Overactive BladderPhase 2NCT00578097
Efficacy and Safety Study of Botulinum Toxin Type-A (Dysport®) in Continent Female Subjects Suffering From Idiopathic Overactive Bladder
A Phase 2 study testing Botulinum toxin type A in people with Overactive Bladder, run by Ipsen at 34 sites in 8 countries.
Trial summary
The purpose of this study is to determine the optimal dose of botulinum toxin type A injected in the detrusor muscle to improve urinary symptoms, urodynamic parameters and quality of life of continent women suffering from idiopathic overactive bladder. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Overactive Bladder
- 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
- 81 participants
- Where
- 34 sitesin 8 countries
- Study dates
- Feb 2008to Dec 2009
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has a diagnosis of idiopathic overactive bladder, without incontinence.
- The subject has ≥ 3 urgency episodes over the course of the 3 days immediately preceding the Baseline visit.
- The subject has ≥ 24 episodes of micturition over the course of the 3 days immediately preceding the Baseline visit.
Who cannot join
- Bladder outlet obstruction (on urodynamic assessment).
- Post-Micturition Residual Volume > 150 ml (ultrasound assessment).
- Evidence of a urinary tract infection at Screening or Baseline in the study.
- Active or history of interstitial cystitis, malignancy of the bladder or urothelial tract, a carcinoma in situ (non malignant melanoma is allowed) bladder and/or kidney stones.
Trial locations and contacts
34 sites in 8 countries.
34 sites in 8 countries
Germany8 sites
Medizinische Einrichtungen der RWTH
Aachen, 52074
Praxis für Urologie
Bad Kreuznach, 55543
Praxis für Urologie
Emmendingen, 79312
Praxis für Urologie
Günzburg, 89312
Praxis für Urologie
Lahr, 77933
Beckenboden Zentrum München
München, 81679
Städtisches Klinikum Neunkirchen gGmbH
Neunkirchen, 66538
Krankenhaus St. Trudpert
Pforzheim, 75177
France5 sites
Hôpital Michallon - CHU de Grenoble
Grenoble, 38043
Groupe Hospitalier Pitié-Salpétrière
Paris, 75661
Hôpital Charles Nicolle - CHU de Rouen
Rouen, 76031
Hôpital Henri Gabrielle - Hôpitaux Civils de Lyon
Saint-Genis-Laval, 69230
Hôpital Rangueil - CHU de Toulouse
Toulouse, 31059
United Kingdom5 sites
Southmead Hospital
Bristol, BS10 5NB
Western General Hospital
Edinburgh, EH4 2XU
St George's Hospital
London, SW17 OQT
Churchill Hospital
Oxford, OX3 7LJ
Royal Berkshire Hospital
Reading, RG1 5AN
Belgium4 sites
ULB Hôpital Erasme
Brussels, B-1070
CH Régional Huy - Polyclinique A Rue Trois Ponts
Huy, 2 4500
UZ Gasthuisberg
Leuven, 3000
CHU Liege Sart Tilman
Liège
Netherlands4 sites
VU Medisch Centrum Amsterdam
Amsterdam, 1081 HV
General Urology Academisch Ziekenhuis Maastricht
Maastricht, P.Debyelaan 25, 6229 HX
UMC St. Radboud
Nijmegen, 6525 GA
Erasmus MC, Universitair Medisch Centrum Rotterdam
Rotterdam, 3000 CA
Italy3 sites
Unità Spinale, Azienda Ospedaliera Careggi
Florence, 50139
Unità Spinale, Ospedale Niguarda
Milan, 20100
Struttura Complessa di Neuro-Urologia
Torino, 1053
Spain3 sites
Hospital San Rafael
Madrid, 28016
Hospital Clínico Universitario Canarias
San Cristóbal de La Laguna, 38330
Hospital Universitario La Fe
Valencia, 46009
Czechia2 sites
Urologická klinika
Olomouc, 775 20
Urologické oddělení
Prague, 140 00
About this study
Official title: A Phase II, International, Multi-centre, Prospective, Randomised, Parallel-group, Double-blind, Dose-ranging, Placebo-controlled, 12-week, Princeps Study to Assess the Efficacy and Safety of a One Injection Cycle With Either Botulinum Toxin Type-A (Dysport® 125, 250 or 500 Units) or Placebo Followed by an Optional 6-month Extension Phase in the Symptomatic Treatment of Micturition Urgency and Frequency in Continent Female Subjects Suffering From Idiopathic Overactive Bladder.
The purpose of this study is to determine the optimal dose of botulinum toxin type A injected in the detrusor muscle to improve urinary symptoms, urodynamic parameters and quality of life of continent women suffering from idiopathic overactive bladder.
- Conditions
- Overactive Bladder
- Being tested
- Botulinum toxin type A, Placebo
- 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 type ABiological
Also called AbobotulinumtoxinA (Dysport®)
Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.
