Urinary IncontinenceNCT02590250
A Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) in Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in India
An observational study of Urinary Incontinence and Overactive Bladder, run by Allergan at 12 sites in India.
Trial summary
This is a Post-Marketing Surveillance study in India to evaluate safety and efficacy of BOTOX® (Botulinum Toxin Type A) in the treatment of patients with urinary incontinence due to neurogenic detrusor overactivity or overactive bladder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Incontinence, Overactive Bladder
- What is being tested?
- botulinum toxin Type A
- How many people
- 250 participants
- Where
- 12 sitesIndia
- Study dates
- 16 Dec 2015to 7 Aug 2017
- Phase
- Observational
- 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
Study population: Patients with urinary incontinence (due to NDO, eg, as a result of SCI or MS, or due to OAB) who have an inadequate response to or are intolerant of an anticholinergic medication
Who may be able to join
- Patients with urinary incontinence due to NDO or OAB treated with BOTOX® as per local standard of care in clinical practice.
Who cannot join
- None
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
India12 sites
Bodyline Hospitals
Ahmedabad, Gujarat, 380007
Fortis Hospitals
Bengaluru, Karnataka, 560076
Global Hospital
Hyderabad, Telangana, 500004
Christian Medical College & Hospital
Ludhiana, Punjab, 141008
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
Mumbai, Maharashtra, 400053
Dr. Ram Manohar Lohia Hospital
New Delhi, National Capital Territory of Delhi, 110001
Indian Spinal Injuries Centre
New Delhi, National Capital Territory of Delhi, 110070
Fortis Escorts Heart Institute
Okhla Road, New Delhi, 110025
NU Hospitals
Padmanabha Nagar, Banglore, 560070
AMAI Charitable Trust's ACE Hospital and Research Centre
Pune, Maharashtra, 411004
Inamdar Multispeciality Hospital
Pune, Maharashtra, 411040
Christian Medical College and Hospital
Vellore, Tamil Nadu, 632004
About this study
Official title: Evaluation of the Safety and Effectiveness of BOTOX® (Botulinum Toxin Type A) in the Treatment of Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder: A Phase IV Non-interventional Post-marketing Surveillance Study in India
This is a Post-Marketing Surveillance study in India to evaluate safety and efficacy of BOTOX® (Botulinum Toxin Type A) in the treatment of patients with urinary incontinence due to neurogenic detrusor overactivity or overactive bladder.
- Conditions
- Urinary Incontinence, Overactive Bladder
- Being tested
- botulinum toxin Type A
- Medical subject headings
- Urinary Incontinence, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin Type ABiological
Also called BOTOX®, onabotulinumtoxinA
Botulinum toxin Type A treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| BOTOX® | Patients who receive botulinum toxin Type A (BOTOX®) treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice. Receives: Biological: botulinum toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline value of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Measured: at up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study start16 Dec 2015
- Primary completion7 Aug 2017
- Study completion7 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahunna Ukah, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590250
- Sponsor's protocol ID
- 191622-140
- Status last verified
- Mar 2018
- First submitted
- 27 Oct 2015
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effectiveness of BOTOX® (Botulinum Toxin Type A) in the Treatment of Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder: A Phase IV Non-interventional Post-marketing Surveillance Study in India
- ClinicalTrials.gov ID
- NCT02590250
- Acronym / sponsor ID
- 191622-140
- Conditions
- Urinary Incontinence, Overactive Bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2015 (actual)
- Primary completion
- 7 Aug 2017 (actual)
- Study completion
- 7 Aug 2017 (actual)
- First posted
- 29 Oct 2015 (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.
This is a Post-Marketing Surveillance study in India to evaluate safety and efficacy of BOTOX® (Botulinum Toxin Type A) in the treatment of patients with urinary incontinence due to neurogenic detrusor overactivity or overactive bladder.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BOTOX® | – | Biological: botulinum toxin Type APatients who receive botulinum toxin Type A (BOTOX®) treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with urinary incontinence (due to NDO, eg, as a result of SCI or MS, or due to OAB) who have an inadequate response to or are intolerant of an anticholinergic medication
Key inclusion criteria (1 listed)
- Patients with urinary incontinence due to NDO or OAB treated with BOTOX® as per local standard of care in clinical practice.
Key exclusion criteria (1 listed)
- None
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 Type AAlso: BOTOX®, onabotulinumtoxinABotulinum toxin Type A treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice. | Biological | BOTOX® |
Primary outcome
Change from the baseline value of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Time frame: at up to 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
Related trials for Urinary Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
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.
Ahunna Ukah study director
Allergan
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Overactive Bladder, run by Allergan at 12 sites in India.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in India. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the baseline value of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) (time frame: at up to 4 months). 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 26 Mar 2018.