Botulinum Toxin in the Treatment of Idiopathic Detrusor Overactivity

Overactive Detrusor Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02009540
• Other study ID #: UHL02/2013
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 29, 2013
• Last updated: December 8, 2013
• Start date: December 2013

Study information

• Verified date: December 2013
• Source: University Hospital of Limerick
• Contact: H D Flood, FRCSI
• Email: e_red1[@]yahoo.co.uk
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Detrusor

Intervention

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.
• 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.

Locations

Country	Name	City	State
Ireland	University Hospital of Limerick	Limerick

Sponsors (1)

Lead Sponsor	Collaborator
Mr HD Flood

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Response Assessment		measured at 3 months following intervention	No
Secondary	Functional outcomes - 3 day sensation related bladder diary	Three day sensation related bladder diary	measured at 3 months following intervention	No
Secondary	IIQ-7 quality of life questionnaire		measured at 3 months following intervention	No
Secondary	Treatment tolerability - numerical rating scale (0-10)		measured at 2 weeks following intervention	Yes
Secondary	UDI-6 quality of life questionnaire		measured at 3 months following intervention