NCT03630406

Brief Summary

Female patients with either stress urinary incontinence (SUI) or vaginal wall weakness and prolapse will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after Carbon Dioxide laser treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

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

August 10, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

1.6 years

First QC Date

August 10, 2018

Last Update Submit

September 12, 2020

Conditions

Laser Burn

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)

Laser treatment

Female patients with either SUI of vaginal wall weakness and prolapse refered for an attempt at laser treatment.

Diagnostic Test: Vaginal Tactile Imaging

Interventions

Vaginal Tactile ImagingDIAGNOSTIC_TEST

Vaginal Tactile Imaging

Laser treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female patients with either SUI or vaginal wall weakness and prolapse.

You may qualify if:

  • Any woman undergoing vaginal Carbon Dioxide laser treatment.

You may not qualify if:

  • Women that are not in the age range.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

Study Officials

  • Roy Lauterbach, MD

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 14, 2018

Study Start

October 1, 2018

Primary Completion

April 30, 2020

Study Completion

August 31, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

IL(1)