Stress Urinary Incontinence
Conditions
Keywords
Vaginal, Medical Device, Female Stress Urinary Incontinence
Brief summary
This is a prospective, randomized, controlled, two-armed multi-center pre-market trial. Nighty-six (96) subjects will be recruited at sites in Sweden. Patients with diagnosed stress urinary incontinence (SUI), will be considered as potential study participants. After written informed consent has been acquired, a medical and surgical history, a physical examination (including pelvic examination), and a confirmation of the diagnosis of SUI will be performed, followed by a confirmation of the inclusion/exclusion criteria. The study subjects fulfilling all the eligibility criteria will thereafter be randomized 3:1 into either the TVS group or the standard of care (SoC) group.
Interventions
DEVICETVS
Efficacy of a novel intra-vaginal device for temporary reduction of urine leakage in women suffering from stress urinary incontinence and to evaluate the safety and ease of use.
Sponsors
Invent Medic Sweden AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
Open Lable
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Signed Informed Consent Form 2. Over the age of 18 years 3. Women diagnosed with stress urinary incontinence 4. Normal voiding without residual urine ≤100mL 5. Leakage of at least 10 grams per 24 hours (based on pad-weight test) 6. Provoking test with leakage
Exclusion criteria
1. History of dominated urgency's symptoms 2. Any contraindication for the investigational device; such as hypersensitivity to silicon rubber 3. Unexplained pelvic bleeding or vaginal discharge 4. Is hysterectomized,has a history of incontinent surgery or surgery for prolapse correction. 5. The woman is currently using prolapse ring 6. Women with prolapse reaching the hymus during coughing. 7. Pregnant or suspicion of pregnancy 8. Urinary tract or vaginal infection 9. History of not being able to use tampons 10. Neurogenic bladder dysfunction 11. The patient is to start, or change an ongoing, pelvic floor training 12. If the patient does not have a well adjusted diuretica, or is to start, or change an ongoing, diuretic treatment 13. The patient is participating in another study on SUI 14. Any other condition that as judged by the investigator may make follow-up or investigations inappropriate 15. Any patient that according to the Declaration of Helsinki is unsuitable for enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute reduction in leakage as measured by pad weight in gram | 3 weeks | The primary endpoint will be the absolute reduction in pad weight from the run-in week (week 1) compared with the final week (week 3). The weight of the pad is defined as the mean weight over the entire week of measurement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success rate in % in reducing urinary leakage measured by pad weight | 3 weeks | Overall success rate, defined as at least 70% reduction in pad weight measured in gram from run-in to the final week (week 3). |
| Reduction of urinary leakage episodes measured by subjective observations | 3 weeks | Reduction of SUI episodes from the run-in week compared to the final week (week 3) by entry of subjective observations in study diary. |
| General impact on quality of life parameters | 3 weeks | General impact on quality of life parameters using European Quality of Life - 5 dimensions (EQ-5D-5L) comparing week 1 and week 3. |
| Impact on disease specific qulity of life parameters | 3 weeks | Disease specific Impact of Quality of life parameters, measured by the Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6) comparing week 1 and week. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by reported events. | 3 weeks | Possible device related adverse reactions |
Countries
Sweden
Outcome results
None listed