Enhancing the autologous fascial sling procedure: A novel fixation method for treating stress urinary incontinence in female patients

Abstract

Background:

Synthetic mid-urethral sling surgery has long been the standard surgical treatment for stress urinary incontinence (SUI) worldwide. Using an autologous fascial sling is an alternative to reduce adverse events. We evaluated the treatment outcomes of a novel fixation method applied to the autologous transobturator fascial (TOF) sling procedure for female patients with SUI.

Methods:

A retrospective study was conducted between 2017 and 2020, including 33 patients with SUI who underwent mid-urethral TOF sling surgery with the novel fixation method. We used a self-locking feature (V-LOC™) that was fixed to each side of skin layer above the obturator foramen, and the tension of the fascia sling was adjusted by manipulating the V-LOC™ suture. We analyzed all data collected through questionnaires, including Urinary Distress Inventory-Short Form (UDI-6), Incontinence Impact Questionnaire-Short Form (IIQ-7), Overactive Bladder Symptom Score (OABSS), and Clinical Global Impressions of Improvement (CGI-I). Adverse events were also recorded.

Results:

This study included 33 female patients aged 39 to 79 (mean 59.76 years). Following the procedure, there was a significant reduction in the total scores of UDI-6, IIQ-7, and OABSS (preoperative 9.73 ± 4.35, 10.21 ± 5.79, 6.06 ± 4.03 and postoperative 3.52 ± 3.41, 0.85 ± 3.67, 3.06 ± 2.90, respectively) (p < 0.001). Further analysis of each sub-score of the questionnaires revealed significant improvement in certain symptoms. The mean total score of CGI-I was 2.00 ± 0.80. The maximum flow rate was documented for 18 patients, and no significant reduction was observed after the procedure (p = 0.804). Complications reported included voiding dysfunction in two patients (6.1%), inguinal pain in one patient (3.0%), and mild delayed wound healing in one patient (3.0%).

Conclusion:

This modified TOF sling surgery with a novel fixation method by V-LOC™ suture offers feasibility and adjustability as its main advantages. Our study demonstrated significant improvements in patient outcomes.

1. INTRODUCTION

The International Continence Society (ICS) defines the symptom of stress urinary incontinence (SUI) as “the complaint of any involuntary loss of urine on effort or physical exertion including sporting activities, or on sneezing or coughing.”¹ Previous research has identified overweight and obesity as risk factors for SUI among women in middle and old age.² Healthcare professionals typically evaluate the severity of incontinence by considering both the frequency and volume of urine leakage. The level of distress experienced by the individual plays a crucial role in guiding treatment decisions.³ Surgical intervention is often chosen for SUI patients who do not respond well to conservative treatments. Among the various available choices for SUI treatment, synthetic mid-urethral slings (MUS) are the most commonly used as the primary surgical option.^4,5 While synthetic MUS surgery has demonstrated favorable effectiveness, it has also raised concerns globally due to potential postoperative complications such as pain, mesh exposure, and urinary tract infections.^6,7 An alternative approach to consider is autologous fascial sling surgery, which eliminates complications associated with mesh materials. This procedure involves utilizing rectus fascia or fascia lata grafts, using various techniques such as pubovaginal or transobturator approaches.⁸ A previous cohort study demonstrated the safety and feasibility of autologous transobturator fascial (TOF) sling surgery with promising short-term outcomes. However, there is still limited data available on the long-term results of this approach.^9,10

In contrast, modifications to the TOF sling surgery that incorporate enhanced tools or techniques can potentially enhance outcomes for patients with SUI. Traditionally, the procedure for the fixation of an autologous fascial sling involved passing strings twice through each side of the bilateral external obturator foramen to create a bridge between them at the end of the autologous sling and fixing it at the level of the aponeurotic muscle plane. After adjusting the sling tension, the autologous fascia sling was sutured with periurethral tissue.¹⁰ In our current study, we modified the TOF sling surgery by incorporating self-locking sutures (V-LOC™) to minimize the size of the external wound over the bilateral inguinal area. Our clinical experience suggested that patients who underwent this modified surgical procedure experienced a noticeable reduction in postoperative inguinal pain. This study aimed to assess the effectiveness, outcomes, and complications of the modified TOF sling surgery for SUI patients.

