NCT03634878

Brief Summary

Indirect promontofixation with prostheses is the standard surgical technique for the reference of uterine prolapse. There is no validated examination to control the position of the prostheses postoperatively. These prostheses are echogenic and perineal ultrasound could be a means of postoperative monitoring. There is no data in the literature on the relationship between prosthesis position and postoperative symptoms

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

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

Study Start

First participant enrolled

April 1, 2016

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

2.5 years

First QC Date

August 6, 2018

Last Update Submit

April 10, 2020

Conditions

Prolapse of the Uterus

Outcome Measures

Primary Outcomes (2)

  • Evaluate the reproducibility study of intra and interobserver measurements of the size of promontofixation prostheses

    10 minutes

  • Evaluate the reproducibility study of intra and interobserver measurements position of promontofixation prostheses

    20 minutes

Secondary Outcomes (2)

  • Collect the position of the strips

    20 minutes

  • Collect the symptoms of the patients

    20 minutes

Study Arms (1)

Perineal ultrasound to visualize the strips and their position

EXPERIMENTAL
Other: perineal ultrasound

Interventions

perineal ultrasoundOTHER

Ultrasound measurement of the size and position of the prostheses.

Perineal ultrasound to visualize the strips and their position

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years of female sex
  • Patient with double laparoscopic promontofixation without associated hysterectomy

You may not qualify if:

  • History of hysterectomy
  • Anterior cure (before index intervention) of prolapse with placement of prosthetic material.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Poitiers

Poitiers, 86021, France

Location

Study Officials

  • Xaviar FRITEL

    Poitiers University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 17, 2018

Study Start

April 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

April 13, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)