Stress Urinary IncontinenceNCT02160314
A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence
A study testing pessary and Absorbent pad in people with Stress Urinary Incontinence, run by Procter and Gamble at 1 site in United States.
Trial summary
This study will evaluate the safety of the pessary device by objective evaluation of vaginal wall integrity and subjective assessment of comfort during in-use conditions. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- pessary and Absorbent pad
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jan 2015
- 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 been given a signed copy;
- be in generally good health as determined by the Investigator;
- have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (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
- are 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 and could impact the safety of the subject or the outcome of the study; or
- for any reason, the Investigator decides that the subject should not participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the safety of the pessary device by objective evaluation of vaginal wall integrity and subjective assessment of comfort during in-use conditions.
- Conditions
- Stress Urinary Incontinence
- Being tested
- pessary, Absorbent pad
- Keywords
- stress urinary incontinence, SUI, pessary
- 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.
pessaryDevice
disposable, single-use pessary
Absorbent padDevice
Also called placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| pad | Placebo comparator | absorbent pad control Receives: Device: Absorbent pad |
| pessary | Experimental | disposable, single-use pessary Receives: Device: pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent Serious Adverse Event
proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionJan 2015
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randall Severance, MD, Principal investigator, Radiant Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160314
- Sponsor's protocol ID
- 2012119
- Status last verified
- Jan 2016
- First submitted
- 4 Jun 2014
- Last updated
- 15 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02160314
- Acronym / sponsor ID
- 2012119
- Conditions
- Stress Urinary Incontinence
- Keywords
- stress urinary incontinence, SUI, pessary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Posted 15 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety of the pessary device by objective evaluation of vaginal wall integrity and subjective assessment of comfort during in-use conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pad | Placebo comparator | Device: Absorbent padabsorbent pad control |
| pessary | Experimental | Device: 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 been given a signed copy;
- be in generally good health as determined by the Investigator;
- have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (self reported);
- be willing to use the pessary investigational device to control stress urinary incontinence;
Key exclusion criteria (9 listed)
- are 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 |
|---|---|---|
| pessarydisposable, single-use pessary | Device | pessary |
| Absorbent padAlso: placebo comparator | Device | pad |
Primary outcome
Treatment-emergent Serious Adverse Event
Time frame: 3 month
proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 pessary and Absorbent pad in people with Stress Urinary Incontinence, 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 15 Feb 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. Some participants in this study may receive a placebo. 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 15 Feb 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?
Treatment-emergent Serious Adverse Event (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2016.