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Urinary IncontinencePhase 3CONTENT2NCT02660359

Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2

A Phase 3 study testing Botulinum toxin type A in people with Urinary Incontinence and Overactive Bladder, run by Ipsen at 82 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® doses (600 units [U] and 800 U), compared to placebo in reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Urinary Incontinence, 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
258 participants
Where
82 sitesin 16 countries
Study dates
8 Jul 2016to 4 Jul 2019
Phase
Phase 3
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Urinary Incontinence for at least 3 months prior to Screening as a result of Neurogenic Detrusor Overactivity due to Spinal Cord Injury or Multiple Sclerosis.
  • Subjects with Spinal Cord Injury must have a stable neurological injury at T1 level or below which occurred at least 6 months prior to Screening.
  • Subjects with Multiple Sclerosis must be clinically stable in the investigator's opinion, with no exacerbation (relapse) of MS for at least 3 months prior to Screening.
  • Subjects must have had an inadequate response after at least 4 weeks of oral medications used in the treatment of NDO (e.g. anticholinergics, beta-3 agonists) and/or have intolerable side-effects.
  • Routinely performing Clean Intermittent Catheterization (CIC) to ensure adequate bladder emptying.
  • An average of at least two episodes per day of Urinary Incontinence recorded on the screening bladder diary.

Who cannot join

  • Any current condition (other than NDO) that may impact on bladder function.
  • Previous or current, tumour or malignancy affecting the spinal column or spinal cord, or any other unstable cause of SCI.
  • Any condition that will prevent cystoscopic treatment administration or CIC usage, e.g. urethral strictures.
  • Current indwelling bladder catheter, or removal of indwelling bladder catheter less than 4 weeks prior to Screening.
  • BTX-A treatment within 9 months prior to Screening for any urological condition (e.g. detrusor or urethral sphincter treatments).
  • Any neuromodulation/electrostimulation usage for urinary symptoms/incontinence within 4 weeks prior to Screening. Any implanted neuromodulation device must be switched off at least 4 weeks prior to Screening.

Trial locations and contacts

82 sites in 16 countries.

82 sites in 16 countries

France11 sites

  • Hôpital Raymond-Poincaré

    Garches

  • Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

    Lille

  • Hôpital de la Conception

    Marseille

  • Groupe Hospitalo-Universitaire Pierre Caremau

    Nîmes

  • Hopital de la Source

    Orléans

  • Hopital Pitie-Salpetriere

    Paris

  • Hôpital Tenon

    Paris

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes

  • CHU de ROUEN - Hôpital Charles Nicolle

    Rouen

  • Hôpital Rangueil

    Toulouse

Other trials in France

Brazil10 sites

  • Universidade Estadual de Campinas - Cidade Universitária Zeferino Vaz

    Campinas, 13083-970

  • Hospital de Clinicas, Federal University of Paraná

    Curitiba, 80060-900

  • Hospital São Vicente de Paulo

    Passo Fundo, 99010-080

  • Santa Casa de Misericórdia de Porto Alegre - Hospital Santa Clara

    Porto Alegre, 90020-090

  • Hospital Moinhos de Vento

    Pôrto Alegre, 90560-030

  • Hospital São Lucas da PUCRS

    Pôrto Alegre, 90610-000

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

    Ribeirão Preto, 14048-900

  • Faculdade de Medicina do ABC

    Santo André, 09060-650

  • Hospital Alemão Oswaldo Cruz

    São Paulo, 01323-020

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, 05422-970

Other trials in Brazil

Russia8 sites

  • Scientific research institute of urology and interventional radiology n. a. N. A. Lopatkin

    Moscow, 105425

  • Ministry of healthcare of the Russian Federation

    Moscow, 129226

  • Penza Regional Clinical Hospital n.a. N.N.Burdenko

    Penza, 440026

  • Rostov State Medical University

    Rostov-on-Don, 344022

  • St. Petersburg Research Institute of Phthisiopulmonology

    Saint Petersburg, 194064

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, 197089

  • City Hospital No. 40

    Saint Petersburg, 197706

  • Hospital Orkli

    Saint Petersburg

Other trials in Russia

Spain7 sites

  • Complexo Hospitalario Universitario A Coruña

    A Coruña

  • Fundacio Puigvert

    Barcelona, 08025

  • Fundació GAEM

    Barcelona

  • Hospital Universitario Vall d'Hebron

    Barcelona

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Virgen del Rocío

    Seville

  • Hospital Universitari i Politècnic La Fe

    Valencia

Other trials in Spain

Peru6 sites

  • Clínica San Pablo Surco

    Lima, 15023

  • Clinica Good Hope

    Lima, Lima18

  • Clinica Internacional Sede Lima

    Lima, Lima1

  • Clínica Anglo Americana

    Lima, Lima27

  • Instituto de Ginecología y Reproducción

    Lima, Lima33

  • Unidad de Investigación de la Clínica Internacional Sede San Borja

    Lima, Lima41

Other trials in Peru

United Kingdom6 sites

  • NHS Grampian - Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • Bedford Hospital