2. METHODS

2.1. Patient recruitment and study design

This retrospective study adhered to the principles outlined in the Declaration of Helsinki and was conducted with approval from the ethics committee approval (Institutional Review Board no. 2023-03-003BC). We reviewed the records of female patients diagnosed with SUI who underwent the modified autologous TOF sling procedure at the Taipei Veterans General Hospital between 2017 and 2020. The data collected included age, gravidity, parity, body mass index (BMI), duration of urinary incontinence, and responses to relevant questionnaires. The assessment tools used were the Urinary Distress Inventory-Short Form (UDI-6), Incontinence Impact Questionnaire-Short Form (IIQ-7), and Overactive Bladder Symptom Score (OABSS). The Clinical Global Impressions of Improvement (CGI-I) was utilized postoperatively. This study examined the rate of complete resolution of SUI. We documented the presence of persistent symptoms after the operation and the postoperative dry rate, which indicated that patients did not experience urinary incontinence in their daily lives. Adverse events and subsequent management were recorded.

2.2. Modified autologous TOF sling operation

Initially, an abdominal anterior rectus fascia sling harvest was performed to obtain an approximately 1 cm × 6 cm segment of fascia (Fig. 1). A single suture with a self-locking feature (V-LOC™) was fixed to each corner of the fascia segment. Subsequently, an anterior wall vaginal dissection was performed, extending from the mid-urethra laterally on each side toward the obturator foramen. Two separate C-shaped trocar punctures were made through the obturator membrane to the mid-urethra, and sutures were secured to the skin through the trocar punctures. The tension of the fascia sling was adjusted by manipulating the V-LOC™ suture (Fig. 2). Finally, the residual part of the suture was cut off, and primary closure was performed on the anterior vagina wall.

Fig. 1.

Preparation of rectus fascia sling A, An approximately 1 cm × 6 cm strip of rectus fascia with self-locking suture (V-LOC™) on each side. B, V-LOC line with a unique dual-angle cut and barbing pattern that creates a strong anchoring barb.

Fig. 2.

The step of fascia sling adjustment. A, The tension of the fascial sling is adjusted by manipulating the V-LOC™ suture, which has only one string pulling out on each side and cannot be pulled back. B, The final position of the fascial sling is achieved after tension adjustment and fixation with stay sutures. It can be further adjusted by preserving the partial cut end of the V-LOC™ suture lines outside the skin wound. C, Illustration of autologous transobturator sling placement.

2.3. Statistical analysis

Unless otherwise noted, quantitative data were presented as mean ± SD in the text. Categorical data were summarized as frequency counts and percentages and were analyzed using the McNemar test. Paired t tests were used to analyze continuous variables. Statistical analyses were performed using SPSS Statistics 23.0 for Windows (SPSS Inc., Chicago, IL). A two-sided p < 0.05 was considered statistically significant.

3. RESULTS

3.1. Patient characteristic

This study reviewed the records of a total of 33 female patients diagnosed with SUI who underwent the modified TOF sling procedure. The mean age of the patients was 59.76 ± 11.22 years, and the mean duration of follow-up was 13.18 ± 9.41 months. Table 1 presents the data gathered at baseline, including patient characteristics, the duration and severity of SUI symptoms, and the presence of symptoms related to urgency urinary incontinence (UUI). Of the 33 patients, 19 (57.58%) had mixed incontinence with UUI symptoms, and 14 (42.42%) had pure SUI.

Table 1.

Characteristics of the patients at baseline

Characteristic	Modified TOF sling operation (N = 33)
Age, y	59.76 ± 11.22
Body mass index	25.50 ± 3.25
Parity: no. of pregnancies	3.21 ± 1.76
Duration of follow-up, mo	13.18 ± 9.41
Duration of SUI symptoms, y	10.48 ± 9.95
SUI symptoms
Incontinence when cough	96.97% (32/33)
Incontinence when sneezing	75.76% (25/33)
Incontinence when heavy lifting	51.52% (17/33)
Incontinence when laughing	54.55% (18/33)
Incontinence when walking	51.52% (17/33)
Dry rate	0% (0/33)
UUI symptoms	57.58% (19/33)
Type 2 DM	6.06% (2/33)
Hypertension	33.33% (11/33)

DM = diabetes mellitus; SUI = stress urinary incontinence; TOF = transobturator fascial; UUI = urgency urinary incontinence.