PlaceboDrug
Single injection cycle, intradetrusor injection at baseline (visit 2).
| Study group | Role | What they receive |
|---|---|---|
| A - 125 units | Experimental | Not described Receives: Biological: Botulinum toxin type A |
| B - 250 units | Experimental | Not described Receives: Biological: Botulinum toxin type A |
| C - 500 units | Experimental | Not described Receives: Biological: Botulinum toxin type A |
| D | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episodes of urgency and frequency of micturition.
Measured: Week 12
Secondary outcomes (11)
The number of episodes of urgency, frequency of micturition, and frequency of nocturia.
Measured: All timepoints
Severity of urgency.
Measured: All timepoints
Maximum flow rate and post-micturition residual volume (PMRV).
Measured: Day 4 and Week 6
Standard International Continence Society (ICS) urodynamic parameters.
Measured: Week 12
Quality of Life (QoL).
Measured: All timepoints
Safety
Measured: All timepoints
Extension study - Duration of effect as determined by the persistence of a positive response.
Measured: All timepoints
Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia.
Measured: All timepoints
Extension study - Severity of urgency.
Measured: All timepoints
Extension study Quality of Life (QoL)
Measured: All timepoints
Extension study safety.
Measured: All timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startFeb 2008
- Primary completionJun 2009
- Study completionDec 2009
Why it stopped: The study was terminated early due to poor recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578097
- Sponsor's protocol ID
- Y-79-52120-126
- Other IDs
- 2007-002999-34
- Status last verified
- Nov 2019
- First submitted
- 18 Dec 2007
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, International, Multi-centre, Prospective, Randomised, Parallel-group, Double-blind, Dose-ranging, Placebo-controlled, 12-week, Princeps Study to Assess the Efficacy and Safety of a One Injection Cycle With Either Botulinum Toxin Type-A (Dysport® 125, 250 or 500 Units) or Placebo Followed by an Optional 6-month Extension Phase in the Symptomatic Treatment of Micturition Urgency and Frequency in Continent Female Subjects Suffering From Idiopathic Overactive Bladder.
- ClinicalTrials.gov ID
- NCT00578097
- Acronym / sponsor ID
- Y-79-52120-126
- Conditions
- Overactive Bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to poor recruitment.
- Enrolment
- 81 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Dec 2007 (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.
The purpose of this study is to determine the optimal dose of botulinum toxin type A injected in the detrusor muscle to improve urinary symptoms, urodynamic parameters and quality of life of continent women suffering from idiopathic overactive bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A - 125 units | Experimental | Biological: Botulinum toxin type A |
| B - 250 units | Experimental | Biological: Botulinum toxin type A |
| C - 500 units | Experimental | Biological: Botulinum toxin type A |
| D | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject has a diagnosis of idiopathic overactive bladder, without incontinence.
- The subject has ≥ 3 urgency episodes over the course of the 3 days immediately preceding the Baseline visit.
- The subject has ≥ 24 episodes of micturition over the course of the 3 days immediately preceding the Baseline visit.
Key exclusion criteria (4 listed)
- Bladder outlet obstruction (on urodynamic assessment).
- Post-Micturition Residual Volume > 150 ml (ultrasound assessment).
- Evidence of a urinary tract infection at Screening or Baseline in the study.
- Active or history of interstitial cystitis, malignancy of the bladder or urothelial tract, a carcinoma in situ (non malignant melanoma is allowed) bladder and/or kidney stones.
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®)Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total. | Biological | A - 125 units, B - 250 units, C - 500 units |
| PlaceboSingle injection cycle, intradetrusor injection at baseline (visit 2). | Drug | D |
Primary outcome
Number of episodes of urgency and frequency of micturition.
Time frame: Week 12
11 secondary outcomes
The number of episodes of urgency, frequency of micturition, and frequency of nocturia.
Time frame: All timepoints
Severity of urgency.
Time frame: All timepoints
Maximum flow rate and post-micturition residual volume (PMRV).
Time frame: Day 4 and Week 6
Standard International Continence Society (ICS) urodynamic parameters.
Time frame: Week 12
Quality of Life (QoL).
Time frame: All timepoints
Safety
Time frame: All timepoints
Extension study - Duration of effect as determined by the persistence of a positive response.
Time frame: All timepoints
Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia.
Time frame: All timepoints
Extension study - Severity of urgency.
Time frame: All timepoints
Extension study Quality of Life (QoL)
Time frame: All timepoints
Extension study safety.
Time frame: All timepoints
Results and safety
The study was stopped early (reason given: The study was terminated early due to poor recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
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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.
Ipsen Medical Director study director
Ipsen
34 sites in 8 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 Overactive Bladder, run by Ipsen at 34 sites in 8 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 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: stopped early, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Germany, France, United Kingdom, Belgium, Netherlands and 3 more countries. 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?
The study was stopped early (reason given: The study was terminated early due to poor recruitment.). 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?
Number of episodes of urgency and frequency of micturition. (time frame: Week 12). 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 22 Nov 2019; AzTrials last refreshed its copy on 7 Nov 2026.