Adverse event reporting and harms {22}
congenital anomaly/birth defect, death, disability/incapacity
EVENTS, DISEASE, ADVERSE EVENT
No specific adverse event is expected in the no sling and sling group other than those related to the surgical procedure for which both groups receive standard of care and postoperative visits. Intervention is therefore regarded as low risk. In the unexpected case of an adverse event occurrence, patients will call the investigators, and additional visits will be organized.A serious adverse event (SAE) is classified as any untoward medical occurrence that:Results in death,Is life-threatening,Requires in-patient hospitalization or prolongation of existing hospitalization,Results in persistent or significant disability/incapacity, or.Is a congenital anomaly/birth defect.In addition, important medical events that may not be immediately life-threatening or result in death, or require hospitalization, but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed above should also usually be considered serious.SAEs should be followed until resolution or stabilization. Participants with ongoing SAEs at study termination (including safety visit) will be further followed up until recovery or until stabilization of the disease after termination.All SAEs must be reported immediately and within a maximum of 24 h to the Sponsor-Investigator (AL) of the study. The Sponsor-Investigator will re-evaluate the SAE and return the form to the site. SAEs resulting in death are reported to the local Ethics Committee (via local Investigator) within 7 days. The other in the trial involved Ethics Committees who receive SAEs resulting in death in Switzerland via Sponsor-Investigator within 7 days.