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Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1 (CONTENT1)

Primary Purpose

Urinary Incontinence, Overactive Bladder

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Botulinum toxin type A

Placebo

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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.

Sites / Locations

UAB School of Medicine Spain Rehabilitation Center (SRC)
Urological Associates of Southern Arizona, P.C.
Atlantic Urology Medical Group
USC Norris Comprehensive Cancer Center
UC Davis Medical Center
University of Colorado Denver
Women's Health Specialty Care
Gousse Urology - The Bladder Heath and Reconstructive Urology Institute
The Iowa Clinic, PC
Chesapeake Urology Associates, PA
University of Michigan Hospital
Weill Cornell Medical College
Delaware Valley Urology,IIC
Urology Group of New Mexico, PC
Montefiore Medical Center
New York University Langone Medical Center and School of Medicine
New York-Presbyterian Hospital/Weill Cornell Medical Center
Advanced Urology Centers of New York
University of North Carolina School of Medicine
Levine Cancer Institute
Louis Stokes Cleveland Veterans Affairs Medical Center
Cleveland Clinic
Lancaster Urology
Thomas Jefferson University Hospital
Medical University of South Carolina (MUSC)
Vanderbilt University Medical Center
Urology Clinics of North Texas
Houston Methodist Hospital
Lahey Hospital & Medical Center
Urology of Virginia, PLLC
Integrity Medical Research
Medical College of Wisconsin - Freodert Hospital
CHUS - Hôpital Fleurimont
Sunnybrook Health Sciences Centre
UBC Hospital - Koerner Pavilion
Spinal Cord Research Centre, University of Manitoba
Fakultní Nemocnice Brno
Karlovarska krajska nemocnice, a.s.
Krajská Nemocnice Liberec, a.s.
Uromedical Center s.r.o.
Fakultní nemocnice Královské Vinohrady
Všeobecná fakultní nemocnice v Praze
Fakultní Nemocnice v Motole
Thomayerova nemocnice
Urologicka Ordinace s.r.o.
Azienda Ospedaliero-Universitaria Careggi - Dipartimento Di Neuro-Urologia
Farmacia Istituto Ospedaliero ICOT "Marco Pasquali"
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Viale Oxford, 81
Ospedale "Bolognini" di Seriate
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
88 Olympic-ro 43-gil, Songpa-gu
Samsung Medical Center
Ulsan University Hospital (UUH)
VU University Medical Center
Radboud UMC
Erasmus MC
Wojewódzki Szpital Zespolony w Elblągu
Nzoz Neuro-Medic Poradnia Wielospecjalistyczna
NZOZ Heureka
Szpital Kliniczny Dzieciątka Jezus w Warszawie
EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu
Hospital de Braga
Centro Hospitalar do Alto Ave, EPE
British Hospital
Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António
Centro Hospitalar de São João, EPE - Hospital de São João
Gnosis Evomed
Spitalul Clinic Colentina
Spitalul Clinic Fundeni Bucureşti
Hifu Terramed Conformal S.R.L
Spitalul Clinic Judeţean Mureş
Ankara Üniversitesi Tıp Fakültesi
Medipol Mega University Hospital
Uludag Universitesi Tip Fakultesi, Uroloji Anabilim Dali, Gorukle
Marmara Üniversitesi Eğitim ve Araştırma Hastanesi
Istanbul Medeniyet Universitesi Goztepe Egitim ve Arastirma Hastanesi Merdivenköy Mah
Erciyes Üniversitesi Tıp Fakültesi
Kocaeli Üniversitesi Tıp Fakültesi
Celal Bayar Universitesi Hafsa Sultan Hastanesi
Ondokuz Mayıs Üniversitesi Tıp Fakültesi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

600 U Dysport® Group

600 U Dysport® Placebo Group

800 U Dysport® Group

800 U Dysport® Placebo Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT02660138

First Posted

January 14, 2016

Last Updated

September 15, 2022

Sponsor

Ipsen

1. Study Identification

Unique Protocol Identification Number

NCT02660138

Brief Title

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

Acronym

CONTENT1

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Terminated

Why Stopped

Low recruitment of patients

Study Start Date

March 2016 (undefined)

Primary Completion Date

November 9, 2018 (Actual)

Study Completion Date

February 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ipsen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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) or multiple sclerosis (MS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence, Overactive Bladder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

227 (Actual)

8. Arms, Groups, and Interventions

Arm Title

600 U Dysport® Group

Arm Type

Experimental

Arm Title

600 U Dysport® Placebo Group

Arm Type

Placebo Comparator

Arm Title

800 U Dysport® Group

Arm Type

Experimental

Arm Title

800 U Dysport® Placebo Group

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

Botulinum toxin type A

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Botulinum toxin type A

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame