Botulinum Toxin in the Treatment of Idiopathic Detrusor Overactivity

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by University Hospital of Limerick
Sponsor:
Information provided by (Responsible Party):
Mr HD Flood, University Hospital of Limerick
ClinicalTrials.gov Identifier:
NCT02009540
First received: November 29, 2013
Last updated: December 8, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Overactive Detrusor
Drug: Botulinum toxin injected to bladder body
Drug: Botulinum toxin injected into trigone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital of Limerick:

Primary Outcome Measures:
  • Global Response Assessment [ Time Frame: measured at 3 months following intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional outcomes - 3 day sensation related bladder diary [ Time Frame: measured at 3 months following intervention ] [ Designated as safety issue: No ]
    Three day sensation related bladder diary

  • IIQ-7 quality of life questionnaire [ Time Frame: measured at 3 months following intervention ] [ Designated as safety issue: No ]
  • Treatment tolerability - numerical rating scale (0-10) [ Time Frame: measured at 2 weeks following intervention ] [ Designated as safety issue: Yes ]
  • UDI-6 quality of life questionnaire [ Time Frame: measured at 3 months following intervention ]

Estimated Enrollment: 60
Study Start Date: December 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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.
Drug: 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. The intervention will be performed under local anaesthetic using a flexible cystoscope.
Other Names:
  • Botulinum toxin
  • Onabotulinumtoxin
  • Botox
Active Comparator: Botulinum toxin injected into trigone
Arm B will receive 100u onaBoNT-A injected into 10x1ml suburothelial peri-trigonal sites (aliquot dose 10u/ml).
Drug: Botulinum toxin injected into trigone
Arm B will receive 100u onaBoNT-A injected into 10x1ml suburothelial peri-trigonal sites (aliquot dose 10u/ml). The procedure will be performed under local anaesthetic by flexible cystoscopy.
Other Names:
  • Botulinum toxin
  • Onabotulinumtoxin
  • Botox

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Urethral stricture of <12ch
  • Pregnancy
  • Sexually active women of childbearing potential who are unwilling to use contraceptive measures for the duration of the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02009540

Contacts
Contact: H D Flood, FRCSI e_red1@yahoo.co.uk

Locations
Ireland
University Hospital of Limerick Not yet recruiting
Limerick, Ireland
Contact: H D Flood         
Sponsors and Collaborators
Mr HD Flood
Investigators
Principal Investigator: H D Flood, FRCSI University Hospital of Limerick
  More Information

No publications provided

Responsible Party: Mr HD Flood, Consultant Urologist, University Hospital of Limerick
ClinicalTrials.gov Identifier: NCT02009540     History of Changes
Other Study ID Numbers: UHL02/2013
Study First Received: November 29, 2013
Last Updated: December 8, 2013
Health Authority: Ireland: Research Ethics Committee

Additional relevant MeSH terms:
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014