Abstract
Anal incontinence is an embarrassing problem that strongly impairs quality of life and often leads patients to depression, anxiety and social isolation. Despite several treatments, reviews concluded that it is difficult to suggest a treatment algorithm which is valid for all patients. In fact, each patient has his own history and different therapies may be proposed, according to clinical and instrumental preoperative evaluation. Sacral nerve stimulation is mainly indicated in patents affected by active fecal incontinence, especially if associated with concomitant bladder dysfunction. A valid option is also represented by tibial nerve stimulation as an initial treatment associated with pelvic floor rehabilitation or as a bridge to other treatments. Stem cell therapy still remains a new approach with good preliminary outcomes, but further studies are needed to identify the source of stem cells guaranteeing the best outcome, considering the costs and the patient’s involvement. Finally, transanal irrigation is spreading as an alternative approach to fecal incontinence after the failure of conservative therapy or as an additional treatment after surgery.
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Keywords
- Fecal incontinence
- Mesenchymal stem cell
- Transanal irrigation
- Tibial nerve stimulation
- Sacral nerve stimulation
1 Sacral Nerve Stimulation
The early experiences with sacral nerve stimulation for refractory overactive bladder (OAB) [1] by urologists stimulated colorectal surgeons to use this procedure also for bowel dysfunctions, such as fecal incontinence (FI) [2] and chronic constipation (CC) [3, 4]. The first experience for FI was described by Matzel [2], and then the International Consultation on Incontinence in 2013 introduced sacral nerve stimulation (SNS) as a first-line treatment for FI in patients without or with minimal sphincter defect and as a second choice in those with moderate or large defects [5].
1.1 How It Works
The sacral nerves S2–S4 modulate pelvic sensitivity and the motility of the urologic and gastrointestinal functions of the pelvic floor. Electrical stimulation of the sacral roots creates a modulation of motor, sensory and autonomous nerve pathways in both the peripheral and central system, accounting for good outcomes in such different conditions as FI, CC, OAB, urinary incontinence, and low anterior resection syndrome (LARS) [6].
1.2 Patient Selection
Patients with prevalent active fecal incontinence are the best candidates, even if they have a damaged sphincter [7]. A large group of patients may have associated symptoms such as urinary incontinence, chronic pelvic pain or CC, which may also improve with SNS. Patients are instructed to keep a bowel diary before and during the trial stimulation, which can last for 4–8 weeks. A ≥ 50% improvement following the trial period is considered good, leading to the definitive implant. The contraindications for SNS are the need for magnetic resonance (MR) or therapeutic ultrasound, sacral skin sepsis, pregnancy or uncompliant patients. In 2020 MR-compatible devices, also with a rechargeable stimulator, were made available, which has extended the surgical indications.
1.3 Surgical Procedure
The procedure requires fluoroscopy. The patient lies in a prone position with the legs lower than the pelvis and a pillow under the lower abdomen to straighten the sacral curvature. The SNS trial may be performed using a temporary or a permanent electrode. In the first case, the temporary electrode remains connected to a stimulator for 14 days and is then removed; in the case of a permanent tined lead electrode, the definitive stimulator may be implanted 4–6 weeks after the trial stimulation. The procedure is generally performed under local anesthesia so as to allow testing of the sensory perception of flutter/vibration in the anovaginal/scrotal region or motor response.
The first step involves placing the needle in both S3 foramina, testing the response and choosing the better side. Then, the electrode is positioned with three poles placed further inside the medial sacral surface and connected through a subcutaneous tunnel with an external stimulator. In the case of failure, both the external stimulator and the electrode are removed, taking care to do this slowly and checking that that the electrode is intact. In the case of a good response, instead, only the external connection is removed and the implantable stimulator is placed in the subcutaneous tissue, generally on the contralateral side to the electrode.
1.4 Complications
The most frequent complications are pain at the site of the implant, infection, and loss of efficacy occurring early (within 1Â year) or after 2Â years or more requiring surgical revision in 33% [8]. The pain at the site of the implant is managed by changing the site or the depth of stimulator placement. Local infection requires removal of all devices and planning a second implant after wound healing (at least 6Â months). Sometimes the tined lead records high impedance during the follow-up and may be a cause of failure. In this case, simultaneous explantation and repositioning of a new electrode may solve the problem.
