Autologous Transobturator Fascia Lata Sling for Female Stress Urinary Incontinence: A Pilot Feasibility and Safety Study

ABSTRACT

Objective

To evaluate the preliminary safety, feasibility, and short‐term outcomes of the autologous transobturator fascia lata sling for female SUI to our knowledge the first series using fascia lata via a transobturator route, in view of the mesh‐related complications of synthetic midurethral slings and the limitations of rectus fascia harvest in women with prior abdominal surgery, central obesity, or scarred fascia.

Methods

Prospective single‐arm pilot feasibility and safety study of 40 women with SUI or stress‐predominant mixed urinary incontinence (MUI) who underwent autologous transobturator fascia lata sling at Al‐Azhar University Hospitals (June 2023 to May 2025; NCT05646745). Outcomes were assessed at 24 h, 2 weeks, and 3 months using the cough stress test, ICIQ‐FLUTS questionnaire, and VAS pain scores.

Results

Mean age was 48.9 ± 7.8 years; BMI 31.4 ± 4.1 kg/m². At 3 months, the overall success rate (cured + improved) was 87.5%, and the objective cure rate (negative cough stress test) was 72.5%. ICIQ‐FLUTS incontinence score decreased from 12.75 ± 3.41 to 3.23 ± 2.91 (p < 0.001, Cohen's d = 2.79); incontinence QOL from 35.88 ± 5.83 to 4.50 ± 7.22 (p < 0.001, d = 5.38). No voiding dysfunction, sling erosion, or major complications occurred. Grade I incontinence achieved 100% success. Thigh and groin pain resolved by 3 months in 92.5% and 100%, respectively.

Conclusion

This preliminary exploratory study suggests that autologous transobturator fascia lata sling is a feasible and promising mesh‐free technique for female SUI with favorable short‐term outcomes at 3 months. These results must be interpreted cautiously given the small sample size, short follow‐up, and absence of a control group. Longer follow‐up, multicenter validation, and randomized comparative studies are warranted.

Trial Registration: ClinicalTrials.gov: NCT05646745

Abbreviations

BMI

body mass index

CI

confidence interval

CS

cesarean section

DM

diabetes mellitus

HTN

hypertension

ICIQ‐FLUTS

International Consultation on Incontinence Questionnaire—Female Lower Urinary Tract Symptoms

IQR

interquartile range

MUI

mixed urinary incontinence

NVD

normal vaginal delivery

PVRU

post‐void residual urine

QOL

quality of life

SD

standard deviation

SUI

stress urinary incontinence

TOT

transobturator tape

UA

urine analysis

UTI

urinary tract infection

VAS

visual analog scale

VD

voiding dysfunction

1. Introduction

Stress urinary incontinence (SUI) is the involuntary leakage of urine on effort, physical exertion, sneezing, or coughing [1]. It is the most prevalent type of urinary incontinence in women, affecting up to 49% of women globally and constituting approximately 50% of all incontinence cases [2]. SUI significantly impacts quality of life, (QOL) social functioning, and psychological well‐being. Synthetic midurethral slings (MUS) have been the most widely adopted surgical treatment for SUI over the past two decades [3]. However, mesh‐related complications—including erosion, chronic pelvic pain, and vaginal extrusion—have raised serious safety concerns. The US FDA issued warnings regarding synthetic mesh for SUI in 2008 and 2011 [4]. In the United Kingdom, vaginal mesh procedures were suspended in 2018. These events have driven renewed interest in autologous tissue alternatives [5]. A recent position statement by the European Urogynaecological Association has further emphasized the need for careful evaluation of implantable devices for female SUI surgery [6].

The primary advantage of autologous material is the elimination of mesh‐related complications. A systematic review and meta‐analysis demonstrated that autologous fascial slings provide continence outcomes similar to synthetic MUS, with significantly lower erosion rates [7]. Several groups have described autologous transobturator slings using rectus fascia, with promising results, combining the benefits of the transobturator route (lower risk of voiding dysfunction) with mesh‐free surgery. More recently, alternative autologous fascial sources have been explored, including the external oblique aponeurosis [8], highlighting the ongoing evolution of mesh‐free surgical options. However, all reported series of autologous transobturator slings have exclusively used rectus fascia. Fascia lata is an alternative graft source with potential advantages: it avoids complications of abdominal incisions (seromas, wound infections, incisional hernias), provides grafts of uniform thickness, and is particularly suitable for patients with prior abdominal surgery, scarred abdominal fascia, or central obesity. Peng et al. compared rectus fascia with fascia lata for retropubic pubovaginal slings and found that fascia lata may decrease perioperative morbidity, especially wound complications, without compromising functional outcomes [9].

