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

PERIGEE :Randomized Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-obturator Way for the Correction of Anterior Prolapse.

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.

Study Overview

• Status: Completed
• Conditions: Anterior Prolapse
• Intervention / Treatment: Procedure: Traditional surgery; Device: Perigee® prosthesis

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Hopital Femme Mere Enfant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correction of prolapse, which is defined by a stage < II on the classification POP-Q, one year after surgery	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Correction of prolapse 2 years after surgery	24 months
Changes in quality of life, occurrence of complications during surgery, evolution of sexuality, onset or worsening of urinary incontinence	at 3,12, 24 months
Pain after surgery	24 months
Duration of intervention	24 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: MELLIER Georges, MD, Hospices Civils de Lyon

Publications and helpful links

General Publications

• Lamblin G, Van-Nieuwenhuyse A, Chabert P, Lebail-Carval K, Moret S, Mellier G. A randomized controlled trial comparing anatomical and functional outcome between vaginal colposuspension and transvaginal mesh. Int Urogynecol J. 2014 Jul;25(7):961-70. doi: 10.1007/s00192-014-2344-7. Epub 2014 Feb 27.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: March 10, 2009
• First Submitted That Met QC Criteria: March 10, 2009
• First Posted (Estimate): March 11, 2009

Study Record Updates

• Last Update Posted (Actual): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: randomized study; correction of anterior prolapse; prosthetic trans-obturator way kit
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: 2007.485/28