- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01770691
Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Tel Aviv, Israel
- Urodynamic Unit, Assuta Medical Centers
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TIPI vaginal pessary
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
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TIPI vaginal pessary G3 model, and TIPI SMD's
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Percentage of Pad Weight Gain (PWG) Change
Time Frame: up to 8 hours of use
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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. |
up to 8 hours of use
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elan Ziv, MD, OBGYN, Urodynamic Unit, Assuta Medical Centers, Tel Aviv, Israel
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TIPI 004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress Urinary Incontinence
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University of New MexicoRecruitingUrinary Incontinence | Urge Incontinence | Stress Incontinence, FemaleUnited States
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University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Stanford...CompletedUrinary Incontinence, Stress | Urge Incontinence | Urinary Stress Incontinence | Stress Incontinence, Urinary | Stress Incontinence | Stress Incontinence, Female | Urgency UrinaryUnited States
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Juna d.o.o.CompletedFemale Stress Urinary Incontinence | Mixed Incontinence, Urge and Stress
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Université de SherbrookeRecruitingUrinary Incontinence | Urinary Stress Incontinence | Post-Prostatectomy Incontinence | Stress Incontinence, MaleCanada
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University Magna GraeciaUnknownStress Urinary IncontinenceItaly
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Hadassah Medical OrganizationCompletedUrinary Stress Incontinence (SI)Israel
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University of California, IrvineWithdrawnStress Urinary IncontinenceUnited States
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Eli Lilly and CompanyBoehringer IngelheimCompleted
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Eli Lilly and CompanyBoehringer IngelheimCompletedUrinary Stress IncontinenceUnited States
Clinical Trials on TIPI vaginal pessary
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Meir Medical CenterUnknownCystocele | Uterine Prolapse | Rectocele | Use of Pessary Reduce the Number of Prolapse Recurrence
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Liv Labs Inc.Eunice Kennedy Shriver National Institute of Child Health and Human Development...Recruiting
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Servicio de Salud Metropolitano Sur OrientePontificia Universidad Catolica de ChileUnknownQuality of Life | Pelvic Organ ProlapseChile
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ConTIPI MedicalUnknown
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University Hospital, GhentRecruiting
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Reia, LLCCompleted
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Chinese University of Hong KongKwong Wah HospitalRecruitingPelvic Organ ProlapseHong Kong
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Procter and GambleCompletedStress Urinary IncontinenceUnited States
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Medical University of ViennaCompletedPostpartum Urinary IncontinenceGermany
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IRCCS San RaffaeleNot yet recruitingPelvic Organ Prolapse | Vaginal ProlapseItaly