The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.
Vaginal prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with women's sex life. There are a number of different surgical procedures which are used to repair prolapse. Sometimes a mesh is placed in the pelvis to support the weakened tissues. There is a lot of research going on to find the most suitable type of mesh to repair vaginal prolapse. The GYNECARE PROLIFT + M\* Pelvic Floor Repair system is similar to a mesh already used for this procedure called ULTRAPRO\*, but is lighter in weight. Currently, ULTRAPRO\* is only approved for use in hernia repair and is not licensed for gynecological procedures. This study will be the first clinical investigation of this mesh in vaginal prolapse.
Study Type
OBSERVATIONAL
Enrollment
126
Pre-shaped mesh implants made of GYNECARE GYNEMESH M composite mesh, comprised of absorbable polyglecaprone 25 monofilament fiber and nonabsorbable polypropylene monofilament fiber
Sint Lodewijkstraat 78
Genk, Belgium
CHRU de Lille
Lille, France
DRT Krankenhaus
Chemnitz, Germany
Martin Luther University
Halle, Germany
Pelvic Organ Prolapse Quantification (POP-Q) score
Time frame: 12 months post-procedure
Summary of treated compartment ICS POP-Q stage
Time frame: 3, 12, 24 and 36 months
Proportion of subjects with the leading edge within the hymen and without further re-intervention for POP
Time frame: 12, 24 and 36 months
Incidence of de novo prolapse (a post-operative prolapse)only in the untreated compartment, provided there was no pre-operative defect in that compartment
Time frame: Procedure to 36 months
Mean scores and change from baseline in PFDI-20 scores, including sub scores (POPDI, CRADI and UDI
Time frame: 3, 12, 24 and 36 months
Mean scores and change from baseline in PFIQ-7, including sub-scores (POPIQ, CRAIQ and UIQ).
Time frame: 3, 12, 24 and 36 months
Days to return to normal activities (walking, driving, work, household activities and sexual intercourse)
Time frame: 1, 3, and 12 months
Assessment of sexual function using PISQ-12 (mean scores and change from baseline) in subjects sexually active at baseline
Time frame: 12, 24 and 36 months
Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia
Time frame: Baseline to 36 months
Adverse Events
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kreiskrankenhaus
Hamelin, Germany
Universitatsklinik Tubingen
Tübingen, Germany
St. Marien-Hospital
Vechta, Germany
Reinier de Graaf Gasthuis
Delft, Netherlands
Time frame: Procedure to 36 months
Determination of any exposures/erosions including location
Time frame: Procedure to 36 months
Summary of International Continence Society (ICS) Stages
Time frame: 3, 24, and 36 months