To our knowledge, this is the first reported series describing the use of fascia lata via the transobturator approach for the treatment of SUI. We hypothesized that autologous fascia lata, delivered via the transobturator route, would provide comparable short‐term continence outcomes to those reported for rectus fascia transobturator slings, while avoiding abdominal harvest‐site morbidity.

To address this gap, we designed a prospective single‐arm pilot feasibility and safety study at our institution. We aimed to evaluate the preliminary safety, feasibility, and short‐term outcomes of this novel technique.

2. Patients and Methods

2.1. Study Design and Population

This prospective single‐arm pilot feasibility and safety study was conducted at Al‐Azhar University Hospitals between June 2023 and May 2025 (ClinicalTrials.gov: NCT05646745). Ethical approval was obtained from the Institutional Review Board of Al‐Azhar University Faculty of Medicine on April 10, 2023 (IRB No: Urosurg/R/2023/0004), and written informed consent was obtained from all participants. Of 108 women presenting with SUI, 43 met the inclusion criteria; three were lost to follow‐up (two relocated before the 2‐week visit; one withdrew consent for personal reasons), yielding 40 patients for analysis. All 43 patients underwent surgery; the 24‐h postoperative assessments of the three lost patients were unremarkable, with successful voiding and insignificant post‐void residual (PVR) (Figure 1).

FIGURE 1.

Patient flow diagram (CONSORT). CONSORT flow diagram showing patient enrollment, allocation, follow‐up, and analysis. Of 108 women assessed for eligibility, 43 were enrolled and underwent autologous transobturator fascia lata sling surgery. Three patients were lost to follow‐up, yielding 40 patients for final analysis. Follow‐up assessments were performed at 24 h, 2 weeks, and 3 months. At 3 months, 35 patients (87.5%) achieved success (29 cured, 6 improved) and 5 patients (12.5%) had a positive stress test (failed). ICIQ‐FLUTS = International Consultation on Incontinence Questionnaire—Female Lower Urinary Tract Symptoms; UA = urine analysis.

Inclusion criteria: women with genuine SUI or stress‐predominant MUI, refractory to or unwilling to continue conservative management. Exclusion criteria: predominant urge incontinence, complete procidentia, recent pelvic surgery, neurogenic bladder dysfunction, previous anti‐incontinence surgery, pregnancy, less than 12 months postpartum, genitourinary malignancy, and current chemo/radiation therapy. All patients were fresh cases with no prior incontinence surgery.

2.2. Preoperative Assessment

All patients underwent: detailed history, physical examination with cough stress test, pelvic examination for prolapse grading, urinalysis with culture, pelvic ultrasound with PVR measurement, and urodynamic study (uroflowmetry, filling cystometry, and pressure‐flow study). The validated ICIQ‐FLUTS questionnaire was administered preoperatively [10].

2.3. Surgical Technique

Under spinal anesthesia with perioperative antibiotics (ceftriaxone 1 g), the procedure was performed in two stages. Stage 1 (lateral position): a thigh incision was made 4 cm above the knee; a 1 × 5 cm fascial strip was harvested from the fascia lata; the defect was left unsutured; two vicryl‐1 stay sutures were placed at the graft corners. Stage 2 (lithotomy): a midline anterior vaginal wall incision was made at the midurethra; bilateral paravaginal dissection to the obturator foramen was performed; a reusable C‐shaped trocar was passed through each obturator membrane; the fascial sling was positioned at the midurethra and secured with periurethral fixation sutures; tension was adjusted to allow minimal leakage at 300 mL bladder fill. A vaginal pack and Foley catheter were placed (Figure 2).

FIGURE 2.

Intraoperative photographs of the autologous transobturator fascia lata sling procedure. (A) Thigh preparation in lateral position. (B) Fascia lata harvest through lateral thigh incision. (C) Harvested 1 × 5 cm fascial strip. (D) Stay sutures placed at graft corners. (E) Anterior vaginal wall incision and trocar passage. (F) Periurethral sling fixation. Yellow arrows with short labels identify the key structure in each panel: (B) fascia lata exposed within the lateral thigh incision; (C) harvested fascial graft (~5 cm) against the ruler for scale; (D) vicryl‐1 stay suture placed at a graft corner; (E) midurethral vaginal wall incision; (F) sling positioned at the midurethra.

