NCT03477214

Brief Summary

Urinary incontinence (UI) and overactive bladder (OAB) in women has high prevalence which is increasing with the age. In adults aged 40 and older in the US demonstrated prevalence rate of 27.2% among man and 43.1% among women, respectively. Urine Incontinence was reported to affect 15% of women ages 40 to 49, 25% ages 60 to 69, and 38% of women age 80 and older.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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 24, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

2.2 years

First QC Date

February 15, 2018

Last Update Submit

April 9, 2020

Conditions

Urinary IncontinenceOveractive Bladder

Outcome Measures

Primary Outcomes (2)

  • Transvaginal biomechanical maps

    Transvaginal biomechanical maps (pressures in Pa) will be recorded and compared for UI and OAB versus normal conditions.

    Four months

  • Transvaginal electromyography maps

    Transvaginal electromyography maps (electrical voltages in mV) will be recorded and compared for UI and OAB versus normal conditions.

    Four months

Study Arms (3)

Normal

No UI, no OAB conditions. Transvaginal biomechanical and electromyography mapping will be completed.

Diagnostic Test: Biomechanical and electromyography mapping

Urinary incontinence

Urinary incontinence conditions. Transvaginal biomechanical and electromyography mapping will be completed.

Diagnostic Test: Biomechanical and electromyography mapping

Overactive bladder

Overactive bladder conditions

Diagnostic Test: Biomechanical and electromyography mapping

Interventions

Biomechanical and electromyography mappingDIAGNOSTIC_TEST

The vaginal tactile imaging probe will acquire biomechanical and electromyography high definition measurements for anterior and posterior compartments along entire vagina.

NormalOveractive bladderUrinary incontinence

Eligibility Criteria

Age21 Years+
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

There is no inclusion or exclusion criteria based on ethnic background, religion, or other division of population other than these stated in Exclusion Criteria section.

You may qualify if:

  • Women above age of 21 with normal pelvic floor condition for the control
  • Women with SUI conditions as defined by International Continence Society guidelines
  • Women with OAB conditions as defined by American Urological Association and Society of Urodinamics, Female Pelvic Medicine \& Urogenital Reconstruction.

You may not qualify if:

  • Any prior pelvic floor surgery related to SUI, POP or OAB conditions
  • Active skin infection or ulceration within the vagina
  • Presence of the vaginal septum
  • Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder
  • Ongoing radiation therapy for pelvic cancer; impacted stool
  • Surgically absent rectum or bladder
  • Sever hemorrhoids
  • Significant circulatory or cardiac conditions that could cause excessive risk
  • Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvodynia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Princeton Urogynecology

Princeton, New Jersey, 08540, United States

Location

Institute of Female Pelvic Medicine & Reconstructive Surgery (IFPM)

Allentown, Pennsylvania, 18103, United States

Location

MeSH Terms

Conditions

Urinary IncontinenceUrinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary Bladder Diseases

Study Officials

  • Heather van Raalte, MD

    Princeton Urogynecology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2018

First Posted

March 26, 2018

Study Start

December 24, 2017

Primary Completion

March 10, 2020

Study Completion

March 15, 2020

Last Updated

April 13, 2020

Record last verified: 2020-04

Locations

US(2)