# Synthetic mid-urethral slings in female spina bifida patients with stress urinary incontinence: Is it worth it?

Alicia Blondeau, Samia Laraqui, Goncalo Mendes, Juliette Hascoet, Camille Haudebert, Charlène Brochard, Claire Richard, Caroline Vairy, Laurent Siproudhis, Krystel Nyangoh Timoh, et al.

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Alicia Blondeau, Samia Laraqui, Goncalo Mendes, Juliette Hascoet, Camille Haudebert, et al. Synthetic mid-urethral slings in female spina bifida patients with stress urinary incontinence: Is it worth it?. The French Journal of Urology, 2025, 10.1016/j.fjurol.2025.102938. hal-05240293

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Original Article

# Synthetic mid-urethral slings in female spina bifida patients with stress urinary incontinence: Is it worth it?

## Les bandelettes sous-urétrales sont associées à de mauvais résultats fonctionnels chez les femmes atteintes de spina-bifida

Alicia Blondeau<sup>a, *</sup>, Samia Laraqui<sup>b</sup>, Goncalo Mendes<sup>b</sup>, Juliette Hascoet<sup>a, c</sup>,

Camille Haudebert<sup>a, c</sup>, Charlène Brochard<sup>c, d</sup>, Claire Richard<sup>a, c</sup>, Caroline Voiry<sup>c, e</sup>,

Laurent Siproudhis<sup>c, d</sup>, Krystel Nyangoh Timoh<sup>f</sup>, Andrea Manunta<sup>c</sup>, Emmanuelle Samson<sup>c, e</sup>,

Benoit Peyronnet<sup>a, c</sup>

ARTICLE INFO

Keywords:

Urinary bladder

Spina bifida

Neurogenic

Mid-urethral sling

Urinary incontinence

ABSTRACT

**Introduction:** The aim of this study was to report the outcomes of synthetic mid-urethral slings (MUS) in female patients with spina bifida and stress urinary incontinence (SUI).

**Methods:** All female patients with spina bifida who were seen at a national referral center between 2007 and 2021 and who had a history of MUS for SUI were included in a retrospective study. The primary outcome of interest was the continence status at 1 year as per patients' subjective perception categorized as complete continence, improved continence, unchanged or worsened SUI.

**Results:** Out of 339 female spina bifida patients; 11 patients had undergone a MUS insertion and were included for analysis (3.2%). The median age was 30 years (range: 19–52 years). There were four postoperative complications (36.4%). The three patients fully continent at three months were still fully continent at one year (27.3%) while three had improved continence (27.3%) and five had unchanged continence (45.5%). After a median follow-up of 102 months, only one patient was still fully continent (9.1%) and three patients had still improved continence (27.3%). Five patients (45.5%) underwent a subsequent anti-incontinence procedure. The only adverse predictor of improved/complete continence at 1 year was a sacral neurological level (OR = 0.05; *p* = 0.03).

**Conclusion:** MUS in women with spina bifida and SUI appears to be safe but less effective than in the non-neurogenic population which may be explained by different underlying pathophysiological mechanisms. These findings question the relevance of this treatment option in these complex population, especially in the current mesh controversy era.

**Level of evidence:** 4.

© 2025 The Authors. Published by Elsevier Masson SAS. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

<footnote><sup>a</sup> Department of Urology, University of Rennes, Rennes, France</footnote>

<footnote><sup>b</sup> Department of Pediatric Surgery, University of Rennes, Rennes, France</footnote>

<footnote><sup>c</sup> French Referral Network of Spina Bifida, Rennes University Hospital, Rennes, France</footnote>

<footnote><sup>d</sup> Department of Gastro-Enterology, University of Rennes, Rennes, France</footnote>

<footnote><sup>e</sup> Department of Physical Medicine and Readaptation, University of Rennes, Rennes, France</footnote>

<footnote><sup>f</sup> Department of Obstetrics and Gynaecology, University of Rennes, Rennes, France</footnote>

<footnote>* Corresponding author. Service d'Urologie, Hôpital Pontchaillou, 2, rue Henri-Le-Guilloux, 35000 Rennes, France.</footnote>
RÉSUMÉ

Mots clés :

Vessie

Spina bifida

Neurogène

Bandelette sous-urétrale

Incontinence urinaire

**Introduction** : L'objectif de cette étude était d'analyser les résultats des bandelettes sous-urétrales (BSU) chez des patientes atteintes d'un spina bifida avec incontinence urinaire d'effort (IUE).

**Méthodes** : Toutes les patientes spina bifida suivies dans un centre de référence national entre 2007 et 2021 avec un antécédent de BSU pour une IUE ont été incluses dans cette étude rétrospective. Le critère de jugement principal était la continence subjective à un an, classée en continence complète, continence améliorée, inchangée ou aggravée.

**Résultats** : Parmi les 339 patientes atteintes de spina-bifida, 11 avaient bénéficié d'une BSU et ont été incluses dans l'analyse (3,2 %). L'âge médian était de 30 ans (19 à 52 ans). Quatre complications postopératoires ont été rapportées (36,4 %). Trois patientes totalement continentes à trois mois l'étaient toujours à un an (27,3 %), tandis que trois avaient une continence améliorée (27,3 %) et cinq une continence inchangée (45,5 %). Après un suivi médian de 102 mois, une seule patiente était encore complètement continente (9,1 %) et trois avaient toujours une continence améliorée (27,3 %). Cinq patientes (45,5 %) ont nécessité d'une nouvelle intervention pour incontinence. Le seul facteur prédictif négatif d'amélioration de la continence ou de continence complète à 1 an était un niveau neurologique sacré (OR = 0,05 ; p = 0,03).

**Conclusion** : Les BSU chez les femmes atteintes de spina bifida pour IUE semblent fiables mais moins efficaces que dans la population non neurologique, probablement en raison de mécanismes physiopathologiques sous-jacents différents. Ces résultats remettent en question la pertinence de cette option thérapeutique dans cette population complexe, en particulier dans le contexte actuel de controverse autour des bandelettes.

Niveau de preuve : 4.

© 2025 Les Auteurs. Publié par Elsevier Masson SAS. Cet article est publié en Open Access sous licence CC BY (http://creativecommons.org/licenses/by/4.0/).

# 1. Introduction

Spina bifida is the most common congenital cause of neurogenic bladder with an incidence of 1/10,000 births in developed countries [1,2]. Neurogenic lower urinary tract dysfunction (NLUTD) may affect over 90% of spina bifida patients [3]. Stress urinary incontinence (SUI) is highly prevalent in women with spina bifida but data on its surgical management are scant [4-6]. Despite the safety and use of the synthetic mid-urethral slings (MUS) has recently come under scrutiny following concern about the use of mesh implants, MUS remain the first-line surgical option in the treatment of female SUI in most parts of the world [7,8]. Some studies suggest they may yield satisfactory outcomes in patients with neurogenic SUI [4,6,9,10] but all of these series included a mix of various neurological conditions and none focused on female patients with spina bifida [10]. The features of spina bifida NLUTD do not match exactly with those typically observed in other neurological conditions such as spinal cord injury (SCI) or multiple sclerosis (MS). Neurological lesions in spina bifida are typically incomplete, often with a mix of central and peripheral nervous systems alterations and frequently a patchy distribution [11] resulting in high proportions of intrinsic sphincter deficiency (ISD), poor bladder compliance and flaccid perineum paralysis with a high prevalence of coexistent pelvic organ prolapse (POP) [3]. Hence, one may hypothesize that the outcomes of MUS in the spina bifida population may differ from the one observed in other neurological populations.

To our knowledge, no series to date have reported the outcomes of MUS in female patients with spina bifida. The aim of this study was to report the outcomes of MUS in female patients with spina bifida and SUI.

