TY - JOUR
T1 - Results of an innovative bulking agent in patients with stress urinary incontinence who are not optimal candidates for mid-urethral sling surgery
AU - Kowalik, Claudia R.
AU - Casteleijn, Fenne M.
AU - van Eijndhoven, Hugo W. F.
AU - Zwolsman, Sandra E.
AU - Roovers, Jan-Paul W. R.
PY - 2018
Y1 - 2018
N2 - AimsTo assess the efficacy and safety of peri-urethral bulking injections (PBI) with an innovative bulking material (PDMS-U) in women with stress-urinary incontinence (SUI) who are not optimal candidates for mid-urethral sling surgery. MethodsA prospective study was performed in women with SUI who, for several reasons, have a relative contraindication for a mid-urethral sling procedure. These reasons include: (i) recurrent SUI after a prior SUI surgical procedure; (ii) a history of oncologic gynaecological surgery; (iii) a history of neurologic disease resulting in voiding problems; (iv) a maximal flow rate of less than 15mL per second or; (v) women with a contraindication for surgery with general or regional anaesthesia. All women were treated with PBI consisting of PDMS-U, a bulking agent that polymerizes in situ. The primary outcome was subjective improvement, defined as a little better to very much better on the PGI-I. Secondary outcomes included objective cure, disease specific quality of life and adverse events. ResultsSubjective improvement was reported by 18 (90%) of the 20 included patients. The subjective cure rate was 56% and the objective cure rate was 65%. There was a statistically significant improvement of all domain scores of the UDI-6, IIQ-7, and PISQ-12 at 6 months follow up. Abnormal post voiding residual volume (>150mL) was the most common adverse event (40%), but persisted in only one patient, based on the patient's preference for a catheter. ConclusionsPBI with PDMS-U is a viable treatment option in women with a relative contra-indication for mid-urethral sling surgery
AB - AimsTo assess the efficacy and safety of peri-urethral bulking injections (PBI) with an innovative bulking material (PDMS-U) in women with stress-urinary incontinence (SUI) who are not optimal candidates for mid-urethral sling surgery. MethodsA prospective study was performed in women with SUI who, for several reasons, have a relative contraindication for a mid-urethral sling procedure. These reasons include: (i) recurrent SUI after a prior SUI surgical procedure; (ii) a history of oncologic gynaecological surgery; (iii) a history of neurologic disease resulting in voiding problems; (iv) a maximal flow rate of less than 15mL per second or; (v) women with a contraindication for surgery with general or regional anaesthesia. All women were treated with PBI consisting of PDMS-U, a bulking agent that polymerizes in situ. The primary outcome was subjective improvement, defined as a little better to very much better on the PGI-I. Secondary outcomes included objective cure, disease specific quality of life and adverse events. ResultsSubjective improvement was reported by 18 (90%) of the 20 included patients. The subjective cure rate was 56% and the objective cure rate was 65%. There was a statistically significant improvement of all domain scores of the UDI-6, IIQ-7, and PISQ-12 at 6 months follow up. Abnormal post voiding residual volume (>150mL) was the most common adverse event (40%), but persisted in only one patient, based on the patient's preference for a catheter. ConclusionsPBI with PDMS-U is a viable treatment option in women with a relative contra-indication for mid-urethral sling surgery
U2 - https://doi.org/10.1002/nau.23299
DO - https://doi.org/10.1002/nau.23299
M3 - Article
C2 - 28452427
SN - 0733-2467
VL - 37
SP - 339
EP - 345
JO - Neurourology and urodynamics
JF - Neurourology and urodynamics
IS - 1
ER -