An Investigation With an Intra-vaginal Device for Stress Urinary Incontinence

Invent Medic

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: TVS

Study type: Interventional

Funder types: Industry

Identifiers

NCT03186651

TVS1000

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

Trans Vagina Support

Experimental group

Description:

Tension Free Vaginal Support (TVS):The subjects in the TVS Group used pads during week 1 (Baseline), fitted, trained and selected device size week 2 and used the selected device size during week 3 (treatment week).

Treatment:

Device: TVS

Standard Care

No Intervention group

Description:

Standard of care (SoC): The subjects in the SoC group continued with conventional treatment i.e. using pads during week 1, 2 and 3. They were offered to use the TVS device for two weeks after completion of week 3.