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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03186651
• Other study ID #: TVS1000
• Status: Completed
• Phase: N/A
• First received: March 24, 2017
• Last updated: April 3, 2018
• Start date: February 27, 2017
• Est. completion date: March 28, 2018

Study information

• Verified date: April 2018
• Source: Invent Medic Sweden AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: March 28, 2018
• Est. primary completion date: February 14, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Sweden	Ladulaas Kliniska Studier	Boras
Sweden	Kvinnokliniken Karolinska Sjukhuset	Huddinge
Sweden	PTC-Skaraborg	Skovde
Sweden	PTC-Göteborg	Västra Frölunda

Sponsors (1)

Lead Sponsor	Collaborator
Invent Medic Sweden AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with treatment-related adverse events as assessed by reported events.	Possible device related adverse reactions	3 weeks
Primary	Absolute reduction in leakage as measured by pad weight in gram	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.	3 weeks
Secondary	Success rate in % in reducing urinary leakage measured by pad weight	Overall success rate, defined as at least 70% reduction in pad weight measured in gram from run-in to the final week (week 3).	3 weeks
Secondary	Reduction of urinary leakage episodes measured by subjective observations	Reduction of SUI episodes from the run-in week compared to the final week (week 3) by entry of subjective observations in study diary.	3 weeks
Secondary	General impact on quality of life parameters	General impact on quality of life parameters using European Quality of Life - 5 dimensions (EQ-5D-5L) comparing week 1 and week 3.	3 weeks
Secondary	Impact on disease specific qulity of life parameters	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.	3 weeks