Clinical trial NCT02278146: Feasibility Study Evaluating the ParaPatch System
Official title: A Multi-center, Open-label, Prospective, Feasibility Study Evaluating the ParaPatch System for the Treatment of Urinary Incontinence and Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: ParaPatch, Inc
Sponsor class: INDUSTRY
First posted: 2014-10-29
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multi-center, open-label, prospective, feasibility study evaluating the ParaPatch System for the treatment of urinary incontinence and overactive bladder.

Detailed description: * Baseline Period

  o The baseline period will allow for washout of any medication affecting bladder function and to allow subject to begin her voiding diary.
* Prospective data collection will take place in the form voiding diary. Leak frequency, and other relevant parameters will be collected.
* Inclusion/exclusion criteria will be rechecked at end of baseline.
* Qol questionnaires will be completed in the office at the end of baseline period.
* Evaluation Period

  o During the evaluation period, the subjects will use the ParaPatch System.
* No medications affecting bladder function will be allowed during the evaluation period.
* Subjects will complete voiding diaries, during the evaluation period. Data capture to include: adverse events, medication use, leak frequency and other relevant parameters.
* Qol questionnaires will be completed in the office at the end of evaluation period.
* Follow-up Period

  o Subjects will be followed for after the evaluation period to check for residual Adverse Events.
* No medications affecting bladder function will be allowed during the follow-up period.
* Subjects will be called by the clinical coordinator at the end of the Follow-up period and asked about potential Adverse Events.

Eligibility criteria: Inclusion Criteria:

* Women aged from \>18 to \< 75 years old.
* Subject has the ability to read and comprehend English, and to reliably record information as required by the Protocol, including the proper completion of the questionnaires.
* Subject is able to provide written informed consent prior to participation in the study.
* Diagnosed with either of the following: a) overactive bladder, or b) urinary stress incontinence.

Exclusion Criteria:

* Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function.
* Subject has demonstrated or is believed to be at risk of non-compliance with study procedures (e.g., for completing the diary or returning for required follow-up visits).
* Subject has undergone onabotulinumtoxin-A injections of the bladder in the last twelve (12) months.
* Subject is not suitable for the study for any reason (including overall health, pre-existing conditions or medications) in the judgment of the investigator.
* Have an untreated recurrent urinary tract infection (\> 2 times within the past 6 months).
* Have neurogenic disorders such as Multiple Sclerosis, ALS, or Parkinson s Disease.
* Patients with a diagnosis of painful bladder syndrome, other pelvic pain or interstitial cystitis.

Primary outcomes:
measure: Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study
timeFrame: up to 3 weeks
Secondary outcomes:
measure: Stress Incontinence Arm
timeFrame: up to 3 weeks
measure: Overactive Bladder Arm
timeFrame: up to 3 weeks
Other outcomes:
Locations:
city: Sherman Oaks
country: United States
facility: Skyline Urology
state: California
city: Torrance
country: United States
facility: Skyline Urology
state: California
Study officials:
affiliation: Sponsor GmbH
name: Cindy Santa Cruz
role: STUDY_DIRECTOR
References: