N/A N=16 Treatment

Feasibility Study Evaluating the ParaPatch System

Urinary Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT02278146 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2017

Primary outcome: Primary: Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study — 8; 6 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ParaPatch (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: ParaPatch, Inc
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study	8; 6	—
SECONDARY Stress Incontinence Arm	83; 75	—
SECONDARY Overactive Bladder Arm	83; 75	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Women aged from >18 to 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02278146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.