Financial disclosures: Peng Zhang certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: None.
Author contributions: PZ had full access to all the data in the study and takes responsibility for the integrity of the data and theaccuracy of the data analysis. Study concept and design: PZ, BF. Acquisition of data: BF, HH. Analysis and interpretation of data: PZ, BF, HH, YX, BW. Drafting of the manuscript: PZ, BF. Critical revision of the manuscript for important intellectual content: 9 PZ, BF. Statistical analysis: BF, YX. Obtaining funding: None. Administrative, technical, or material support: PZ, XZ. Supervision: PZ. Other (specify): None. All authors read and approved the final manuscript.
Peng Zhang and Bohan Fan are first author.
The study on SIMS and SMUS as a whole by Alyaa Mostafa et al showed that after excluding the TVT-S sling, there is no significant difference in patient-reported cure rate and objective cure rate between these two methods. In this paper, we systematically evaluate the relevant data on SIMS-Ajust and TVT-O/TOT and further confirm their safety and effectiveness, providing reliable clinical evidence.
By searching the Medline, Embase, Scopus, and Web of Science databases and the Cochrane Database of Systematic Reviews combined with manual searches, all reports on randomized controlled trials (RCTs) of single-incision mini-sling (SIMS-Ajust) and transobturator tension-free vaginal tape (TVT-O/TOT) surgeries were collected. Using RevMan 5.2 statistical software, the patient-reported cure rate, objective cure rate, operative time, postoperative pain, lower urinary tract injuries, groin pain, postoperative voiding difficulties, de novo urgency and/or worsening of preexisting surgery, vaginal tape erosion, repeated continence surgery, and other related data on both surgical methods were evaluated.
A total of 154 relevant research reports were retrieved, and five randomized controlled trials were included in this study, involving a total of 678 patients. The meta-analysis results show no significant difference in the patient-reported cure rate and objective cure rate between SIMS-Ajust and TVT-O/TOT [RR = 0.95, 95 % CI (0.87 to 1.04), P > 0.05; RR = 0.97, 95 % CI (0.90–1.05), P > 0.05]. With respect to operation time and groin pain, SIMS-Ajust outperforms TVT-O/TOT [MD = −1.61, 95 % CI (−2.48 to 0.74), P < 0.05; RR = 0.30, 95 % CI (0.11 to 0.85), P < 0.05]. In terms of postoperative pain, lower urinary tract injuries, postoperative voiding difficulties, de novo urgency and/or worsening of preexisting surgery, vaginal tape erosion, and repetition of continence surgery, there is no significant difference between SIMS-Ajust and TVT-O/TOT [RR = 0.50, 95 % CI(0.18–1.43), P > 0.05; RR = 2.82, 95 % CI(0.14–57.76), P > 0.05; RR = 0.64, 95 % CI(0.28–1.45), P > 0.05; RR = 1.06, 95 % CI(0.66–1.71), P > 0.05; RR = 1.04, 95 % CI(0.24–4.45), P > 0.05; RR = 1.64, 95 % CI(0.41–6.61), P > 0.05].
SIMS-Ajust is safe and effective in the treatment of female stress urinary incontinence. Compared with TVT-O/TOT surgery, SIMS-Ajust surgery has the same high objective cure rate and patient-reported cure rate and low incidence of perioperative complications, in addition to its short operative time and low incidence of groin pain. Its long-term efficacy needs further observation.
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- Meta-analysis of female stress urinary incontinence treatments with adjustable single-incision mini-slings and transobturator tension-free vaginal tape surgeries
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