2 Percutaneous Tibial Nerve Stimulation
The first uses of tibial nerve stimulation (TNS) methods were reported in 1983 [9] through adhesive electrodes and then in 1999 [10] through needle electrodes in posterior tibial nerve stimulation (PTNS) to treat urinary dysfunctions such as lower urinary tract symptoms or OAB.
2.1 Procedure
The original technique consists of placing a 34-gauge needle in the lower leg, 3–4 cm above the medial malleolus and a grounding pad on the ipsilateral calcaneus. The patient lies supine with the knees adducted and flexed (frog position). Generally, the current levels have a range of 0.5–0.9 mA at 10–20 Hz and a pulse width of 200 μs and the intensity of the current is adjusted to the patient’s motor response often visible from the flexion of the big toe or extension of the entire foot or on the sensory response in the ankle area or on the sole of the foot.
Although some studies have shown the efficacy of TNS for both urinary and bowel dysfunctions, PTNS has been hypothesized to be more effective as the proximity of the needle to the tibial nerve attenuates the effect of skin impedance, and lower current intensities are sufficient to have a sensory and motor stimulation [11]. The duration of the treatment is about 20–30 min while the frequency of the treatments can be variable [12]. Some authors have already hypothesized that longer or more frequent treatments yield faster results [13].
2.2 Literature Results
Thomas et al. randomized 30 patients with fecal incontinence to receive treatment once a day or twice a week and demonstrated that patients in the daily group experienced a significant improvement in lifestyle and embarrassment on the Rockwood FI quality of life (QoL) assessment [14]. The actual benefits of PTNS on FI treatment are not yet reliably established. In 2015, Knowles et al. randomized 227 patients to receive PTNS or sham stimulation failing to demonstrate any effective benefit of PTNS to treat FI in adults [15]. The most recent results on PTNS use are more encouraging, as in most studies the manometric results intended as resting pressure and squeeze pressure and the Wexner score after treatment were improved [16, 17]. In a trial by Solon et al., 81 patients with FI performed PTNS with an 80% success rate. In these patients the rates of FI and defecatory urgency were significantly reduced in the first year and remained so until the end of the 2-year follow-up, also leading to an improvement in QoL [18].
3 Stem Cell Therapy
The current application of mesenchymal stem cells (MSCs) has its origin in the experiments of Caplan in 1991, who demonstrated that bone marrow (BM) transplantation into different sites induces a de novo ectopic bone and marrow [19].
BM, as well as adipose tissue (AT), dental pulp, and umbilical cord, is a source of MSCs/progenitor cells, but AT represents the ideal source due to the high concentration of regenerative cells, easy access and low risk associated with autologous therapies. Owing to these characteristics, new processing devices have now been developed and made available on the market to obtain ready-to-use, minimally manipulated autologous MSCs, such as Lipogems (Lipogems International S.p.A., Milan, Italy) [20].
In recent decades the use of human MSCs derived from AT has spread in different surgical fields [21], with a recent application to treat AI [22]. The whole surgical procedure including pre- and post-treatment 3D 360° transanal ultrasound has already been described [23].
However, autologous AT currently represents least common source of MSCs for AI treatment. In fact, in a recent review the most frequent sites were skeletal muscle and BM. In 44 studies, MSCs originated from muscle in 28 studies (17 skeletal and 11 smooth), from BM in 10, and from AT in 6. Eight studies used neural cells for bioengineered constructs and one publication used umbilical cord [24].
Hence, the overall preclinical and clinical results have demonstrated the safety of MSCs to treat AI. Although the preliminary results were highly promising, only three studies were controlled with placebo injection. Further studies are therefore needed to identify the source of MSCs guaranteeing the best outcome, considering the costs and the patient’s involvement.
4 Transanal Irrigation
Transanal irrigation (TAI), also known as retrograde irrigation (RI), represents an alternative approach to the management of FI after the failure of conservative therapy or as additional treatment after surgical treatment. The use of this method goes back in time, and the control of continence with irrigation or enema was the first treatment described in history. In recent times, TAI was first used in 1987 in children with spina bifida suffering from FI. Subsequently, its use also spread for other disorders and in 1989 Iwama et al. used a conventional colostomy irrigation set through the anus in order to clean the last part of the colon in patients with defecatory urgency and impaired bowel control after low anterior resection [25]. The main goal of TAI is to restore a regular bowel routine and, for this reason, its field of application has expanded, with TAI being used for a series of intestinal dysfunctions ranging from incontinence, constipation, neurogenic diseases, up to LARS [26].
4.1 Procedure
The patient, sitting on the toilet, can autonomously introduce a short probe into the rectum through the anus. The probe is connected to a plastic bag that can be filled with lukewarm tap water. With a balloon catheter delivery system, once the catheter is inserted, the balloon is inflated inside the rectum, which allows continence to be maintained during administration of the enema. With a cone delivery system, the cone has to be held in place during instillation of the irrigation fluid and the patient needs a degree of flexibility. The water is instilled either by gravity or by means of a pump that the patient can activate or deactivate differently depending on the model. It is common to consider 400–500 cm3 of warm water to be an appropriate starting volume for irrigation in adults [27] but there is little evidence in the literature about optimal irrigation volumes. A randomized trial compared high- and low-volume irrigations in adult patients with CC [28] but the volume of water and the frequency of administrations can vary depending on the patient’s requirements and bowel disorder.
4.2 How It Works
TAI does not appear to alter the function of the anorectal sphincter but rather it increases rectal tolerability and its distension. One study found that, in patients with FI treated with TAI, the resting and squeeze pressures were relatively lower in the follow-up. This finding, however, is to be attributed to the course of the disease rather than to TAI as the patients with CC treated with TAI did not show any alteration of sphincter function [29]. TAI is a type of treatment that requires the patients’ commitment but has relatively rare side effects and can be stopped or resumed at any time. It is also relatively cheap and the training can be delivered entirely by the nursing staff without the aid of a doctor [30].
4.3 Literature Results
Most published studies analyze the efficacy of TAI simultaneously on FI and CC [31]. Alterations in lifestyle, co**, depression, social isolation and embarrassment are the fundamental elements lowering the QoL of patients suffering from FI [32]. Although most of the studies do not use validated questionnaires, the results tend to suggest an increase in the QoL of patients who perform TAI [30, 33]. In 2006, Christensen et al. found that TAI improved symptoms related to QoL in spinal cord–injured patients [34]; more recently, other studies have confirmed the marked improvement in QoL also in other categories of defecatory disorders [35, 36] and in patients with LARS [37]. Although it has generally been shown that TAI increases the QoL of patients with defecatory dysfunction, the drop-out rate with this therapy is still very high and, in some series, less than 50% of patients continued TAI [38]. The main reasons are dislike of the treatment, resolution of the symptoms, time consumption, side effects, and practical problems such as fluid leakage or catheter expulsion [33, 39]. Recently, a retrospective series of 108 patients analyzed the predictors of compliance in the treatment of fecal disorders. In this study, patients with FI gave the best results and 54.5% remained compliant with TAI. In the analysis of predictive factors, training sessions were found to be the only factor that predicts patient compliance with TAI [38]. Patient education in TAI remains a key step in this treatment. Although the procedure is in most cases well tolerated and easy to perform, some cases of rectal and enterovaginal perforations have been described [36, 40]. A recent global audit that collected data from 2005 to 2013 has estimated a risk of perforation of less than 2 per million procedures [41]. Professional nurses experienced in the field of TAI have the task of carefully selecting motivated patients and instructing them by explaining the procedure and any relative and absolute contraindications.
References
Tanagho EA, Schmidt RA. Bladder pacemaker: scientific basis and clinical future. Urology. 1982;20(6):614–9.
Matzel KE, Stadelmaier U, Hohenfellner M, Gall FP. Electrical stimulation of sacral spinal nerves for treatment of faecal incontinence. Lancet. 1995;346(8983):1124–7.
Ganio E, Masin A, Ratto C, et al. Short-term sacral nerve stimulation for functional anorectal and urinary disturbances: results in 40 patients: evaluation of a new option for anorectal functional disorders. Dis Colon Rectum. 2001;44(9):1261–7.