2.4. Follow‐Up and Outcome Measures

The catheter and pack were removed at 24 h. Follow‐up at 2 weeks and 3 months included: cough stress test, ICIQ‐FLUTS, urinalysis, PVR measurement, wound assessment, and VAS pain evaluation. The primary outcome was overall success rate at 3 months, using a composite endpoint of cured plus improved to align with reporting conventions in the autologous transobturator sling literature [7, 8, 9, 10, 11, 12] and facilitate cross‐study comparison. We acknowledge that the improved category incorporates subjective assessment and report the objective cure rate separately as a more conservative efficacy estimate. Outcomes were defined as follows: cured (objective cure)—negative cough stress test; improved—subjective improvement reported by the patient with a persistently positive cough stress test; failed—neither cured nor improved. Throughout this manuscript, “cured” and “objective cure rate” refer to a negative cough stress test (the more conservative endpoint), and “overall success” refers to the composite of cured plus improved. These definitions are applied consistently across the abstract, text, tables, and figure legends. All PVR measurements throughout follow‐up were insignificant.

2.5. Statistical Analysis

Data were analyzed using Python (SciPy v1.12). As this is an early exploratory study describing a novel technique, no formal a priori sample size calculation was performed. Quantitative variables were expressed as mean ± SD. Categorical variables were summarized as frequencies and percentages. Non‐parametric tests were selected given the small sample size and non‐normal distribution of ICIQ‐FLUTS scores: the Wilcoxon signed‐rank test was used for paired comparisons between preoperative and 3‐month ICIQ‐FLUTS scores, and the Friedman test for repeated‐measures analysis across all three time points (preoperative, 2 weeks, 3 months). Fisher's exact test (2 × 2 tables) and the Freeman–Halton extension (2 × 3 tables) were used for subgroup comparisons. Cohen's d was calculated using the preoperative SD as the denominator to estimate effect sizes. Wilson score intervals were used to construct 95% confidence intervals (CIs) for proportions. All tests were two‐tailed; p < 0.05 was considered statistically significant. No correction for multiple comparisons was applied, given the exploratory nature of the subgroup analyses. In addition, exploratory univariable odds ratios (ORs) with 95% CIs were derived for preoperative factors potentially associated with overall success at 3 months (Stamey Grade III vs. I–II, type of incontinence [MUI vs. pure SUI], menopausal status, and BMI category), using the subgroup cell counts and a Haldane–Anscombe continuity correction for zero cells. A multivariable logistic regression model was not fitted because the small number of failures (n = 5) yielded an events‐per‐variable ratio far below the conventional threshold of 10, which would have produced unstable estimates; the univariable ORs are reported as hypothesis‐generating only.

3. Results

3.1. Patient Demographics

The cohort comprised 40 women (mean age 48.9 ± 7.8 years; range 36–65 years). Mean BMI was 31.4 ± 4.1 kg/m² (57.5% obese). Mean parity was 4.05 ± 1.18 (77.5% NVD). Twenty‐two (55%) were pre‐menopausal. Comorbidities included DM (22.5%), HTN (17.5%), cardiac disease (7.5%), hypothyroidism (5%), and hepatic disease (2.5%). Fifteen patients (37.5%) had prior operations including cesarean section (n = 9), hysterectomy (n = 5), and thyroidectomy (n = 1). Nineteen (47.5%) had pure SUI and 21 (52.5%) had stress‐predominant MUI. Stamey grades: I (32.5%), II (45%), and III (22.5%) (Table 1).

TABLE 1.

Baseline demographics and clinical characteristics (N = 40).

Variables	Value (N = 40)
Age (years), mean ± SD (range)	48.9 ± 7.8 (36–65)
BMI (kg/m2), mean ± SD (range)	31.4 ± 4.1 (25–41)
BMI category, n (%)
Overweight (25–29.9)	17 (42.5%)
Obese (≥ 30)	23 (57.5%)
Parity, mean ± SD (range)	4.1 ± 1.2 (2–8)
Menopausal status, n (%)
Pre‐menopausal	22 (55.0%)
Post‐menopausal	18 (45.0%)
Comorbidities, n (%)
Diabetes mellitus	9 (22.5%)
Hypertension	7 (17.5%)
Cardiac disease	3 (7.5%)
Hypothyroidism	2 (5.0%)
Hepatic disease	1 (2.5%)
Prior abdominal/pelvic surgery, n (%)	15 (37.5%)
Cesarean section	9
Hysterectomy	5
Thyroidectomy	1
Type of incontinence, n (%)
Pure SUI	19 (47.5%)
Stress‐predominant MUI	21 (52.5%)
Stamey incontinence grade, n (%)
Grade I	13 (32.5%)
Grade II	18 (45.0%)
Grade III	9 (22.5%)
Operative time (min), mean ± SD (range)	70.8 ± 12.7 (60–90)
Catheter removal	24 h (all patients)

Abbreviations: BMI = body mass index, CS = cesarean section, MUI = mixed urinary incontinence, NVD = normal vaginal delivery, SD = standard deviation, SUI = stress urinary incontinence.

3.2. Surgical Outcomes

No major intraoperative complications occurred. Vaginal mucosal tears occurred in 6 cases (15%), all within the first 15 cases (learning curve), with no tears in the subsequent 25 cases; all were repaired intraoperatively without sequelae. This learning‐curve effect has important implications for technique reproducibility and external adoption: surgeons adopting this procedure should anticipate a learning curve of approximately 10–15 cases, and we recommend beginning with Grade I–II cases before progressing to more complex patients. Mean operative time was 70.8 ± 12.7 min (Table S1). At 2 weeks, 24 patients (60%) were cured, 9 (22.5%) improved, and 7 (17.5%) failed (overall success 82.5%). At 3 months, 29 (72.5%) were cured, 6 (15%) improved, and 5 (12.5%) failed, for an overall success rate of 87.5% [95% CI: 74.3%–94.8%]. The objective cure rate (negative cough stress test, “cured” only) was 72.5% at 3 months (Figure 3) (Table 2).

FIGURE 3.

Surgical outcomes at 2 weeks and 3 months (N = 40). Stacked bar chart showing surgical outcomes at 2 weeks and 3 months postoperatively. (A) At 2 weeks, 24 patients (60.0%) were cured, 9 (22.5%) improved, and 7 (17.5%) failed, for an overall success rate of 82.5%. (B) At 3 months, 29 patients (72.5%) were cured, 6 (15.0%) improved, and 5 (12.5%) failed, yielding an overall success rate of 87.5% (95% CI: 74.3%–94.8%). Success was defined as negative cough stress test (cured) or subjective improvement (improved). Success = cured + improved. CI = confidence interval.

TABLE 2.

Surgical outcomes at 2 weeks and 3 months (N = 40).

Outcome	2 Weeks	3 Months
Cured (negative stress test), n (%)	24 (60.0%)	29 (72.5%)
Improved, n (%)	9 (22.5%)	6 (15.0%)
Failed, n (%)	7 (17.5%)	5 (12.5%)
Overall success rate, n (%)	33 (82.5%)	35 (87.5%)
95% CI for success rate	68.1%–91.3%	74.3%–94.8%

Note: Success = cured + improved. Cured = negative cough stress test. Improved = subjective improvement with positive stress test. Wilson score method used for 95% CI.

Abbreviation: CI = confidence interval.

3.3. ICIQ‐FLUTS Outcomes

Significant improvements were observed across all clinically relevant ICIQ‐FLUTS domains (Table 3). The filling score decreased from 8.45 ± 2.23 to 3.75 ± 2.08 (55.6% reduction, p < 0.001, Cohen's d = 2.11). The incontinence score decreased from 12.75 ± 3.41 to 3.23 ± 2.91 (74.7% reduction, p < 0.001, d = 2.79). Incontinence QOL improved from 35.88 ± 5.83 to 4.50 ± 7.22 (87.5% reduction, p < 0.001, d = 5.38). Voiding scores remained near‐zero throughout (voiding: 0.15 ± 0.48 to 0.03 ± 0.16, p = 0.129), confirming zero voiding dysfunction (Table 3, Figure 4; Figure S2).

TABLE 3.

ICIQ‐FLUTS domain scores: preoperative versus postoperative (N = 40).

