Prevention of Bladder Dysfunction in Acute Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

— BOT-SCI  

Official title:

Prevention of Bladder Dysfunction in Acute Spinal Cord Injury. A Double-blind, Randomized, Placebo-controlled Study to Explore the Effect of Early Treatment With Onabotulinumtoxin A on Development of Detrusor Overactivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698138
• Other study ID #: 2012/1151
• Status: Completed
• Phase: Phase 4
• Start date: September 2012
• Est. completion date: December 20, 2020

Study information

• Verified date: November 2022
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a double blind, randomized, placebo controlled trial to explore the effect of early treatment with Onabotulinumtoxin A in patients with acute complete motor spinal cord injury (SCI) on the development of neurogenic detrusor overactivity (NDO). A total of 20 patients will be randomized to intra-detrusor injection of 300 U Onabotulinumtoxin A in 30 ml NaCl 0.9 % or placebo with 30 ml NaCl 0.9 %. Bladder biopsies will be obtained in the same procedure. The treatment will be repeated after three months. All included patients will be evaluated with urodynamic examinations. Follow-up is 12 months after the first treatment. The primary endpoint of the study is development of NDO.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 20, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with documented acute, motor complete C6 to Th11 spinal cord injury
• Patients can be included in the study less than four weeks after injury
• Male or female, aged 18 to 80 years old
• Patient weight > 40 kg
• Patient is able and willing to sign informed consent
• Patient is able to complete all study requirements

Exclusion Criteria:

• Neurogenic detrusor overactivity with contractions greater than 40 cm H2O at first visit
• History or evidence of previous urological abnormalities, disease or surgery, except bladder dysfunction after spinal cord injury
• History of haematuria or ongoing haematuria, if the hematuria is determined to be a pathologic condition or is uninvestigated
• Pregnancy or females of childbearing potential unwilling to use a reliable form of contraception
• Breastfeeding
• Known allergy to Onabotulinumtoxin A
• Grave psychiatric disorder
• Use of anti-platelet or anti-coagulant other than low molecular weight heparin (LMWH) or acetylsalicylic acid
• Haemophilia or other clotting disorders that cause bleeding diathesis
• Treatment with antimuscarinic medication within 3 months of randomization
• Treatment with botulinum toxin of any serotype within 3 months of randomization
• Patient has been immunized for any botulinum toxin serotype
• Patient has any medical condition that may put the patient at increased risk with exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert syndrome or amyotrophic lateral sclerosis
• 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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Urinary Bladder, Overactive
• Wounds and Injuries

Intervention

Drug:
• Onabotulinumtoxin A
30 transurethral injections, each of 1 ml solution containing 300 U Onabotulinumtoxin A (Botox ®, "Allergan") in 30 ml of NaCl 0.9 %.
• Placebo
30 transurethral injections, each of 1 ml solution containing NaCl.

Locations

Country	Name	City	State
Norway	Sunnaas Hospital	Nesoddtangen
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Sunnaas Rehabilitation Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Detrusor pathophysiology	Differences in levels of transmitters and receptors relevant to development of bladder dysfunction, measured in urine samples and bladder biopsies, to gain knowledge of the pathophysiology behind neurogenic detrusor overactivity.	12 months
Primary	Presence of neurogenic detrusor overactivity during cystometry, defined as contractions with amplitudes above 40 cm H2O.		12 months
Secondary	Urodynamic parameters	Maximal detrusor pressure (cmH2O), maximal bladder capacity (ml), compliance (?cmH2O/?ml), and occurrence of DSD.	12 months
Secondary	Quality of life (QOL) in the treated group compared to the placebo group 12 months after first treatment.		12 months
Secondary	Occurrence of complications.		12 months