Evaluation of pre-surgical high resolution magnetic resonance imaging (MRI) compared to post-surgical MRI results of mesh-repair surgery in women with pelvic organ prolapse (implantation of polypropylene synthetic grafts).

Evaluation of pre-surgical high resolution magnetic resonance imaging (MRI) compared to post-surgical MRI results of mesh-repair surgery in women with pelvic organ prolapse (implantation of polypropylene synthetic grafts). - VisiTexKAB

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00014232

Enrollment

Registered

2018-03-05

Start date

2016-10-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

N81.8 N39.3

Interventions

Group 1: Patients with POP (pelvic organ prolapse) who undergo pelvic floor reconstrucitve surgery with MR-visible meshes. Study patients: women with symptomatic pelvic floor disorders (e.g. cystocel

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: female pelvic organ prolapse (cystocele, rectocele, uterine prolapse), symptomatic pelvic floor disorder, quality-of-life impairment, planned pelvic floor reconstructive surgery with alloplastic material (including MR-visible meshes), >18 years of age, female, no history of repair surgery with alloplastic material in the anamesis, written informed consent.

Exclusion criteria

Exclusion criteria: contraindication against MRI, age belo 18, no written informed consent

Design outcomes

Primary

Measure	Time frame
To evaluate the behavior of the pelvic floor before and after pelvic floor reconstructive surgery with MR-visible mesh implant and visualize postsurgical the full course of the MR-visible implant.	—

Secondary

Measure	Time frame
1. Evaluation if a POP improvement is visible on the postsurgical MRI (after surgery) 2. Visualization of the MR-visible mesh and evaluation of the mesh dimension in comparison to the design measurement parameters (length, width, distance of mesh arms to one another, etc.) 3. Visualization of the mesh on MRI and evaluation of its spatial relation to impiortant pelvic anatomic structures (bony: e.g. ischial spines; soft-tissue: e.g. pudendal or obturator nerve-vessel bundle, sacrospinal ligaments, etc.) 4. Correlation of the gained MRI data to the data obtained clinically (anamnesis, urogynecological examination, P-QOL questionnaire).	—

Measure

Time frame

1. Evaluation if a POP improvement is visible on the postsurgical MRI (after surgery) 2. Visualization of the MR-visible mesh and evaluation of the mesh dimension in comparison to the design measurement parameters (length, width, distance of mesh arms to one another, etc.) 3. Visualization of the mesh on MRI and evaluation of its spatial relation to impiortant pelvic anatomic structures (bony: e.g. ischial spines; soft-tissue: e.g. pudendal or obturator nerve-vessel bundle, sacrospinal ligaments, etc.) 4. Correlation of the gained MRI data to the data obtained clinically (anamnesis, urogynecological examination, P-QOL questionnaire).

—

Countries

Germany

Contacts

Public ContactKerstin A. Brocker

Universitätsfrauenklinik Heidelberg

kerstin.brocker@med.uni-heidelberg.de062215637977

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026