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).

Recruiting

Conditions: N81.8
N39.3
Other female genital prolapse
Stress incontinence

Registration Number: DRKS00014232

Lead Sponsor: niversitätsfrauenklinik Heidelberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 50

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

contraindication against MRI, age belo 18, no written informed consent

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Evaluation if a POP improvement is visible on the postsurgical MRI (after surgery)<br>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.)<br>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.)<br>4. Correlation of the gained MRI data to the data obtained clinically (anamnesis, urogynecological examination, P-QOL questionnaire).