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NCT Number: NCT03186651

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

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ladulaas Kliniska Studier, Borås, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Absolute reduction in leakage as measured by pad weight in gram

    Time frame: 3 weeks

    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.

Secondary outcomes

  1. Success rate in % in reducing urinary leakage measured by pad weight

    Time frame: 3 weeks

    Overall success rate, defined as at least 70% reduction in pad weight measured in gram from run-in to the final week (week 3).

  2. Reduction of urinary leakage episodes measured by subjective observations

    Time frame: 3 weeks

    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. General impact on quality of life parameters

    Time frame: 3 weeks

    General impact on quality of life parameters using European Quality of Life - 5 dimensions (EQ-5D-5L) comparing week 1 and week 3.

  4. Impact on disease specific qulity of life parameters

    Time frame: 3 weeks

    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.

Other outcomes

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

    Time frame: 3 weeks

    Possible device related adverse reactions

Sponsors and collaborators

Lead sponsor

Invent Medic Sweden AB

Industry

Registry information

Official study title

An Open Randomized Controlled Multicenter Clinical Investigation With an Intra-vaginal Device for Stress Urinary Incontinence in Comparison to Using Standard of Care

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 14, 2017
Registry last updated
Apr 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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