3.2. Patient-reported outcomes

On the UDI-6 questionnaire, there was a significant improvement in total scores from the preoperative (9.73 ± 4.35) to postoperative (3.52 ± 3.41) period following the TOF procedure (p < 0.001). Comparing individual questions before and after surgery, notable improvements were observed in “Frequent urination” (1.70 ± 1.33 vs 0.76 ± 1.03, p < 0.001), “Urine leakage related to urgency” (1.58 ± 1.44, 0.48 ± 1.00, p < 0.001), “Urine leakage related to physical activity” (2.88 ± 0.42 vs 0.55 ± 1.00, p < 0.001), and “Small amounts of urine leakage” (2.09 ± 1.23 vs 0.48 ± 0.97, p < 0.001). However, there were no significant changes in “Difficulty emptying your bladder or difficulty urinating” (1.06 ± 1.30 vs 0.97 ± 1.24, p = 0.720) and “Pain or discomfort in your lower abdominal, pelvic, or genital area” (0.42 ± 0.97 vs 0.27 ± 0.80, p = 0.443) (Table 2).

Table 2.

The score of UDI-6 and IIQ-7 of pre- and post-TOF sling operation

Questions	Pre-TOF sling operation	Post-TOF sling operation	p
UDI-6 score	9.73 ± 4.35	3.52 ± 3.41	<0.001
Frequent urination	1.70 ± 1.33	0.76 ± 1.03	<0.001
Urine leakage related to urgency	1.58 ± 1.44	0.48 ± 1.00	<0.001
Urine leakage related to physical activity	2.88 ± 0.42	0.55 ± 1.00	<0.001
Small amounts of urine leakage	2.09 ± 1.23	0.48 ± 0.97	<0.001
Difficulty emptying your bladder or difficulty urination	1.06 ± 1.30	0.97 ± 1.24	0.720
Pain or discomfort in your lower abdominal, pelvic, or genital area	0.42 ± 0.97	0.27 ± 0.80	0.443
IIQ-7 score	10.21 ± 5.79	0.85 ± 3.67	<0.001
Ability to do household chores	1.09 ± 1.04	0.09 ± 0.52	<0.001
Physical recreation such as walking, swimming, or other exercise	1.73 ± 1.01	0.24 ± 0.71	<0.001
Entertaining activities	1.45 ± 1.06	0.09 ± 0.52	<0.001
Ability to travel by car or bus more than 30 min from home	1.52 ± 1.06	0.09 ± 0.52	<0.001
Participation in social activities outside your home	1.09 ± 1.01	0.09 ± 0.52	<0.001
Emotional health	1.76 ± 0.94	0.12 ± 0.55	<0.001
Feeling frustrated	1.58 ± 1.09	0.12 ± 0.55	<0.001

IIQ-7 = Incontinence Impact Questionnaire-Short Form; TOF = transobturator fascial; UDI-6 = Urinary Distress Inventory-Short Form.

On the IIQ-7 questionnaire, there was a significant improvement in total scores from the preoperative (10.21 ± 5.79) to postoperative (0.85 ± 3.67) period following the TOF procedure (p < 0.001). Individual IIQ-7 question responses showed significant improvement in various aspects of daily life, including “Ability to do household chores” (1.09 ± 1.04 vs 0.09 ± 0.52, p < 0.001), “Engaging in physical recreation such as walking, swimming, or other exercise” (1.73 ± 1.01 vs 0.24 ± 0.71, p < 0.001), “Participating in entertaining activities” (1.45 ± 1.06, 0.09 ± 0.52, p < 0.001), “Ability to travel by car or bus for more than 30 minutes from home” (1.52 ± 1.06, 0.09 ± 0.52, p < 0.001), “Engaging in social activities outside of the home” (1.09 ± 1.01, 0.09 ± 0.52, p < 0.001), “Emotional health” (1.76 ± 0.94, 0.12 ± 0.55, p < 0.001), and “Feelings of frustration” (1.58 ± 1.09, 0.12 ± 0.55, p < 0.001) (Table 2).

The OABSS questionnaire also demonstrated a significant improvement in total scores from the preoperative (6.06 ± 4.03) to postoperative (3.06 ± 2.90) period (p < 0.001). All OABSS questions showed significant improvement, including “Frequency of urination from waking in the morning until sleeping at night” (0.91 ± 0.58 vs 0.48 ± 0.57, p < 0.001), “Frequency of nocturia” (1.55 ± 1.06 vs 1.30 ± 0.98, p = 0.018), “Frequency of urgency episodes” (2.09 ± 1.89 vs 0.88 ± 1.52, p < 0.001), and “Frequency of urgency incontinence episodes” (1.52 ± 1.60 vs 0.39 ± 0.97, p < 0.001). In the mixed incontinence subgroup, there were significant improvements in UDI-6 (11.89 ± 3.03 vs 4.63 ± 3.90, p < 0.001), IIQ-7, (10.84 ± 5.97 vs 1.47 ± 4.79, p < 0.001), and OABSS (8.63 ± 2.99 vs 4.26 ± 3.05, p < 0.001). The pure SUI subgroup also had significant improvements in UDI-6 (6.79 ± 4.19 vs 2.00 ± 1.80, p < 0.001), IIQ-7, (9.36 ± 5.62 vs 0 ± 0, p < 0.001), and OABSS (2.57 ± 2.21 vs 1.43 ± 1.70, p = 0.007). In the CGI-I questionnaires, the mean score was 2.00 ± 0.803, indicating the patients’ positive feelings following the surgery. Furthermore, the percentage of postoperative dry rate revealed a significant improvement (Table 3).