Malouf AJ, Wiesel PH, Nicholls T, et al. Short-term effects of sacral nerve stimulation for idiopathic slow transit constipation. World J Surg. 2002;26(2):166–70.
Abrams P, Cardozo L, Wagg A, Wein A. Incontinence (Volume 1). 6th ed. Bristol, UK: International Continence Society; 2017.
Huang Y, Koh CE. Sacral nerve stimulation for bowel dysfunction following low anterior resection: a systematic review and meta-analysis. Colorectal Dis. 2019;21(11):1240–8.
Ratto C, Litta F, Parello A, et al. Sacral nerve stimulation is a valid approach in fecal incontinence due to sphincter lesions when compared to sphincter repair. Dis Colon Rectum. 2010;53(3):264–72.
Hetzer FH, Bieler A, Hahnloser D, et al. Outcome and cost analysis of sacral nerve stimulation for faecal incontinence. Br J Surg. 2006;93(11):1411–7.
McGuire EJ, Zhang SC, Horwinski ER, Lytton B. Treatment of motor and sensory detrusor instability by electrical stimulation. J Urol. 1983;129(1):78–9.
Nuhoğlu B, Fidan V, Ayyildiz A, et al. Stoller afferent nerve stimulation in woman with therapy resistant over active bladder; a 1-year follow up. Int Urogynecol J. 2006;17(3):204–7.
van der Pal F, van Balken MR, Heesakkers JPFA, et al. Percutaneous tibial nerve stimulation in the treatment of refractory overactive bladder syndrome: is maintenance treatment necessary? BJU Int. 2006;97(3):547–50.
Sarveazad A, Babahajian A, Amini N, et al. Posterior tibial nerve stimulation in fecal incontinence: a systematic review and meta-analysis. Basic Clin Neurosci. 2019;10(5):419–31.
Yoong W, Ridout AE, Damodaram M, Dadswell R. Neuromodulative treatment with percutaneous tibial nerve stimulation for intractable detrusor instability: outcomes following a shortened 6-week protocol. BJU Int. 2010;106(11):1673–6.
Thomas GP, Dudding TC, Bradshaw E, et al. A pilot study to compare daily with twice weekly transcutaneous posterior tibial nerve stimulation for faecal incontinence. Colorectal Dis. 2013;15(12):1504–9.
Knowles CH, Horrocks E, Bremner SA, et al. Percutaneous tibial nerve stimulation versus sham electrical stimulation for the treatment of faecal incontinence in adults (CONFIDeNT): a double-blind, multicentre, pragmatic, parallel-group, randomised controlled trial. Lancet. 2015;386(10004):1640–8.
LĂ³pez-Delgado A, Arroyo A, Ruiz-Tovar J, et al. Effect on anal pressure of percutaneous posterior tibial nerve stimulation for faecal incontinence. Colorectal Dis. 2014;16(7):533–7.
Manso B, Alias D, Franco R, et al. Percutaneous electrical stimulation of the posterior tibial nerve for the treatment of fecal incontinence: manometric results after 6 months of treatment. Int J Colorectal Dis. 2020;35(11):2049–54.
Solon JP, Waudby P, O’Grady H. Percutaneous tibial nerve stimulation can improve symptoms and quality of life in selected patients with faecal incontinence – A single-centre 5-year clinical experience. Surgeon. 2020;18(3):154–8.
Caplan AI. Mesenchymal stem cells. J Orthop Res. 1991;9(5):641–50.
Bianchi F, Maioli M, Leonardi E, et al. A new nonenzymatic method and device to obtain a fat tissue derivative highly enriched in pericyte-like elements by mild mechanical forces from human lipoaspirates. Cell Transplant. 2013;22(11):2063–77.
Naldini G, Sturiale A, Fabiani B, et al. Micro-fragmented adipose tissue injection for the treatment of complex anal fistula: a pilot study accessing safety and feasibility. Tech Coloproctol. 2018;22(2):107–13.
Sarveazad A, Newstead GL, Mirzaei R, et al. A new method for treating fecal incontinence by implanting stem cells derived from human adipose tissue: preliminary findings of a randomized double-blind clinical trial. Stem Cell Res Ther. 2017;8(1):40. https://doi.org/10.1186/s13287-017-0489-2.
