Restorelle for laparoscopic sacrocolpopexy for pelvic organ prolapse

Not Applicable

Completed

• Conditions: Vaginal prolapse; Urological and Genital Diseases; Other female genital prolapse

• Registration Number: ISRCTN19907894
• Lead Sponsor: Manchester Royal Infirmary (UK)

Brief Summary

2019 results in https://doi.org/10.1016/j.eurox.2019.100008

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2012-11-05
• Study Start: 2013-08-21
• Last Update Posted: 18 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 260

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

Does not meet inclusion criteria

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. To study the performance of Restorelle mesh used for laparoscopic sacrocolpopexy<br> 2. To compare the performance of Restorelle mesh with other polypropylene meshes previously employed for laparoscopic sacrocolpopexy<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 2. To assess the subjective impression of improvement after treatment, via PGI-I (Patient Global Impression of Improvement) Questionnaire for urogenital prolapse<br> 3. To assess condition-specific quality-of-life factors before and after treatment, via the PFDI-20 (Pelvic Floor Distress Inventory-Short Form)<br>