Pelvic Organ Prolapse
Conditions
Keywords
Biocompatible Materials, Female, Humans, Pelvic Floor, Polypropylenes, Prostheses and Implants, Surgical Mesh, Uterine Prolapse/*therapy
Brief summary
Head to Head comparison of perioperative complications and secondary the impact of operation techniques with or without mesh on patients suffering from pelvic organ prolapse on quality of life.
Detailed description
During the last decade a substantial progress in the detailed knowledge of morphology and function of different compartments of the female pelvic floor was achieved. The obtained informations were quickly implemented in the clinical practice especially in the application of special meshes and of novel techniques of their implantation. Their success rate was evaluated only in pilot companies supported studies. We do miss randomised studies not sponsored by company comparing different surgical techniques and their impact on the quality of life (QoL); the objective estimation of those consequences is for the longlasting effect of the surgery inevitable. The new methods bring also new complications which were not yet relevantly and objectively documented. In the study we compare the techniques contemporary used - in the groups with or without mesh, in size relevant for the statistical evaluation
Interventions
PROCEDUREVaginal fixation Amreich-Richter
Descending vaginal cuff will be treated with fixation of the cuff on sacrospinous ligament
PROCEDUREProlift total
Descending vaginal cuff will be treated with insertion of site-specific mesh into the vesico-vaginal and recto-vaginal space
Sponsors
Ministry of Health, Czech Republic
Charles University, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* female sex * age 18 and more * subscribed informed consent * objective symptoms of prolapse-POP-Q 3 and more according to ICS standards * compliance of the patient
Exclusion criteria
* patients with evidence of malignant lesion in small pelvis * history of radiotherapy in small pelvis * patients suffering from any form of PID within inclusion process * pregnancy * lactation * total eversion of uterus and vagina * serious internal disorders * history of recto- or vesico-vaginal fistula * history of rejection of any artificial material * symptoms of primary genuine stress urinary incontinence * patients who were not able to subscribe the informed consent * patients, who couldn´t be reached for further follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective evaluation o perioperative complications and comparison of patients with pelvic organ prolapse treated with Amreich-Richter procedure or Prolift implants. | 3 month |
Secondary
| Measure | Time frame |
|---|---|
| Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires | 1 year |
Countries
Czechia
Contacts
Primary ContactMichael Krcmar, MD
Backup ContactKamil Svabik, MD
Outcome results
None listed