Back to resultsAn Investigation With an Intra-vaginal Device for Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
TVS
Sponsored by
About this trial
This is an interventional other trial for Stress Urinary Incontinence focused on measuring Vaginal, Medical Device, Female Stress Urinary Incontinence
Eligibility Criteria
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
Sites / Locations
- Ladulaas Kliniska Studier
- Kvinnokliniken Karolinska Sjukhuset
- PTC-Skaraborg
- PTC-Göteborg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Trans Vagina Support
Standard Care
Arm 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).
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03186651
Brief Title
An Investigation With an Intra-vaginal Device for Stress Urinary Incontinence
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
February 14, 2018 (Actual)
Study Completion Date
March 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Invent Medic Sweden AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Vaginal, Medical Device, Female Stress Urinary Incontinence
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open Lable
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trans Vagina Support
Arm Type
Experimental
Arm 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).
Arm Title
Standard Care
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
TVS
Intervention Description
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 Outcome Measure Information:
Title
Absolute reduction in leakage as measured by pad weight in gram
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Success rate in % in reducing urinary leakage measured by pad weight
Description
Overall success rate, defined as at least 70% reduction in pad weight measured in gram from run-in to the final week (week 3).
Time Frame
3 weeks
Title
Reduction of urinary leakage episodes measured by subjective observations
Description
Reduction of SUI episodes from the run-in week compared to the final week (week 3) by entry of subjective observations in study diary.
Time Frame
3 weeks
Title
General impact on quality of life parameters
Description
General impact on quality of life parameters using European Quality of Life - 5 dimensions (EQ-5D-5L) comparing week 1 and week 3.
Time Frame
3 weeks
Title
Impact on disease specific qulity of life parameters
Description
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.
Time Frame
3 weeks
Other Pre-specified Outcome Measures:
Title
Number of participants with treatment-related adverse events as assessed by reported events.
Description
Possible device related adverse reactions
Time Frame
3 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aino Fianu Jonasson, MD, PhD
Organizational Affiliation
Kvinnokliniken Karolinska sjukhuset
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ladulaas Kliniska Studier
City
Boras
ZIP/Postal Code
50630
Country
Sweden
Facility Name
Kvinnokliniken Karolinska Sjukhuset
City
Huddinge
ZIP/Postal Code
14186
Country
Sweden
Facility Name
PTC-Skaraborg
City
Skovde
ZIP/Postal Code
54150
Country
Sweden
Facility Name
PTC-Göteborg
City
Västra Frölunda
ZIP/Postal Code
421 44
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Investigation With an Intra-vaginal Device for Stress Urinary Incontinence
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