Cystocele
Conditions
Brief summary
The main purpose of this study is to evaluate the long-term (5-8 years) functional prolapse recurrence rate of the 147 patients enrolled, randomized and analyzed in the study PRO-CURE I.
Detailed description
Secondary objectives include comparing the following elements between the two randomized groups at a long-term time point (5-8 years): A. The anatomic failure rate of cystocele (POP-Q stage \> or = 2) B. Late postoperative morbidity C. Residual post-operative pain (visual analog scale (VAS)) D. Patient satisfaction via the PGI-I questionnaire E. Quality of life via the PFDI and PFIQ questionnaires F. Sexual activity via the PISQ-12 questionnaire G. The rate of vaginal erosion H. Displacement and secondary shrinkage of meshs
Interventions
DEVICEUGYTEX
Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)
PROCEDURENo mesh.
Patients in this arm had subvesical plication without reinforcement.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must have given her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * Patient included in, randomized and analysed in the PROCURE study (NCT00153257)
Exclusion criteria
* The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * Patient not included in the PROCURE study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional failure | 5 years | The primary efficacy endpoint of this study, is the functional failure at 5 years, defined using the functional response at 12 months in NCT00153257, the concept of surgery for prolapse and the answer to question No. 5 of the PFDI questionnaire submitted between 5 and 8 years postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anatomical failure | 5-8 years | The anatomical failure is defined by a failure or recurrence at 12 months (data from NCT00153257), or surgery for prolapse or anatomic recurrence (recurrence of cystocele stage 2 or higher) upon examination at 5 to 8 years. |
| Post-operative complications | 5-8 years | Major complications include surgery for prolapse repair, re-hospitalization or functional complications. Minor complications include all adverse events that are not major complications. Mesh-specific complications include vaginal pain, vaginal erosions, displacement and retraction of the mesh. |
| The PGI-I questionnaire | 5-8 years | — |
| The PFIQ questionnaire | 5-8 years | — |
| The PISQ-12 questionnaire | 5-8 years | — |
| The PFDI questionnaire | 5-8 years | — |
Countries
France
Outcome results
None listed