Female Stress IncontinenceNCT06451796
Investigation of Novel Non-CE Marked Catheter
An observational study of Female Stress Incontinence, run by MagCath at 1 site in Denmark.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Female Stress Incontinence
- What is being tested?
- Obtinu
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Jun 2024to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult women suffering from stress urinary incontinence
Who may be able to join
- 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.
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- Min. 2 months local vaginal estrogen treatment if the woman is postmenopausal.
- Mobile and self-reliant woman.
- Motivated.
Who cannot join
- Allergy to the silicone material
- Pregnancy or breastfeeding
- Unexplained hematuria.
- Current inflammatory disorders
- Malignant disorders of the urethra.
- Urethral stricture
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- Visual diverticulum.
- AK treatment.
- Prosthetic heart valve surgery.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
GynCare
Herlev, DK, 2730
Tanja Vang, +45 44 94 12 12
About this study
Official title: 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
Read the 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?
- Conditions
- Female Stress Incontinence
- Being tested
- Obtinu
- Keywords
- Female Stress Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObtinuDevice
Treatment of Female Stress Incontinence with a hydrophilic coated valved intraurethral catheter
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety primary: Migration of device to bladder
Number of Participants with Migration of device to bladder
Measured: 2 weeks
Secondary outcomes (8)
Safety secondary: Culture confirmed urinary tract infections.
Number of Participants with urinary tract infections.
Measured: 2 weeks
Safety secondary:Need for antibiotics.
Number of Participants with need for antibiotics.
Measured: 2 weeks
Safety secondary: Discomfort at self-catheterization.
Number of Participants with discomfort at self-catheterization.
Measured: 2 weeks
Safety secondary: Difficulties emptying the bladder.
Number of Participants with difficulties emptying the bladder.
Measured: 2 weeks
Safety secondary: Discomfort at catheter removal.
Number of Participants with discomfort at catheter removal.
Measured: 2 weeks
Safety secondary: Hematuria (stick test/macroscopic).
Number of Participants with Hematuria (stick test/macroscopic).
Measured: 2 weeks
Safety secondary: Allergy.
Number of Participants with Allergy.
Measured: 2 weeks
Safety secondary: Loss of device.
Number of lost devices
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start18 Jun 2024
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Stress IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MagCath
- Collaborators
- Herlev Hospital
- Responsible party
- Sponsor
- Investigators
- Pia Sander, MD PhD, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451796
- Sponsor's protocol ID
- CIV-23-10-044313
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Urethral Valve Catheter for the Treatment of Women With Stress Urinary Incontinence (SUI)
- ClinicalTrials.gov ID
- NCT06451796
- Acronym / sponsor ID
- CIV-23-10-044313
- Conditions
- Female Stress Incontinence
- Keywords
- Female Stress Incontinence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- MagCath
- Collaborators
- Herlev Hospital
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women suffering from stress urinary incontinence
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- Allergy to the silicone material
- Pregnancy or breastfeeding
- Unexplained hematuria.
- Current inflammatory disorders
- Malignant disorders of the urethra.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObtinuTreatment of Female Stress Incontinence with a hydrophilic coated valved intraurethral catheter | Device | – |
Primary outcome
Safety primary: Migration of device to bladder
Time frame: 2 weeks
Number of Participants with Migration of device to bladder
8 secondary outcomes
Safety secondary: Culture confirmed urinary tract infections.
Time frame: 2 weeks
Safety secondary:Need for antibiotics.
Time frame: 2 weeks
Safety secondary: Discomfort at self-catheterization.
Time frame: 2 weeks
Safety secondary: Difficulties emptying the bladder.
Time frame: 2 weeks
Safety secondary: Discomfort at catheter removal.
Time frame: 2 weeks
Safety secondary: Hematuria (stick test/macroscopic).
Time frame: 2 weeks
Safety secondary: Allergy.
Time frame: 2 weeks
Safety secondary: Loss of device.
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pia Sander, MD PhD principal investigator
Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Stress Incontinence, run by MagCath at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorthe Snejbjerg, MD Phd ((+45) 44 94 12 12, info@gyncare.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety primary: Migration of device to bladder (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.