Botulinum Toxin in the Treatment of Idiopathic Detrusor Overactivity

NCT02009540 | Unknown Phase 4

• 1 other identifier: UHL02/2013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Detrusor

Outcome Measures

Primary Outcomes (1)

• Global Response Assessment

  measured at 3 months following intervention

Secondary Outcomes (4)

• Functional outcomes - 3 day sensation related bladder diary

  measured at 3 months following intervention

• 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

Study Arms (2)

Botulinum toxin injected to bladder body

PLACEBO COMPARATOR

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

Botulinum toxin injected into trigone

ACTIVE COMPARATOR

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

Drug: Botulinum toxin injected into trigone

Interventions

Botulinum toxin injected to bladder body DRUG

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.

Also known as: Botulinum toxin, Onabotulinumtoxin, Botox

Botulinum toxin injected to bladder body

Botulinum toxin injected into trigone DRUG

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.

Also known as: Botulinum toxin, Onabotulinumtoxin, Botox

Botulinum toxin injected into trigone

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mr HD Flood: lead

Study Sites (1)

University Hospital of Limerick

Limerick, Ireland

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum Toxins; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

• H D Flood, FRCSI

  University Hospital of Limerick

  PRINCIPAL INVESTIGATOR

Central Study Contacts

H D Flood, FRCSI

CONTACT

e_red1@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Urologist

Study Record Dates

• First Submitted: November 29, 2013
• First Posted: December 12, 2013
• Study Start: December 1, 2013
• Primary Completion: January 1, 2014
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

IE (1)