NCT01762345

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2012

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

March 24, 2016

Completed
Last Updated

March 24, 2016

Status Verified

February 1, 2016

Enrollment Period

7 months

First QC Date

December 12, 2012

Results QC Date

January 15, 2016

Last Update Submit

February 23, 2016

Conditions

Stress Urinary Incontinence

Keywords

Stress urinary incontinenceSUI

Outcome Measures

Primary Outcomes (2)

  • Change in Pad Weight Gain

    Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.

    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.

    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

    from the 14-day baseline period to the first 7 days of 14-day device usage period

  • Change in Stress Urinary Incontinence Episodes

    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)

    baseline and end-of-treatment

Other Outcomes (2)

  • Percentage of Responders for Pad Weight Gain

    from the 14-day baseline period to the last 7 days of 14-day device usage period

  • Percentage of Responders for SUI Episodes

    from the 14-day baseline period to the last 7 days of 14-day device usage period

Study Arms (1)

pessary device

EXPERIMENTAL

pessary (disposable intra-vaginal device)

Device: pessary (disposable intra-vaginal device)

Interventions

pessary (disposable intra-vaginal device)DEVICE

pessary device(disposable intra-vaginal device)manufactured by Procter \& Gamble

pessary device

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have a ≥ 3 month history of experiencing Stress Urinary Incontinence
  • be willing to use the pessary investigational device to control stress incontinence

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Study Center

Chandler, Arizona, 85224, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Pessaries

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Results Point of Contact

Title
Mylissa Trowbridge
Organization
Procter & Gamble Company Global Clinical Sciences
trowbridge.mm@pg.com

Study Officials

  • Randall Severance, MD

    Radiant Research, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2012

First Posted

January 7, 2013

Study Start

December 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 24, 2016

Results First Posted

March 24, 2016

Record last verified: 2016-02

Locations

US(1)