NCT03301818

Brief Summary

Female patients with USI will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after surgery for the repair of the USI. Surgical repair will be performed by a single surgeon who will perform a tension free vaginal tape obturator (TVT-O) repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration 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

First Submitted

Initial submission to the registry

September 29, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

1.9 years

First QC Date

September 29, 2017

Last Update Submit

July 24, 2020

Conditions

Stress Incontinence, Female

Outcome Measures

Primary Outcomes (1)

  • Vaginal elasticity assessment

    Vaginal elasticity as measured by the vaginal tactile imager

    up to 3 months from enrollment

Study Arms (1)

Patients undergoing USI repair

EXPERIMENTAL
Device: Vaginal tactile imager

Interventions

Vaginal tactile imagerDEVICE

Patients will undergo elasticity assessment with vaginal tactile imaging the be once before surgical repair and twice after during a 3 month interval.

Patients undergoing USI repair

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any woman undergoing USI repair.

You may not qualify if:

  • Women with high grade pelvic floor prolapse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

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

Study Officials

  • Roy Lauterbach, MD

    Rambam healthcare campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2017

First Posted

October 4, 2017

Study Start

August 1, 2018

Primary Completion

June 30, 2020

Study Completion

July 20, 2020

Last Updated

July 27, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)