    Bedford, MK42 9DJ

  • National Hospital for Neurology and Neurosurgery - UCL

    London, WC1N 3BG

  • Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital

    Sheffield, S10 2JF

  • Royal National Orthopaedic Hospital Trust

    Stanmore, HA7 4LP

  • The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital

    Wakefield, WF1 4DG

Other trials in United Kingdom

Argentina5 sites

  • Instituto Urológico Buenos Aires

    Buenos Aires, 1060

  • Centro de Urologia

    Buenos Aires, C1120AAS

  • Centro Urológico Profesor Bengió

    Córdoba, X5000

  • Hospital Privado - Centro Médico de Córdoba

    Córdoba, X5016KEH

  • Instituto Médico Rodriguez Alfici

    Godoy Cruz, M5501AAP

Other trials in Argentina

Colombia5 sites

  • Solano & Terront Servicios Medicos LTDA- Unidad Integral de Endocrinologia

    Bogotá, 110221

  • Fundación Valle del Lili

    Cali, 760032

  • Centro Medico Imbanaco

    Cali, 760042

  • Asociacion IPS Medicos Internistas de Caldas

    Manizales, 170004

  • Centro de Investigaciones Clinicas - CIC

    Medellín, 5001000

Other trials in Colombia

Israel5 sites

  • Rambam Medical Center

    Haifa, 31096

  • Carmel Medical Center

    Haifa, 34362

  • Meir Medical Center

    Kfar Saba, 44281

  • Rabin Medical Center - Davidoff Center

    Petah Tikva, 49100

  • The Chaim Sheba Medical Center

    Ramat Gan, 52621

Other trials in Israel

Mexico4 sites

  • Centro Medico Puerta de Hierro - Colima

    Colima, 28018

  • Clinstile, S.A. de C.V.

    Cuauhtémoc, 06700

  • Hospital Universitario "Dr. José Eleuterio González"

    Monterrey, 64460

  • Consultorio Privado

    Zapopan, 45040

Other trials in Mexico

Belgium3 sites

  • Antwerp University hospital

    Antwerp

  • Hôpital Erasme

    Brussels, 1070

  • Ourthe-Amblève

    Esneux, 4130

Other trials in Belgium

Chile3 sites

  • Clínica Uromed

    Santiago, 7500787

  • Hospital del Trabajador

    Santiago, 7501241

  • Clínica Las Condes

    Santiago, 7591046

Other trials in Chile

Germany3 sites

  • Universitätsklinikum Bonn Klinik und Poliklinik für Urologie

    Bonn, 53127

  • Kliniken Maria Hilf GmbH - Krankenhaus St. Franziskus

    Mönchengladbach

  • Universitätsklinikum Münster

    Münster, 48149

Other trials in Germany

Australia2 sites

  • Prince of Wales Hospital (POWH)

    Sydney, 2031

  • Westmead Hospital

    Westmead, 2145

Other trials in Australia

Lithuania2 sites

  • Estetines Chirurgijos Centas, UAB

    Kaunas, 49476

  • Vilnius University Hospital Santariskiu Klinikos

    Vilnius, 8661

Other trials in Lithuania

Ukraine2 sites

  • Municipal Healthcare Institution "Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval", Urology Department

    Kharkiv, 61037

  • Kiev City Clinical Hospital No. 3

    Kiev, 02125

Other trials in Ukraine

About this study

Official title: A Phase III, Multicentre, Randomised, Double Blind, Parallel Group, Placebo Controlled Study To Assess The Efficacy And Safety Of One Or More Intradetrusor Treatments Of 600 Or 800 Units Of Dysport® For The Treatment Of Urinary Incontinence In Subjects With Neurogenic Detrusor Overactivity Due To Spinal Cord Injury Or Multiple Sclerosis

The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® doses (600 units [U] and 800 U), compared to placebo in reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS).

Being tested
Botulinum toxin type A, Placebo
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 AbobotulinumtoxinA (Dysport®), Clostridium BTX-A-haemagglutinin complex

    600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points.

  • Botulinum toxin type ABiological

    Also called AbobotulinumtoxinA (Dysport®), Clostridium BTX-A-haemagglutinin complex

    800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points

  • PlaceboDrug

    AbobotulinumtoxinA Placebo 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points

  • PlaceboDrug

    AbobotulinumtoxinA Placebo 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points

Study groups in NCT02660359
Study groupRoleWhat they receive
600 U Dysport® GroupExperimentalNot described
Receives: Biological: Botulinum toxin type A
600 U Dysport® Placebo GroupPlacebo comparatorNot described
Receives: Drug: Placebo
800 U Dysport® GroupExperimentalNot described
Receives: Biological: Botulinum toxin type A
800 U Dysport® Placebo GroupPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle

    The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The least square (LS) mean of the change in weekly number of UI episodes at 6 weeks after the first study treatment was calculated using a mixed model repeated measures (MMRM) analysis.

