Detrusor Muscle HyperactivityPhase 2NCT01357980
Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis
A Phase 2 study testing Botulinum toxin type A in people with Detrusor Muscle Hyperactivity, run by Ipsen at 17 sites in 5 countries.
Trial summary
The purpose of this study is to determine the efficacy and safety of a single dose of 750 U of Dysport compared to placebo for the improvement in the daily incontinence episode frequency for each administration mode in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Detrusor Muscle Hyperactivity
- What is being tested?
- Botulinum toxin type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 17 sitesin 5 countries
- Study dates
- May 2011to Mar 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject, family member or care giver was willing and able to perform clean intermittent catheterisation (CIC) for the duration of the study
- Inadequate response or refractory to anticholinergic medication
- Botulinum Toxin naive for intradetrusor injections and with no previous treatment with Botulinum Toxin of any type, within 3 months prior to study entry for any other condition
- Have a minimum of 2 incontinences per day calculated as the average daily incontinence episode frequency (IEF) over the 3 days preceding the baseline visit
Who cannot join
- Significant Baseline renal and/or urinary tract pathology
- Previous treatment with any endovesical pharmacology agent including detrusor Botulinum Toxin injection
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
France11 sites
Hopital Raymond Poincaré
Garches
Hopital HURIET
Lille
Hôpital Lyon Sud -Hospices Civils de Lyon
Lyon
Hopital de la conception
Marseille
CHU Hotel Dieu
Nantes
Groupe Hospitalier La Pitié Salpetriere
Paris
Hopital Tenon
Paris
CMRRF Kerpape
Ploemeur
CHU Rouen - Hopital Charles Nicolle
Rouen
Nouvel Hopital civil de Strasbourg
Strasbourg
CHU Toulouse - Hopital Rangueil
Toulouse
Germany2 sites
Universitätsklinik Kiel
Kiel
Städtisches Klinikum Neunkirchen
Neunkirchen
About this study
Official title: A Phase IIa, Multicentre, Double Blind, Single Dose, Parallel Group, Placebo Controlled, Clinical Pilot Study to Assess the Efficacy and Safety of a Single Dose, Intra-Detrusor Injections of 750 Units of Dysport® in Subjects Suffering From Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis.
The purpose of this study is to determine the efficacy and safety of a single dose of 750 U of Dysport compared to placebo for the improvement in the daily incontinence episode frequency for each administration mode in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis.
- Conditions
- Detrusor Muscle Hyperactivity
- Being tested
- Botulinum toxin type A, Placebo
- Keywords
- Detrusor Muscle Overactivity
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 AbobotulinumtoxinA (Dysport®)
750 U intra detrusor injection on Day 1 (single dose)
PlaceboDrug
Intra detrusor injection on Day 1 (single dose)
| Study group | Role | What they receive |
|---|---|---|
| Dysport 750 U (15 injection sites) | Experimental | Not described Receives: Biological: Botulinum toxin type A |
| Placebo (15 injection sites) | Placebo comparator | Not described Receives: Drug: Placebo |
| Dysport 750 U (30 injection sites) | Experimental | Not described Receives: Biological: Botulinum toxin type A |
| Placebo (30 injection sites) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Incontinence Episode Frequency (IEF)
Measured: Baseline and Day 84
Secondary outcomes (8)
Urodynamics: Maximum Cystometric Capacity
Maximum Cystometric Capacity is an urodynamic parameter that indicates the volume at which a patient feels he (she) can no longer delay release of urine from the urinary bladder. Baseline urodynamics exams done at screening visit.
Measured: Baseline, Days 14, 42 and 84
Urodynamics:Maximum Detrusor Pressure
Maximum Detrusor Pressure is an urodynamic parameter that is the maximum value of the pressure within the bladder which is measured during the filling phase of the urodynamic exam. Baseline urodynamics exams done at screening visit.
Measured: Baseline, Days 14, 42 and 84
Physician's Global Assessment Score of Treatment Response
The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.
Measured: Day 14
Physician's Global Assessment Score of Treatment Response
The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.
Measured: Day 42
Physician's Global Assessment Score of Treatment Response
The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.
Measured: Day 84
Quality of Life (QoL) Total Summary Score
Mean Change from Baseline in Short Form (SF)-Qualiveen Questionnaire Calculated Total Score.
The SF-Qualiveen questionnaire is a specific health related QoL questionnaire validated for urinary disorders in subjects with neurological conditions containing 8 items looking at four scales: limitations (2 items); constraints (2 items); fears (2 items) and feelings (2 items). The 8 items each having a 5-point Likert-type scale ranging from 0="Not at all" to 4="Extremely" for the first 6 items, from 0="Never" to 4="Always" for item 7 and from 0="Always" to 4="Never" for item 8. The score per scale has been calculated as the mean of the two items. In case of one missing item among the 2 items for a given scale, the score has not been calculated.
