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Clinical Trials/ISRCTN97985616
ISRCTN97985616
Completed
Not Applicable

A randomised controlled trial comparing the use of a urethral insert, (FemSoft®) with vaginal tampons in the management of female stress urinary incontinence

Rochester Medical Ltd (UK)0 sites90 target enrollmentAugust 24, 2011
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ConditionsFemale stress urinary incontinenceUrological and Genital DiseasesStress incontinence

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Female stress urinary incontinence
Sponsor
Rochester Medical Ltd (UK)
Enrollment
90
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 24, 2011
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Rochester Medical Ltd (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. Female participants over 18 years of age
  • •2\. Not pregnant and if of child\-bearing age agrees to use reliable contraception throughout the trial
  • •3\. Able and willing to use tampons
  • •4\. Sufficient mobility / dexterity to use device and competent mentally
  • •5\. Able to give consent
  • •6\. Confirmed moderate to severe (at least one episode per day on average) SUI or mixed incontinence that is SUI predominant (cough test or urodynamic assessment)
  • •7\. Period of trial representative of normal activities (e.g. does not include a holiday)

Exclusion Criteria

  • •1\. Body mass index (BMI) \> 40
  • •2\. Previous surgery for SUI
  • •3\. Pelvic organ prolapse (POP) \> stage 2
  • •4\. Using medication to treat urinary incontinence such as anticholinergics or duloxetine
  • •5\. History of recurrent urinary tract infections or signs and symptoms of a urinary tract infection
  • •6\. Signs and symptoms of vaginal / urethral irritations
  • •7\. Post residual volumes greater than 200 ml
  • •8\. Unable to understand instructions for use of the device

Outcomes

Primary Outcomes

Not specified

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