# 2. Methods

## 2.1. Study design

The charts of all female spina bifida patients included in the prospective database of a national referral center were screened. All female spina bifida patients with a history of MUS insertion who were seen for follow-up at this national referral center for spina bifida from 2007 to 2021 were included in the present retrospective analysis. The patients were included regardless of the date or center of MUS insertion and of the type of MUS used.

Due to the retrospective study design, the surgical techniques as well as the indications for MUS insertion were not standardized. The surgical approach used (i.e. tension-free vaginal tape [TVT] or transoburator tape [TOT]) was also surgeons' dependent. Urodynamics were not systematically performed preoperatively.

The following baseline characteristics were recorded for each patient in a dedicated computerized dataset: gender, age at the time of MUS insertion, bladder management (clean-intermittent catheterization (CIC) vs. spontaneous voiding); type of spinal dysraphism (open vs. closed); the neurological level (categorized as sacral, lumbar or thoracic); the mobility status (wheelchair user vs. ambulator); the menopausal status (premenopausal vs. postmenopausal); history of previous pelvic surgery; the parity status (nulliparous, history of previous vaginal delivery and/or cesarean section); history of augmentation cystoplasty and history of previous anti-incontinence procedure.

This study was approved by the Comité National Informatique et liberté (CNIL 1412467), and was conducted following the principles of the Helsinki declaration.

## 2.2. Outcomes of interest

The primary outcome of interest was the continence status at 1 year as per patients' subjective perception categorized as complete continence (no pads), improved continence, unchanged or worsened SUI. The other outcomes of interest were the continence status at 3 months and at last follow-up; and the need of subsequent urological surgeries to achieve complete continence. The 90-day postoperative complications were collected retrospectively and graded using the Clavien-Dindo classification [12]. Major complications were defined as any Clavien grade of 3 or higher.

## 2.3. Statistical analysis

Continuous variables were reported as medians and interquartile ranges (IQRs) and categorical variables were reported as proportions. Univariate logistic regression was performed to seek predictors of complete/improved continence at one year. Comparisons between groups were performed using $\chi^2$ test and Fisher exact test for discrete variables and Mann-Whitney test for continuous variables. Statistical analyses were performed using JMP v.12.0 software (SAS Institute Inc, Cary, NC, USA). All tests were two-sided with a significance level at $P < 0.05$.

# 3. Results

## 3.1. Patients' characteristics

Out of 339 female spina bifida patients; eleven patients had undergone a MUS insertion and were included for analysis (3.2%) (Fig. 1). The
A. Blondeau et al.

The French Journal of Urology xxx (xxxx) xxx-xxx

<figure><img src="image_3.png" /><figcaption>**Fig. 1.** Patients flow chart. The unchanged group includes patients who underwent subsequent anti-incontinence procedure.</figcaption></figure>

patients' characteristics are presented in Table 1. The MUS insertions were carried out at eight different institutions, mostly by urologists (9/11; 81.8%), the other being performed by gynecologists. The patients were mostly young adults at the time of implantation with a median age of 30 years (range: 19–52 years). Most patients were self-catheterizing (60%) and premenopausal (81.8%). Two patients had undergone augmentation cystoplasty and peri-urethral bulking agents' injection (18.2%). All other patients were naive of anti-incontinence procedure for SUI. Six patients had an open spinal dysraphism/myelomeningocele (54.5%) and all, but one had sacral or lumbar neurological levels (91%). Four patients were wheelchair-users (36.4%). The majority of patients were nulliparous (63.6%), three (27.3%) patients had a history of vaginal delivery and one (9.1%) had multiple C-sections.

The clinical and urodynamic features are summarized in Table 2. Six patients were described as having urethral hypermobility on physical examination (54.5%) and three had coexistent pelvic organ prolapse (27.3%). Urodynamic data were available for seven of the patients. The median maximum urethral closure pressure (MUCP) was 33 (range: 20–

**Table 1**

Patients' characteristics.

