Credibility of Ultrasound Detection of Female Genital Prolapse Mesh

NCT06000215 | Completed FDA Device

• 1 other identifier: Dnr: 2018/1523-31
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the credibility of ultrasound in detection of synthetic polypropylene vaginal implants. In detail, the study investigates if the ultrasound examiner experience and the standard method of examination may affect the detection of synthetic polypropylene vaginal implants by ultrasound. The primary hypothesis is if 90% of prolapse mesh could be detected by the ultrasound examiners who are blinded to the previous prolapse surgery, the ultrasound is credible for prolapse mesh detection. The secondary hypothesis is if the ultrasound detection is not significantly different between the ultrasound examiners, the method of ultrasound examination is mandatory to acheive credible ultrasound detection of the prolapse mesh.

Conditions

Ultrasound Therapy; Complications

Outcome Measures

Primary Outcomes (2)

• Detection of which mesh without being informed of previous surgery

  Without being informed of previous surgery, examiners are to separately diagnose which mesh vs no mesh

  Maximum of 10 minutes for all examination

• Precision of mesh detection

  Being informed of which surgery, examiners are to separately measure the midsagittal lengths of the mesh.

  Maximum of 10 minutes for all examination

Study Arms (4)

Uphold™ Lite Vaginal mesh - Boston Scientific (Anterior)

Patients previousely received the Uphold™ Lite for the surgical management of apical and/or anterior vaginal mesh prolapse.

Diagnostic Test: Perineal/introital ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery.; Diagnostic Test: Perineal/introital ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.

Pinnacle posterior Vaginal mesh - Boston Scientific

Patients previousely received the Pinnacle posterior Vaginal mesh for the surgical management of posterior and/or apical vaginal mesh prolapse.

Diagnostic Test: Perineal/introital ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery.; Diagnostic Test: Perineal/introital ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.

Artisyn® Y-Shaped Mesh (Robotic-assisted Sacral colpopexy)

Patients previousely received the Artisyn® Y-Shaped Mesh via robotic-assisted approach Patients previousely received th Artisyn® Y-Shaped Mesh via robotic-assisted approach for the surgical management of apical prolapse..

Diagnostic Test: Perineal/introital ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery.; Diagnostic Test: Perineal/introital ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.

Native tissue repair

Patients previousely received native tissue repair for the surgical management of prolapse.

Diagnostic Test: Perineal/introital ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery.; Diagnostic Test: Perineal/introital ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.

Interventions

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

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.

Also known as: Vaginal ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery

Artisyn® Y-Shaped Mesh (Robotic-assisted Sacral colpopexy); Native tissue repair; Pinnacle posterior Vaginal mesh - Boston Scientific; Uphold™ Lite Vaginal mesh - Boston Scientific (Anterior)

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

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.

Also known as: Vaginal ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.

Artisyn® Y-Shaped Mesh (Robotic-assisted Sacral colpopexy); Native tissue repair; Pinnacle posterior Vaginal mesh - Boston Scientific; Uphold™ Lite Vaginal mesh - Boston Scientific (Anterior)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Patients are only females previousely received surgery for female genital prolapse.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients operated by one of the procedures: 1. Anterior TVM (Uphold™ Lite Vaginal mesh - Boston Scientific. 2. Posterior POP mesh (Pinnacle posterior - Boston Scientific or equal) 3. Y-shaped mesh via robotic assisted sacroclpopexy (Artisyn® Y-Shaped Mesh - Ethicon or equal). 4. patients received anterior and/or posterior colporraphy i.e. native tissue repair i.e. no synthetic materials used (control group).

You may qualify if:

• Patients operated by one of the procedures mentioned 1. Anterior TVM (Uphold™ Lite Vaginal mesh - Boston Scientific. 2. Posterior POP mesh (Pinnacle posterior - Boston Scientific or equal) 3. Y-shaped mesh via robotic assisted sacroclpopexy (Artisyn® Y-Shaped Mesh - Ethicon or equal). and 4. patients received anterior and/or posterior colporraphy i.e. native tissue repair i.e. no synthetic materials used (control group).
• All patients should have suffered prolapse symptoms before surgery such as pelvic heaviness and/or vaginal bulging, extra.
• Being able to make an informed consent on participation
• Physically and cognitively capable of participating in the examination

You may not qualify if:

• Patients operated by different procedures t.ex. two different mesh types
• Advanced procedure in the pelvic floor such as current pelvic organ cancer (regardless of treatment)
• Other clinically relevant pelvic disorders for which surgery with other materials (not polypropylene mesh) was previously provided.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

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

Stockholm, 18288, Sweden

Location

Study Officials

• Edward Morcos, MD, PhD

  Karolinska Institutet - Danderyds Sjukhus (KIDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD. Senior Consultant.

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: August 21, 2023
• Study Start: October 21, 2018
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)