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Article History

Received: 9 June 2022

Accepted: 13 July 2022

First Online: 3 August 2022

Declarations

:

: Ethical approval was obtained from the South West – Frenchay REC on 24 October 2019 (reference number: 19/SW/0209) and applies to all NHS sites taking part in the study. Health Research Authority (HRA) and Heath and Care Research Wales (HCRW) approval was obtained on 19 December 2019 and applies to all participating sites in England and Wales. Any amendments to study documents, including the study protocol, after receiving initial study approvals will be submitted to the REC/HRA for approval prior to implementation. A copy of the current study protocol (v4.0) is available from the NIHR Journals Library [].Written informed consent (including electronic (e)consent) will be obtained, according to ICH GCP guidelines, from all patients who are deemed eligible and agree to take part before entering the study.

: This manuscript does not contain any details or personal data relating to individual persons. Informed consent materials for the trial are available from the corresponding author on request.

: <i>Authors</i>TG is a personal consultant for Boston Scientific and Contura; is a speaker for Allergan, Boston Scientific, Contura, Ferring, Olympus and Medtronic; is a GURS board member (AUA), ESGURS board member (EAU), and member of the EAU Urethral Stricture Guidelines Committee; has received institutional grants/ sponsorship to run the annual Female Urology and Urogynaecology Masterclass at UCLH from Allergan, Astellas, Axonics, Boston Scientific, Contura, Ferring, June Medical, Laborie, Mediplus, Medtronic, Olympus and Vesica Urology; has received sponsorship from Medtronic for a Neuromodulation Fellow at UCLH (now replaced by the Medipoints system); has received an education grant from Laborie for an ICS-approved UDS course at UCLH; and has received equipment and a staff loan from Olympus, Storz, Cook and Mediplus.WA has received trainer and speaker fees from CR Bard, Contura, NHS Ayrshire and Arran, and the London Medical Education Academy; sponsorship from Boston Scientific and Neomedic; expert fees from NHS Scotland and various law firms in the UK, Ireland, the USA and Australia in relation to mesh litigation; and institutional research support as principal investigator for the SIMS Pilot, PROSPECT and VUE studies, and as co-chief investigator for PURSUIT study. Wael Agur is also a member of an All Party Parliamentary Group on surgical mesh.HH is speaker for Boston Scientific, Allergan, Medtronic and Ferring; is a committee member of ESSFU and BAUS FNUU; and is associate editor of Neurourology and Urodynamics and BJUI Compass journals. He has received institutional grants to run Medtronic courses on sacral neuromodulation and has received speaker fees from Medtronic for mentorship and lecturing. HH is chair of the ICS mesh complications working group and CI for NIHR UNBLOCS trial, co-applicant on PURSUIT, CATHETER II, TRIUMPH and FUTURE.<i>Principal Investigators at study sites</i>Magda Kujawa is a site PI. MK has been a previous speaker for and carried out consultancy work for Contura, manufacturers of Bulkamid (Axonics).Aethele Khunda is a site PI. AK has not received any sponsorship in the last 2 years. AK has previously received an educational grant and/or speaker fees from Medtronic, Axonic, Astellas and Specialty European Pharma and has received travel and accommodation expenses from conference organising committees when invited as a speaker.