Total score has been calculated as the mean of all the items completed among the 8 items.
Lower scores indicate a better QoL (i.e. no limitations, fears, constraints, or negative feelings) and higher scores indicate poorer QoL.
Measured: Baseline, 14, 42 and 84
Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection
Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.
Measured: Baseline
Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure
Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Detrusor Muscle HyperactivityStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Study Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357980
- Sponsor's protocol ID
- Y-52-52120-155
- Other IDs
- 2010-023210-31
- Status last verified
- Sep 2022
- First submitted
- 17 May 2011
- Last updated
- 27 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
Publications
Denys P, Del Popolo G, Amarenco G, Karsenty G, Le Berre P, Padrazzi B, Picaut P; Dysport Study Group. Efficacy and safety of two administration modes of an intra-detrusor injection of 750 units dysport(R) (abobotulinumtoxinA) in patients suffering from refractory neurogenic detrusor overactivity (NDO): A randomised placebo-controlled phase IIa study. Neurourol Urodyn. 2017 Feb;36(2):457-462. doi: 10.1002/nau.22954. Epub 2016 Jan 12.
PubMed 26756554
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Multicentre, Double Blind, Single Dose, Parallel Group, Placebo Controlled, Clinical Pilot Study to Assess the Efficacy and Safety of a Single Dose, Intra-Detrusor Injections of 750 Units of Dysport® in Subjects Suffering From Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT01357980
- Acronym / sponsor ID
- Y-52-52120-155
- Conditions
- Detrusor Muscle Hyperactivity
- Keywords
- Detrusor Muscle Overactivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 May 2011 (estimated)
- Results
- Posted 1 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy and safety of a single dose of 750 U of Dysport compared to placebo for the improvement in the daily incontinence episode frequency for each administration mode in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dysport 750 U (15 injection sites) | Experimental | Biological: Botulinum toxin type A |
| Placebo (15 injection sites) | Placebo comparator | Drug: Placebo |
| Dysport 750 U (30 injection sites) | Experimental | Biological: Botulinum toxin type A |
| Placebo (30 injection sites) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject, family member or care giver was willing and able to perform clean intermittent catheterisation (CIC) for the duration of the study
- Inadequate response or refractory to anticholinergic medication
- Botulinum Toxin naive for intradetrusor injections and with no previous treatment with Botulinum Toxin of any type, within 3 months prior to study entry for any other condition
- Have a minimum of 2 incontinences per day calculated as the average daily incontinence episode frequency (IEF) over the 3 days preceding the baseline visit
Key exclusion criteria (2 listed)
- Significant Baseline renal and/or urinary tract pathology
- Previous treatment with any endovesical pharmacology agent including detrusor Botulinum Toxin injection
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: AbobotulinumtoxinA (Dysport®)750 U intra detrusor injection on Day 1 (single dose) | Biological | Dysport 750 U (15 injection sites), Dysport 750 U (30 injection sites) |
| PlaceboIntra detrusor injection on Day 1 (single dose) | Drug | Placebo (15 injection sites), Placebo (30 injection sites) |
Primary outcome
Daily Incontinence Episode Frequency (IEF)
Time frame: Baseline and Day 84
8 secondary outcomes
Urodynamics: Maximum Cystometric Capacity
Time frame: Baseline, Days 14, 42 and 84
Urodynamics:Maximum Detrusor Pressure
Time frame: Baseline, Days 14, 42 and 84
Physician's Global Assessment Score of Treatment Response
Time frame: Day 14
Physician's Global Assessment Score of Treatment Response
Time frame: Day 42
Physician's Global Assessment Score of Treatment Response
Time frame: Day 84
Quality of Life (QoL) Total Summary Score
Time frame: Baseline, 14, 42 and 84
Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection
Time frame: Baseline
Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26756554Denys P, Del Popolo G, Amarenco G, Karsenty G, Le Berre P, Padrazzi B, Picaut P; Dysport Study Group. Efficacy and safety of two administration modes of an intra-detrusor injection of 750 units dysport(R) (abobotulinumtoxinA) in patients suffering from refractory neurogenic detrusor overactivity (NDO): A randomised placebo-controlled phase IIa study. Neurourol Urodyn. 2017 Feb;36(2):457-462. doi: 10.1002/nau.22954. Epub 2016 Jan 12.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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.
Ipsen Study Director study director
Ipsen
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum toxin type A in people with Detrusor Muscle Hyperactivity, run by Ipsen at 17 sites in 5 countries.
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 4 inclusion and 2 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 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France, Czechia, Germany, Italy, Poland. 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 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?
Yes. Results are posted in the registry (first posted 1 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Daily Incontinence Episode Frequency (IEF) (time frame: Baseline and Day 84). 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 NCT01357980, which also lists 1 linked publication.
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 27 Sep 2022.