Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence

NCT01770691 | Completed Results

• 1 other identifier: TIPI 004
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 8 hours of use

Study Arms (1)

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

Device: TIPI vaginal pessary

Interventions

TIPI vaginal pessary DEVICE

TIPI vaginal pessary G3 model, and TIPI SMD's

TIPI vaginal pessary

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assuta Hospital Systems: lead

Study Sites (1)

Urodynamic Unit, Assuta Medical Centers

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Elan Ziv
• Organization: ConTIPI LTD.

eziv@contipi.com

972-4-627-6066

Study Officials

• Elan Ziv, MD, OBGYN

  Urodynamic Unit, Assuta Medical Centers, Tel Aviv, Israel

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: January 18, 2013
• Study Start: September 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: January 16, 2015
• Results First Posted: January 16, 2015

Record last verified: 2015-01

Locations

IL (1)