NCT06000215 - Credibility of Ultrasound Detection of Female Genital Prolapse Mesh | Biotech Hunter

Enrollment

120

Participants

Timeline

Start Date

October 21, 2018

Primary Completion Date

December 21, 2018

Study Completion Date

December 21, 2018

Conditions

Ultrasound Therapy; Complications

Interventions

DIAGNOSTIC_TEST

Perineal/introital ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery.

"Each examiner to answer:~1. Is there a mesh or not: Yes or No~2. If Yes:~ * Which type of mesh? Uphold, Pinnacle Posterior or Artisyn® Y-Shaped Mesh~ * What is the length of the mesh in a single midsagittal view image~3. Examination record time is to be registered."

DIAGNOSTIC_TEST

Perineal/introital ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.

"Each examiner to answer:~1. Is there a mesh or not: Yes or No~2. If Yes:~ * Which type of mesh? Uphold, Pinnacle Posterior or Artisyn® Y-Shaped Mesh~ * What is the length of the mesh in a single midsagittal view image~3. Examination record time is to be registered."

Trial Locations (1)

18288

Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet Danderyd University Hospital, Stockholm