Minimally Invasive Treatment of Stress Urinary Incontinence in Women: A Prospective Comparative Analysis between Bulking Agent and Single-Incision Sling.

The study aims to compare the efficacy and safety of bulking agents and single-incision slings in the treatment of urinary incontinence in 159 patients during a 29-month follow-up period.

Of the 159 patients suffering from stress urinary incontinence, 64 were treated with bulking agents (PAHG Bulkamid®) and 75 with a single-incision sling (Altis®). The ICIQ-UI-SF (Incontinence Questionnaire-Urine Incontinence-Short Form), PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaires short form), FSFI (Female Sexual Function Index), FSDS (Female Sexual Distress Scale), and PGI-I (Patient Global Improvement Index) were used to assess efficiency and quality of life.

The bulking agents showed high efficacy and safety during the 29-month follow-up. Post-operative complications were recorded in both groups, with only two significant differences. The Bulkamid group experienced no pain, while 10.8% of the ALTIS group experienced groin pain and 5% experienced de novo urgency. Furthermore, patients treated with bulking agents experienced reduced nicturia (0.78 vs. 0.92 in patients treated with single-incision slings.). In both groups, we noticed a significant improvement in QoL (quality of life), with a halved ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urine Incontinence-Short Form) score which was completed to assess the impact of urine symptoms. After 24 months of therapy, the Bulkamid group saw a decrease from 14.58 ± 5.11 at baseline to 5.67 ± 1.90 (p < 0.0001), whereas the ALTIS group experience a decrease from 13.75 ± 5.89 to 5.83 ± 1.78. Similarly, we observed an improvement in sexual function, with the number of sexually active patients increasing from 29 to 44 (56.4%) in the Bulkamid group (p = 0.041) and from 31 to 51 (61.7%) in the ALTIS group (p = 0.034). According to the most recent statistics, the PISQ-12, FSFI, and FSDS scores all demonstrated an improvement in women's sexual function.

In terms of efficacy and safety, bulking agents had notable results over the 29-month follow-up period. Furthermore, the patients treated with bulking agents reported a lower incidence of postoperative complications and a no discernible difference in terms of quality of life and sexual activity compared to the ones treated with single-incision slings. Bulking agents can be considered a very reliable therapeutic option based on accurate patient selection.

Healthcare (Basel, Switzerland). 2024 Mar 29*** epublish ***

Lorenzo Campanella, Gianluca Gabrielli, Erika Chiodo, Vitaliana Stefanachi, Ermelinda Pennacchini, Debora Grilli, Giovanni Grossi, Pietro Cignini, Andrea Morciano, Marzio Angelo Zullo, Pierluigi Palazzetti, Carlo Rappa, Marco Calcagno, Vincenzo Spina, Mauro Cervigni, Michele Carlo Schiavi

Department of Obstetrics and Gynaecology, Ospedale Sandro Pertini, 00157 Rome, Italy., Department of Obstetrics and Gynaecology, Pia Fondazione Cardinale G. Panico, 73039 Tricase, Italy., AIUG Research Groups, Associazione Italiana di UroGinecologia e del Pavimento Pelvico, 00168 Rome, Italy., Department of Obstetrics and Gynecology, Santo Spirito Hospital, 00193 Rome, Italy., Maternal and Child Department, S. Camillo de Lellis Hospital, 02100 Rieti, Italy.