Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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 sclerosis.

Condition or disease	Intervention/treatment	Phase
Detrusor Muscle Hyperactivity	Drug: Botulinum type A toxin (Dysport®); Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	47 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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.
Study Start Date :	May 2011
Actual Primary Completion Date :	March 2013
Actual Study Completion Date :	March 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Dysport 750 U (15 injection sites)	Drug: Botulinum type A toxin (Dysport®); 750 U intra detrusor injection on Day 1 (single dose)
Placebo Comparator: Placebo (15 injection sites)	Drug: Placebo; Intra detrusor injection on Day 1 (single dose)
Experimental: Dysport 750 U (30 injection sites)	Drug: Botulinum type A toxin (Dysport®); 750 U intra detrusor injection on Day 1 (single dose)
Placebo Comparator: Placebo (30 injection sites)	Drug: Placebo; Intra detrusor injection on Day 1 (single dose)

Outcome Measures

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Primary Outcome Measures :

1. Daily Incontinence Episode Frequency (IEF) [ Time Frame: Baseline and Day 84 ]

Secondary Outcome Measures :

1. Urodynamics: Maximum Cystometric Capacity [ Time Frame: Baseline, Days 14, 42 and 84 ]
   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.
2. Urodynamics:Maximum Detrusor Pressure [ Time Frame: Baseline, Days 14, 42 and 84 ]
   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.
3. Physician's Global Assessment Score of Treatment Response [ Time Frame: Day 14 ]
   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'.
4. Physician's Global Assessment Score of Treatment Response [ Time Frame: Day 42 ]
   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'.
5. Physician's Global Assessment Score of Treatment Response [ Time Frame: Day 84 ]
   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'.
6. Quality of Life (QoL) Total Summary Score [ Time Frame: Baseline, 14, 42 and 84 ]

   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.

7. Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection [ Time Frame: Baseline ]
   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.
8. Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure [ Time Frame: Baseline ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Significant Baseline renal and/or urinary tract pathology
• Previous treatment with any endovesical pharmacology agent including detrusor Botulinum Toxin injection

Contacts and Locations

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Locations

Czech Republic
Faculty Hospital Motol
Praha, Czech Republic
THOMAYER Faculty Hospital
Praha, Czech Republic
France
Hopital Raymond Poincaré
Garches, France
Hopital HURIET
Lille, France
Hôpital Lyon Sud -Hospices Civils de Lyon
Lyon, France
Hopital de la conception
Marseille, France
CHU Hotel Dieu
Nantes, France
Groupe Hospitalier La Pitié Salpetriere
Paris, France
Hopital Tenon
Paris, France
CMRRF Kerpape
Ploemeur, France
CHU Rouen - Hopital Charles Nicolle
Rouen, France
Nouvel Hopital civil de Strasbourg
Strasbourg, France
CHU Toulouse - Hopital Rangueil
Toulouse, France
Germany
Universitätsklinik Kiel
Kiel, Germany
Städtisches Klinikum Neunkirchen
Neunkirchen, Germany
Italy
Ospedale Careggi
Firenze, Italy
Poland
NZOZ Centrum Medyczne Mazovia
Warszawa, Poland

Sponsors and Collaborators

Ipsen

Investigators

Study Director:	Ipsen Study Director	Ipsen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ipsen
ClinicalTrials.gov Identifier:	NCT01357980 History of Changes
Other Study ID Numbers:	Y-52-52120-155
First Posted:	May 23, 2011
Results First Posted:	September 1, 2014
Last Update Posted:	September 1, 2014
Last Verified:	August 2014

Keywords provided by Ipsen:

Detrusor Muscle Overactivity

Additional relevant MeSH terms:

Sclerosis; Multiple Sclerosis; Spinal Cord Injuries; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System	Wounds and Injuries; abobotulinumtoxinA; Botulinum Toxins, Type A; onabotulinumtoxinA; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents