Long-term outcomes of intramural rectal botulinum toxin injections for urge fecal incontinence: a salvage therapy for sacral neuromodulation nonresponders?

Philippe Onana Ndong; Véronique Vitton

doi:10.3393/ac.2025.00332.0047

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Original Article Anorectal benign disease Long-term outcomes of intramural rectal botulinum toxin injections for urge fecal incontinence: a salvage therapy for sacral neuromodulation nonresponders?: Philippe Onana Ndong¹, Véronique Vitton²; Annals of Coloproctology 2025;41(5):417-423.
DOI: https://doi.org/10.3393/ac.2025.00332.0047
Published online: October 23, 2025

¹Department of Gastroenterology, Hôpital L'Archet 2, Centre Hospitalier Universitaire de Nice, Nice, France

²Department of Gastroenterology, Hôpital Nord, Assistance Publique–Hôpitaux de Marseille, Aix-Marseille Université, Marseille, France

Correspondence to: Philippe Onana Ndong, MD Department of Gastroenterology, Hôpital L'Archet 2, Centre Hospitalier Universitaire de Nice, 151 Route de Saint Antoine de Ginestière, Nice 06202, France Email: onana-ndong.p@chu-nice.fr

• Received: March 24, 2025 • Revised: May 21, 2025 • Accepted: May 27, 2025

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Abstract
Graphical abstract
INTRODUCTION
METHODS
RESULTS
DISCUSSION
ARTICLE INFORMATION
REFERENCES

Abstract

Purpose
Sacral neuromodulation (SNM) failure in fecal incontinence (FI) management represents a therapeutic challenge, often leading to more invasive, less accepted alternatives with inconsistent efficacy. In this context, intramural rectal botulinum toxin A (BoNT-A) injection has recently emerged as a promising minimally invasive alternative for urge FI. This study aimed to evaluate the effectiveness of intramural rectal BoNT-A injections in the challenging subgroup of SNM nonresponders.
Methods
This retrospective, single-center study included patients with urge FI who underwent intramural rectal BoNT-A injections after SNM failure, between February 2018 and September 2024. The procedure involved endoscopic injection of 200 units of BoNT-A at 10 circumferential sites in the rectal wall. Treatment efficacy was assessed using the Cleveland Clinic Fecal Incontinence Score (CCFIS) and a visual analog scale (VAS) for symptom severity.
Results
Fifteen female patients met the inclusion criteria, with a median follow-up of 22.5 months (range, 4.4–103.2 months). Patients received a median of 2 injections, with a median reinjection interval of 9.8 months. CCFIS scores demonstrated significant improvement (median, 15 [range, 8–20] vs. 8 [range, 0–20]; P=0.001), as did VAS symptom scores (median, 4 [range, 0–5] vs. 2 [range, 0–5]; P=0.001). No adverse events were reported.
Conclusion
This study provides long-term evidence supporting intramural rectal BoNT-A injections as an effective option for managing urge FI, including as salvage therapy in SNM nonresponders. Further studies are necessary to confirm these findings and define the optimal role of BoNT-A within the therapeutic algorithm for urge FI.
Keywords: Fecal incontinence; Botulinum toxins; Sacral neuromodulation; Treatment outcome

Graphical abstract

INTRODUCTION

Fecal incontinence (FI) is a debilitating condition that presents significant therapeutic challenges. When first-line treatments—primarily consisting of lifestyle modifications, transit modulators, and pelvic floor rehabilitation—fail, remaining therapeutic options are typically surgical or palliative.

Over the years, various surgical approaches have been explored; however, most have been abandoned in favor of sacral neuromodulation (SNM) due to its lower morbidity and well-established efficacy [1–3]. Among patients responding positively during the test phase, approximately two-thirds experience sustained clinical improvement with SNM [1, 4, 5]. This technique has markedly improved patient management by reducing reliance on more radical and less acceptable procedures, such as colostomy [6].

Despite its benefits, SNM remains an invasive procedure associated with potential complications, sometimes necessitating surgical revision or device removal. Additionally, its significant economic burden must be considered in therapeutic decision-making [7]. Moreover, SNM is unsuitable for patients in whom the test phase fails, frequently leaving them with limited, often invasive or palliative, alternatives.

To expand treatment options, minimally invasive approaches have been explored. A promising advancement is intramural rectal botulinum toxin (BoNT-A) injection, which enhances rectal compliance in urge FI. Following encouraging pilot studies [8, 9], Leroi et al. [10] demonstrated short-term (3 months) efficacy with favorable safety outcomes in a randomized trial involving 200 patients. More recently, Onana Ndong et al. [11] reported long-term efficacy, with a median follow-up of 2 years and a median injection interval of 9.8 months. These encouraging findings highlight the need to reassess intramural rectal BoNT-A injection's role within the FI therapeutic algorithm. This approach may help reduce reliance on invasive surgical procedures or serve as salvage therapy for patients in whom SNM fails, who would otherwise require radical surgery.

To explore this hypothesis, we conducted a retrospective study aiming to assess the long-term efficacy of intramural rectal BoNT-A injection in patients with active FI following SNM failure.

METHODS

Ethics statement

This study complied with the European General Data Protection Regulation and followed the recommendations of the French Data Protection Authority under the French National Commission on Informatics and Liberty (Commission Nationale de l’Informatique et des Libertés, CNIL). Patient data were anonymized and retrieved from the Assistance Publique–Hôpitaux de Marseille (AP-HM) electronic medical records with approval from the institution’s data protection officer. The study was registered under the reference number LAEJUL (2023). In accordance with the current regulations in France, informed consent was not required for this study, due to its retrospective design and utilization of anonymized patient data. The study protocol followed the principles of the Declaration of Helsinki.

Study population and design

This retrospective, single-center case series was conducted in the physiological unit of the gastroenterology department at North Hospital, AP-HM (Marseille, France). The study included patients previously described in the cohort by Onana Ndong et al. [11], as well as additional newly recruited patients.

All patients who underwent intramural rectal BoNT-A injections for urge FI following SNM failure were included. The inclusion period extended from February 2018 to September 2024. Urge FI was defined as a sudden and compelling need to defecate, with an inability to reach the toilet in time [3]. All patients experienced secondary SNM failure, meaning they initially responded positively during the test phase, underwent device implantation, but later had either loss of symptom control or recurrence of urge FI symptoms. Secondary failure was specifically defined as symptom recurrence occurring at least 6 months after implantation.

This study followed the methodology previously described by Onana Ndong et al. [11]. In accordance with standard practice in our unit, each patient completed a questionnaire at every follow-up visit to assess FI severity. Symptom severity was evaluated using the Cleveland Clinic Fecal Incontinence Score (CCFIS) [12] and a visual analog scale (VAS), as previously described by Onana Ndong et al. [11].

VAS for fecal urgency assessment

The VAS for fecal urgency assessment ranges from 0 to 5, with each score reflecting increasing levels of discomfort and symptom severity: 0, no discomfort or symptoms related to fecal urgency; 1, very mild and infrequent discomfort, not affecting daily activities; 2, moderate discomfort with occasional symptoms, slightly disrupting daily life; 3, noticeable discomfort with frequent symptoms, affecting some activities; 4, significant discomfort with regular symptoms, limiting daily activities; and 5, severe discomfort with disabling symptoms, preventing usual activities and requiring constant adjustments.

Reinjection indications were determined by the attending physician in cases of recurrent or persistent FI symptoms, with a minimum interval of 3 months following the initial injection. Adverse events were retrospectively assessed based on clinical documentation from follow-up visits. During these visits, patients were queried about any new or persistent symptoms potentially related to the treatment. Specifically, clinical records were reviewed for reports of rectal pain, discomfort during defecation, rectal bleeding, transient worsening of FI, new-onset urinary symptoms, fever, and constipation. However, no standardized adverse event reporting form or symptom diary was used, and adverse events were not graded according to a formal classification system.

Procedure

Patients underwent bowel preparation with a rectal enema administered both on the evening before and on the morning of the procedure, as described previously by Onana Ndong et al. [11]. Injections were performed in an outpatient setting during flexible sigmoidoscopy, without general anesthesia. Following the protocol developed by Leroi et al. [10], a total of 200 units of BoNT-A (OnabotulinumtoxinA/BOTOX, AbbVie) were injected at 10 circumferential sites in the rectal wall, located 2 to 10 cm above the dentate line (Fig. 1). The injections targeted the submucosal or superficial muscular layer, aiming to modulate rectal sensorimotor activity while avoiding direct involvement of the anal sphincters.

Assessment criteria

The primary objective of this study was to evaluate the effectiveness of intramural rectal BoNT-A injections for treating urge FI, as measured by a reduction in the CCFIS during follow-up. Secondary objectives included assessing the reduction in symptom severity using the VAS (based on patient-reported outcomes), determining the number of injections received per patient, and analyzing intervals between successive injections.

Statistical analysis

Descriptive statistics were applied to the entire study cohort. Continuous variables were expressed as means with standard deviations or medians with minimum and maximum values, and categorical data as frequencies and percentages. Normality of data was verified using the Shapiro-Wilk test. The differences between CCFIS values before and after treatment were assessed using the Student paired t-test. Alpha risk was set at 5% (α=0.05). Statistical analyses were performed using EasyMedStat ver. 3.38 (EasyMedStat; https://www.easymedstat.com/).

RESULTS

Demographic data and follow-up

Between February 2018 and September 2024, 57 patients who received intramural rectal BoNT-A injections were screened. Eighteen patients (all female) met the inclusion criteria, whereas the remaining patients were excluded due to lack of prior SNM failure. Among these 18 preselected patients, 3 were subsequently excluded because of insufficient data. The demographic characteristics of the study population are summarized in Table 1.

The median follow-up duration was 22.5 months (range, 4.4–103.2 months). Patients received a median of 2 BoNT-A injections, ranging from 1 to 8 injections per patient. The median interval between injections was 9.8 months, with intervals ranging from a minimum of 5.5 months to a maximum of 18.4 months.

Efficacy

A significant reduction in CCFIS was observed following intramural rectal BoNT-A injections, as illustrated in Fig. 2. Mean CCFIS values were significantly lower after treatment (8.73±5.76) compared to baseline (14.0±3.36), with a mean difference of 5.27 (95% confidence interval, 2.53–8.01; P=0.001). Median CCFIS values also significantly decreased from 15 (range, 8–20) before treatment to 8 (range, 0–20) after treatment (P=0.001). Similarly, median VAS scores for symptom severity significantly decreased from 4 (range, 0–5) before treatment to 2 (range, 0–5) after treatment (P=0.001).

Throughout the study period, only 1 patient experienced worsening of CCFIS, and 2 patients showed no improvement. CCFIS scores improved in all other cases after treatment (Fig. 3). No adverse events were reported throughout the study period.

DISCUSSION

Our study provides long-term evidence supporting the efficacy of intramural rectal BoNT-A injections in managing urge FI. Notably, these findings were obtained in a patient population with SNM failure, a subgroup often facing limited therapeutic alternatives. The observed significant and sustained reductions in both CCFIS and VAS symptom scores suggest that BoNT-A injections may serve as an effective salvage therapy, potentially reducing the need for invasive or palliative interventions such as definitive colostomy.

The emergence of BoNT-A injections as a treatment for urge FI stems from the need for effective, minimally invasive alternatives to surgery. Initially utilized in urology for conditions such as neurogenic detrusor overactivity (NDO) and overactive bladder (OAB), BoNT-A demonstrated promising symptom control by modulating muscle hyperactivity, paving the way for its application in colorectal disorders. The first evidence supporting BoNT-A for urge FI emerged from 2 pilot studies. In 2012, Bridoux et al. [8] reported a 50% reduction in clinical severity scores and improved quality of life in 6 patients. Subsequently, in 2016, Gourcerol et al. [9] confirmed these findings in 26 patients, showing significant improvement in CCFIS and Fecal Incontinence Quality of Life scores at 3 months. A major step forward came in 2023 with a randomized controlled trial by Leroi et al. [10], demonstrating substantial short-term reductions in daily FI and urgency episodes in the BoNT-A group compared to placebo, with a favorable safety profile. More recently, our team published the first long-term efficacy data on intramural rectal BoNT-A injections for urge FI, reporting a median follow-up of 2 years and a median reinjection interval of 9.8 months [11]. Our findings indicated that reinjection successfully restored treatment efficacy, enabling sustained symptom relief. The current study further reinforces these findings, demonstrating comparable symptom improvement and injection efficacy duration. With a median follow-up of 22.5 months, patients received a median of 2 injections, with a median reinjection interval of 9.8 months. The significant reduction in CCFIS median values (15 [range, 8–20] vs. 8 [range, 0–20], P=0.001) and VAS median scores (4 [range, 0–5] vs. 2 [range, 0–5], P=0.001) after treatment further supports the long-term efficacy of BoNT-A, even in the challenging subgroup of SNM nonresponders. These findings reinforce BoNT-A’s role as a minimally invasive and effective alternative, potentially delaying or even preventing the need for radical surgical interventions, such as colostomy.

Notably, in urology—particularly in OAB management—several studies have reported median durations of BoNT-A efficacy extending beyond the commonly cited 3 to 6 months. For example, a long-term study by Nitti et al. [13] demonstrated a median duration of effect of 7.6 months in patients receiving onabotulinumtoxinA for OAB, with sustained improvements in urinary symptoms and quality of life. Similarly, Cruz et al. [14] reported a median duration of response of approximately 42.1 weeks (around 9.7 months) in patients with NDO. These findings suggest that BoNT-A therapeutic duration may vary according to factors such as dosage, injection technique and sites, and patient characteristics. These aspects may partly explain the longer reinjection interval observed in our cohort.

The efficacy of BoNT-A in urge FI is primarily linked to its ability to modulate rectal compliance and sensorimotor function. By blocking acetylcholine release at the neuromuscular junction, BoNT-A reduces excessive rectal contractions, thus enhancing stool retention capacity and delaying urgency episodes. This therapeutic approach is inspired by urological applications, where BoNT-A injections into the detrusor muscle effectively manage NDO and OAB. In these conditions, BoNT-A has provided symptom control comparable to, or superior to, SNM [15, 16], further justifying its potential application in urge FI treatment.

Clearly differentiating the subtypes of FI is essential to define the target population for the technique studied here. According to Rome IV criteria, FI is characterized by recurrent, uncontrolled fecal passage lasting at least 3 months [17]. Its complex pathophysiology involves isolated or combined dysfunction of rectal compliance, sensitivity, sphincter apparatus, and neural regulation, along with stool consistency as an additional key factor. This complexity results in distinct clinical presentations typically classified into 3 subtypes based on patient awareness: active FI (patients perceive stool but cannot retain it), passive FI (unperceived stool leakage), and mixed FI (combining active and passive episodes) [3]. Differentiating these subtypes is crucial, as studies have revealed significant differences in sphincteric tone, rectal compliance, and treatment response [18]. To date, published studies on intramural rectal BoNT-A injections have exclusively targeted urge FI due to its distinct pathophysiological profile.

The aim of our study was to evaluate the efficacy of intramural rectal BoNT-A injections for urge FI. These encouraging results support existing data and suggest a potential role for this innovative approach within the therapeutic algorithm. Although BoNT-A was used in this study after SNM failure, findings from our previous work [11] and the study by Leroi et al. [10] indicate that it could also be considered earlier in the therapeutic algorithm, following first-line treatment failure. Given its demonstrated efficacy and favorable safety profile, BoNT-A may offer significant advantages over other surgical options that have been progressively abandoned due to inconsistent outcomes and morbidity [3, 6, 19, 20]. Nonetheless, additional comparative studies involving larger cohorts are necessary to better define BoNT-A’s optimal position, particularly relative to SNM, in the management of urge FI.

This study has several limitations. Its retrospective design may have introduced selection and information biases, and the small sample size limits the generalizability of our findings. Furthermore, the retrospective approach restricts the accuracy and completeness of adverse event reporting. As data collection was based on medical records and routine follow-up visits, minor, transient, or delayed adverse events may have been underreported or entirely undocumented. Additionally, the absence of standardized monitoring protocols and patient diaries could have contributed to variability in how adverse effects were identified, recorded, and interpreted across individual cases. In our study, the decision to perform reinjection was based on clinical judgment by the referring physician in response to recurrent or persistent symptoms, assessed during scheduled follow-up visits every 3 months. Establishing specific thresholds for clinical scores (e.g., worsening CCFIS or VAS scores) could standardize decision-making, particularly in prospective study designs. The absence of such standardization may impact the reproducibility of our results, particularly regarding the number of reinjections required and the intervals between them. Nevertheless, while objective clinical scores enhance methodological rigor and reproducibility in therapeutic evaluations, they may not fully capture subjective patient improvements. This consideration is especially relevant in functional disorders like FI, where discrepancies are frequently observed between patient-reported outcomes—such as VAS scores—and validated clinical scores. Additionally, patient preferences and expectations, which were not assessed in this study, may significantly influence therapeutic decision-making. Individual experiences, perceived benefits, and quality-of-life considerations can greatly affect a patient's desire to repeat or discontinue treatment.

Despite these limitations, our results provide encouraging long-term data on intramural rectal BoNT-A injections in the challenging subgroup of SNM nonresponders. These findings support the potential role of this therapeutic approach and underscore the need for larger prospective studies to confirm its position within the therapeutic management of urge FI.

ARTICLE INFORMATION

Conflict of interest

No potential conflict of interest relevant to this article was reported.

Funding

None.

Acknowledgments

The authors thank Gwendoline Matignon (Department of Gastroenterology, Hôpital Nord, Assistance Publique–Hôpitaux de Marseille, Aix-Marseille Université) for her valuable assistance in data entry.

Author contributions

Conceptualization: all authors; Data curation: PON; Formal analysis: PON; Investigation: all authors; Methodology: all authors; Resources: VV; Software: PON; Validation: VV; Writing–original draft: PON; Writing–review & editing: all authors. All authors read and approved the final manuscript.

Fig. 1.

Anatomical landmarks for intramural rectal botulinum toxin injection.

Fig. 2.

Cleveland Clinic Fecal Incontinence Score (CCFIS) before and after treatment (n=15).

Fig. 3.

Individual changes in the Cleveland Clinic Fecal Incontinence Score (CCFIS) before and after intramural rectal botulinum toxin A injection.

Table 1.

Baseline characteristics of the population (n=15)

Characteristic	Value
Age (yr)	63.8±12.9
Sex
Male	0 (0)
Female	15 (100)
Body mass index (kg/m²)	24.7±5.4
Previous abdominal surgery^a	13 (86.7)
Associated urinary incontinence	8 (53.3)
Previous treatment
Sacral neuromodulation	15 (100)
Posterior tibial nerve stimulation	7 (46.7)
Sphincter repair surgery	4 (26.7)
Transanal irrigation system	2 (13.3)
Follow-up duration (mo)	22.5 (4.4–103.2)
Before rectal BoNT-A injection
CCFIS before rectal BoNT-A injection	15 (8–20)
Symptom severity (VAS^b)	4 (0–5)
High-resolution anorectal manometry (n=11)^c
Resting sphincter pressure (mmHg)	53.4 (18.2–118.4)
Squeeze sphincter pressure (mmHg)	96.4 (26.2–170.6)

Values are presented as mean±standard deviation, number (%), or median (range).

BoNT-A, botulinum toxin A; CCFIS, Cleveland Clinic Fecal Incontinence Score; VAS, visual analog scale.

^aExcluding anorectal surgery. ^bThe VAS for fecal urgency assessment ranges from 0 to 5. ^cMissing data excluded.

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