Domain	Preop	2 Weeks	3 Months	d	Δ%	pᵂ	pᶠ	Interpreted
Filling	8.45 ± 2.23	4.72 ± 2.32	3.75 ± 2.08	2.11	55.6	< 0.001	< 0.001	Large
Fill QOL	18.77 ± 4.62	6.95 ± 5.76	3.58 ± 4.07	3.29	81.0	< 0.001	< 0.001	Huge
Voiding	0.15 ± 0.48	0.10 ± 0.38	0.03 ± 0.16	0.26	83.3	0.129	0.321	NS
Void QOL	0.23 ± 0.70	0.20 ± 0.76	0.05 ± 0.32	0.25	77.8	0.157	0.368	NS
Incont.	12.75 ± 3.41	4.65 ± 3.03	3.23 ± 2.91	2.79	74.7	< 0.001	< 0.001	Huge
Inc QOL	35.88 ± 5.83	9.55 ± 8.72	4.50 ± 7.22	5.38	87.5	< 0.001	< 0.001	Huge

Note: Values are mean ± SD.

Abbreviations: Δ% = percentage reduction from pre‐operative, d = Cohen's d (preop SD as denominator), NS = not significant, pᶠ = Friedman test across all three timepoints, pᵂ = Wilcoxon signed‐rank test (preop vs. 3 months), QOL = quality of life.

FIGURE 4.

ICIQ‐FLUTS scores: preoperative versus postoperative (N = 40). Box‐and‐whisker plots showing ICIQ‐FLUTS domain scores at preoperative, 2‐week, and 3‐month timepoints for (A) filling symptoms, (B) filling QOL impact, (C) incontinence symptoms, and (D) incontinence QOL impact. Boxes represent interquartile range (IQR); horizontal lines indicate medians; diamond markers (◇) indicate means; whiskers extend to 1.5 × IQR. Mean values are displayed above each box. Significance brackets show Wilcoxon signed‐rank test p values (preoperative vs. 3 months). Cohen's d effect sizes and percentage reductions are shown in green badges. All four domains demonstrated statistically significant improvement (p < 0.001) with large to huge effect sizes (d = 2.11–5.38). Outliers hidden for clarity. d = Cohen's d effect size; QOL = quality of life.

3.4. Complications and Safety

All complications were Clavien–Dindo Grade I. At 2 weeks, urinalysis‐detected bacteriuria/UTI was present in 18 patients (45%); of these, 7 (17.5% of the cohort) were symptomatic (dysuria, frequency, or suprapubic discomfort) and 11 (27.5%) represented asymptomatic bacteriuria identified on routine urinalysis. All received culture‐guided antibiotics. At 3 months, 10 patients (25%) had positive urinalysis, of whom 3 (7.5%) were symptomatic. Vaginal discharge was noted in 16 (40%) at 2 weeks and 9 (22.5%) at 3 months, with no sling exposure or erosion on examination. Thigh wound infection occurred in 2 (5%) at 2 weeks, managed conservatively, with complete resolution by 3 months. No sling erosion, vaginal extrusion, voiding dysfunction, or urinary retention occurred at any timepoint; however, the short follow‐up period limits conclusions about delayed graft‐related morbidity (Table S2 and Figure S3).

3.5. Pain Trajectory

At 24 h, severe thigh pain was present in 31 patients (77.5%) and severe groin pain in 27 (67.5%). Pain decreased substantially by 2 weeks. By 3 months, 37 patients (92.5%) reported no thigh pain, and all 40 (100%) reported no groin pain (Figure S1).

3.6. Subgroup Analysis

Success rates by complaint type: pure SUI 94.7% versus MUI 81.0% (Fisher's p = 0.345). By menopausal status: pre‐menopausal 90.9% versus post‐menopausal 83.3% (p = 0.642). By Stamey grade: Grade I 100%, Grade II 88.9%, and Grade III 66.7% (Grade I–II vs. III: p = 0.065). By BMI: overweight 88.2% versus obese 87.0% (p = 1.000). The exploratory grade‐stratified analysis suggested a possible trend toward lower success with increasing severity, though this did not reach statistical significance and should be interpreted with caution given very small subgroup sizes (n = 9–18) (Figure 5; Table S3, Figure S4).

FIGURE 5.

Subgroup analysis of success rates at 3 months with 95% Wilson CIs. Forest plot displaying success rates with 95% Wilson confidence intervals for pre‐specified subgroups at 3 months. Subgroups include incontinence type (pure SUI vs. stress‐predominant MUI), menopausal status (pre‐ vs post‐menopausal), Stamey incontinence grade (I–III), and BMI category (overweight vs. obese). Grade I incontinence achieved 100% success (13/13). The overall success rate (87.5%, red dashed line) serves as the reference. No subgroup comparisons were statistically significant at α = 0.05, though a trend was observed for Stamey grade (p = 0.065). The corrected Grade II success rate is 88.9% (16/18). p values: Fisher's exact test (2 × 2) or Freeman–Halton test (2 × 3). BMI = body mass index, CI = confidence interval, MUI = mixed urinary incontinence, SUI = stress urinary incontinence.

Univariable ORs for failure of overall success at 3 months, derived from the subgroup cell counts with Haldane–Anscombe continuity correction for zero cells, were as follows: Stamey Grade III versus I–II, OR 7.25 (95% CI 0.99–53.22; Fisher's exact p = 0.065); MUI versus pure SUI, OR 4.24 (95% CI 0.43–41.80; p = 0.345); post‐menopausal versus pre‐menopausal status, OR 2.00 (95% CI 0.30–13.51; p = 0.642); and obese versus overweight BMI category, OR 1.12 (95% CI 0.17–7.60; p = 1.000). Higher Stamey grade emerged as the strongest candidate predictor of failure in this exploratory analysis, but all CIs are very wide and cross unity, and only five failures occurred in total. These results should therefore be regarded as hypothesis‐generating only and require external validation in larger cohorts (Table S5).

4. Discussion

This early exploratory study presents the first reported series of autologous transobturator fascia lata sling for female SUI, with preliminary results showing an overall success rate of 87.5% (72.5% objective cure) at 3 months. These findings extend the autologous transobturator approach beyond the rectus fascia source used in all previously reported series [12, 13, 14, 15, 16]. The use of fascia lata in the transobturator approach represents a novel contribution to this evolving field.

The rationale for fascia lata is supported by our cohort characteristics. In our cohort—57.5% obese, 37.5% with prior abdominal surgery, including 12.5% with prior hysterectomy—the abdominal wall may be compromised for fascial harvest. The autologous fascia lata transobturator sling may be particularly suitable for specific patient subsets: women with prior abdominal surgery in whom rectus fascia access may be compromised by adhesions; patients with central obesity where abdominal fascial harvest carries higher wound morbidity; patients with scarred or attenuated abdominal fascia after multiple cesarean sections; and settings where synthetic mesh is unavailable, unaffordable, or declined by the patient. Conversely, patients with lower limb vascular disease, prior thigh surgery, or connective tissue disorders may not be ideal candidates for fascia lata harvest. Similarly, Liapis et al. recently described the use of external oblique muscle aponeurosis as an alternative autologous fascial source for pubovaginal slings when rectus fascia is unsuitable [8]. Peng et al. [9] compared rectus fascia with fascia lata for pubovaginal slings and found fascia lata decreased perioperative morbidity, especially wound complications (0% vs. 14.3%), without compromising functional outcomes. Johnson et al. [11] reported that less than 25% of patients experienced lasting harvest‐site symptoms after fascia lata collection. The postoperative UTI rate (45% at 2 weeks, 25% at 3 months) warrants discussion. Several contributing factors may explain this finding: all patients received single‐dose perioperative ceftriaxone, which may be insufficient given the two‐stage procedure involving vaginal dissection and 24‐h Foley catheterization; the cohort characteristics (high parity, mean 4.1; 52.5% with stress‐predominant MUI; 45% postmenopausal) are established UTI risk factors; and our definition included asymptomatic bacteriuria detected on routine urinalysis, which may overestimate clinically significant UTI. Comparable rates (30%–45%) have been reported in similar sling series. Future studies should evaluate extended antibiotic prophylaxis protocols. The vaginal discharge rate (40% at 2 weeks, 22.5% at 3 months) also deserves attention; while no sling exposure or erosion was identified on examination, these patients require ongoing monitoring.

