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Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound

Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03634878
Acronym
PROMONOTECHO
Enrollment
50
Registered
2018-08-17
Start date
2016-04-30
Completion date
2018-10-31
Last updated
2020-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prolapse of the Uterus

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

Interventions

Ultrasound measurement of the size and position of the prostheses.

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Evaluate the reproducibility study of intra and interobserver measurements of the size of promontofixation prostheses10 minutes
Evaluate the reproducibility study of intra and interobserver measurements position of promontofixation prostheses20 minutes

Secondary

MeasureTime frame
Collect the position of the strips20 minutes
Collect the symptoms of the patients20 minutes

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026