Feasibility Study Evaluating the ParaPatch System

A study testing ParaPatch in people with Urinary Incontinence, run by ParaPatch, Inc at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for: Urinary Incontinence
What is being tested?: ParaPatch
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 2 sitesUnited States
Study dates: Nov 2014to Feb 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Skyline Urology
Sherman Oaks, California, 91411
Skyline Urology
Torrance, California, 90505

Other trials in United States

About this study

Official title: A Multi-center, Open-label, Prospective, Feasibility Study Evaluating the ParaPatch System for the Treatment of Urinary Incontinence and Overactive Bladder

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

Read the detailed description

Baseline Period
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
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
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.

Conditions: Urinary Incontinence
Being tested: ParaPatch
Medical subject headings: Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ParaPatchDevice
A device for the treatment of urinary incontinence

Study groups in NCT02278146
Study group	Role	What they receive
1) Stress urinary incontinence	Experimental	Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System Receives: Device: ParaPatch
2) Overactive bladder	Experimental	Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System Receives: Device: ParaPatch

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: up to 3 weeks

Secondary outcomes (2)

Stress Incontinence Arm
Percentage of participants with less daily leaks from baseline to 3 weeks.
Measured: up to 3 weeks
Overactive Bladder Arm
Percentage of participants with less daily voids from baseline to 3 weeks.
Measured: up to 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Feb 2016

First posted29 Oct 2014 (estimated)
Study startNov 2014
Primary completionDec 2015
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02278146
Sponsor's protocol ID: PP-01-2014
Status last verified: Nov 2016
First submitted: 21 Oct 2014
Last updated: 24 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruiting
Transcutaneous Tibial Nerve Stimulation for Urinary Incontinence After Radical Prostatectomy
Urinary Incontinence (UI), Prostatectomy
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction

All Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Open-label, Prospective, Feasibility Study Evaluating the ParaPatch System for the Treatment of Urinary Incontinence and Overactive Bladder
ClinicalTrials.gov ID: NCT02278146
Acronym / sponsor ID: PP-01-2014
Conditions: Urinary Incontinence
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: ParaPatch, IncIndustry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: Dec 2015 (actual)
Study completion: Feb 2016 (actual)
First posted: 29 Oct 2014 (estimated)
Results: Posted 24 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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
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
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
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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1) Stress urinary incontinence	Experimental	Device: ParaPatchStress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System
2) Overactive bladder	Experimental	Device: ParaPatchOveractive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ParaPatchA device for the treatment of urinary incontinence	Device	1) Stress urinary incontinence, 2) Overactive bladder

Primary outcome

Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study
Time frame: up to 3 weeks
Documentation, follow-up and characterization of all adverse events in all subjects who use the ParaPatch System, through the completion of the study.

2 secondary outcomes

Stress Incontinence Arm
Time frame: up to 3 weeks
Overactive Bladder Arm
Time frame: up to 3 weeks

Results and safety

Results posted to the registry on 24 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1) Stress Urinary Incontinence	6	6
2) Overactive Bladder	10	8

Primary outcome: Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study

Time frame: up to 3 weeks. Number. Unit: participants

Measure	1) Stress Urinary Incontinence n = 8	2) Overactive Bladder n = 6
Value	8	6

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 weeks during the device usage and for 1 week after completing device usage. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1) Stress Urinary Incontinence	0 of 6 (0%)	0 of 6 (0%)	Not reported
2) Overactive Bladder	0 of 8 (0%)	0 of 8 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Urinary Incontinence

Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruiting
Transcutaneous Tibial Nerve Stimulation for Urinary Incontinence After Radical Prostatectomy
Urinary Incontinence (UI), Prostatectomy
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cindy Santa Cruz study director

Sponsor GmbH

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ParaPatch in people with Urinary Incontinence, run by ParaPatch, Inc at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study (time frame: up to 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02278146.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.