Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-Obturator Way for the Correction of Anterior Prolapse

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00859417
First received: March 10, 2009
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

The classical surgical treatment of an anterior prolapse is the use of autologous tissue. In front of the high rate of recurrences with this technique, the use of synthetic prosthesis made their appearance. But the drawback of the use of prosthesis is their tolerability. The system Perigee®, a prosthetic kit by trans-obturator way, was designed to obtain high efficiency in the correction of the prolapse while reducing the risk of complications. The lack of prospective and randomized studies makes difficult to assess the interest. The investigators, therefore, have put in place a randomized prospective study seeking the evaluation of the system Perigee® compared to the conventional surgical technique.


Condition Intervention
Anterior Prolapse
Procedure: Traditional surgery
Device: Perigee® prosthesis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PERIGEE :Randomized Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-obturator Way for the Correction of Anterior Prolapse.

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Correction of prolapse, which is defined by a stage < II on the classification POP-Q, one year after surgery [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Correction of prolapse 2 years after surgery [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Changes in quality of life, occurrence of complications during surgery, evolution of sexuality, onset or worsening of urinary incontinence [ Time Frame: at 3,12, 24 months ] [ Designated as safety issue: Yes ]
  • Pain after surgery [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Duration of intervention [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 78
Study Start Date: September 2008
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Traditional surgical method without prosthesis
Procedure: Traditional surgery
Traditional surgical method without prosthesis (correction of the anterior prolapse through vaginal tract with the use of autologous tissue).
Experimental: 2
Surgical method with Perigee prosthesis
Device: Perigee® prosthesis
Surgical method with Perigee® prosthesis

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women over 18 years old
  • Genital anterior prolapse requiring surgical correction and with stage III or IV in the classification of Pelvic Organ Prolapse - Quantification or POP-Q
  • Ability to understand the information and to sign a consent form
  • Patients wishing an intervention because of the inconvenience caused by the prolapse.

Exclusion Criteria:

  • Prolapse stage <III in the classification POP-Q, and prolapse without functional inconvenience
  • Progressive or latent infection, or signs of tissue necrosis in the clinical examination
  • Troubles resulting in an unacceptable risk of post-surgery complications investigated at the interview with the patient (disorders of blood clotting, immune system disorders, progressive diseases….)
  • Mobility of the lower limbs reduced (not permitting the positioning for the surgery)
  • Pregnancy or any desire of pregnancy during the study, within two years
  • Pelvic surgery in the last 6 months
  • Patients who have had radiotherapy of the pelvic area in an irrespective time
  • A history of pelvic cancer
  • Known hypersensitivity to any component of the prosthesis (polypropylene)
  • Uncontrolled diabetes (HbA1c> 8%)
  • Treatment modifying the immune response (immuno-modulators), current or stopped for less than one month
  • Inability to understand the information and to sign a consent
  • A person not subject to social security, deprived of freedom, or under legal guardian
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859417

Locations
France
Hôpital femme Mère Enfant
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: MELLIER Georges, MD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00859417     History of Changes
Other Study ID Numbers: 2007.485/28
Study First Received: March 10, 2009
Last Updated: November 29, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
correction of anterior prolapse
prosthetic trans-obturator way kit
randomized study

Additional relevant MeSH terms:
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 20, 2014