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Investigation of Novel Non-CE Marked Catheter

Recruiting
18 - 75 years of age
Female
Phase N/A

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Overview

Hypothesis: Treatment with the hydrophilic coated valved intraurethral catheter up to 16 hours per day is effective, well tolerated and seemingly safe for treatment of women with stress incontinence.

Test persons: Ten to twenty stress incontinent women. Treatment time: Up to two weeks

Description

Demonstrate ease and comfort of device insertion, indwelling and removal. Patient acceptability during use.

Other
  • Symptom and QOL questionnaire.
  • Drop out analysis.
  • Is the patient motivated to continue using the valve catheter?
  • Is the patient motivated to recommend the valve catheter to other stress incontinent women?

Eligibility

Inclusion Criteria:

  • Willing to participate
  • Adult, competent woman who understands Danish.
  • SUI as dominant symptom; daily or almost daily.
  • Residual urine < 150 ml.
  • POP-Q prolapse ≤ grade 2.
  • Negative urine stix/Urine D+R.
  • Min. 2 months local vaginal estrogen treatment if the woman is postmenopausal.
  • Mobile and self-reliant woman.
  • Motivated.

Exclusion Criteria:

  • Allergy to the silicone material
  • Pregnancy or breastfeeding
  • Unexplained hematuria.
  • Current inflammatory disorders
  • Malignant disorders of the urethra.
  • Urethral stricture
  • Visual diverticulum.
  • AK treatment.
  • Prosthetic heart valve surgery.

Study details

Female Stress Incontinence

NCT06451796

MagCath

26 June 2024

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