Clinical trial NCT00859417: Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-Obturator Way for the Correction of Anterior Prolapse
Official title: PERIGEE :Randomized Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-obturator Way for the Correction of Anterior Prolapse.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Prolapse
Keywords: correction of anterior prolapse
prosthetic trans-obturator way kit
randomized study
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2009-03-11
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Correction of prolapse, which is defined by a stage < II on the classification POP-Q, one year after surgery
timeFrame: 12 months
Secondary outcomes:
measure: Correction of prolapse 2 years after surgery
timeFrame: 24 months
measure: Changes in quality of life, occurrence of complications during surgery, evolution of sexuality, onset or worsening of urinary incontinence
timeFrame: at 3,12, 24 months
measure: Pain after surgery
timeFrame: 24 months
measure: Duration of intervention
timeFrame: 24 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital femme Mère Enfant
Study officials:
affiliation: Hospices Civils de Lyon
name: MELLIER Georges, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.