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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00572702
Recruitment Status : Unknown
Verified July 2009 by Charles University, Czech Republic.
Recruitment status was:  Recruiting
First Posted : December 13, 2007
Last Update Posted : August 3, 2009
Ministry of Health, Czech Republic
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Procedure: Vaginal fixation Amreich-Richter Procedure: Prolift total Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open, Randomized, Prospective, Comparative, Multicentric to Treat Prolapse of Vaginal Cuff After Hysterectomy With Amreich Procedure or Total Prolift Procedure
Study Start Date : January 2007
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: A
Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with Amreich-Richter procedure; it will be set randomly
Procedure: Vaginal fixation Amreich-Richter
Descending vaginal cuff will be treated with fixation of the cuff on sacrospinous ligament

Active Comparator: B
Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with total Prolift procedure; it will be set randomly
Procedure: Prolift total
Descending vaginal cuff will be treated with insertion of site-specific mesh into the vesico-vaginal and recto-vaginal space
Other Name: Prolift total - polypropylen mesh

Primary Outcome Measures :
  1. The objective evaluation o perioperative complications and comparison of patients with pelvic organ prolapse treated with Amreich-Richter procedure or Prolift implants. [ Time Frame: 3 month ]

Secondary Outcome Measures :
  1. Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00572702

Contact: Michael Krcmar, MD +420607675842
Contact: Kamil Svabik, MD +420603583456

Czech Republic
Dpt. Obstetrics and gynecology, General Teaching Hospital Recruiting
Prague, Czech Republic, 12800
Contact: Kamil Svabik, MD.    +420603583456   
Institute for the care of mother and child Recruiting
Prague, Czech Republic, 147 10
Contact: Ladislav Krofta, MD.,PhD.    +420604480886   
Dpt. of gynecology, Central military hospital Recruiting
Prague, Czech Republic, 169 02
Contact: Tomas Rittstein, MD.    +420606369793   
Dpt. Obstetrics and gynecology, Teaching hospital Bulovka Recruiting
Prague, Czech Republic, 18000
Contact: Michal Krcmar, MD.    +420607675842   
Dpt. of Obstetrics and gynecology, Bata hospital Recruiting
Zlin, Czech Republic, 762 75
Contact: Zdenek Adamik, MD., PhD.    +420603241176   
Sponsors and Collaborators
Charles University, Czech Republic
Ministry of Health, Czech Republic
Principal Investigator: Michael Halaska, MD,PhD Charles University, Prague, Czech Republic

Responsible Party: prof. Michael Halaska, MD., PhD., Inner Grant Agency, Ministry of Health, Czech republic Identifier: NCT00572702     History of Changes
Other Study ID Numbers: NR/9309-3 IGA
NR/9309-3 IGA
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: August 3, 2009
Last Verified: July 2009

Keywords provided by Charles University, Czech Republic:
Biocompatible Materials
Pelvic Floor
Prostheses and Implants
Surgical Mesh
Uterine Prolapse/*therapy

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Pathological Conditions, Anatomical