Table 3.

The score of OABSS and clinical outcomes of pre- and post-TOF sling operation

Questions	Pre-TOF sling operation	Post-TOF sling operation	p
OABSS score	6.06 ± 4.03	3.06 ± 2.90	<0.001
How many times do you typically urinate from waking in the morning until sleeping at night	0.91 ± 0.58	0.48 ± 0.57	<0.001
How many times do you typically wake up to urinate from sleeping at night until waking in the morning	1.55 ± 1.06	1.30 ± 0.98	0.018
How often do you have a sudden desire to urinate, which is difficult to defer	2.09 ± 1.89	0.88 ± 1.52	<0.001
How often do you leak urine because you cannot defer the sudden desire to urinate	1.52 ± 1.60	0.39 ± 0.97	<0.001
CGI-I (N = 32)		2.00 ± 0.803
Dry rate (%)	0 (0/33)	72.7 (24/33)	<0.001
Qmax (N = 18)	23.52 ± 10.08	24.10 ± 10.01	0.804

CGI-I = Clinical Impressions scale- Improvement; OABSS = Overactive Bladder Symptom Score; Qmax = maximum urinary flow; TOF = transobturator fascial.

3.3. Safety and adverse events

Of the 33 patients, 18 had maximum urinary flow data available before and after surgery. This subgroup showed no significant reduction after the procedure (23.52 ± 10.08, vs 24.10 ± 10.01, p = 0.804). Regarding postoperative adverse events, two patients (6.1%) reported voiding dysfunction, with symptoms gradually resolved with medication. One patient (3.0%) experienced inguinal pain after surgery and required prolonged pain management. Another patient (3.0%) had mild delayed wound healing that did not require surgical intervention.

4. DISCUSSION

In recent years, there has been increasing concern regarding synthetic mesh exposure and chronic pelvic pain in the context of surgical treatment for SUI. A systematic review conducted in 2021 found that the mesh erosion rate in SUI patients was 1.9%.¹¹ The SIMS trial indicated that 2.5% of patients who underwent single-incision mini-sling procedures required additional surgical intervention due to mesh exposure.¹² Despite the relatively low incidence of mesh exposure, the use of synthetic slings remains a topic of ongoing debate and discussion. A recent review acknowledged that the available long-term safety data, extending beyond 5 years, are heterogeneous and of inadequate quality.¹³ Consequently, there has been a gradual shift towards older techniques, such as autologous fascial slings utilizing rectus fascia, which may potentially involve fewer complications.

Autologous fascial sling procedures can generally be performed via two different routes: the retropubic route and the transobturator route. While there is limited research comparing these two routes for autologous fascial slings, numerous studies have compared synthetic slings, specifically tension-free vaginal tape (TVT) and transobturator tape (TOT). In a systematic review and meta-analysis,¹⁴ the TOT method demonstrated shorter operation time and hospital stays compared to the TVT procedure. However, there was no significant difference in the impact on quality of life (IIQ-7), urinary distress (UDI-6), and pain scores (visual analog scale [VAS]). Additionally, the complication rates were comparable between the two methods. Another network meta-analysis concluded that the TOT was the optimal method for SUI, demonstrating high efficacy and moderate safety when compared to the TVT procedure.¹⁵ Long-term follow-up studies, such as the systematic review and meta-analysis by Leone Roberti Maggiore et al,¹⁶ suggest that TOT is equally effective and safe as TVT during extended evaluation periods exceeding 5 years.