Our 87.5% success rate is consistent with the literature. Vasudeva et al. [12] reported 100% negative stress test at 12 months using rectus fascia (n = 30). Çubuk et al. [13] achieved complete dryness at 6 months in a single‐case report. Laufer et al. [14] demonstrated symptomatic improvement in 17/18 patients at 9 months median follow‐up. Dogan [15] compared autologous rectus fascia and synthetic TOT in 62 patients with similar efficacy. Mourad et al. [16] found comparable success rates between autologous and synthetic slings at 6 months. A recent meta‐analysis by Güler [7] confirmed equivalent continence rates between autologous fascial and synthetic slings. Similarly, Mangir et al. [17] conducted a systematic review and meta‐analysis comparing autologous mid‐urethral fascial slings with retropubic synthetic slings and found comparable cure rates, though autologous slings were associated with longer operative times. Recent studies continue to support these findings; Zargham et al. compared autologous rectus fascia with PVDF tape slings and reported comparable mid‐term continence outcomes with at least 3 years of follow‐up [18]. Luo et al. demonstrated the efficacy of autologous fascial pubovaginal slings for recurrent SUI after failed MUS procedures [19] (Tables 4 and S4).

TABLE 4.

Comparison of the present study with published autologous transobturator and fascia lata sling series.

Study (year)	N	Graft	Approach	Follow‐up	Outcome reported
Present study	40	Fascia lata	Transobturator	3 months	Overall success 87.5% (objective cure 72.5%)
Vasudeva et al. (2021) [12]	30	Rectus fascia	Transobturator	3 and 12 months	100% negative cough stress test at 12 months
Çubuk et al. (2019) [13]	1 (case report)	Rectus fascia	Transobturator	3 and 6 months	Totally dry at last follow‐up
Laufer et al. (2019) [14]	18	Rectus fascia	Transobturator	Median 9 months (range 6–15)	Symptomatic improvement in 17/18 (94.4%)
Dogan (2022) [15]	31 vs. 31 synthetic	Rectus fascia	Transobturator	Not reported in abstract	UDI‐6 and IIQ‐7 comparable to synthetic TOT
Mourad et al. (2018) [16]	62 vs. 64 synthetic	Rectus fascia (sheath)	Pubovaginal	1 and 6 months	Success rate and QoL comparable to synthetic
Linder and Elliott (2015) [20]	10 (feasibility)	Rectus fascia	Transobturator	Short‐term	Feasibility demonstrated; ICIQ‐FLUTS and 24‐h pad test
Peng et al. (2020) [9]	21 FL / 84 RF	Fascia lata vs. rectus fascia	Retropubic pubovaginal	Latest available	Continence at latest follow‐up: FL 66.7% vs. RF 65.8% (p = 0.87)

Note: Outcome metrics, follow‐up timing, and definitions of success vary across studies; this table is intended for descriptive comparison only and is not a head‐to‐head efficacy comparison. Data extracted from the abstracts/full texts of each cited study; where a parameter was not specified in the published abstract this is indicated.

Abbreviations: FL = fascia lata, IIQ‐7 = Incontinence Impact Questionnaire short form, RF = rectus fascia, TOT = transobturator tape, UDI‐6 = Urogenital Distress Inventory short form.

A key finding is the complete absence of voiding dysfunction, confirmed by preserved ICIQ‐FLUTS voiding scores (0.15 ± 0.48 to 0.03 ± 0.16, p = 0.129) and consistently insignificant PVR. This contrasts with some rectus fascia series reporting 6.4%–6.7% voiding dysfunction rates [12, 15]. The transobturator route is known to reduce voiding dysfunction risk compared to retropubic approaches, and recent evidence by Bortolini et al. has explored sling adjustment techniques to further minimize retention risk [3, 21]. Long‐term data from Lin et al. [22] further support the durability and safety of the transobturator approach, with favorable outcomes over a 12‐year follow‐up period.

The ICIQ‐FLUTS analysis demonstrated large effect sizes (Cohen's d = 2.11–5.38) across all clinically relevant domains. The incontinence QOL domain showed d = 5.38 (87.5% reduction); however, this magnitude is unusually large and almost certainly inflated by the characteristics of this dataset rather than reflecting a true effect of that size. Three factors contribute to apparent inflation: (i) the small uncontrolled cohort (N = 40), which produces wide CIs on standardized effect estimates; (ii) the use of the preoperative SD as the denominator, which is conservative in absolute terms but mathematically magnifies d when post‐operative scores collapse toward zero; and (iii) floor effects in the post‐operative incontinence QOL scores (mean 4.50, SD 7.22), which compress the post‐treatment distribution. The directional finding—clinically meaningful improvement consistent with prior autologous sling series—is supported, but the precise numerical value of d should not be over‐interpreted, and external validation in larger controlled samples is required.

