Inclusion and exclusion criteria
neurological disease, incontinence, cystocele, prolapse, enuresis, DSD, fistula, urogenital cancer, acontractile detrusor, hypersensitivity, congenital abnormality
NEUROLOGICAL DISEASE, INCONTINENCE, URETHRAL STENOSIS, URINARY TRACT DISEASES, CYSTOCELE, PROLAPSE, ENURESIS, INCONTINENCE, PAD, MUSCULAR DISEASE, HYPERSENSITIVITY, DETRUSOR INSTABILITY
The main inclusion criteria were: female gender; age 20–60 years; a clinical diagnosis of SUI grade ≥I according to the Stamey classification for at least 6 months; and post-void residual (PVR) <100 ml.The main exclusion criteria were: a history of anti-incontinence or prolapse surgery; a previous diagnosis of urinary tract diseases (cystocele, fistula, congenital abnormality or interstitial cystitis); UUI; adult enuresis; urodynamically proven detrusor instability or detrusor–sphincter–dyssynergia (DSD); hyposensitive and/or acontractile detrusor; urethral stenosis; a history of urogenital cancer or pelvic radiotherapy; pregnancy or <12 months postpartum; and unstable systemic, neurological disease or genetically determined muscular disease.Objective and subjective assessments were performed during the screening (baseline) visit to guarantee that the female patients met the strict inclusion and exclusion criteria. The screening visit included the acquisition of personal medical history, physical examination, vital signs, blood tests, pregnancy test, hypersensitivity test to the injection solution (subcutaneous injection), uroflowmetry, ultrasound of the bladder (including measurement of the PVR) and the kidneys, 1-h pad test, incontinence questionnaire (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-UI-SF]), urodynamic study and magnetic resonance imaging (MRI) of the pelvis.