In the conventional surgical technique of autologous rectus fascial sling, the ends of the sling are secured using polypropylene (Prolene) or polydioxanone (PDS) suture, one on each side. Needle passers are carefully utilized, passing through the transobturator or pubovaginal route twice on each side.^17,18 However, this method often results in more extensive bilateral wounds and increased postoperative pain. A prior randomized controlled trial revealed significantly higher pain scores (VAS) in the transobturator autologous rectus fascial sling group compared to the transobturator TVTs group on postoperative days 1 and 7.¹⁹

This study presents a novel fixation method for autologous transobturator urethral sling procedures, which utilizes self-locking suture lines (V-LOC™) instead of the traditional Prolene or PDS suture lines.⁹ By anchoring the self-locking sutures (V-LOC™) on the corner of the fascia segment on each side, the procedure allows for smaller bilateral incisions and easier adjustments to the tension of the fascial sling. This innovative approach has been shown to reduce postoperative pain and facilitate wound healing, making it a promising alternative to traditional methods.

SUI is primarily diagnosed based on clinical presentation, with limited objective measures available to evaluate the effectiveness of surgical interventions for SUI. As a result, patient-reported outcomes (PROs) and PRO measures (PROMs) play a crucial role in assessing clinical conditions after surgery. A review conducted in 2022 concluded that there is a lack of consensus regarding the usage of PROs and PROMs in research on SUI surgery. However, the review highlighted the top five PROMs as PGI-I, UDI-6, International Consultation on Incontinence Questionnaire (ICIQ-SF), Incontinence Impact Questionnaire-Short Form (IIQ-7), and Kings Health Questionnaire (KHQ). These PROMs were deemed valid and strongly recommended for evaluating clinical conditions in SUI patients.²⁰

In this study, we utilized four PROMs: UDI-6, IIQ-7, OABSS, and CGI-I. Our results showed significant improvements in the total scores of UDI-6, IIQ-7, and OABSS. Specifically, UDI-6 revealed improvements in frequency, urgency, and SUI symptoms, while IIQ-7 indicated significant enhancements in physical activities and emotional well-being. OABSS also demonstrated improvements in urgency and urge urinary incontinence. According to the CGI-I questionnaire, the majority of patients reported an improvement in their condition compared to preoperative status, with a mean score of 2.00 ± 0.803.

One of the major complications following autologous rectus fascial sling surgery is voiding dysfunction, with previous reviews reporting postoperative voiding dysfunction rates ranging from 1.5% to 7.8%.⁸ Symptoms can manifest as either storage, voiding, or both. Additionally, the risk of urinary retention (5%-20%) following surgery was also higher compared to synthetic MUS procedures. A prior study revealed that 9% of the patients who underwent TOF sling surgery experienced urinary retention and required temporary catheterization for less than a week.⁹ In our study, no patients reported urinary retention. Nevertheless, 5.88% of patients reported voiding dysfunction, which gradually resolved with medication and did not require catheterization. Mild delayed wound healing occurred in one patient (3%), but no reoperation or removal of the autologous fascial sling was needed. Furthermore, we evaluated the maximum urinary flow in 18 out of 33 patients and found no significant reduction after the procedure.

It is important to acknowledge the limitations of our study. First, it was a single-arm, retrospective study without a control group, such as those undergoing synthetic MUS or standard TOF sling procedures. As a result, the evidence supporting the superiority or non-inferiority of our modified method is limited. Future research should aim to provide a higher level of evidence by comparing the autologous rectus fascial pubovaginal method with the transobturator method. Movalled et al²⁰ noted that most of functional urology recommendations are not based on systemic review and meta-analysis of randomized controlled trials. Therefore, more high-quality studies are needed in the future. Second, the small sample size may not have provided sufficient statistical power to validate the efficacy and reduced morbidity of our approach. Third, we acknowledge that additional PROMs, such as ICIQ-SF and KHQ, could have been utilized to comprehensively evaluate preoperative and postoperative conditions and enhance the overall assessment of patient outcomes.²¹ Fourth, our study did not include preoperative conservative intervention like pulsed electromagnetic field (PEMF) stimulation or pelvic floor muscle training with biofeedback. PEMF stimulation could also reduce incontinence symptoms.²² Preoperative pelvic floor muscle training has also shown benefits for urinary incontinence.²³ Therefore, preoperative conservative management should be included in the future research to analyze the prognosis. Finally, extended follow-up durations are warranted in future studies to establish the long-term efficacy of the modified TOF sling surgery and provide more robust insights. The available studies to date have not provided sufficient evidence in this regard.

In conclusion, this present study demonstrates the feasibility of the novel fixation method in the modified TOF procedure as a promising alternative treatment for patients with SUI, with a mean follow-up of 13.18 ± 9.41 months. Our findings indicate a lower complication rate associated with this modified technique. A significant advantage is its postoperative adjustability by preserving the partial cut end of V-LOC™ suture lines outside the skin wound.