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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Traditional surgical method without prosthesis (correction of the anterior prolapse through vaginal tract with the use of autologous tissue).
Surgical method with Perigee® prosthesis
Hôpital femme Mère Enfant
Bron, France
Correction of prolapse, which is defined by a stage < II on the classification POP-Q, one year after surgery
Time frame: 12 months
Correction of prolapse 2 years after surgery
Time frame: 24 months
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
Pain after surgery
Time frame: 24 months
Duration of intervention
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.