    Measured: Baseline and Week 6 of DBPC Cycle

Secondary outcomes (8)

  1. Percentage of Subjects With No Episodes of UI at Week 6 of DBPC Cycle

    The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The number of subjects with no UI episodes at 6 weeks after the first study treatment was recorded. Percentage of subjects with no episodes of UI (≥100% Improvement) was calculated as: Total number of subjects with no weekly number of UI episodes at Week 6 / Total number of subjects with any number of UI events at Week 6.

    Measured: Baseline and Week 6 of DBPC Cycle

  2. Percentage of Subjects With a UI Response at Improvement Levels ≥30%, ≥50%, and ≥75% at Week 6 of the DBPC Cycle

    The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The percentage of subjects showing an improvement of ≥30%, ≥50% and ≥75% was calculated as: Total number of subjects with UI response level >=30% or >=50% or >=75% improvement at Week 6 / Total number of subjects with any UI response at Week 6.

    Measured: Baseline and Week 6 of DBPC Cycle

  3. Median Time Between Treatments

    Duration of effect for time between treatments was calculated by: (the date of the first retreatment visit - date of first treatment administration in the DBPC cycle). The median number of days between treatments was determined and subjects with no retreatment were censored at the last visit.

    Measured: Day of first treatment (baseline) to day of retreatment, up to 2 years

  4. Mean Change From Baseline in Volume Per Void at Week 6 of DBPC Cycle

    The volume per void was measured during one 24-hour period of the 7-day bladder diary. The LS mean of the change in volume per void at 6 weeks after the first study treatment was calculated using a MMRM analysis.

    Measured: Baseline and Week 6 of DBPC Cycle

  5. Mean Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 6 of DBPC Cycle

    Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the MCC. The LS mean of the change in MCC at 6 weeks after the first study treatment was calculated using an analysis of covariance (ANCOVA).

    Measured: Baseline and Week 6 of DBPC Cycle

  6. Mean Change From Baseline in Maximum Detrusor Pressure (MDP) During Storage at Week 6 of DBPC Cycle

    Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the MDP. The LS mean of the change in MDP at 6 weeks after the first study treatment was calculated using an ANCOVA.

    Measured: Baseline and Week 6 of DBPC Cycle

  7. Mean Change From Baseline in Volume at First Involuntary Detrusor Contraction (Vol@1stIDC) at Week 6 of DBPC Cycle

    Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the Vol@1stIDC which is the instilled volume when first IDC commences. Subjects who did not exhibit a post-treatment IDC at Week 6 had Vol@1stIDC imputed using the recorded corrected MCC volume at Week 6. The LS mean of the change in Vol@1stIDC at 6 weeks after the first study treatment was calculated using an ANCOVA.

    Measured: Baseline and Week 6 of DBPC Cycle

  8. Percentage of Subjects With No Involuntary Detrusor Contraction (IDCs) During Storage at Week 6 of DBPC Cycle

    Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the occurrence of IDCs. The percentage of subjects without IDCs at 6 weeks after the first study treatment was recorded.

    Measured: Baseline and Week 6 of DBPC Cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2016 (estimated)
  2. Study start8 Jul 2016
  3. Primary completion9 Nov 2018
  4. Study completion4 Jul 2019

Why it stopped: Slow recruitment of patients

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02660359
Sponsor's protocol ID
D-FR-52120-223
Other IDs
2015-000507-44, 2015
Acronym
CONTENT2
Status last verified
Sep 2022
First submitted
14 Jan 2016
Last updated
28 Sep 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
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

  • Kennelly M, Cruz F, Herschorn S, Abrams P, Onem K, Solomonov VK, Del Rosario Figueroa Coz E, Manu-Marin A, Giannantoni A, Thompson C, Vilain C, Volteau M, Denys P; Dysport CONTENT Program Group. Efficacy and Safety of AbobotulinumtoxinA in Patients with Neurogenic Detrusor Overactivity Incontinence Performing Regular Clean Intermittent Catheterization: Pooled Results from Two Phase 3 Randomized Studies (CONTENT1 and CONTENT2). Eur Urol. 2022 Aug;82(2):223-232. doi: 10.1016/j.eururo.2022.03.010. Epub 2022 Apr 7.

    PubMed 35400537

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Botulinum toxin type A in people with Urinary Incontinence and Overactive Bladder, run by Ipsen at 82 sites in 16 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 6 inclusion and 6 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 28 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 82 sites in France, Brazil, Russia, Spain, Peru and 11 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 16 Jun 2021). 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?

Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle (time frame: Baseline and Week 6 of DBPC Cycle). 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 NCT02660359, 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 28 Sep 2022.

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