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Clinical Trials/EUCTR2005-001378-29-GB
EUCTR2005-001378-29-GB
Active, not recruiting
Phase 1

A double blinded randomised controlled trial of injection of botulinum toxin versus normal saline into the puborectalis muscle in patients with pelvic floor dyssynergia.

Bradford Teaching Hospitals NHS Foundation Trust0 sites20 target enrollmentApril 21, 2005
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ConditionsObstructed defeacation
DrugsBotox

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Obstructed defeacation
Sponsor
Bradford Teaching Hospitals NHS Foundation Trust
Enrollment
20
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 21, 2005
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Presence of obstructed defeacation according to the Rome II criteria
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Unfit for general anaesthesia, hypersensitivity to Botox, Myaesthenia gravis, Eaton Lamberrt Syndrome

Outcomes

Primary Outcomes

Not specified

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