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A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence

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ClinicalTrials.gov Identifier: NCT02160314
Recruitment Status : Completed
First Posted : June 10, 2014
Results First Posted : February 15, 2016
Last Update Posted : February 15, 2016
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble

Brief 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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Device: pessary Device: Absorbent pad Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence
Study Start Date : May 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: pad
absorbent pad control
Device: Absorbent pad
Other Name: placebo comparator

Experimental: pessary
disposable, single-use pessary
Device: pessary
disposable, single-use pessary




Primary Outcome Measures :
  1. Treatment-emergent Serious Adverse Event [ Time Frame: 3 month ]
    proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160314


Locations
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United States, Arizona
Study Center
Chandler, Arizona, United States, 85224
Sponsors and Collaborators
Procter and Gamble
Investigators
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Principal Investigator: Randall Severance, MD Radiant Research, Inc.
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Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT02160314    
Other Study ID Numbers: 2012119
First Posted: June 10, 2014    Key Record Dates
Results First Posted: February 15, 2016
Last Update Posted: February 15, 2016
Last Verified: January 2016
Keywords provided by Procter and Gamble:
stress urinary incontinence, SUI, pessary
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders