Primary and secondary outcomes
incontinence, necrosis
NECROSIS, INCONTINENCE, ABERRANT TISSUE, PAD, ADVERSE EVENT, LEAKAGE, URETHRA
To analyse the safety and feasibility of our therapy, primary outcomes were defined as any adverse event (AE) during the follow-up period. AEs were classified according to Clavien–Dindo grade I–V. Secondary outcomes were chosen as objective and subjective outcome parameters. Objective parameters were uroflowmetry, PVR and the 1-h pad test. Further, the results from the urodynamic study included maximal bladder capacity, bladder compliance, presence and amount of leakage, maximal urethral closure pressure (MUCP) and functional urethra length (FUL) at rest and under stress (continuous coughing). Subjective parameters were patient-reported outcomes (PROMs) as in the evaluation of the filled-in questionnaires (ICIQ-UI-SF [0–21 points] including amount of pad usage per day, Visual Analogue Scale [VAS 0–10 points] for degree of suffering and quality of life) and necessity of subsequent incontinence surgery during follow-up. Anatomical aspects (aberrant tissue or necrosis formation) and the diameter of the EUS were measured before treatment and at EOS on the MRI of the pelvis in every patient.