Status:
COMPLETED
A Feasibility Study With a Novel, Dynamic and Disposable Over-the-counter Device for Stress Urinary Incontinence
Lead Sponsor:
Gynamics LTD
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief Summary
This study was designed as an open label, feasibility, single-center, cross-over prospective study in women with stress urinary incontinence. Subjects served as their own control.
Detailed Description
The primary objectives of this feasibility study were to evaluate the short-term efficacy of the Nolix device by measuring a reduction of SUI following a modified 1-hour PWG test and to measure the sa...
Eligibility Criteria
Inclusion
- Females aged 21 and above
- Suffering from Stress Urinary Incontinence
- Women who can understand the nature of the study, are physically able to perform all required tasks and consent to it by signing a written Informed Consent Form prior to participation in the study
Exclusion
- Age ≤ 21 years
- Pregnant or planning to become pregnant during the study.
- Vaginal birth or Cesarean section for the last 3 months prior to entering the study.
- Severely atrophic vagina.
- A history of Toxic Shock Syndrome (TSS).
- Active urinary tract or vaginal infection.
- Patients prone to recurrent vaginal or urinary tract infections (i.e. more than 3 times in the past year).
- Has experienced unusual or unexpected vaginal bleeding within the last 6 months.
- Vaginal surgery within the last 3 months prior to entering the study.
- Has experienced difficulties with the use of intra-vaginal devices, including tampons.
- Presence of any condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Average daily PWG as measured in the baseline pad period is less than 4 grams /12 hours.
Key Trial Info
Start Date :
October 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2018
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04325477
Start Date
October 31 2017
End Date
October 30 2018
Last Update
April 7 2020
Active Locations (1)
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1
Assuta Medical Center
Haifa, Israel