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Prevention of Bladder Dysfunction in Acute Spinal Cord Injury

NCT01698138 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-11-23

No results posted yet for this study

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

Interventions

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 %.

DRUG

Placebo

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

Sponsors & Collaborators

  • Sunnaas Rehabilitation Hospital

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Lars Frich, MD, PhD · University of Oslo

  • Ole Jacob Nilsen, MD · University of Oslo

  • Thomas Glott, MD · Sunnaas Rehabilitation Hospital, Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2020-12-20
Completion
2020-12-20

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01698138 on ClinicalTrials.gov