Stress urinary incontinence (SUI) is a common condition affecting up to 50% of women in developed countries, with the risk of requiring surgery of about 4%.1,2 Surgical treatment is indicated when conservative management fails.3 Many types of surgery have been performed over the years. To date, mid-urethral slings are considered the first option because of high efficacy rates.4 Different synthetic sling procedures are available. Single-incision slings (SISs) were introduced in 2006 with the purpose to decrease the risk of complications including visceral injury, major bleeding, infection, and neurological pain.5,6 SISs showed cure rates comparable with standard tapes in the short-term, with efficacy unaffected by age, body mass index (BMI), obstetrical history, and proper bilateral anchoring on obturator membranes.5,7-9 Nevertheless, there is a lack of evidence about long-term outcomes.
There are only a few studies considering the long-term outcomes of SIS. Sun et al. compared 31 TVT-O patients versus 33 SISs (TVT-Secur) 10 years after implantation.10 Their results showed that transobturator tape is superior in objective cure and subjective satisfaction and tends to decline less over 10 years. However, TVT-Secur was criticized for poor performance compared with other SISs, even in the short-term, and finally was withdrawn from the market.11 In a prospective study at 8 years follow-up, Mira Gon et al. evaluated the outcomes of Ophira implanted either as a first (20 patients) or repeated anti-incontinence procedure (20 women).12 Authors found that in the subgroup of naive patients Ophira demonstrated sustained results and no long-term complications.
To the best of our knowledge, this is the largest study available on the long-term (≥ 10 years) follow-up of SISs including a homogeneous population of naïve patients with pure SUI.
We stated that patients maintain excellent objective and subjective cure rates 10 years after SIS implantation. Moreover, no long-term mesh-related complications such as mesh exposure and chronic pain syndrome occurred, and patients’ satisfaction was very high.
Even with the limitations of the retrospective single-arm design and the discontinued surgical kit analyzed (Miniarc®), this study highlighted the need to investigate the long-term outcomes of SISs, as they have the potential to become a first-line treatment for SUI, like standard mid-urethral tapes. There is a need for randomized prospective clinical studies to define the role of SISs as an SUI treatment option.
Written by: Stefano Manodoro, MD, ASST Santi Paolo e Carlo, Ospedale San Paolo, via Antonio di Rudini, Milan, Italy, and Matteo Frigerio, MD, ASST Monza, San Gerardo Hospital, Monza, Italy
- Ford, Abigail A., Lynne Rogerson, June D. Cody, Patricia Aluko, and Joseph A. Ogah. "Mid‐urethral sling operations for stress urinary incontinence in women." Cochrane Database of Systematic Reviews 7 (2017).
- Aydın, Serdar, and Çağrı Arıoğlu Aydın. "Effect of concomitant single incision vaginal surgery on mid urethral sling success." Neurourology and urodynamics 35, no. 8 (2016): 995-999.
- Rovner, Eric S., and Alan J. Wein. "Treatment options for stress urinary incontinence." Reviews in urology 6, no. Suppl 3 (2004): S29.
- Cox, Ashley, Sender Herschorn, and Livia Lee. "Surgical management of female SUI: is there a gold standard?." Nature Reviews Urology 10, no. 2 (2013): 78.
- Mostafa, Alyaa, Chou Phay Lim, Laura Hopper, Priya Madhuvrata, and Mohamed Abdel-Fattah. "Single-incision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: an updated systematic review and meta-analysis of effectiveness and complications." European urology 65, no. 2 (2014): 402-427.
- Spelzini, Federico, Matteo Frigerio, Cristina Regini, Stefania Palmieri, Stefano Manodoro, and Rodolfo Milani. "Learning curve for the single‐incision suburethral sling procedure for female stress urinary incontinence." International Journal of Gynecology & Obstetrics 139, no. 3 (2017): 363-367.
- Palmieri, Stefania, Matteo Frigerio, Federico Spelzini, Stefano Manodoro, and Rodolfo Milani. "Risk factors for stress urinary incontinence recurrence after single‐incision sling." Neurourology and urodynamics 37, no. 5 (2018): 1711-1716.
- Frigerio, Matteo, Cristina Regini, Stefano Manodoro, Federico Spelzini, and Rodolfo Milani. "Mini-sling efficacy in obese versus non-obese patients for treatment of stress urinary incontinence." Minerva ginecologica 69, no. 6 (2017): 533.
- Spelzini, Federico, Maria Cristina Cesana, Debora Verri, Serena Polizzi, Matteo Frigerio, and Rodolfo Milani. "Three-dimensional ultrasound assessment and middle term efficacy of a single-incision sling." International urogynecology journal 24, no. 8 (2013): 1391-1397.
- Sun, Zhijing, Xiuqi Wang, Jinghe Lang, Tao Xu, Ye Zhang, Jia Kang, Meng Mao, and Lan Zhu. "Comparison of outcomes between single‐incision sling and transobturator sling for treating stress urinary incontinence: A 10‐year prospective study." Neurourology and Urodynamics 38, no. 7 (2019): 1852-1858.
- Lucas MG, Bedretdinova D, Bosch JLHR, et al. European Association of Urology (EAU) guidelines. Guidelines on urinary incontinence. 2015. https://uroweb.org/wp-content/uploads/EAU- Guidelines-Urinary-Incontinence-2015.pdf
- Gon, Lucas Mira, Cassio Luis Zanettini Riccetto, Caio Cesar Citatini de Campos, Brunno Raphael Iamashita Voris, Leonardo O. Reis, and Paulo Cesar Rodrigues Palma. "Mini-Sling Ophira at 8 Years Follow-Up: Does It Sustain Results?." Urologia internationalis 102, no. 3 (2019): 326-330.