Investigation of Novel Non-CE Marked Catheter

A Urethral Valve Catheter for the Treatment of Women With Stress Urinary Incontinence (SUI)

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

Study Overview

• Status: Recruiting
• Conditions: Female Stress Incontinence
• Intervention / Treatment: Device: Obtinu

Detailed 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?

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Dorthe Snejbjerg, MD Phd; Phone Number: (+45) 44 94 12 12; Email: info@gyncare.dk

Study Locations

• Denmark
  • DK
    • Herlev, DK, Denmark, 2730
      • Recruiting
      • Gyncare
      • Contact: Tanja Vang; Phone Number: +45 44 94 12 12

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult women suffering from stress urinary incontinence

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety primary: Migration of device to bladder	Number of Participants with Migration of device to bladder	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety secondary: Culture confirmed urinary tract infections.	Number of Participants with urinary tract infections.	2 weeks
Safety secondary:Need for antibiotics.	Number of Participants with need for antibiotics.	2 weeks
Safety secondary: Discomfort at self-catheterization.	Number of Participants with discomfort at self-catheterization.	2 weeks
Safety secondary: Difficulties emptying the bladder.	Number of Participants with difficulties emptying the bladder.	2 weeks
Safety secondary: Discomfort at catheter removal.	Number of Participants with discomfort at catheter removal.	2 weeks
Safety secondary: Hematuria (stick test/macroscopic).	Number of Participants with Hematuria (stick test/macroscopic).	2 weeks
Safety secondary: Allergy.	Number of Participants with Allergy.	2 weeks
Safety secondary: Loss of device.	Number of lost devices	2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality: Is long term continuous use acceptable?	Is long term continuous use acceptable?	2 weeks

Collaborators and Investigators

• Sponsor: MagCath
• Collaborators: Herlev Hospital
• Investigators: Principal Investigator: Pia Sander, MD PhD, Herlev Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Female Stress Incontinence
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence, Stress
• Other Study ID Numbers: CIV-23-10-044313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No