Plain English Summary
Background and study aims
Laparoscopic sacrocolpopexy is a prolapse operation which aims to provide support for the vagina and pelvic organs. This is achieved by attaching one end of a piece of special surgical mesh to the top of the vagina and the other end to the lower backbone. Different kinds of mesh can be used for this operation.
The National Institute of Clinical Excellence (NICE) has encouraged healthcare professionals to conduct further research into the different types of mesh currently used for a laparoscopic sacrocolpopexy, as they think that there might be fewer complications with newer types of mesh such as Restorelle, but we need to find out if that is correct.
At the moment there is not enough evidence for us to be able to compare the success rates and complication rates of different types of mesh used for this operation.
The study aims to find out whether using Restorelle mesh for a laparoscopic sacrocolpopexy improves womens prolapse symptoms better than other types of mesh, and whether women who have had this operation using Restorelle mesh have more, the same, or less chance of getting problems following the operation than those who had the same operation but a different type of mesh.
Who can participate?
Women who are eligible to participate in the study are those who have had a laparoscopic sacrocolpopexy performed using Restorelle mesh at Saint Marys Hospital, Manchester. The women must also be willing and able to provide informed consent and complete the study activities.
What does the study involve?
The study involves participants completing a questionnaire to tell us about their prolapse symptoms since the operation and attending an additional follow-up clinic appointment where they will receive a vaginal examination.
What are the potential benefits and risks of participating?
The potential benefit for participants taking part in this research is the satisfaction of helping others by contributing to medical knowledge and an additional follow-up appointment which offers the opportunity to discuss any post-operative issues which may have arisen. We do not anticipate that any harm will come to you by taking part in the study as it does not involve any treatment or procedure apart from filling in a questionnaire and having a pelvic examination.
Where is the study run from?
The study is being run from The Warrell Unit, Saint Marys Hospital, Central Manchester University Hospital and NHS Foundation Trust.
When is the study starting and how long is it expected to run for?
The study started in May 2012 and ran for 6 months, ending in November 2012.
Who is funding the study?
The study is being funded by Coloplast Corporation, the company who make Restorelle mesh.
Who is the main contact?
Lucy Dwyer (Research Nurse)
The Warrell Unit, Saint Mary's Hospital, UK
REstorelle for Laparoscopic sacrocoplpopexy for pelvic organ prolapse
RELease has been designed to study the performance of Restorelle mesh used for laparoscopic sacrocolpopexy repair of pelvic organ prolapse (POP), to compare the performance of Restorelle mesh with other polypropylene meshes previously used for laparoscopic sacrocolpopexy, to assess quality of life factors, and to assess mesh-related adverse events.
NRES Committee North West - Greater Manchester Central, 17/05/2012, ref: 12/NW/0277
Retrospective study with prospective follow-up components
Primary study design
Secondary study design
Patient information sheet
Pelvic Organ Prolapse
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 attend an additional follow-up appointment where they will receive a vaginal examination.
Primary outcome measures
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 outcome measures
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)
Overall trial start date
Overall trial end date
Participant 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
Target number of participants
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
The Warrell Unit
Manchester Royal Infirmary (UK)
c/o Lynne Webster
Research & Development
Postgraduate Medical Centre
Coloplast Corporation (Denmark)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting