Prevention of Bladder Dysfunction in Acute Spinal Cord Injury

NCT01698138 | Completed Phase 4

• 1 other identifier: 2012/1151
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Spinal Cord Injuries; Urinary Bladder, Overactive

Keywords

Spinal cord injury; Neurogenic overactive bladder; Onabotulinum toxin A; Prevention; Botulinum Toxins, Type A

Outcome Measures

Primary Outcomes (1)

• Presence of neurogenic detrusor overactivity during cystometry, defined as contractions with amplitudes above 40 cm H2O.

  12 months

Secondary Outcomes (3)

• Urodynamic parameters

  12 months

• Quality of life (QOL) in the treated group compared to the placebo group 12 months after first treatment.

  12 months

• Occurrence of complications.

  12 months

Other Outcomes (1)

• Detrusor pathophysiology

  12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

30 transurethral injections, each of 1 ml solution containing NaCl.

Drug: Placebo

Onabotulinumtoxin A

ACTIVE COMPARATOR

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

Drug: Onabotulinumtoxin A

Interventions

Onabotulinumtoxin A DRUG

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

Also known as: Botox ®, "Allergan"

Onabotulinumtoxin A

Placebo DRUG

30 transurethral injections, each of 1 ml solution containing NaCl.

Also known as: NaCl

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Sunnaas Rehabilitation Hospital: collaborator

Study Sites (2)

Sunnaas Hospital

Nesoddtangen, 1450, Norway

Location

Oslo University Hospital

Oslo, 0027, Norway

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Lars Frich, MD, PhD

  University of Oslo

  PRINCIPAL INVESTIGATOR

• Ole Jacob Nilsen, MD

  University of Oslo

  PRINCIPAL INVESTIGATOR

• Thomas Glott, MD

  Sunnaas Rehabilitation Hospital, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: October 2, 2012
• Study Start: September 1, 2012
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2020
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

NO (2)