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NCT Number: NCT01698138

Prevention of Bladder Dysfunction in Acute Spinal Cord Injury

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sunnaas Hospital, Nesoddtangen, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 %.

Other names: Botox ®, "Allergan"

Placebo

Drug

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

Other names: NaCl

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. Urodynamic parameters

    Time frame: 12 months

    Maximal detrusor pressure (cmH2O), maximal bladder capacity (ml), compliance (ΔcmH2O/Δml), and occurrence of DSD.

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

    Time frame: 12 months

  3. Occurrence of complications.

    Time frame: 12 months

Other outcomes

  1. Detrusor pathophysiology

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Sunnaas Rehabilitation Hospital

Registry information

Official study 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

Acronym: BOT-SCI

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Oct 2, 2012
Registry last updated
Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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