Sturiale A, Fabiani B, Celedon Porzio F, et al. Micro-fragmented autologous adipose tissue injection to treat anal incontinence – a video vignette. Colorectal Dis. 2020;22(11):1767–8.
Balaphas A, Meyer J, Meier RPH, et al. Cell therapy for anal sphincter incontinence: where do we stand? Cell. 2021;10(8):2086. https://doi.org/10.3390/cells10082086.
Iwama T, Imajo M, Yaegashi K, Mishima Y. Self washout method for defecational complaints following low anterior rectal resection. Jpn J Surg. 1989;19(2):251–3.
Annicchiarico A, Martellucci J, Solari S, et al. Low anterior resection syndrome: can it be prevented? Int J Colorectal Dis. 2021;36(12):2535–52.
Emmett C, Close H, Yiannakou Y, Mason J. Trans-anal irrigation therapy to treat adult chronic functional constipation: systematic review and meta-analysis. BMC Gastroenterol. 2015;15:139. https://doi.org/10.1186/S12876-015-0354-7.
Emmett C, Close H, Mason J, et al. Low-volume versus high-volume initiated trans-anal irrigation therapy in adults with chronic constipation: study protocol for a randomised controlled trial. Trials. 2017;18(1):151. https://doi.org/10.1186/S13063-017-1882-Y.
Faaborg PM, Christensen P, Buntzen S, et al. Anorectal function after long-term transanal colonic irrigation. Colorectal Dis. 2010;12(10 Online):e314–9.
Crawshaw AP, Pigott L, Potter MA, Bartolo DCC. A retrospective evaluation of rectal irrigation in the treatment of disorders of faecal continence. Colorectal Dis. 2004;6(3):185–90.
Mekhael M, Kristensen H, Larsen H, et al. Transanal irrigation for neurogenic bowel disease, low anterior resection syndrome, faecal incontinence and chronic constipation: a systematic review. J Clin Med. 2021;10(4):753. https://doi.org/10.3390/jcm10040753.
Bartlett L, Nowak M, Ho YH. Impact of fecal incontinence on quality of life. World J Gastroenterol. 2009;15(26):3276–82.
Juul T, Christensen P. Prospective evaluation of transanal irrigation for fecal incontinence and constipation. Tech Coloproctol. 2017;21(5):363–71.
Christensen P, Bazzocchi G, Coggrave M, et al. A randomized, controlled trial of transanal irrigation versus conservative bowel management in spinal cord-injured patients. Gastroenterology. 2006;131(3):738–47.
Koch S, Melenhorst J, van Gemert W, Baeten C. Prospective study of colonic irrigation for the treatment of defaecation disorders. Br J Surg. 2008;95(10):1273–9.
Emmanuel A, Kumar G, Christensen P, et al. Long-term cost-effectiveness of transanal irrigation in patients with neurogenic bowel dysfunction. PLoS One. 2016;11(8):e0159394. https://doi.org/10.1371/journal.pone.0159394.
Rosen H, Robert-Yap J, Tentschert G, et al. Transanal irrigation improves quality of life in patients with low anterior resection syndrome. Colorectal Dis. 2011;13(10):e335–8.
Bildstein C, Melchior C, Gourcerol G, et al. Predictive factors for compliance with transanal irrigation for the treatment of defecation disorders. World J Gastroenterol. 2017;23(11):2029–36.
Christensen P, Krogh K, Buntzen S, et al. Long-term outcome and safety of transanal irrigation for constipation and fecal incontinence. Dis Colon Rectum. 2009;52(2):286–92.
Gallo G, Graziani S, Realis Luc A, et al. Teaching transanal irrigation (TAI): why it is mandatory. Tech Coloproctol. 2018;22(3):239–41.
Christensen P, Krogh K, Perrouin-Verbe B, et al. Global audit on bowel perforations related to transanal irrigation. Tech Coloproctol. 2016;20(2):109–15.
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Naldini, G. et al. (2023). Sacral and Percutaneous Tibial Nerve Stimulation, Stem Cell Therapy, and Transanal Irrigation Device. In: Docimo, L., Brusciano, L. (eds) Anal Incontinence. Updates in Surgery. Springer, Cham. https://doi.org/10.1007/978-3-031-08392-1_10
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