<table><thead><tr><th></th><th>n = 11</th></tr></thead><tbody><tr><td>Median age (years)</td><td>30 (range: 19–52)</td></tr><tr><td>Menopausal status</td><td></td></tr><tr><td>Premenopausal</td><td>9 (81.8%)</td></tr><tr><td>Postmenopausal</td><td>2 (18.2%)</td></tr><tr><td>Type of spinal dysraphism</td><td></td></tr><tr><td>Open</td><td>6 (54.5%)</td></tr><tr><td>Closed</td><td>5 (45.5%)</td></tr><tr><td>Bladder emptying method</td><td></td></tr><tr><td>Clean intermittent catheterization</td><td>6 (54.5%)</td></tr><tr><td>Spontaneous voiding</td><td>5 (45.5%)</td></tr><tr><td>Median body mass index (kg/m²)</td><td>30 (range: 22–41)</td></tr><tr><td>Mobility status</td><td></td></tr><tr><td>Wheelchair user</td><td>4 (36.4%)</td></tr><tr><td>Ambulator</td><td>7 (63.6%)</td></tr><tr><td>Neurological level</td><td></td></tr><tr><td>Thoracic</td><td>1 (9.1%)</td></tr><tr><td>Lumbar</td><td>4 (36.4%)</td></tr><tr><td>Sacral</td><td>6 (54.5%)</td></tr><tr><td>Parity status</td><td></td></tr><tr><td>Nulliparous</td><td>7 (63.6%)</td></tr><tr><td>History of vaginal delivery</td><td>3 (27.3%)</td></tr><tr><td>History of caesarian sections</td><td>1 (9.1%)</td></tr><tr><td>History of previous stress urinary incontinence surgery</td><td>52 (18.2%)</td></tr></tbody></table>

**Table 2**

Clinical and urodynamic features.

<table><thead><tr><th></th><th>n = 11</th></tr></thead><tbody><tr><td>Urethral hypermobility</td><td>6 (54.5%)</td></tr><tr><td>Median number of pads per day preoperatively</td><td>3 (range: 3–7)</td></tr><tr><td>Coexistent pelvic organ prolapse</td><td>3 (27.3%)</td></tr><tr><td>Median maximum urethral closure pressure (cmH₂O)</td><td>33 (range: 20–50)</td></tr><tr><td>Detrusor overactivity and/or poor bladder compliance (&lt; 20 mL/cmH₂O)</td><td>2 (28.6%)<br>Missing data<br>n = 4</td></tr></tbody></table>

Italic means complete data were unavailable for four patients.

50) and two patients had detrusor overactivity and/or poor bladder compliance (28.6%).

## 3.2. Perioperative parameters

The MUS insertions were performed from 1998 to 2018. The MUS were tension-free vaginal tape (TVT) and transoburator tape (TOT) in 8 and 3 cases respectively. No intraoperative complication was observed. The median length of hospital stay was one day (range: 0–2). There were four postoperative complications (36.4%): one chronic urinary retention resulting in complete mesh removal at 3 months (Clavien grade 3B); two chronic urinary retention requiring initiation of self-catheterization (Clavien grade 2) and one pain requiring analgesics for several weeks (Clavien grade 1).

## 3.3. Functional outcomes and subsequent surgical treatment

At three months, three patients were fully continent (27.3%), four patients had improved continence (36.4%), three patients had unchanged continence (27.3%) and one patient had worsened SUI (9.1%). At one year, the three patients fully continent at three months were still fully continent at one year (27.3%) while three had improved continence (27.3%) and five had unchanged continence (45.5%). After a median follow-up of 102 months (range: 6–242), only one patient was still fully continent (9.1%) and three patients had still improved continence (27.3%). Five patients (45.5%) underwent a subsequent anti-incontinence procedure: one adjustable continence therapy (ACT) peri-urethral balloon, two artificial urinary sphincters, one bladder neck closure procedure and one autologous fascial pubovaginal sling. The remaining two patients had unchanged incontinence (18.2%). No further mesh-related complication was observed over the follow-up period resulting in a 9.1% sling removal rate (one MUS removal at 3 months for chronic urinary retention).

## 3.4. Predictive factors of improved/complete continence at 1 year

The detailed results of the univariate logistic regression seeking predictors of improved/complete continence are presented in Table 3. The only variable significantly associated with improved/complete continence at 1 year was the neurological level, a sacral neurological level being an adverse predictor (OR = 0.05; P = 0.03).

## 4. Discussion

Spina bifida is a common congenital neuroembryological disorder affecting multiple organ systems [1]. Urological disorders can be a significant source of morbidity and mortality in spina bifida patients [13]. SUI is frequent in female spina bifida patients and significantly affects their quality of life. Several options exist for its management but still no clear guidelines are available due to scarce data in the literature regarding SUI treatment in this specific subset of neurological patients [14]. MUS is still regarded as the gold standard treatment of female SUI in most parts of the world [8]. Data regarding the long-term outcomes of MUS in women
<caption>**Table 3**</caption>

Predictors of complete/improved continence at 1 year (univariate logistic regression).

<table><thead><tr><th></th><th>Odds ratio<br>[95% CI]</th><th>P-value</th></tr></thead><tbody><tr><td>Body mass index</td><td>1.14<br>[0.91-1.53]</td><td>0.26</td></tr><tr><td>Age</td><td>1.04<br>[0.93-1.19]</td><td>0.23</td></tr><tr><td>Neurological level</td><td></td><td>0.03</td></tr><tr><td>Lumbar/thoracic</td><td>1 [Ref]</td><td></td></tr><tr><td>Sacral</td><td>0.05 [0.01-0.76]</td><td></td></tr><tr><td>Type of slings</td><td></td><td>0.38</td></tr><tr><td>TVT</td><td>1 [Ref]</td><td></td></tr><tr><td>TOT</td><td>0.3 [0.10-4.53]</td><td></td></tr><tr><td>Type of spinal dysraphism</td><td></td><td>0.37</td></tr><tr><td>Open</td><td>1 [Ref]</td><td></td></tr><tr><td>Closed</td><td>0.33 [0.03-3.72]</td><td></td></tr><tr><td>Parity status</td><td></td><td>0.13</td></tr><tr><td>Nulliparous</td><td>1 [Ref]</td><td></td></tr><tr><td>History of previous childbirth</td><td>0.13 [0.04-1.77]</td><td></td></tr><tr><td>Bladder emptying method</td><td></td><td>0.37</td></tr><tr><td>Spontaneous voiding</td><td>1 [Ref]</td><td></td></tr><tr><td>Clean intermittent catheterization</td><td>3 [0.27-43.95]</td><td></td></tr><tr><td>Urethral hypermobility</td><td></td><td>0.37</td></tr><tr><td>No</td><td>1 [Ref]</td><td></td></tr><tr><td>Yes</td><td>3 [0.27-43.95]</td><td></td></tr><tr><td>Maximum urethral closure pressure</td><td>1.03<br>[0.97-1.29]</td><td>0.38</td></tr></tbody></table>

TVT: tension-free vaginal tape; TOT: transoburator tape.

with neurological bladder are sparse [4,5,9,10]. Most of the existing series include a mix of neurological and non-neurological patients without distinction [10]. This series is, to our knowledge, the first to evaluate the effectiveness of MUS in female patients with spina bifida. We observed that MUS yielded poorer outcomes in female patients with spina bifida compared to non-neurogenic and other neurological populations although the morbidity appeared to be relatively low. These poor outcomes may explain why MUS was used only in a very small subgroup of our female spina bifida cohort (3.2%).

