Urinary Bladder, OveractiveNCT01750645
Management of the Idiopathic Overactive Bladder With Botulinum Toxin: Systematic Review
An observational study of Urinary Bladder, Overactive, run by Clínica Infantil Colsubsidio at 1 site in Colombia.
Trial summary
Overactive bladder is defined as a syndrome composed of urgency, increased urinary frequency, and sometimes urinary incontinence; its etiology may be characterized as neurogenic or non-neurogenic (i.e., idiopathic). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- Intradetrusor Injection of Type-A Botulinum Toxin and Other interventions analyzed according to protocol
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteColombia
- Study dates
- Jul 2012to Jan 2013
- 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: Adult patients diagnosed with idiopathic overactive bladder
Who may be able to join
- Controlled randomized clinical trials
- Adult patients diagnosed with idiopathic overactive bladder
- Language of the study: english
Who cannot join
- Diagnosis of neurogenic overactive bladder
- Patients under 18 years old
- Use of Type-B Botulinum Toxin as the intervention
- Other types of studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of the Idiopathic Overactive Bladder With Intradetrusor Injection of Type-A Botulinum Toxin: Systematic Review of the Literature
Overactive bladder is defined as a syndrome composed of urgency, increased urinary frequency, and sometimes urinary incontinence; its etiology may be characterized as neurogenic or non-neurogenic (i.e., idiopathic). This illness has a great impact in quality of life and one of the available treatments is the injection of Botulinum Toxin. This study aims to review the efficacy and safety of type-A Botulinum Toxin in the management of Idiopathic Overactive Bladder. A systematic search was performed in MEDLINE, EMBASE, CENTRAL and LILACS, and the controlled randomized clinical trials were chosen to review with the CONSORT criteria by independent reviewers. Outcomes analyzed were the efficacy of the intervention for relieving the symptoms (urgency, frequency and urgency incontinence), adverse events to treatment, change in quality of life and urodynamic measures.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- Intradetrusor Injection of Type-A Botulinum Toxin, Other interventions analyzed according to protocol
- 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.
Intradetrusor Injection of Type-A Botulinum ToxinDrug
Other interventions analyzed according to protocolOther
- Placebo
- Different dosage of Type-A Botulinum Toxin injected
- Anticholinergic drugs
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Not described Receives: Drug: Intradetrusor Injection of Type-A Botulinum Toxin | |
| Control Group | Not described Receives: Other: Other interventions analyzed according to protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the intervention for relieving the symptoms (urgency, frequency and urgency incontinence)
Measured: Minimun follow-up period of 12 weeks
Secondary outcomes (3)
Adverse events to treatment (urinary retention and urinary tract infections)
Measured: Minimun follow-up period of 12 weeks
Change in quality of life
Measured: Minimun follow-up period of 12 weeks
Change in urodynamic measures
Increase in maximum cystometric capacity, first desire to void, normal desire to void, postvoid residual volume, and the presence/abscence of detrusor overactivity.
Measured: Minimun follow-up period of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2012
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies 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
Sponsor and investigators
- Lead sponsor
- Clínica Infantil Colsubsidio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hugo Enrique López, MD, Clínica Infantil Colsubsidio
- Investigators
- Hugo E López, MD, Principal investigator, Clínica Infantil Colsubsidio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750645
- Sponsor's protocol ID
- COLS-201207
- Status last verified
- Dec 2012
- First submitted
- 11 Dec 2012
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of the Idiopathic Overactive Bladder With Intradetrusor Injection of Type-A Botulinum Toxin: Systematic Review of the Literature
- ClinicalTrials.gov ID
- NCT01750645
- Acronym / sponsor ID
- COLS-201207
- Conditions
- Urinary Bladder, Overactive
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Clínica Infantil ColsubsidioUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (estimated)
- First posted
- 17 Dec 2012 (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 is defined as a syndrome composed of urgency, increased urinary frequency, and sometimes urinary incontinence; its etiology may be characterized as neurogenic or non-neurogenic (i.e., idiopathic). This illness has a great impact in quality of life and one of the available treatments is the injection of Botulinum Toxin. This study aims to review the efficacy and safety of type-A Botulinum Toxin in the management of Idiopathic Overactive Bladder. A systematic search was performed in MEDLINE, EMBASE, CENTRAL and LILACS, and the controlled randomized clinical trials were chosen to review with the CONSORT criteria by independent reviewers. Outcomes analyzed were the efficacy of the intervention for relieving the symptoms (urgency, frequency and urgency incontinence), adverse events to treatment, change in quality of life and urodynamic measures.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Drug: Intradetrusor Injection of Type-A Botulinum Toxin |
| Control Group | – | Other: Other interventions analyzed according to protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with idiopathic overactive bladder
Key inclusion criteria (3 listed)
- Controlled randomized clinical trials
- Adult patients diagnosed with idiopathic overactive bladder
- Language of the study: english
Key exclusion criteria (4 listed)
- Diagnosis of neurogenic overactive bladder
- Patients under 18 years old
- Use of Type-B Botulinum Toxin as the intervention
- Other types of studies
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 |
|---|---|---|
| Intradetrusor Injection of Type-A Botulinum Toxin | Drug | Intervention Group |
| Other interventions analyzed according to protocol* Placebo * Different dosage of Type-A Botulinum Toxin injected * Anticholinergic drugs | Other | Control Group |
Primary outcome
Efficacy of the intervention for relieving the symptoms (urgency, frequency and urgency incontinence)
Time frame: Minimun follow-up period of 12 weeks
3 secondary outcomes
Adverse events to treatment (urinary retention and urinary tract infections)
Time frame: Minimun follow-up period of 12 weeks
Change in quality of life
Time frame: Minimun follow-up period of 12 weeks
Change in urodynamic measures
Time frame: Minimun follow-up period of 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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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.
Hugo E López, MD principal investigator
Clínica Infantil Colsubsidio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder, Overactive, run by Clínica Infantil Colsubsidio at 1 site in Colombia.
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 3 inclusion and 4 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 17 Dec 2012. 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 Colombia. 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?
Results are not available in the source record.
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?
Efficacy of the intervention for relieving the symptoms (urgency, frequency and urgency incontinence) (time frame: Minimun follow-up period of 12 weeks). 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 17 Dec 2012.