Stress Urinary IncontinenceNCT03186651
An Investigation With an Intra-vaginal Device for Stress Urinary Incontinence
A study testing TVS in people with Stress Urinary Incontinence, run by Invent Medic Sweden AB at 4 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- TVS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 4 sitesSweden
- Study dates
- 27 Feb 2017to 28 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Ladulaas Kliniska Studier
Borås, 50630
Kvinnokliniken Karolinska Sjukhuset
Huddinge, 14186
PTC-Skaraborg
Skövde, 54150
PTC-Göteborg
Västra Frölunda, 421 44
About this study
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
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
- Being tested
- TVS
- Keywords
- Vaginal, Medical Device, Female Stress Urinary Incontinence
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (4)
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).
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start27 Feb 2017
- Primary completion14 Feb 2018
- Study completion28 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invent Medic Sweden AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aino Fianu Jonasson, MD, PhD, Principal investigator, Kvinnokliniken Karolinska sjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186651
- Sponsor's protocol ID
- TVS1000
- Status last verified
- Apr 2018
- First submitted
- 24 Mar 2017
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03186651
- Acronym / sponsor ID
- TVS1000
- Conditions
- Stress Urinary Incontinence
- Keywords
- Vaginal, Medical Device, Female Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Invent Medic Sweden ABIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 14 Feb 2018 (actual)
- Study completion
- 28 Mar 2018 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trans Vagina Support | Experimental | Device: TVSTension 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 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TVSEfficacy 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. | Device | Trans Vagina Support |
Primary outcome
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.
4 secondary outcomes
Success rate in % in reducing urinary leakage measured by pad weight
Time frame: 3 weeks
Reduction of urinary leakage episodes measured by subjective observations
Time frame: 3 weeks
General impact on quality of life parameters
Time frame: 3 weeks
Impact on disease specific qulity of life parameters
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aino Fianu Jonasson, MD, PhD principal investigator
Kvinnokliniken Karolinska sjukhuset
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TVS in people with Stress Urinary Incontinence, run by Invent Medic Sweden AB at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute reduction in leakage as measured by pad weight in gram (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018.