Safety evaluation of mid-urethral slings (SOFT)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44571
• EU PAS number:
  EUPAS44570
• Study ID:
  44571
• Official title and acronym:
  Safety evaluation of mid-urethral slings (SOFT)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  In the field of urology, an emblematic example of the need for post-marketing evaluation of implantable devices is that of sub-urethral slings (SUBs), implanted to treat female urinary incontinence. These devices present a risk of infection, erosion or urinary obstruction that may lead to further surgery. They also present a risk of chronic pain. It is against this backdrop that in 2019 in the UK, BSUs were removed from NICE's management guidelines for stress urinary incontinence in women. The main aim of this study is to estimate the incidence of surgical re-interventions after suburethral sling placement, in the short (up to one year of follow-up), medium (between 1 and 5 years of follow-up) and long (5 years of follow-up)term.
• Study status:
  Ongoing

Research institution and networks

Institutions

Assistance Publique - Hôpitaux de Paris (AP-HP)

France

Study timelines

Date when funding contract was signed

Planned: 01/01/2021

Actual: 23/06/2021

Study start date

Planned: 01/01/2021

Actual: 07/07/2021

Data analysis start date

Planned: 01/04/2022

Date of final study report

Planned: 30/06/2023

Sources of funding

Other

More details on funding

French Ministry of Health

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable