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

Not Applicable

Completed

• Conditions: Anterior Prolapse
• Interventions: Procedure: Traditional surgery; Device: Perigee® prosthesis

• Registration Number: NCT00859417
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-03-10
• Study First Submitted QC: 2009-03-10
• Study First Posted: 2009-03-11
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-11
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Traditional surgery	Traditional surgical method without prosthesis
2	Perigee® prosthesis	Surgical method with Perigee prosthesis

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Correction of prolapse 2 years after surgery	24 months

Trial Locations

Locations (1)

Hôpital femme Mère Enfant; 🇫🇷 Bron, France