Restorelle for laparoscopic sacrocolpopexy for pelvic organ prolapse

ISRCTN	ISRCTN19907894
DOI	https://doi.org/10.1186/ISRCTN19907894
Secondary identifying numbers	1.1

Submission date: 19/04/2012
Registration date: 21/08/2013
Last edited: 22/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Ms Lucy Dwyer
Scientific

The Warrell Unit
Women’s Outpatient Department
Saint Mary’s Hospital
Manchester University NHS Foundation Trust
Oxford Road
Manchester
M13 9WL
United Kingdom

Phone	+44 (0)161 276 6910
Email	Lucy.dwyer@mft.nhs.uk

Study information

Study design	Retrospective study with prospective follow-up components
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Screening
Scientific title	REstorelle for Laparoscopic sacrocolpopexy for pelvic organ prolapse
Study acronym	RELease
Study objectives	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.
Ethics approval(s)	NRES Committee North West - Greater Manchester Central, 17/05/2012, ref: 12/NW/0277
Health condition(s) or problem(s) studied	Vaginal prolapse
Intervention	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.
Intervention type	Device
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	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 study start date	08/05/2012
Completion date	05/11/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	260
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	08/05/2012
Date of final enrolment	05/11/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

The Warrell Unit

Manchester
M13 9WL
United Kingdom

Sponsor information

Manchester Royal Infirmary (UK)
Hospital/treatment centre

c/o Lynne Webster
Research & Development
Postgraduate Medical Centre
Oxford Road
Manchester
M13 9WL
England
United Kingdom

Website	http://www.cmft.nhs.uk/
"ROR"	https://ror.org/03kr30n36

Funders

Funder type

Industry

Coloplast Corporation (Denmark)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2019		Yes	No

Editorial Notes

22/02/2019: The following changes have been made:
1. Publication reference added.
2. The intervention type has been changed from 'other' to 'device'.
3. The condition has been changed from "Pelvic Organ Prolapse" to "Vaginal prolapse".
4. The condition category has been changed from 'Musculoskeletal diseases' to 'Urological and genital diseases'.
5. Dr Anthony Smith has been replaced as the scientific contact by Lucy Dwyer.
08/06/2017: No publications found in PubMed, verifying study status with principal investigator