Detrusor Muscle Hyperactivity Clinical Trial
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.
| Verified date | September 2022 |
| Source | Ipsen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 47 |
| Est. completion date | March 2013 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Faculty Hospital Motol | Praha | |
| Czechia | THOMAYER Faculty Hospital | Praha | |
| 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 | |
| Germany | Universitätsklinik Kiel | Kiel | |
| Germany | Städtisches Klinikum Neunkirchen | Neunkirchen | |
| Italy | Ospedale Careggi | Firenze | |
| Poland | NZOZ Centrum Medyczne Mazovia | Warszawa |
| Lead Sponsor | Collaborator |
|---|---|
| Ipsen |
Czechia, France, Germany, Italy, Poland,
Denys P, Del Popolo G, Amarenco G, Karsenty G, Le Berre P, Padrazzi B, Picaut P; Dysport Study Group. Efficacy and safety of two administration modes of an intra-detrusor injection of 750 units dysport® (abobotulinumtoxinA) in patients suffering from refractory neurogenic detrusor overactivity (NDO): A randomised placebo-controlled phase IIa study. Neurourol Urodyn. 2017 Feb;36(2):457-462. doi: 10.1002/nau.22954. Epub 2016 Jan 12. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Daily Incontinence Episode Frequency (IEF) | Baseline and Day 84 | ||
| Secondary | Urodynamics: Maximum Cystometric Capacity | 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. | Baseline, Days 14, 42 and 84 | |
| Secondary | Urodynamics:Maximum Detrusor Pressure | 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. | Baseline, Days 14, 42 and 84 | |
| Secondary | Physician's Global Assessment Score of Treatment Response | 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'. | Day 14 | |
| Secondary | Physician's Global Assessment Score of Treatment Response | 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'. | Day 42 | |
| Secondary | Physician's Global Assessment Score of Treatment Response | 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'. | Day 84 | |
| Secondary | Quality of Life (QoL) Total Summary Score | 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. |
Baseline, 14, 42 and 84 | |
| Secondary | Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection | 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. | Baseline | |
| Secondary | Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure | 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. | Baseline |