The early postoperative pain pattern is unique to fascia lata harvest. At 24 h, 77.5% experienced severe thigh pain—more than reported with suprapubic rectus fascia harvest. However, resolution was complete, with 92.5% having no thigh pain and 100% no groin pain by 3 months. This trajectory should be discussed during informed consent. Johnson et al. [11] similarly reported thigh symptoms after fascia lata harvest, with the majority resolving.

The operative time (70.8 ± 12.7 min) was longer than most rectus fascia series (41.7–57.3 min) [12, 13, 14, 15, 16], attributable to position changes and the learning curve. A post hoc comparison of the first 15 versus the subsequent 25 cases supports a learning‐curve effect: mean operative time was 81.3 ± 11.9 min in the first 15 cases versus 64.5 ± 8.4 min in the subsequent 25 cases, vaginal mucosal tears occurred in 6/15 (40%) of the first 15 cases versus 0/25 (0%) thereafter, and the rate of symptomatic UTI was numerically lower in the second group. Although these subset comparisons are exploratory and underpowered, they suggest that operative efficiency and intraoperative morbidity improve appreciably after approximately 10–15 cases, consistent with the learning‐curve trajectory described for other autologous sling techniques.

4.1. Limitations

Several important limitations warrant acknowledgment. No formal a priori sample size calculation was performed; the cohort of 40 patients provides sufficient data for preliminary feasibility assessment but limits statistical power, and the subgroup analyses should be considered strictly exploratory and hypothesis‐generating. The 3‐month follow‐up represents the most significant limitation of this study; for anti‐incontinence procedures, durability is a critical outcome that cannot be assessed within this timeframe. Longer‐term data are needed, as other series have reported sustained results at 12–18 months [12, 13]. The single‐arm design precludes direct comparison with rectus fascia or synthetic slings. The learning curve may have influenced early complications and operative times. A single‐center setting limits generalizability.

5. Conclusion

In this small pilot cohort, autologous transobturator fascia lata sling appeared feasible and was associated with favorable short‐term continence outcomes at 3 months (87.5% overall success, 72.5% objective cure) without voiding dysfunction or sling erosion. Fascia lata provides a potentially viable alternative graft source, particularly for patients in whom abdominal fascia harvest may be challenging. These findings should be interpreted with caution given the short 3‐month follow‐up, small single‐center sample, single‐arm exploratory design, and absence of a comparator; durability, recurrence, and rare adverse events cannot be assessed within this timeframe. No definitive conclusions about the relative efficacy or safety of this technique can be drawn from the present data. Longer‐term follow‐up, multicenter replication, and randomized comparative trials against rectus fascia and synthetic midurethral slings are required before any recommendation regarding clinical adoption.

Author Contributions

A.A.H. conceived the study, performed the surgical procedures, collected data, performed statistical analysis, and drafted the manuscript. H.K.M.K. supervised the study design and critically revised the manuscript. A.M.A.H. assisted with data collection and follow‐up assessments. M.F.A.S. assisted with surgical procedures and reviewed the manuscript. All authors read and approved the final manuscript.

Funding

The authors have nothing to report.

Ethics Statement

This study was approved by the Institutional Review Board (IRB) of the Faculty of Medicine, Al‐Azhar University, Cairo, Egypt on April 10, 2023 (IRB No: Urosurg/R/2023/0004). The study was conducted in accordance with the Declaration of Helsinki.

Consent

Written informed consent was obtained from all participants before enrollment.

Conflicts of Interest

The authors declare no conflicts of interest.

Supporting information

Table S1: Perioperative data.

Table S2: Complications (Clavien–Dindo classification).

Table S3: Subgroup analysis at 3 months.

Table S4: Exploratory univariable odds ratios for failure of overall success at 3 months.

Figure S1: Pain trajectory from 24 h to 3 months.

Figure S2: ICIQ‐FLUTS domain scores (all six domains).

Figure S3: Objective cure and complication rates.

Figure S4: Outcomes by incontinence grade.

Data Availability Statement

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.