Several hypotheses could be formulated to explain the low efficacy of MUS in the spina bifida population. First the pathophysiology underpinning SUI is probably quite different in spina bifida patients compared to other neurogenic population. In a recent systematic review of the nine main series on MUS in neurological patients published so far, the mean patients' age was 52 years [10]. Our patients' population was much younger and inherently most of our patients were nulliparous and non-menopausal. Hence, one may hypothesize that urethral hypermobility rarely factored in the genesis of our patients' SUI while this may well be the case in other neurological populations with history of childbirth and undergoing MUS insertion while menopausal [15]. The sacral neurological level being the only predictor of MUS failure would suggest that the existence and severity of intrinsic sphincter deficiency (ISD) due to altered somatic innervation to the striated sphincter adversely affected MUS efficacy. Neurogenic ISD is very common in spina bifida patients [3] and may not be similar to the ISD observed in other neurogenic populations due to the mix of central and peripheral nervous lesions. Finally, there were a high proportion of obese women in our series (median BMI = 30). Obesity has been shown to be highly prevalent in adults with spina bifida [16].

Under the current climate of mesh controversies surrounding the use of synthetic mid-urethral slings [7,8,17] and knowing that female patient with spina bifida have risk factors for complications (i.e. increased theoretical risk of mesh extrusion or exposure due to wheelchair use and clean intermittent catheterization), the absence of major complication in our population could be regarded as surprising. This might be due to the good tissues' trophicity as most patients were non-menopausal young adults at the time of implantation. Another possible explanation is that the proportions many patients in these series were neither wheelchair-bound

nor self-catheterizing and may then not be regarded as the highest risk spina bifida population in terms of urinary complications.

Several surgical options have been investigated for female neurogenic SUI. Autologous fascia pubovaginal sling (AFPVS) has been so far regarded by many as the procedure of choice as it may tackle ISD, avoid the risk inherent to synthetic material and because it can be tightened ad libitum given that most of these patients are already self-catheterizing [18,19]. However, very limited data are available regarding AFPVS in neurological patients [18,19] and its long-term efficacy and need for subsequent procedures are unknown. Artificial urinary sphincter in female patients with spina bifida has been associated with satisfactory long-term functional outcomes but at the cost of a high reoperation rate [20]. Other options such as sphincter injections may be of interest but warrant further investigations [21]. Studies comparing those various surgical procedures are needed to help building a therapeutic algorithm for SUI in neurological patients in general and in spina bifida patients in particular.

This study has several limitations that should be acknowledged. The main shortcomings were those inherent to its retrospective design. The study population was included at the time they were seen at the national referral center for spina bifida. Hence, the surgical technique and treatment decision making algorithms were not standardized and the surgery were performed over a very long period of time. Another limitation is the assessment of the continence status based on patients' subjective perception and not on pad-test or validated questionnaires. Nonetheless, we opted for a stringent definition of complete continence (i.e., no use of pads). Unfortunately, data regarding the quality of life were not available owing to the retrospective study design. Due to the very large inclusion period, only limited data were available and urodynamic data were often missing which prevented to assess accurately the impact of preoperative urodynamics on MUS outcomes. Data on assessment and treatment targeting the filling phase, such as antimuscarinics or botulinum toxin injections, as well as data on pain and analgesic use, were also missing. As anti-incontinence procedures can increase the risk to the upper urinary tract in patients with detrusor overactivity or poor bladder compliance by suppressing leakage, and since we did not assess this point in our study, this issue should be investigated separately in a dedicated safety analysis of MUS in spina bifida patients. Finally, the sample size was small as in many studies on rare diseases such as spina bifida, which inherently limited the statistical power. We therefore chose not to perform multivariable logistic regression to avoid potentially aberrant or misleading results.

## 5. Conclusion

MUS in women with spina bifida and SUI appears to be safe but less effective than in the non-neurogenic population and other neurogenic populations which may be explained by different underlying pathological mechanisms. The outcomes may be even poorer in patients with sacral neurological level. These findings question the relevance of this treatment option in these complex populations, especially in the current mesh controversy era. Further studies are needed to help determine the best surgical treatment for SUI in female patients with spina bifida.

## Disclosure of interest

The authors declare that they have no competing interest.

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