteria

Inclusion Criteria

  • Fulfil ICS criteria for OAB
  • Urodynamically proven detrusor instability
  • Symptoms lasting \>6/12
  • Patients must discontinue anticholinergic medication \>14 days prior to randomisation and withhold the use of anticholinergics for the duration of the study.
  • Patients with mixed incontinence are eligible if their urge symptoms are predominant. These will be instruced to record only episodes of urge urinary incontinence.
  • Providing informed consent to participate in the study
  • At least 18 years of age

Exclusion Criteria

  • Previous BoNT-A injection within 9 months of randomisation
  • History of any neurological condition e.g. MS, Parkinsons, CVA
  • Contraindication to BoNT e.g. Myaesthenia gravis
  • Urinary tract infection in previous 6/12
  • Antimicrobial therapy in previous 6/12
  • Previous or current diagnosis of prostate or bladder cancer
  • History of treatment with cyclophosphamide
  • Radiation cystitis
  • Urethral dilatation, cystometrogram, bladder cystoscopy under anaesthetic or a bladder biopsy in previous 3/12
  • Augmentation cystoplasty, cystectomy or neurectomy

Arms & Interventions

Botulinum toxin injected to bladder body

arm will receive 100u of onaBoNT-A in 20x1ml aliquots (5u/ml). 20 injections will be given into the bladder wall, sparing the trigone. Injections will be given through all layers of the bladder eg suburothelially and intradetrusor.

Intervention: Botulinum toxin injected to bladder body

Botulinum toxin injected into trigone

Arm B will receive 100u onaBoNT-A injected into 10x1ml suburothelial peri-trigonal sites (aliquot dose 10u/ml).

Intervention: Botulinum toxin injected into trigone

Outcomes

Primary Outcomes

Global Response Assessment

Time Frame: measured at 3 months following intervention

Secondary Outcomes

  • IIQ-7 quality of life questionnaire(measured at 3 months following intervention)
  • Treatment tolerability - numerical rating scale (0-10)(measured at 2 weeks following intervention)
  • UDI-6 quality of life questionnaire(measured at 3 months following intervention)
  • Functional outcomes - 3 day sensation related bladder diary(measured at 3 months following intervention)

Study Sites (1)

Loading locations...

Similar Trials