Overactive DetrusorPhase 4NCT02009540
Botulinum Toxin in the Treatment of Idiopathic Detrusor Overactivity
A Phase 4 study testing Botulinum toxin injected to bladder body and Botulinum toxin injected into trigone in people with Overactive Detrusor, run by Mr HD Flood at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Detrusor
- What is being tested?
- Botulinum toxin injected to bladder body and Botulinum toxin injected into trigone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIreland
- Study dates
- Dec 2013to Jan 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
H D Flood, FRCSI contact
About this study
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.
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.
Read more
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
- Being tested
- Botulinum toxin injected to bladder body, Botulinum toxin injected into trigone
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin injected to bladder bodyDrug
Also called Botulinum toxin, Onabotulinumtoxin, Botox
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 trigoneDrug
Also called Botulinum toxin, Onabotulinumtoxin, Botox
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Botulinum toxin injected into trigone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Response Assessment
Measured: measured at 3 months following intervention
Secondary outcomes (4)
Functional outcomes - 3 day sensation related bladder diary
Three day sensation related bladder diary
Measured: measured at 3 months following intervention
IIQ-7 quality of life questionnaire
Measured: measured at 3 months following intervention
Treatment tolerability - numerical rating scale (0-10)
Measured: measured at 2 weeks following intervention
UDI-6 quality of life questionnaire
Measured: measured at 3 months following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive DetrusorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mr HD Flood
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mr HD Flood, University Hospital of Limerick
- Investigators
- H D Flood, FRCSI, Principal investigator, University Hospital of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009540
- Sponsor's protocol ID
- UHL02/2013
- Status last verified
- Dec 2013
- First submitted
- 29 Nov 2013
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02009540
- Acronym / sponsor ID
- UHL02/2013
- Conditions
- Overactive Detrusor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mr HD FloodUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jan 2014 (estimated)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin injected to bladder body | Placebo comparator | Drug: Botulinum toxin injected to bladder bodyarm 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. |
| Botulinum toxin injected into trigone | Active comparator | Drug: Botulinum toxin injected into trigoneArm B will receive 100u onaBoNT-A injected into 10x1ml suburothelial peri-trigonal sites (aliquot dose 10u/ml). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin injected to bladder bodyAlso: Botulinum toxin, Onabotulinumtoxin, Botoxarm 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. | Drug | Botulinum toxin injected to bladder body |
| Botulinum toxin injected into trigoneAlso: Botulinum toxin, Onabotulinumtoxin, BotoxArm 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. | Drug | Botulinum toxin injected into trigone |
Primary outcome
Global Response Assessment
Time frame: measured at 3 months following intervention
4 secondary outcomes
Functional outcomes - 3 day sensation related bladder diary
Time frame: measured at 3 months following intervention
IIQ-7 quality of life questionnaire
Time frame: measured at 3 months following intervention
Treatment tolerability - numerical rating scale (0-10)
Time frame: measured at 2 weeks following intervention
UDI-6 quality of life questionnaire
Time frame: measured at 3 months following intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
Related trials for Overactive Detrusor
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
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Not yet recruitingObservational study
Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for Lower Urinary Tract Dysfunction
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RecruitingPhase 1/2
Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adults With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization
Neurogenic Detrusor Overactivity, Spinal Cord Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H D Flood, FRCSI contact
H D Flood, FRCSI principal investigator
University Hospital of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum toxin injected to bladder body and Botulinum toxin injected into trigone in people with Overactive Detrusor, run by Mr HD Flood at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact H D Flood, FRCSI (e_red1@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Response Assessment (time frame: measured at 3 months following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2013.