Randomized,Multicentric Study to Treat Prolapse After Hysterectomy With Amreich Procedure or Total Prolift Procedure

Not Applicable

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Vaginal fixation Amreich-Richter; Procedure: Prolift total

• Registration Number: NCT00572702
• Lead Sponsor: Charles University, Czech Republic

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

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-12
• Study First Posted: 2007-12-13
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-31
• Last Update Posted: 2009-08-03
• Primary Completion: 2009-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Vaginal fixation Amreich-Richter	Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with Amreich-Richter procedure; it will be set randomly
B	Prolift total	Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with total Prolift procedure; it will be set randomly

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires	1 year

Trial Locations

Locations (5)

Dpt. of gynecology, Central military hospital; 🇨🇿 Prague, Czech Republic

Dpt. Obstetrics and gynecology, General Teaching Hospital; 🇨🇿 Prague, Czech Republic

Institute for the care of mother and child; 🇨🇿 Prague, Czech Republic

Dpt. Obstetrics and gynecology, Teaching hospital Bulovka; 🇨🇿 Prague, Czech Republic

Dpt. of Obstetrics and gynecology, Bata hospital; 🇨🇿 Zlin, Czech Republic