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

NCT03186651 | Completed DMC

• 1 other identifier: TVS1000
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 4

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

Keywords

Vaginal; Medical Device; Female Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Success rate in % in reducing urinary leakage measured by pad weight

  3 weeks

• Reduction of urinary leakage episodes measured by subjective observations

  3 weeks

• General impact on quality of life parameters

  3 weeks

• Impact on disease specific qulity of life parameters

  3 weeks

Other Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by reported events.

  3 weeks

Study Arms (2)

Trans Vagina Support

EXPERIMENTAL

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).

Device: TVS

Standard Care

NO INTERVENTION

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.

Interventions

TVS 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.

Trans Vagina Support

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Over the age of 18 years
• Women diagnosed with stress urinary incontinence
• Normal voiding without residual urine ≤100mL
• Leakage of at least 10 grams per 24 hours (based on pad-weight test)
• Provoking test with leakage

You may not qualify if:

• History of dominated urgency's symptoms
• Any contraindication for the investigational device; such as hypersensitivity to silicon rubber
• Unexplained pelvic bleeding or vaginal discharge
• Is hysterectomized,has a history of incontinent surgery or surgery for prolapse correction.
• The woman is currently using prolapse ring
• Women with prolapse reaching the hymus during coughing.
• Pregnant or suspicion of pregnancy
• Urinary tract or vaginal infection
• History of not being able to use tampons
• Neurogenic bladder dysfunction
• The patient is to start, or change an ongoing, pelvic floor training
• If the patient does not have a well adjusted diuretica, or is to start, or change an ongoing, diuretic treatment
• The patient is participating in another study on SUI
• Any other condition that as judged by the investigator may make follow-up or investigations inappropriate
• Any patient that according to the Declaration of Helsinki is unsuitable for enrollment

Sponsors & Collaborators

• Invent Medic Sweden AB: lead

Study Sites (4)

Ladulaas Kliniska Studier

Borås, 50630, Sweden

Location

Kvinnokliniken Karolinska Sjukhuset

Huddinge, 14186, Sweden

Location

PTC-Skaraborg

Skövde, 54150, Sweden

Location

PTC-Göteborg

Västra Frölunda, 421 44, Sweden

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aino Fianu Jonasson, MD, PhD

  Kvinnokliniken Karolinska sjukhuset

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Lable
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: June 14, 2017
• Study Start: February 27, 2017
• Primary Completion: February 14, 2018
• Study Completion: March 28, 2018
• Last Updated: April 4, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)