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Urinary IncontinencePhase 3CONTENT1NCT02660138

Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1

A Phase 3 study testing Botulinum toxin type A in people with Urinary Incontinence and Overactive Bladder, run by Ipsen at 81 sites in 10 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® (AbobotulinumtoxinA) 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)… 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
227 participants
Where
81 sitesin 10 countries
Study dates
Mar 2016to 14 Feb 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

81 sites in 10 countries.

81 sites in 10 countries

United States32 sites

  • Urology Group of New Mexico, PC

    Albuquerque, New Mexico, 87109

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109

  • University of Colorado Denver

    Aurora, Colorado, 80045-2527

  • UAB School of Medicine Spain Rehabilitation Center (SRC)

    Birmingham, Alabama, 35249

  • Lahey Hospital & Medical Center

    Burlington, Vermont, 01805-0001

  • University of North Carolina School of Medicine

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • Levine Cancer Institute

    Charlotte, North Carolina, 28207

  • Louis Stokes Cleveland Veterans Affairs Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Urology Clinics of North Texas

    Dallas, Texas, 75231

  • Weill Cornell Medical College

    Denville, New Jersey, 07834

  • Women's Health Specialty Care

    Farmington, Connecticut, 06032-1933

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Lancaster Urology

    Lancaster, Pennsylvania, 17601

  • Atlantic Urology Medical Group

    Long Beach, California, 90806

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90089

  • Medical College of Wisconsin - Freodert Hospital

    Milwaukee, Wisconsin, 53226

  • Gousse Urology - The Bladder Heath and Reconstructive Urology Institute

    Miramar, Florida, 33029-5593

  • Integrity Medical Research

    Mountlake Terrace, Washington, 98043

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • New York University Langone Medical Center and School of Medicine

    New York, New York, 10016

  • New York-Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York, 10065

  • Chesapeake Urology Associates, PA

    Owings Mills, Maryland, 21117

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Advanced Urology Centers of New York

    Plainview, New York, 11783

  • UC Davis Medical Center

    Sacramento, California, 95817-2307

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Urological Associates of Southern Arizona, P.C.

    Tucson, Arizona, 85715-3808

  • Urology of Virginia, PLLC

    Virginia Beach, Virginia, 23462-1815

  • Delaware Valley Urology,IIC

    Voorhees Township, New Jersey, 08043

  • The Iowa Clinic, PC

    West Des Moines, Iowa, 50266

Other trials in United States

Czechia9 sites

  • Fakultní Nemocnice Brno

    Brno, 62500

  • Karlovarska krajska nemocnice, a.s.

    Karlovy Vary, 360 01

  • Krajská Nemocnice Liberec, a.s.

    Liberec, 46063

  • Uromedical Center s.r.o.

    Olomouc, 77900

  • Fakultní nemocnice Královské Vinohrady

    Prague, 100 34

  • Všeobecná fakultní nemocnice v Praze

    Prague, 12808

  • Thomayerova nemocnice

    Prague, 14059

  • Fakultní Nemocnice v Motole

    Prague, 15006

  • Urologicka Ordinace s.r.o.

    Sternberk, 785 01

Other trials in Czechia

Turkey (Türkiye)9 sites

  • Ankara Üniversitesi Tıp Fakültesi

    Ankara, 6100

  • Medipol Mega University Hospital

    Bağcılar, 34200

  • Uludag Universitesi Tip Fakultesi, Uroloji Anabilim Dali, Gorukle

    Bursa, 16059

  • Marmara Üniversitesi Eğitim ve Araştırma Hastanesi

    Istanbul, 34670

  • Istanbul Medeniyet Universitesi Goztepe Egitim ve Arastirma Hastanesi Merdivenköy Mah

    Istanbul, 34732

  • Erciyes Üniversitesi Tıp Fakültesi

    Kayseri, 38039

  • Kocaeli Üniversitesi Tıp Fakültesi

    Kocaeli, 41380

  • Celal Bayar Universitesi Hafsa Sultan Hastanesi

    Manisa, 45040

  • Ondokuz Mayıs Üniversitesi Tıp Fakültesi

    Samsun, 55139

Other trials in Turkey (Türkiye)

Italy6 sites

  • Azienda Ospedaliero-Universitaria Careggi - Dipartimento Di Neuro-Urologia

    Florence, 50134

  • Farmacia Istituto Ospedaliero ICOT "Marco Pasquali"

