Investigation of Novel Non-CE Marked Catheter

Female Stress Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06451796
• Other study ID #: CIV-23-10-044313
• Status: Recruiting
• Start date: June 18, 2024
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: MagCath
• Contact: Dorthe Snejbjerg, MD Phd
• Phone: (+45) 44 94 12 12
• Email: info[@]gyncare.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

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.

Related Conditions & MeSH terms

• Female Stress Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Obtinu
Treatment of Female Stress Incontinence with a hydrophilic coated valved intraurethral catheter

Locations

Country	Name	City	State
Denmark	GynCare	Herlev	DK

Sponsors (2)

Lead Sponsor	Collaborator
MagCath	Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functionality: Is long term continuous use acceptable?	Is long term continuous use acceptable?	2 weeks
Primary	Safety primary: Migration of device to bladder	Number of Participants with Migration of device to bladder	2 weeks
Secondary	Safety secondary: Culture confirmed urinary tract infections.	Number of Participants with urinary tract infections.	2 weeks
Secondary	Safety secondary:Need for antibiotics.	Number of Participants with need for antibiotics.	2 weeks
Secondary	Safety secondary: Discomfort at self-catheterization.	Number of Participants with discomfort at self-catheterization.	2 weeks
Secondary	Safety secondary: Difficulties emptying the bladder.	Number of Participants with difficulties emptying the bladder.	2 weeks
Secondary	Safety secondary: Discomfort at catheter removal.	Number of Participants with discomfort at catheter removal.	2 weeks
Secondary	Safety secondary: Hematuria (stick test/macroscopic).	Number of Participants with Hematuria (stick test/macroscopic).	2 weeks
Secondary	Safety secondary: Allergy.	Number of Participants with Allergy.	2 weeks
Secondary	Safety secondary: Loss of device.	Number of lost devices	2 weeks