Estudio multicéntrico de seguimiento a largo plazo de la seguridad y eficacia de dos niveles de dosis del complejo de neurotoxina purificada BOTOX® (toxina botulínica tipo A) en pacientes con incontinencia urinaria debida a hiperactividad neurógena del detrusorA Multicenter, Long-term Follow-up Study of the Safety and Efficacy of Two Dose Levels of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity

Phase 1

• Conditions: Incontinencia urinaria debida a hiperactividad neurógena del detrusor Urinary incontinence due to neurogenic detrusor overactivity; MedDRA version: 9.1Level: LLTClassification code 10029279Term: Neurogenic bladder

• Registration Number: EUCTR2009-009216-53-ES
• Lead Sponsor: Allergan Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-19
• Study Completion: 2013-09-04
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 388

Inclusion Criteria

1. Patient has successfully completed participation in study 191622-515 or 191622-516 and the following criteria are fulfilled:
? Patient has completed at least 52 weeks in the preceding study, with at least 12 weeks of follow-up after the last treatment
? No longer than 6 months has elapsed since completion of the preceding study
2. Written informed consent has been obtained.
3 Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained.
4. Written Data Protection Consent (European sites only) has been obtained.
5. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable.
6. Patient is able to complete study requirements including diary completion and attend all study visits, in the opinion of the investigator.
7. Patient currently uses or is willing to use clean intermittent catheterization (CIC) to empty the bladder (indwelling catheter is not permitted). Caregiver may perform CIC.
8. Patient has a negative pregnancy result if female and of childbearing potential.
9. Patient weighs more than or equal to 50 kg (110 lb).

Additionally, for the patient to qualify for treatment, the following criteria must be satisfied (the request for treatment can occur either at a scheduled visit or between scheduled visits):

? Patient must initiate request for treatment
? Patient reports at least 1 urinary incontinence episode in 3 days as determined by completion of patient bladder diary (over 3 consecutive days) prior to visit.
? A minimum of 12 weeks must have elapsed since previous study treatment (either in the preceding study or in the current study) and treatment cannot occur later than 144 weeks from Study Entry/Day 1
? A minimum of 12 weeks must have elapsed since any BOTOX® (botulinum toxin type A) treatment for any non-urological condition (use of any botulinum toxin of any serotype, is prohibited for the treatment of urological conditions, except for treatment administered as part of study participation)

Once the above criteria have been met, the patient will be considered qualified for treatment. The following criteria must be met prior to the patient being treated with study medication:

? Investigator determines treatment appropriate and no condition or situation exists which, in the investigator's opinion, puts the patient at significant risk from treatment
? Patient has discontinued any antiplatelet or anticoagulant therapy or medications with
anticoagulative effects within at least 3 days prior to treatment (some medications may need to be withheld for >3 days per clinical judgment of the investigator). If needed, low molecular weight heparin can be given up to 24 hours prior to treatment
? Negative pregnancy test result for women of childbearing potential
? In the investigator's opinion, patient is asymptomatic for urinary tract infection (UTI) on day of treatment
? Patient has taken appropriate antibiotic medication:
a) For patients with a negative urine culture result, an antibiotic must be taken for at least 3 days immediately prior to study treatment and continued for at least 3 days following the study treatment procedure (or longer as needed)
b) For patients with a positive urine culture (defined as a urine culture result with a bacteriuria count of > 105 CFU/mL), an antibiotic to which the identified organism is sensitive must be taken at least 5 days immediately prior to study treatment and c

Exclusion Criteria

1. Patient has evidence of any pelvic or urological abnormalities including but not limited to the following:
? interstitial cystitis in the opinion of the investigator
? presence of bladder stones, including any bladder stones detected in the previous study
? surgery or bladder disease other than detrusor overactivity that may impact bladder function (with the exception of surgery performed more than 1 year from screening in the preceding study for stress incontinence, uterine prolapse, rectocele, or cystocele)
2. Patient has received botulinum toxin therapy of any serotype for any urological condition (except for treatment administered as part of study participation in the preceding protocol).
3. Patient has had treatment within 12 weeks of Study Entry/Day 1 of botulinum toxin of any serotype for any non-urological condition
4. Patient has been immunized for any botulinum toxin serotype.
5. Patient has a history, or current diagnosis of prostate cancer.
6. Patient has a history, or current diagnosis of bladder cancer.
7. Patient has hemophilia or other clotting factor deficiencies or disorders that cause bleeding diatheses.
8. Patient has concurrent treatment or treatment within 6 months of Study Entry/Day 1 with intravesical capsaicin, resiniferatoxin, or any other intravesical treatment for overactive bladder.
9. Patient is currently using or plans to use an implanted or non-implantable electrostimulation/neuromodulation device for the treatment of overactive bladder or a baclofen pump.
10. Patient has a known allergy or sensitivity to any components of the study medication, anesthetics or antibiotics or any other products associated with the treatment and general study procedures.
11. Patient has any medical condition that may put the patient at increased risk with exposure to BOTOX® including diagnosed myasthenia gravis, Eaton-Lambert syndrome or amyotrophic lateral sclerosis.
12. Patient is female and pregnant, nursing or planning a pregnancy during the study, or of childbearing potential and unable or unwilling to use a reliable form of contraception during the study.
13. Patient has any condition or situation which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study.
14. Patient is currently participating in, or has previously participated in another therapeutic or device study since exiting study 191622-515 or 191622-516.
15. Any study drug related or study treatment related serious adverse event (SAE) 191622-515 or 191622-516 in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety and maintenance of efficacy of each of 2 dosages of BOTOX® (200 U or 300 U) injected into the detrusor for the treatment of urinary incontinence caused by neurogenic detrusor overactivity in patients who have not been adequately managed with anticholinergic therapy.;Secondary Objective: N/A;Primary end point(s): Number of episodes of urinary incontinence as recorded by patient bladder diary during the 3 consecutive days prior to each study visit. The change from baseline in the daily average frequency of episodes of urinary incontinence. The primary efficacy timepoint is Week 6 after the 1st treatment in this study.