    Latina, 04100

  • Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia

    Perugia, 06132

  • Viale Oxford, 81

    Roma, 00133

  • Ospedale "Bolognini" di Seriate

    Seriate, 24068

  • Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia

    Udine, 33100

Other trials in Italy

Poland5 sites

  • Wojewódzki Szpital Zespolony w Elblągu

    Elblag, 82-300

  • Nzoz Neuro-Medic Poradnia Wielospecjalistyczna

    Katowice, 40-752

  • NZOZ Heureka

    Piaseczno, 05-500

  • Szpital Kliniczny Dzieciątka Jezus w Warszawie

    Warsaw, 02-005

  • EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu

    Wroclaw, 54-144

Other trials in Poland

Portugal5 sites

  • Hospital de Braga

    Braga, 4700-001

  • Centro Hospitalar do Alto Ave, EPE

    Guimarães, 4835-044

  • British Hospital

    Lisbon, 1600-209

  • Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António

    Porto, 4099-001

  • Centro Hospitalar de São João, EPE - Hospital de São João

    Porto, 4200-319

Other trials in Portugal

Romania5 sites

  • Gnosis Evomed

    Bucharest, 031864

  • Spitalul Clinic Colentina

    Bucharest, 20125

  • Spitalul Clinic Fundeni Bucureşti

    Bucharest, 22328

  • Hifu Terramed Conformal S.R.L

    Bucharest, 31864

  • Spitalul Clinic Judeţean Mureş

    Târgu Mureş, 540103

Other trials in Romania

Canada4 sites

  • CHUS - Hôpital Fleurimont

    Sherbrooke, 02114-2621

  • Sunnybrook Health Sciences Centre

    Toronto, 02115-6110

  • UBC Hospital - Koerner Pavilion

    Vancouver, V6T 2B5

  • Spinal Cord Research Centre, University of Manitoba

    Winnipeg, R3A 1M4

Other trials in Canada

Netherlands3 sites

  • VU University Medical Center

    Amsterdam, 1081 HV

  • Radboud UMC

    Nijmegen, 6525 GA

  • Erasmus MC

    Rotterdam, 3015 CE

Other trials in Netherlands

South Korea3 sites

  • 88 Olympic-ro 43-gil, Songpa-gu

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 6351

  • Ulsan University Hospital (UUH)

    Ulsan, 44033

Other trials in South Korea

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® (AbobotulinumtoxinA) 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 NCT02660138
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 (9)

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

    All 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

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

    All 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

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

    All 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

  4. Number 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 and the percentage of subjects was also calculated from the total number of subjects with any number of UI events at Week 6.

    Measured: Baseline and Week 6 of DBPC Cycle

  5. Number of Subjects With No IDCs During Storage at Week 6 of DBPC Cycle

    All subjects had a standardised urodynamic filling cystometry assessment at baseline (screening) and again at Week 6 to determine the occurrence of IDCs. The number of subjects without IDCs at 6 weeks after the first study treatment was recorded and the percentage of subjects was also calculated from the total number of subjects with data available for analysis at Week 6.

    Measured: Baseline and Week 6 of DBPC Cycle

  6. Mean Change From Baseline in Incontinence Quality of Life (I-QoL) Questionnaire Total Summary Score at Week 6 of DBPC Cycle

    The I-QoL questionnaire is a validated, disease-specific questionnaire designed to measure the effect of UI on subjects' QoL. It consists of 22 items in 3 domains (avoidance and limiting behaviour, psychosocial impact and social embarrassment). Subjects used a 5-point response scale for each of the 22 items with values ranging from 1 (extremely) to 5 (not at all). The total summary score was transformed to a 100 point scale ranging from 0 to 100, with higher scores indicating a better QoL. The LS mean of the change in the I-QoL total summary score at 6 weeks after the first study treatment was calculated using a MMRM analysis.

    Measured: Baseline and Week 6 of DBPC Cycle

  7. Number 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 number of baseline UI episodes was compared with the number of UI episodes at Week 6 to determine the level of response each subject reached, i.e. a decrease of ≥30%, ≥50% or ≥75% . The number of subjects showing an improvement of ≥30%, ≥50% and ≥75% were recorded and the percentage of subjects was also calculated from the total number of subjects with any number of UI events at Week 6.

    Measured: Baseline and Week 6 of DBPC Cycle

  8. 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

  9. 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 based on the Kaplan-Meier method. Subjects with no retreatment were censored at the last visit.

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

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 startMar 2016
  3. Primary completion9 Nov 2018
  4. Study completion14 Feb 2019

Why it stopped: Low 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
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02660138
Sponsor's protocol ID
D-FR-52120-222
Other IDs
2015-003471-30, 2015
Acronym
CONTENT1
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 81 sites in 10 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 81 sites in United States, Czechia, Turkey (Türkiye), Italy, Poland and 5 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 NCT02660138, 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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