Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound

Prolapse of the Uterus Clinical Trial

— PROMONOTECHO  

Official title:

Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634878
• Other study ID #: PROMONTECHO
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: October 2018

Study information

• Verified date: April 2020
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age = 18 years of female sex

• Patient with double laparoscopic promontofixation without associated hysterectomy

Exclusion Criteria:

• History of hysterectomy

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

Related Conditions & MeSH terms

• Prolapse
• Prolapse of the Uterus

Intervention

Other:
• perineal ultrasound
Ultrasound measurement of the size and position of the prostheses.

Locations

Country	Name	City	State
France	Chu de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the reproducibility study of intra and interobserver measurements of the size of promontofixation prostheses		10 minutes
Primary	Evaluate the reproducibility study of intra and interobserver measurements position of promontofixation prostheses		20 minutes
Secondary	Collect the position of the strips		20 minutes
Secondary	Collect the symptoms of the patients		20 minutes