Daniel Altman1, Francesca Ghilotti, Rino Bellocco, Jan Zetterström, Helena Kopp Kallner. 1. From the *Stockholm Urogynecological Clinic; †Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital, Stockholm, Sweden; ‡Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy; §Department of Medical Epidemiology and Biostatistics, Karolinska Institutet; ∥Ultragyn, Sophiahemmet and ¶Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.
Abstract
OBJECTIVES: This study aims to determine the effects of transurethral polyacrylamide hydrogel injection in patients considered ineligible for midurethral sling surgery. METHODS: In this prospective observational study, 81 patients received treatment with transurethral polyacrylamide hydrogel injection. Patients were considered ineligible for placement of a midurethral sling based on significant comorbidity (48%), 1 or more previously failed invasive treatments (16%), mixed urinary incontinence (27%), continuous incontinence (5%), or previous pelvic radiation therapy (4%). Longitudinal assessment of subjective treatment outcomes was performed using the validated Urinary Distress Inventory (UDI) and the Pelvic Floor Impact Questionnaire at baseline, 2, and 6 months. To deal with repeated measurements, mixed linear models were used to assess changes in the outcomes over time. RESULTS: There was a significant improvement in the overall UDI score from baseline to month 2 follow-up (FU) (P<0.001). No major differences between the month 2 and 6 FUs were observed. The largest difference in effect was observed for the irritative and stress subscales. Twenty-five patients (33%) requested a second injection at the month 2 FU visit. At month 6 FU, the UDI scores for patients having had only 1 injection were largely unchanged, whereas all UDI domains worsened further for patients having had a second injection at the month 2 visit. After the injection, there were 3 minor adverse events (3.7%) and no serious adverse events. CONCLUSIONS: In patients considered ineligible for midurethral sling surgery, transurethral injection with polyacrylamide hydrogel may alleviate urinary incontinence symptoms. Repeat injections did not improve outcomes in this complicated group of patients.
OBJECTIVES: This study aims to determine the effects of transurethral polyacrylamide hydrogel injection in patients considered ineligible for midurethral sling surgery. METHODS: In this prospective observational study, 81 patients received treatment with transurethral polyacrylamide hydrogel injection. Patients were considered ineligible for placement of a midurethral sling based on significant comorbidity (48%), 1 or more previously failed invasive treatments (16%), mixed urinary incontinence (27%), continuous incontinence (5%), or previous pelvic radiation therapy (4%). Longitudinal assessment of subjective treatment outcomes was performed using the validated Urinary Distress Inventory (UDI) and the Pelvic Floor Impact Questionnaire at baseline, 2, and 6 months. To deal with repeated measurements, mixed linear models were used to assess changes in the outcomes over time. RESULTS: There was a significant improvement in the overall UDI score from baseline to month 2 follow-up (FU) (P<0.001). No major differences between the month 2 and 6 FUs were observed. The largest difference in effect was observed for the irritative and stress subscales. Twenty-five patients (33%) requested a second injection at the month 2 FU visit. At month 6 FU, the UDI scores for patients having had only 1 injection were largely unchanged, whereas all UDI domains worsened further for patients having had a second injection at the month 2 visit. After the injection, there were 3 minor adverse events (3.7%) and no serious adverse events. CONCLUSIONS: In patients considered ineligible for midurethral sling surgery, transurethral injection with polyacrylamide hydrogel may alleviate urinary incontinence symptoms. Repeat injections did not improve outcomes in this complicated group of patients.