Stress Urinary IncontinenceNCT01762345
A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary Incontinence
A study testing pessary (disposable intra-vaginal device) in people with Stress Urinary Incontinence, run by Procter and Gamble at 1 site in United States.
Trial summary
This pilot study will evaluate the efficacy of the pessary (disposable intra-vaginal device) by reduction in urine leakage in women with stress urinary incontinence (SUI). 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 (disposable intra-vaginal device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jul 2013
- 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
- have a ≥ 3 month history of experiencing Stress Urinary Incontinence
- be willing to use the pessary investigational device to control stress incontinence
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
- a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS
- experience difficulty inserting or wearing an intra-vaginal device, including a tampon
- 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
- 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 pilot study will evaluate the efficacy of the pessary (disposable intra-vaginal device) by reduction in urine leakage in women with stress urinary incontinence (SUI).
- Conditions
- Stress Urinary Incontinence
- Being tested
- pessary (disposable intra-vaginal device)
- Keywords
- 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.
pessary (disposable intra-vaginal device)Device
pessary device(disposable intra-vaginal device)manufactured by Procter \& Gamble
| Study group | Role | What they receive |
|---|---|---|
| pessary device | Experimental | pessary (disposable intra-vaginal device) Receives: Device: pessary (disposable intra-vaginal device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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
Secondary outcomes (3)
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 14-day device usage period
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 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionJul 2013
- Study completionJul 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 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
- NCT01762345
- Sponsor's protocol ID
- 2012099
- Status last verified
- Feb 2016
- First submitted
- 12 Dec 2012
- Last updated
- 24 Mar 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 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01762345
- Acronym / sponsor ID
- 2012099
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress urinary incontinence, SUI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 7 Jan 2013 (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.
This pilot study will evaluate the efficacy of the pessary (disposable intra-vaginal device) by reduction in urine leakage in women with stress urinary incontinence (SUI).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pessary device | Experimental | Device: pessary (disposable intra-vaginal device)pessary (disposable intra-vaginal device) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- have a ≥ 3 month history of experiencing Stress Urinary Incontinence
- be willing to use the pessary investigational device to control stress incontinence
Key exclusion criteria (8 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
- a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS
- experience difficulty inserting or wearing an intra-vaginal device, including a tampon
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 |
|---|---|---|
| pessary (disposable intra-vaginal device)pessary device(disposable intra-vaginal device)manufactured by Procter \& Gamble | Device | pessary device |
Primary outcome
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 from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.
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 from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.
3 secondary outcomes
Change in Pad Weight Gain
Time frame: from the 14-day baseline period to the first 7 days of 14-day device usage period
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 Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)
Time frame: baseline and end-of-treatment
Results and safety
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.
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Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
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The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
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RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for 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 pessary (disposable intra-vaginal device) 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 2 inclusion and 8 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?
Change in Pad Weight Gain (time frame: from the 14-day baseline period to the last 7 days of 14-day device usage period). The study lists 2 primary outcomes in all. 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 24 Mar 2016.