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

NCT00572702 | Unknown

• 1 other identifier: NR/9309-3 IGA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

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.

Conditions

Pelvic Organ Prolapse

Keywords

Biocompatible Materials; Female; Humans; Pelvic Floor; Polypropylenes; Prostheses and Implants; Surgical Mesh; Uterine Prolapse/*therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires

  1 year

Study Arms (2)

A

ACTIVE COMPARATOR

Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with Amreich-Richter procedure; it will be set randomly

Procedure: Vaginal fixation Amreich-Richter

B

ACTIVE COMPARATOR

Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with total Prolift procedure; it will be set randomly

Procedure: Prolift total

Interventions

Vaginal fixation Amreich-Richter PROCEDURE

Descending vaginal cuff will be treated with fixation of the cuff on sacrospinous ligament

A

Prolift total PROCEDURE

Descending vaginal cuff will be treated with insertion of site-specific mesh into the vesico-vaginal and recto-vaginal space

Also known as: Prolift total - polypropylen mesh

B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients with evidence of malignant lesion in small pelvis
• history of radiotherapy in small pelvis
• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Ministry of Health, Czech Republic: collaborator

Study Sites (5)

Dpt. Obstetrics and gynecology, General Teaching Hospital

Prague, 12800, Czechia

RECRUITING

Institute for the care of mother and child

Prague, 147 10, Czechia

RECRUITING

Dpt. of gynecology, Central military hospital

Prague, 169 02, Czechia

RECRUITING

Dpt. Obstetrics and gynecology, Teaching hospital Bulovka

Prague, 18000, Czechia

RECRUITING

Dpt. of Obstetrics and gynecology, Bata hospital

Zlín, 762 75, Czechia

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Halaska, MD,PhD

  Charles University, Prague, Czech Republic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Krcmar, MD

CONTACT

+420607675842; xkrcmar@centrum.cz

Kamil Svabik, MD

CONTACT

+420603583456; kamil@svabik.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 13, 2007
• Study Start: January 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 3, 2009

Record last verified: 2009-07

Locations

CZ (5)