NCT02278146

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 24, 2017

Completed
Last Updated

January 24, 2017

Status Verified

November 1, 2016

Enrollment Period

1.1 years

First QC Date

October 21, 2014

Results QC Date

May 23, 2016

Last Update Submit

November 28, 2016

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study

    Documentation, follow-up and characterization of all adverse events in all subjects who use the ParaPatch System, through the completion of the study.

    up to 3 weeks

Secondary Outcomes (2)

  • Stress Incontinence Arm

    up to 3 weeks

  • Overactive Bladder Arm

    up to 3 weeks

Study Arms (2)

1) Stress urinary incontinence

EXPERIMENTAL

Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System

Device: ParaPatch

2) Overactive bladder

EXPERIMENTAL

Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System

Device: ParaPatch

Interventions

ParaPatchDEVICE

A device for the treatment of urinary incontinence

1) Stress urinary incontinence2) Overactive bladder

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Skyline Urology

Sherman Oaks, California, 91411, United States

Location

Skyline Urology

Torrance, California, 90505, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Fredrick Wolk, MD
Organization
Skyline Urology
fred.wolk@skyuro.com
+1 310.602.5005

Study Officials

  • Cindy Santa Cruz

    Sponsor GmbH

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2014

First Posted

October 29, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

January 24, 2017

Results First Posted

January 24, 2017

Record last verified: 2016-11

Locations

US(2)