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Clinical Trials/EUCTR2008-006526-34-DK
EUCTR2008-006526-34-DK
Active, Not Recruiting
Phase 1

Intravesikal instillation af Botulinum toxin type A til patienter med urge urininkontinens

Gynækologisk-obstetrisk afd. G, Glostrup Hospital0 sites20 target enrollmentNovember 26, 2008
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DrugsXeomin

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Gynækologisk-obstetrisk afd. G, Glostrup Hospital
Enrollment
20
Status
Active, Not Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 26, 2008
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Gynækologisk-obstetrisk afd. G, Glostrup Hospital

Eligibility Criteria

Inclusion Criteria

  • •\- Myndig habil kvinde \= 18 år der forstår dansk
  • •\- Mindst 6 måneders anamnese med UUI som dominerende symptom i.h.t. ICS\-definition
  • •\- Forsøgt mindst 2 forskellige antimuskarinika
  • •\- Heldøgns vandladningsfrekvens (TV) \= 10/døgn ved 4\-dages væske\-vandladningsskema (VVS)
  • •\- Inkontinensepisodefrekvens (IEF) \= 1/døgn ved 4\-dages VVS
  • •\- Døgndiurese \< 40 ml/kg
  • •\- Residualurin \< 100 ml
  • •\- POP\-Q \= stadium 2
  • •\- Spontan uroflowmetri \> 15 ml/sek ved ladt volumen \> 150 ml, eller normal invasiv tryk\-flow under\-søgelse
  • •\- Cystometrisk overaktiv detrusor inkontinens ved volumen \< 300 ml

Exclusion Criteria

  • •\- Blæreneoplasier
  • •\- Symptomer eller tegn på neurologisk eller neuromuskulære lidelser, herunder myastenia gravis
  • •\- Behandling med aminoglykosider
  • •\- Graviditet eller amning
  • •\- Ønsker eller evner ikke oplæring i ren intermitterende selvkateterisation (RIK)

Outcomes

Primary Outcomes

Not specified

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