Overactive BladderPhase 2NCT02735499
Instillation of Botox in the Bladder in Women With Overactive Bladder (OAB)
A Phase 2 study testing onabotulinum toxin A in people with Overactive Bladder, run by The Hospital of Vestfold at 1 site in Norway.
Trial summary
Instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- onabotulinum toxin A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2016to Oct 2016
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent form signed
- OAB/urgency incontinence of at least 3 months duration
- Conservative treatment (medicines, electrical stimulation) has been tried without sufficient benefit
- There is indication for cystoscopic injection treatment with Botox®
- More than 3 months since any previous treatment with Botox®
- Detrusor overactivity documented by cystometry is desirable, but not obligatory
Who cannot join
- Age below 18 years
- Mixed incontinence with predominant stress component
- Insufficient understanding of Norwegian and / or unable to fill out the necessary forms
- Ongoing urinary tract infection (UTI) (defined as positive urine stix (nitrite and leucocytes) with symptoms of UTI) must be treated before inclusion.
- Any contraindication stated in the Summary of product characteristics (SPC) for Botox
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bladder Instillation of Botox With EMDA for OAB - a Pilot Study
Instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder
Read the detailed description
Pilot study to evaluate the effect of instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder using Electromotive Drug Application (EMDA) in women with overactive bladder.
15 women with therapy-resistant OAB will be included. All patients must be qualified for conventional cystoscopic Botox injection. The study is not randomized or blinded. Follow-up time is six months with voiding charts and three questionnaires (Urinary Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7), International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) as well as a satisfaction with treatment Visual analog scale (VAS).
- Conditions
- Overactive Bladder
- Being tested
- onabotulinum toxin A
- Keywords
- onabotulinum toxin A, Urinary bladder, EMDA, iontophoresis, electrophoresis, Urinary incontinence
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onabotulinum toxin ADrug
Also called Botox
Onabotulinum toxin A is installed into the bladder and EMDA (Electromotive Drug Application) is applied for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Botox | Experimental | Onabotulinum toxin A. 200 units of Botox installed into the bladder by catheter. Receives: Drug: onabotulinum toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of leakage episodes
Measured with a 24-hour voiding chart
Measured: 24 hours
Secondary outcomes (7)
Change in grams leakage
Measured with a 24-hour voiding chart
Measured: 24 hours
Change in number of voids
Measured with a 24-hour voiding chart
Measured: 24 hours
Change in mean voided volume
Measured with a 24-hour voiding chart
Measured: 24 hours
Change in Urinary Distress Inventory-6 score (UDI-6)
Questionnaire
Measured: 6 months
Change in Incontinence Impact Questionnaire-7 score (IIQ-7)
Questionnaire
Measured: 6 months
Change in International Consultation on Incontinence Questionnaire-Short Form score (ICIQ-SF)
Questionnaire
Measured: 6 months
Change in flow rate
Measured by flowmetry
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital of Vestfold
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Responsible party
- Principal investigator, Dr Hjalmar A Schiotz, MD, PhD, The Hospital of Vestfold
- Investigators
- Hjalmar A Schiotz, MD, PhD, Principal investigator, Vestfold Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735499
- Sponsor's protocol ID
- Botox instillation study
- Status last verified
- Nov 2018
- First submitted
- 6 Apr 2016
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Duthie JB, Vincent M, Herbison GP, Wilson DI, Wilson D. Botulinum toxin injections for adults with overactive bladder syndrome. Cochrane Database Syst Rev. 2011 Dec 7;2011(12):CD005493. doi: 10.1002/14651858.CD005493.pub3.
PubMed 22161392Kajbafzadeh AM, Ahmadi H, Montaser-Kouhsari L, Sharifi-Rad L, Nejat F, Bazargan-Hejazi S. Intravesical electromotive botulinum toxin type A administration--part II: Clinical application. Urology. 2011 Feb;77(2):439-45. doi: 10.1016/j.urology.2010.06.003. Epub 2010 Aug 30.
