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

NCT ID: NCT03186651

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-27
• Study Completion Date: 2018-03-28

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Trans Vagina Support

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).

Group Type: EXPERIMENTAL

TVS

Intervention Type: DEVICE

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.

Standard Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TVS

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Invent Medic Sweden AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aino Fianu Jonasson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kvinnokliniken Karolinska sjukhuset

Locations

Ladulaas Kliniska Studier

Borås, , Sweden

Kvinnokliniken Karolinska Sjukhuset

Huddinge, , Sweden

PTC-Skaraborg

Skövde, , Sweden

PTC-Göteborg

Västra Frölunda, , Sweden

Countries

Sweden

Other Identifiers

TVS1000

Identifier Type: -

Identifier Source: org_study_id