NCT03311685

Brief Summary

Female patients with POP will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after surgery for the repair of the POP. Surgical repair will be performed by a single surgeon who will perform either a laparoscopic or vaginal repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

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
18 days until next milestone

First Posted

Study publicly available on registry

October 17, 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

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • Vaginal elasticity assessment

    Vaginal elasticity as measured by the vaginal tactile imager measuring the local vaginal pressure (in mmHg)

    Up to 3 months from enrollment

Secondary Outcomes (1)

  • Comparison of vaginal elasticity between repair methods

    Up to 3 months from enrollment

Study Arms (2)

Laparoscopic POP repair

EXPERIMENTAL

Patients undergoing laparoscopic surgery for the repair of pelvic organ prolapse. vaginal tactile imager

Device: vaginal tactile imager

Vaginal POP repair

EXPERIMENTAL

Patients undergoing vaginal surgery for the repair of pelvic organ prolapse. vaginal tactile imager

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 surgery in a 3 month interval.

Laparoscopic POP repairVaginal POP 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 POP repair

You may not qualify if:

  • Women above or below the age limit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Roy Lauterbach, MD

    Rambam healthcare campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2017

First Posted

October 17, 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)