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

NCT00859417 | Completed DMC

• 1 other identifier: 2007.485/28
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Prolapse

Keywords

correction of anterior prolapse; prosthetic trans-obturator way kit; randomized study

Outcome Measures

Primary Outcomes (1)

• Correction of prolapse, which is defined by a stage < II on the classification POP-Q, one year after surgery

  12 months

Secondary Outcomes (4)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Traditional surgical method without prosthesis

Procedure: Traditional surgery

2

EXPERIMENTAL

Surgical method with Perigee prosthesis

Device: Perigee® prosthesis

Interventions

Traditional surgery PROCEDURE

Traditional surgical method without prosthesis (correction of the anterior prolapse through vaginal tract with the use of autologous tissue).

1

Perigee® prosthesis DEVICE

Surgical method with Perigee® prosthesis

2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital femme Mère Enfant

Bron, 69677, France

Location

Related Publications (1)

• 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.

  PMID: 24573358 RESULT

Study Officials

• MELLIER Georges, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 11, 2009
• Study Start: September 1, 2008
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 28, 2019

Record last verified: 2013-11

Locations

FR (1)