Stress Urinary IncontinenceNCT01770691
Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence
A study testing TIPI vaginal pessary in people with Stress Urinary Incontinence, run by Assuta Hospital Systems at 1 site in Israel.
Trial summary
Stress urinary incontinence (SUI) is most prevalent among women. SUI is characterized by loss of urine from increased abdominal pressures caused by coughing, laughing, sneezing, running, lifting or walking. SUI cause women to avoid routine physical activities, thus detracting significantly from their quality of life. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- TIPI vaginal pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2007to Jun 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females aged 18 to 60 years
- Had ≥ 1 deliveries
- Suffering from genuine stress urinary incontinence confirmed by urodynamic testing (Urodynamic stress urinary incontinence) and normal voiding without abnormal residual urine
- Baseline PWG (no usage of TIPI device) ≥ 6gr/8hrs
- Average reduction of urinary incontinence of at least 70% following 3 days usage of the cleared TIPI G3 device
- The patient has the ability to understand the nature of the study and give her consent by signing a written informed consent form.
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- Successful experience with the use of vaginal tampons
- Willing to undergo urodynamic investigation
- Normal pap smear within past 24 months
- Patient is able and agrees to arrive to the study site area for a period of about 4-6 hours during 6-12 non consequent study days.
Who cannot join
- Patient is pregnant, or suspected to be pregnant or is planning to be pregnant during the course of the study
- Patients with present or suspected urinary infection
- Patients with present or suspected vaginal infection
- Severely atrophic vagina
- Women who did not manage to insert a vaginal tampon, for any reason, in the past
- Abnormal vaginal bleeding
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- Patient is currently participating in another clinical study that may directly or indirectly affect the results of this study
- Was/is being treated for urinary incontinence by other means such as medications, surgical intervention etc. that might influence study results
- Vaginal wall prolapse of any type reaching the level of the introitus (grade 2)
- Co-morbid condition(s) that could limit the patient's ability to participate in the study, or impact the scientific integrity of the study
Trial locations and contacts
1 site in 1 country.
About this study
Stress urinary incontinence (SUI) is most prevalent among women. SUI is characterized by loss of urine from increased abdominal pressures caused by coughing, laughing, sneezing, running, lifting or walking. SUI cause women to avoid routine physical activities, thus detracting significantly from their quality of life.
The purpose of this study is to evaluate the performance of new designs of the TIPI device, a conservative, disposable, treatment for temporary management of SUI.
- Conditions
- Stress Urinary Incontinence
- Being tested
- TIPI vaginal pessary
- 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.
TIPI vaginal pessaryDevice
TIPI vaginal pessary G3 model, and TIPI SMD's
| Study group | Role | What they receive |
|---|---|---|
| TIPI vaginal pessary | Experimental | Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary. Not all subjects will use all types of SMD's Receives: Device: TIPI vaginal pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percentage of Pad Weight Gain (PWG) Change
All eligible subjects underwent a 3-day Pad period to establish baseline Average PWG. During this period, pre-weighed pads were worn for 8 hours a day and subjects were asked to perform predefined physical activities and drink a certain amount of liquid, daily. Pads were collected and weighed in the clinic to determine baseline urine leakage. Subjects then used SMDs or the cleared TIPI (G3) with pads for up to 8 hours. The average PWG tests results with the TIPI devices were compared to the average PWG 8 hrs test without the device and were presented as percentages.
The efficacy endpoint for the study was mean percent change of PWG using a certain device compared to the values obtained at the baseline period, as calculated by the following formula:
% Reduction = 1-(Device/Baseline )*100
Where, Device = the average pad weight gain (PWG) during device usage. Baseline = the average pad weight gain (PWG) during the days of baseline period.
Measured: up to 8 hours of use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startSep 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elan Ziv, MD, OBGYN, Principal investigator, Urodynamic Unit, Assuta Medical Centers, Tel Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770691
- Sponsor's protocol ID
- TIPI 004
- Status last verified
- Jan 2015
- First submitted
- 16 Jan 2013
- Last updated
- 16 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01770691
- Acronym / sponsor ID
- TIPI 004
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Posted 16 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stress urinary incontinence (SUI) is most prevalent among women. SUI is characterized by loss of urine from increased abdominal pressures caused by coughing, laughing, sneezing, running, lifting or walking. SUI cause women to avoid routine physical activities, thus detracting significantly from their quality of life.
The purpose of this study is to evaluate the performance of new designs of the TIPI device, a conservative, disposable, treatment for temporary management of SUI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TIPI vaginal pessary | Experimental | Device: TIPI vaginal pessaryEach subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary. Not all subjects will use all types of SMD's |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Females aged 18 to 60 years
- Had ≥ 1 deliveries
- Suffering from genuine stress urinary incontinence confirmed by urodynamic testing (Urodynamic stress urinary incontinence) and normal voiding without abnormal residual urine
- Baseline PWG (no usage of TIPI device) ≥ 6gr/8hrs
- Average reduction of urinary incontinence of at least 70% following 3 days usage of the cleared TIPI G3 device
Key exclusion criteria (10 listed)
- Patient is pregnant, or suspected to be pregnant or is planning to be pregnant during the course of the study
- Patients with present or suspected urinary infection
- Patients with present or suspected vaginal infection
- Severely atrophic vagina
- Women who did not manage to insert a vaginal tampon, for any reason, in the past
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 |
|---|---|---|
| TIPI vaginal pessaryTIPI vaginal pessary G3 model, and TIPI SMD's | Device | TIPI vaginal pessary |
Primary outcome
Mean Percentage of Pad Weight Gain (PWG) Change
Time frame: up to 8 hours of use
All eligible subjects underwent a 3-day Pad period to establish baseline Average PWG. During this period, pre-weighed pads were worn for 8 hours a day and subjects were asked to perform predefined physical activities and drink a certain amount of liquid, daily. Pads were collected and weighed in the clinic to determine baseline urine leakage. Subjects then used SMDs or the cleared TIPI (G3) with pads for up to 8 hours. The average PWG tests results with the TIPI devices were compared to the average PWG 8 hrs test without the device and were presented as percentages. The efficacy endpoint for the study was mean percent change of PWG using a certain device compared to the values obtained at the baseline period, as calculated by the following formula: % Reduction = 1-(Device/Baseline )*100 Where, Device = the average pad weight gain (PWG) during device usage. Baseline = the average pad weight gain (PWG) during the days of baseline period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Elan Ziv, MD, OBGYN principal investigator
Urodynamic Unit, Assuta Medical Centers, Tel Aviv, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIPI vaginal pessary in people with Stress Urinary Incontinence, run by Assuta Hospital Systems at 1 site in Israel.
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 10 inclusion and 10 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 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Yes. Results are posted in the registry (first posted 16 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Percentage of Pad Weight Gain (PWG) Change (time frame: up to 8 hours of use). 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 16 Jan 2015.