Macroplastique Is a Safe and Effective Long-term Surgical Treatment for Stress Urinary Incontinence: Prospective Study with 10-Year Follow-up

Maurizio Serati; Chiara Scancarello; Giada Mesiano; Chiara Cimmino; Maria Rosaria Campitiello; Stefano Salvatore; Fabio Ghezzi; Giorgio Caccia; Andrea Papadia; Andrea Braga

doi:10.1016/j.euf.2024.07.010

Macroplastique Is a Safe and Effective Long-term Surgical Treatment for Stress Urinary Incontinence: Prospective Study with 10-Year Follow-up

Eur Urol Focus. 2024 Aug 2:S2405-4569(24)00130-5. doi: 10.1016/j.euf.2024.07.010. Online ahead of print.

Authors

Affiliations

¹ Department of Obstetrics and Gynecology, Del Ponte Hospital, University of Insubria, Varese, Italy. Electronic address: maurizio.serati@uninsubria.it.
² Department of Obstetrics and Gynecology, Del Ponte Hospital, University of Insubria, Varese, Italy.
³ Department of Obstetrics and Gynecology and Physiopathology of Human Reproduction, ASL Salerno, Salerno, Italy.
⁴ Department of Obstetrics and Gynecology, IRCSS San Raffaele Scientific Institute, Milan, Italy.
⁵ Department of Gynecology and Obstetrics, Ente Ospedaliero Cantonale-Beata Vergine Hospital, Mendrisio, Switzerland.
⁶ Department of Gynecology and Obstetrics, Ente Ospedaliero Cantonale-Ospedale Regionale di Lugano, Lugano, Switzerland; Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland.
⁷ Department of Gynecology and Obstetrics, Ente Ospedaliero Cantonale-Beata Vergine Hospital, Mendrisio, Switzerland; Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland.

PMID: 39095217
DOI: 10.1016/j.euf.2024.07.010

Abstract

Background and objective: Until a few years ago, a midurethral sling was considered the gold standard for the treatment of female stress urinary incontinence (SUI) after failure of conservative therapies. However, criticisms regarding the rate of mesh exposure and lack of long-term efficacy have led to reconsideration of other surgical procedures. Our aim was to investigate long-term subjective and objective outcomes after injection of Macroplastique, a urethral bulking agent.

Methods: We prospectively enrolled all consecutive women complaining of pure SUI symptoms with urodynamically proven SUI who received a Macroplastique injection. We investigated patient-reported subjective outcomes using International Consultation on Incontinence Questionnaire-Short Form, Urogenital Distress Inventory, Patient Global Impression of Improvement, and Visual Analog Scale (VAS) questionnaires, and the cough stress test to assess objective outcomes. Adverse events were recorded during follow-up.

Key findings and limitations: At 10 yr after Macroplastique injection, the objective cure rate was 56% and 71% of patients reported that they were satisfied. Long-term data revealed no significant decline in subjective or objective cure rates. No serious complications were reported. Study limitations include the small sample size and the lack of pad tests and bladder diaries for postoperative evaluations.

Conclusions and clinical implications: Our study shows that Macroplastique injection can be an effective and safe option for the treatment of female SUI in the long term, even when used in the first-line setting.

Patient summary: We evaluated outcomes for women with stress urinary incontinence (SUI) who were treated with an injection of Macroplastique gel into the wall of the urethra to prevent leakage of urine. We found that this is a safe option for treatment of female SUI that is effective in the long term.

Keywords: Bulking agent; Efficacy; Long-term follow-up; Macroplastique; Stress urinary incontinence; Urethral injection.