Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

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 women’s 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 Mary’s 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 Mary’s 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

Trial website

Contact information



Primary contact

Ms Lucy Dwyer


Contact details

The Warrell Unit
Women’s Outpatient Department
Saint Mary’s Hospital
Manchester University NHS Foundation Trust
Oxford Road
M13 9WL
United Kingdom
+44 (0)161 276 6910

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

REstorelle for Laparoscopic sacrocolpopexy for pelvic organ prolapse



Study hypothesis

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

NRES Committee North West - Greater Manchester Central, 17/05/2012, ref: 12/NW/0277

Study design

Retrospective study with prospective follow-up components

Primary study design


Secondary study design

Cohort study

Trial setting


Trial type


Patient information sheet


Vaginal 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.

Intervention type



Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


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

Participant type


Age group




Target number of participants


Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

The Warrell Unit
M13 9WL
United Kingdom

Sponsor information


Manchester Royal Infirmary (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Coloplast Corporation (Denmark)

Alternative name(s)

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

Basic results (scientific)

Publication list

2019 results in

Publication citations

Additional files

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