Back to resultsStudy Evaluating the Effectiveness of the Use of Prosthesis With Trans-Obturator Way for the Correction of Anterior Prolapse
Primary Purpose
Anterior Prolapse
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Traditional surgery
Perigee® prosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Prolapse focused on measuring correction of anterior prolapse, prosthetic trans-obturator way kit, randomized study
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
Sites / Locations
- Hôpital femme Mère Enfant
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Traditional surgical method without prosthesis
Surgical method with Perigee prosthesis
Outcomes
Primary Outcome Measures
Correction of prolapse, which is defined by a stage < II on the classification POP-Q, one year after surgery
Secondary Outcome Measures
Correction of prolapse 2 years after surgery
Changes in quality of life, occurrence of complications during surgery, evolution of sexuality, onset or worsening of urinary incontinence
Pain after surgery
Duration of intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00859417
Brief Title
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
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Prolapse
Keywords
correction of anterior prolapse, prosthetic trans-obturator way kit, randomized study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Traditional surgical method without prosthesis
Arm Title
2
Arm Type
Experimental
Arm Description
Surgical method with Perigee prosthesis
Intervention Type
Procedure
Intervention Name(s)
Traditional surgery
Intervention Description
Traditional surgical method without prosthesis (correction of the anterior prolapse through vaginal tract with the use of autologous tissue).
Intervention Type
Device
Intervention Name(s)
Perigee® prosthesis
Intervention Description
Surgical method with Perigee® prosthesis
Primary Outcome Measure Information:
Title
Correction of prolapse, which is defined by a stage < II on the classification POP-Q, one year after surgery
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Correction of prolapse 2 years after surgery
Time Frame
24 months
Title
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
Title
Pain after surgery
Time Frame
24 months
Title
Duration of intervention
Time Frame
24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MELLIER Georges, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital femme Mère Enfant
City
Bron
ZIP/Postal Code
69677
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
24573358
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.
Results Reference
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Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-Obturator Way for the Correction of Anterior Prolapse
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