Investigation of Novel Non-CE Marked Catheter | NCT06451796

Studies
Investigation of Novel Non-CE Marked Catheter

NCT06451796

Sponsor

MagCath

Status

Unknown status

Last Update Posted

Jun 21, 2024Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Female Stress Incontinence

Interventions

Obtinu

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 18, 2024Actual

Primary Completion Date

Sep 2024Estimated

Completion Date

Sep 2024Estimated

First Submitted Date

May 28, 2024

First Submission Date that Met QC Criteria

Jun 4, 2024

First Posted Date

Jun 11, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2024

Last Update Posted Date

Jun 21, 2024Actual

Name	Class
Herlev Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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?

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Obtinu	Device	Treatment of Female Stress Incontinence with a hydrophilic coated valved intraurethral catheter

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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.

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Adult women suffering from stress urinary incontinence

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dorthe Snejbjerg, MD Phd	Contact	(+45) 44 94 12 12		info@gyncare.dk

Overall Officials

Name	Affiliation	Role
Pia Sander, MD PhD	Herlev Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GynCare	Recruiting	Herlev	DK	2730	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided