Vaginal prolapse Urological and Genital Diseases Other female genital prolapse
Conditions
Interventions
There will be no interventions as a result of study participation.
RELease is an observational follow-up study, therefore participants will be asked to complete a questionnaire and at
Sponsors
Manchester Royal Infirmary (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Participants must have been previously implanted with Restorelle mesh for laparoscopic sacrocolpopexy treatment of Pelvic Organ Prolapse (POP) 2. Participants must have source data available in physician records and/or database for the retrospective aspect of study 3. Participants must be willing and able to provide informed consent and complete study activities
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To study the performance of Restorelle mesh used for laparoscopic sacrocolpopexy 2. To compare the performance of Restorelle mesh with other polypropylene meshes previously employed for laparoscopic sacrocolpopexy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess mesh-related complications, including but not limited to mesh erosion and palpability, based on International Continence Society/International urogynecological association (ICS/IUGA) classification codes 2. To assess the subjective impression of improvement after treatment, via PGI-I (Patient Global Impression of Improvement) Questionnaire for urogenital prolapse 3. To assess condition-specific quality-of-life factors before and after treatment, via the PFDI-20 (Pelvic Floor Distress Inventory-Short Form) | — |
Countries
United Kingdom
Outcome results
None listed