Stress Urinary Incontinence (SUI)NCT02131311

A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence (SUI)

A study testing disposable, single-use pessary in people with Stress Urinary Incontinence (SUI), run by Procter and Gamble at 1 site in United States.

Completed

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

Official record

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Trial summary

This study will evaluate the effectiveness of the pessary device by assessing reduction in urine leakage in approximately 80 women with SUI. Efficacy will be assessed by pad weight gain, frequency of stress urinary incontinence events, and a quality of life questionnaire. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Stress Urinary Incontinence (SUI)
What is being tested?: disposable, single-use pessary
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 145 participants
Where: 1 siteUnited States
Study dates: Apr 2014to Sep 2014
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

be female 18 years or older;
provide written informed consent prior to study participation and receive a signed copy;
be in generally good health as determined by the Investigator;
have a ≥ 3 month history of experiencing SUI (self reported);
be willing to use the pessary investigational device to control stress urinary incontinence;
be willing to comply with study requirements and instructions;

Who cannot join

pregnant, lactating or planning to become pregnant during the study;
within 3 months post partum;
intrauterine device (IUD) placement of less than 6 months;
has self-reported difficulty emptying her bladder;
a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS;
experience difficulty inserting or wearing an intra-vaginal device, including a tampon;

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vaginal surgery, perineal surgery, uterine surgery, or abortion (spontaneous or induced) within the past 3 months;
has any Screening laboratory value outside the laboratory reference range considered clinically significant by the Investigator which could impact the safety of the subject or the outcome of the study;
for any reason, the Investigator decides that the subject should not participate in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study Center
Chandler, Arizona, 85224

Other trials in United States

About this study

Official title: A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence

Conditions: Stress Urinary Incontinence (SUI)
Being tested: disposable, single-use pessary
Keywords: single use, disposable, pessary, stress urinary incontinence, sui
Medical subject headings: Urinary Incontinence, Stress

What participants receive

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

disposable, single-use pessaryDevice

Study groups in NCT02131311
Study group	Role	What they receive
pessary	Experimental	disposable, single-use pessary Receives: Device: disposable, single-use pessary

What is being measured

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

Percentage of Responders for Pad Weight Gain or SUI Episodes
Measured: from the 14-day baseline period to the last 7 days of 14-day device usage period

Secondary outcomes (6)

Change in Stress Urinary Incontinence Episodes
change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.
Measured: from the 14-day baseline period to the last 7 days of 14-day device usage period
Change in Pad Weight Gain
change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.
Measured: from the 14-day baseline period to the last 7 days of 14-day device usage period
Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)
The IIQ-7 is based on 7 questions referring to areas which may have been influenced or changed by accidental urine loss and/or prolapse. These questions are assigned a value of, 0 = 'Not at all,' 1= 'Slightly,' 2 = 'Moderately,' or 3 'Greatly.' The IIQ-7 is scored by taking the average score of items and then multiplying the average by 33 1/3 to put scores on a scale from 0 to 100. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores from baseline reflects improved quality of life.
Measured: baseline and end-of-treatment
Change in Stress Urinary Incontinence Episodes
change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.
Measured: from the 14-day baseline period to the first 7 days of 14-day device usage period
Change in Pad Weight Gain
change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.
Measured: from the 14-day baseline period to the first 7 days of a 14-day device usage period
Percentage of Responders for Pad Weight Gain or SUI Episodes
Measured: from the 14-day baseline period to the first 7 days of 14-day device usage period

Timeline

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

Apr 2014Sep 2014

First posted6 May 2014 (estimated)
Study startApr 2014
Primary completionSep 2014
Study completionSep 2014

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 Stress Urinary Incontinence (SUI)Studies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02131311
Sponsor's protocol ID: 2012118
Status last verified: Feb 2016
First submitted: 2 May 2014
Last updated: 24 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

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Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy
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All Stress Urinary Incontinence (SUI) trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence
ClinicalTrials.gov ID: NCT02131311
Acronym / sponsor ID: 2012118
Conditions: Stress Urinary Incontinence (SUI)
Keywords: single use, disposable, pessary, stress urinary incontinence, sui
Study type: Interventional
Recruitment status: Completed
Enrolment: 145 participants (actual)
Lead sponsor: Procter and GambleIndustry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 6 May 2014 (estimated)
Results: Posted 24 Mar 2016

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
pessary	Experimental	Device: disposable, single-use pessarydisposable, single-use pessary

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

be female 18 years or older;
provide written informed consent prior to study participation and receive a signed copy;
be in generally good health as determined by the Investigator;
have a ≥ 3 month history of experiencing SUI (self reported);
be willing to use the pessary investigational device to control stress urinary incontinence;

Key exclusion criteria (9 listed)

pregnant, lactating or planning to become pregnant during the study;
within 3 months post partum;
intrauterine device (IUD) placement of less than 6 months;
has self-reported difficulty emptying her bladder;
a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS;

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
disposable, single-use pessary	Device	pessary

Primary outcome

Percentage of Responders for Pad Weight Gain or SUI Episodes
Time frame: from the 14-day baseline period to the last 7 days of 14-day device usage period

6 secondary outcomes

Change in Stress Urinary Incontinence Episodes
Time frame: from the 14-day baseline period to the last 7 days of 14-day device usage period
Change in Pad Weight Gain
Time frame: from the 14-day baseline period to the last 7 days of 14-day device usage period
Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)
Time frame: baseline and end-of-treatment
Change in Stress Urinary Incontinence Episodes
Time frame: from the 14-day baseline period to the first 7 days of 14-day device usage period
Change in Pad Weight Gain
Time frame: from the 14-day baseline period to the first 7 days of a 14-day device usage period
Percentage of Responders for Pad Weight Gain or SUI Episodes
Time frame: from the 14-day baseline period to the first 7 days of 14-day device usage period

Results and safety

Results posted to the registry on 24 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pessary	90	86

Primary outcome: Percentage of Responders for Pad Weight Gain or SUI Episodes

Time frame: from the 14-day baseline period to the last 7 days of 14-day device usage period. Number. Unit: percentage of subjects

Measure	Pessary n = 87
Value	69

Population analysed: Intent-to-Treat (ITT) population. The "Number of Participants Analyzed" is the number subjects with available (non-missing) data in week 2

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: two weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pessary	0 of 90 (0%)	6 of 90 (6.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Stress Urinary Incontinence (SUI)

Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Active, not recruiting
A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
Stress Urinary Incontinence (SUI)
Recruiting
Comparing the Effect of Two Types of Pelvic Floor Muscle Stimulation Devices to Improve Symptoms of Urinary Incontinence in Women.
Urinary Incontinence, Mixed Urinary Incontinence
Recruiting
Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy
Urinary Incontinence , Stress, Prostatectomy
Recruiting
The Effects of Expiratory Muscle Strength Training in Women With Stress Urinary Incontinence
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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.

Randall Severance, MD principal investigator

Radiant Research, Inc.

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

Questions about this trial

What is this clinical trial studying?

A study testing disposable, single-use pessary in people with Stress Urinary Incontinence (SUI), run by Procter and Gamble at 1 site 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 6 inclusion and 9 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 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Mar 2016). 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?

Percentage of Responders for Pad Weight Gain or SUI Episodes (time frame: from the 14-day baseline period to the last 7 days of 14-day device usage period). 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 NCT02131311.

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 Mar 2016.