PubMed 20800886Schiøtz HA, Mai HT, Zabielska R. Intravesical Electromotive Botulinum Toxin in Women with Overactive Bladder - a pilot study. AJGO 2017; 2: 4-10. https://www.arcjournals.org/pdfs/ajgo/v2-i2/2.pdf
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Instillation of Botox With EMDA for OAB - a Pilot Study
- ClinicalTrials.gov ID
- NCT02735499
- Acronym / sponsor ID
- Botox instillation study
- Conditions
- Overactive Bladder
- Keywords
- onabotulinum toxin A, Urinary bladder, EMDA, iontophoresis, electrophoresis, Urinary incontinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The Hospital of VestfoldUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Study start
- Mar 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 12 Apr 2016 (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.
Instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder
Detailed description
Pilot study to evaluate the effect of instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder using Electromotive Drug Application (EMDA) in women with overactive bladder.
15 women with therapy-resistant OAB will be included. All patients must be qualified for conventional cystoscopic Botox injection. The study is not randomized or blinded. Follow-up time is six months with voiding charts and three questionnaires (Urinary Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7), International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) as well as a satisfaction with treatment Visual analog scale (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Botox | Experimental | Drug: onabotulinum toxin AOnabotulinum toxin A. 200 units of Botox installed into the bladder by catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent form signed
- OAB/urgency incontinence of at least 3 months duration
- Conservative treatment (medicines, electrical stimulation) has been tried without sufficient benefit
- There is indication for cystoscopic injection treatment with Botox®
- More than 3 months since any previous treatment with Botox®
Key exclusion criteria (5 listed)
- Age below 18 years
- Mixed incontinence with predominant stress component
- Insufficient understanding of Norwegian and / or unable to fill out the necessary forms
- Ongoing urinary tract infection (UTI) (defined as positive urine stix (nitrite and leucocytes) with symptoms of UTI) must be treated before inclusion.
- Any contraindication stated in the Summary of product characteristics (SPC) for Botox
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 |
|---|---|---|
| onabotulinum toxin AAlso: BotoxOnabotulinum toxin A is installed into the bladder and EMDA (Electromotive Drug Application) is applied for 30 minutes | Drug | Treatment with Botox |
Primary outcome
Change in number of leakage episodes
Time frame: 24 hours
Measured with a 24-hour voiding chart
7 secondary outcomes
Change in grams leakage
Time frame: 24 hours
Change in number of voids
Time frame: 24 hours
Change in mean voided volume
Time frame: 24 hours
Change in Urinary Distress Inventory-6 score (UDI-6)
Time frame: 6 months
Change in Incontinence Impact Questionnaire-7 score (IIQ-7)
Time frame: 6 months
Change in International Consultation on Incontinence Questionnaire-Short Form score (ICIQ-SF)
Time frame: 6 months
Change in flow rate
Time frame: 4 weeks
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 Nov 2018.
- Background: PubMed 22161392Duthie JB, Vincent M, Herbison GP, Wilson DI, Wilson D. Botulinum toxin injections for adults with overactive bladder syndrome. Cochrane Database Syst Rev. 2011 Dec 7;2011(12):CD005493. doi: 10.1002/14651858.CD005493.pub3.
- Background: PubMed 20800886Kajbafzadeh AM, Ahmadi H, Montaser-Kouhsari L, Sharifi-Rad L, Nejat F, Bazargan-Hejazi S. Intravesical electromotive botulinum toxin type A administration--part II: Clinical application. Urology. 2011 Feb;77(2):439-45. doi: 10.1016/j.urology.2010.06.003. Epub 2010 Aug 30.
- Results publicationSchiøtz HA, Mai HT, Zabielska R. Intravesical Electromotive Botulinum Toxin in Women with Overactive Bladder - a pilot study. AJGO 2017; 2: 4-10. https://www.arcjournals.org/pdfs/ajgo/v2-i2/2.pdf
- Final articleLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Hjalmar A Schiotz, MD, PhD principal investigator
Vestfold Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing onabotulinum toxin A in people with Overactive Bladder, run by The Hospital of Vestfold at 1 site in Norway.
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 6 inclusion and 5 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 Nov 2018. 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 Norway. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 in number of leakage episodes (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02735499, which also lists 3 linked publications.
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 Nov 2018.