PERIGEE :Randomized Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-obturator Way for the Correction of Anterior Prolapse.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Correction of prolapse, which is defined by a stage < II on the classification POP-Q, one year after surgery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- 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 \ 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
Arms & Interventions
1
Traditional surgical method without prosthesis
Intervention: Traditional surgery (Procedure)
2
Surgical method with Perigee prosthesis
Intervention: Perigee® prosthesis (Device)
Outcomes
Primary Outcomes
Correction of prolapse, which is defined by a stage < II on the classification POP-Q, one year after surgery
Time Frame: 12 months
Secondary Outcomes
- 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)