Clinical trial NCT03186651: An Investigation With an Intra-vaginal Device for Stress Urinary Incontinence
Official title: An Open Randomized Controlled Multicenter Clinical Investigation With an Intra-vaginal Device for Stress Urinary Incontinence in Comparison to Using Standard of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Vaginal
Medical Device
Female Stress Urinary Incontinence
Lead sponsor: Invent Medic Sweden AB
Sponsor class: INDUSTRY
First posted: 2017-06-14
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Absolute reduction in leakage as measured by pad weight in gram
timeFrame: 3 weeks
Secondary outcomes:
measure: Success rate in % in reducing urinary leakage measured by pad weight
timeFrame: 3 weeks
measure: Reduction of urinary leakage episodes measured by subjective observations
timeFrame: 3 weeks
measure: General impact on quality of life parameters
timeFrame: 3 weeks
measure: Impact on disease specific qulity of life parameters
timeFrame: 3 weeks
Other outcomes:
measure: Number of participants with treatment-related adverse events as assessed by reported events.
timeFrame: 3 weeks
Locations:
city: Boras
country: Sweden
facility: Ladulaas Kliniska Studier
city: Huddinge
country: Sweden
facility: Kvinnokliniken Karolinska Sjukhuset
city: Skovde
country: Sweden
facility: PTC-Skaraborg
city: Västra Frölunda
country: Sweden
facility: PTC-Göteborg
Study officials:
affiliation: Kvinnokliniken Karolinska sjukhuset
name: Aino Fianu Jonasson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: