Introduction

Stress urinary incontinence (SUI) is a common problem that occurs in women who complain of involuntary urine release during physical activity, coughing, or sneezing. Such patients report a significant reduction in quality of life and health [1]. This disease is treated by a wide range of therapy options, including physical therapy, pessaries, urethral bulking injections, and surgery. The surgical treatments are represented by various types of interventions such as Burch colposuspension, pubovaginal sling, synthetic midurethral slings (SMUS), and single-incision mini-slings [2]. Midurethral slings are currently considered the standard and preferred surgical treatment for SUI in women.

Synthetic midurethral slings are presented with retropubic and transobturator approaches and demonstrate comparable efficacy [3]. However, synthetic slings are a controversial issue regarding the safety of these methods. There are known court actions in the UK, USA, Australia, Canada, and some European countries against the use of slings and tapes [4, 5]. In this regard, in recent years, there has been renewed interest in the use of autologous pubovaginal or fascial sling as an alternative surgical option for SUI treatment [6].

Autologous fascial sling (AFS) is one of the longest used methods of surgical treatment of SUI. In this method, lata fascia or rectus fascia is used to create support for the urethra and the neck of the bladder [7]. The advantages of AFS include the low incidence of adverse effects such as vaginal erosions, infections, and urethral injury associated with the use of synthetic mesh. AFS can be used to manage patients in situations where a synthetic mesh sling is contraindicated, such as prior pelvic radiation therapy and repair of urethrovaginal fistulas [8]. In the international literature, pubovaginal fascial sling has been shown to be a safe and effective procedure for patients with SUI, adequately correcting both urethral hypermobility and intrinsic sphincter insufficiency [9]. The aim of this study is to evaluate the efficacy and safety of AFS compared with other surgical methods for the female SUI treatment.

Materials and Methods

This systematic review included all published scientific articles that evaluated the effectiveness of slings in comparison with other surgical methods used to treat patients with SUI. The primary purpose was to evaluate the effectiveness of achieving better continence and quality of life for women with diagnosed SUI. Efficacy was assessed based on the cure rate (objectively and subjectively, including pad test, cough test, and patient satisfaction). Secondary outcome was to assess the safety and intervention complications.

The systematic review was conducted in accordance with the Population, Intervention, Comparison, and Outcome framework and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 checklist [10]. The systematic review registration number Prospective Register of Systematic Reviews 2023 CRD42023412868 was obtained from the PROSPERO international prospective register of systematic reviews by the National Institute for Health Research [11]. The approval of the institutional review board was not requested, as this study is a review of published studies. Relevant trials were identified through searches in PubMed, Cochrane Library, and MEDLINE databases up to September 2023 using key words: “autologous,” “incontinence.”

An electronic search of the above databases was independently conducted by the two researchers. All articles were screened following the search based on their titles and abstracts. The full texts of the studies that seemed to be appropriate according to their titles and abstracts were then reviewed. To identify additional potential studies, the reference lists of eligible trials were also manually searched. The eligibility of the articles based on the presence of inclusion criteria was verified by two investigators independently reading the full text of the preselected articles. Studies with duplicate datasets were excluded. All disagreements regarding the inclusion or exclusion of a preselected study as well as other disagreements during the review process were resolved by a third author. Studies were collected independently using a standardized data extraction procedure (authors, year of publication, study design, patient characteristics, intervention, and results).

Only randomized controlled trials (RCTs) including a minimum of 10 adult women with clinically confirmed SUI were considered for inclusion in the systematic review. Studies involving patients with other urinary incontinence types, combined pharmacological treatment, and articles with pregnant and lactating patients, were excluded. The data were pooled in a meta-analysis using RevMan (Review Manager version 5.4, The Cochrane Collaboration, 2011). Two investigators independently assessed the quality of the selected studies using risk-of-bias assessment based on the Cochrane Handbook for Systematic Reviews of Interventions, and the third investigator was consulted when disagreements occurred [12]. TheRoB2tool was used to assess the risk of bias in randomized controlled studies following the Cochrane Handbook for Systematic Reviews of Interventions [13].

Results

The electronic search of PubMed, Cochrane Library, and MEDLINE databases retrieved 877 articles (Fig. 1). After the removal of duplicates and the search for the title and abstract of the articles, 41 publications were selected. After reading the full-text articles, 21 of them were excluded. Four of these studies were reviews and 17 articles were not eligible owing to noncompliance with the inclusion criteria. These studies included 10 articles without comparison or inappropriate patients and interventions, 6 articles were not RCTs, 1 article was a case report [14], and 1 article was a cost-effectiveness article [15]. The references of the selected articles were checked for acceptable studies (n = 350). Twenty-five publications matched the title, but 23 were duplicates and 2 were excluded owing to noncompliance with the inclusion criteria. In conclusion, 20 randomized clinical trials were included in the systematic review and 10 in the meta-analysis (Table 1).

Fig. 1
figure 1

Flow diagram

Full size image
Table 1 Description of the randomized controlled trials included in the systematic review
Full size table

The study by Sharifiaghdas et al. [16] compared AFS and a mid-urethral minisling (Ophira). Based on a cough-induced stress test, the rectus facia sling group had an objective cure rate of 89.2%, whereas the minisling group had an objective cure rate of 88.6% (p = 1.0). The postoperative mean IIQ-7 score decreased to 42.7 ± 11.4 and 50.2 ± 11.1 in the minisling group.

Fifteen studies compared AFS with SMUS [17,18,19,20,21,22,23,24,25,26,27,28,29,30,31]. The follow-up duration ranged from 1 week to 10 years among the studies. Two of them additionally provide a comparison with porcine dermis (Pelvicol) [20, 21].

Five studies compared AFS with Burch colposuspension. Bai et al. [31] included a comparison of AFS, colposuspension and tension-free vaginal tape (TVT). Initially, the cure rates showed no statistically significant changes. After 12 months, the pubovaginal sling procedure was found to be significantly more efficient than the tension-free vaginal tape or Burch colposuspension surgeries.

The first meta-analysis assessed a cure rate after operation of between AFS and standard midurethral slings in 8 studies with 522 patients. There was no statistically significant difference between the two methods (RR = 0.97, 95% CI: 0.92 to 1.03, p = 0.32, I2 = 0%; Fig. 2A).

Fig. 2
figure 2

Meta-analyses. A Cure rate in autologous fascial slings (AFS) vs. synthetic midurethral slings (SMUS). B Urinary retention in AFS vs. SMUS. C Self-catheterization in AFS vs. SMUS D Long-term postoperative complications in AFS vs. SMUS. E AFS vs. SMUS in de novo urgency

Full size image

The second meta-analysis including 7 studies with 412 participants compared the frequency of urinary retention in AFS and SMUS. There was no statistically significant difference (RR = 1.44, 95% CI: 0.72 to 2.90, p = 0.30, I2 = 0%; Fig. 2B).

The frequency of self-catheterization for AFS compared with SMUS was assessed in the third meta-analysis. Four studies with 402 patients were included. There was no statistically significant difference (RR = 2.15, 95% CI: 0.83 to 5.59, p = 0.12, I2 = 0%; Fig. 2C).

The fourth meta-analysis including 4 studies that evaluated 292 patients compared long-term postoperative complications in AFS and SMUS (RR = 0.12, 95% CI: 0.03 to 0.50, p = 0.004, I2 = 0%). There was a statistically significant difference: SMUS showed more long-term postoperative complications (Fig. 2D).

The next meta-analysis compared AFS and SMUS in de novo urgency and included 5 studies with 398 patients. There was a statistically significant difference: AFS showed more de novo urgency cases (RR = 2.84, 95% CI: 1.13 to 7.10, p = 0.03, I2 = 0%; Fig. 2E).

The sixth meta-analysis assessed the operation time of AFS compared with SMUS, including 7 studies with 427 patients. The operation time of SMUS was lower and there was a statistically significant difference (RR = 2.87, 95% CI: 2.56 to 3.19, p < 0.00001, I2 = 97%; Fig. 3A).

Fig. 3
figure 3

Meta-analyses. A Operation time of autologous fascial slings (AFS) versus synthetic midurethral slings (SMUS). B Hospital stay duration in AFS vs. SMUS

Full size image

The seventh meta-analysis was aimed at comparing AFS and SMUS with regard to hospital stay duration. It included 2 studies assessing 110 patients. There was a statistically significant difference: SMUS showed a shorter hospital stay duration (RR = 1.92, 95% CI: 1.44 to 2.41, p < 0.00001, I2 = 96%; Fig. 3B).

The risk of bias in each of the included studies was independently evaluated by two reviewers in accordance with the Cochrane Handbook using RoB2.0 for randomized controlled trials. All disagreements were resolved by a third author. The visualization tools were created using the ROBVIS application [32]. This application generated “traffic light” plots of the domain-level judgments for each result and weighted bar plots of the distribution of risk-of-bias judgments within each bias domain. Based on RoB instrument 2 for randomized trials (Figs. 4 and 5) two trials showed a high risk of bias, 10 trials showed some concerns, and 8 trials showed a low risk of bias.

Fig. 4
figure 4

RoB2.0 tool for randomized controlled trials (traffic light plot)

Full size image
Fig. 5
figure 5

RoB2.0 tool for randomized controlled trials (summary plot)

Full size image

Discussion

This systematic review and meta-analysis was conducted to evaluate the efficacy and safety of AFS compared with other surgical treatments for female SUI. All available information from the 20 included RCTs were analyzed and summarized. According to the results of this study, the effectiveness of AFS and SMUS was similar. AFS showed a lower incidence of long-term postoperative complications. Despite the statistical significance, it is excessively low. SMUS demonstrated shorter operation time, shorter hospital stay, and lower de novo urgency.

According to International Continence Society Standards 2023, the development of voiding dysfunction is the most common complication of AFS [33]. Athanasopoulos et al. [34] performed a retrospective analysis of 264 patients who underwent AFS surgery. The authors reported a de novo urgency rate of 49 (18.5%) patients, whereas 224 patients (85%) reported significant improvement. In a systematic review and meta-analysis in 2017, Fusco et al. [2] evaluated SMUS and other surgical treatments for SUI. The efficacy in objective cure rate of SMUS and AFS was similar but showed superiority over Burch colposuspension. In another systematic review and meta-analysis by Schimpf et al. [35], AFS showed lower rates of wound infection, bowel injury and bladder or vaginal perforation compared with Burch’s colposuspension. In a 2020 prospective study [36] the autologous transobturator tape showed similar objective and subjective cure rates and overall complication rates, as well as better outcomes for postoperative voiding dysfunction and de novo filling phase symptoms compared with the standard transobutrator tape.

A prospective cohort study by Parker et al. [37] reported results of AFS surgery in 229 patients with primary AFS and in 59 patients with primary SMUS. Of 59 patients, 34 had a failed sling with recurrent SUI, 20 had sling extrusion, and 5 patients suffered from obstruction requiring sling lysis or excision. At a median follow-up of 14 months, prior MUS placement was not associated with a significant difference in objective (55.9% vs 62.4%, p = 0.37) or subjective cure (66.1% vs 69.0%, p = 0.75) compared with patients undergoing placement of an initial AFS. Patients undergoing AFS after prior SMUS did have a significantly higher rate of urinary retention requiring intermittent catheterization (8.5% vs 3.1%, p < 0.001) and re-operation (13.6% vs 3.5%, p = 0.01) for persistent incontinence.

Furthermore, a randomized controlled trial by Maher et al. [38] was not included in the systematic review but is worth considering in the context of the question of the effectiveness of AFS. Autologous pubovaginal sling and transurethral bulking Macroplastique were compared in the treatment of female SUI and intrinsic sphincter deficiency. At 62 months’ follow-up, the response rate was 60% in both groups, with the sling group reporting better continence success (69% vs 21%) and satisfaction rates (69% vs 29%, p = 0.057).

The AFS is considered a reasonable primary treatment option for uncomplicated SUI in women. This surgical intervention can be used following the removal of a synthetic MUS. Moreover, given the current status of slings in some countries and possible contraindications to the use of synthetic slings, AFS has emerged as an option in the treatment of SUI.

The limitations of this systematic review and meta-analysis include a small sample size and low quality of some old studies. At the same time, there is a limited amount of research conducted with a high-quality rate. The short follow-up duration is also noteworthy in some studies. In addition, studies with a high risk of bias (critical or high risk of bias) were included. In some articles and in the primary outcome there was no clear division of the cure rate into objective and subjective, which would have been more informative. Owing to different outcomes and follow-up periods, it was not possible to conduct a quantitative synthesis comparing AFS and Burch colposuspension. Moreover, 4 studies were the same trial (SISTER trial) [39,40,41,42]. Concerning implications for future research, more well-conducted prospective and randomized trials with long-term follow-up and large sample size are required to assess the advantages and disadvantages of autologous slings in female SUI management. In order to ensure the objectiveness of the results, studies should have common standardized measures for continence surgery.

Conclusion

In this systematic review and meta-analysis, autologous slings demonstrated the same efficacy in comparison with SMUS in the management of SUI in women. AFS showed lower incidence of long-term postoperative complications. SMUS demonstrated lower operation time, hospital stay and de novo urgency. However, more well conducted studies with long-term follow-up and standard outcome measures will be useful in the further study of this issue and the surgical method choice for the female SUI treatment.