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

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: NCT00859417
Recruitment Status : Completed
First Posted : March 11, 2009
Last Update Posted : December 2, 2013
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
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 or disease Intervention/treatment Phase
Anterior Prolapse Procedure: Traditional surgery Device: Perigee® prosthesis Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : September 2008
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Correction of prolapse 2 years after surgery [ Time Frame: 24 months ]
  2. 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 ]
  3. Pain after surgery [ Time Frame: 24 months ]
  4. Duration of intervention [ Time Frame: 24 months ]

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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): NCT00859417

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

Responsible Party: Hospices Civils de Lyon Identifier: NCT00859417     History of Changes
Other Study ID Numbers: 2007.485/28
First Posted: March 11, 2009    Key Record Dates
Last Update Posted: December 2, 2013
Last Verified: November 2013

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

Additional relevant MeSH terms:
Pathological Conditions, Anatomical