Sequential assessment of bowel function and anorectal physiology after anterior resection for cancer: a prospective cohort study.

AIM: The aim of this study was to investigate changes in bowel function and anorectal physiology (ARP) after anterior resection for colorectal cancer. METHOD: Patients were recruited from November 2006 to September 2008. Cleveland Clinic Incontinence (CCI) scores and stool frequency were determined by patient questionnaires before surgery (t0 ) and at three (t3 ), six (t6 ), nine (t9 ) and 12 (t12 ) months after restoration of intestinal continuity. ARP measurements were recorded at T0 , T3 and T12 . Endoanal ultrasound was performed at T0 and T12 . RESULTS: Eighty-nine patients were included. CCI score increased postoperatively then normalized, whereas stool frequency did not change. Patients who had neoadjuvant radiotherapy or a lower anastomosis had increased incontinence and stool frequency in the postoperative period, whereas those with defunctioning stomas or open surgery had increased stool frequency alone. Maximum resting pressure, volume at first urge and maximum rectal tolerance were reduced throughout the postoperative period. Radiotherapy, lower anastomosis and defunctioning stoma (but not operative approach) altered manometric parameters postoperatively. Maximum rectal tolerance correlated with incontinence and first urge with stool frequency. The length of the anterior internal anal sphincter decreased postoperatively. CONCLUSIONS: Incontinence recovers in the first year after anterior resection. Radiotherapy, lower anastomosis, defunctioning stoma and open surgery have a negative influence on bowel function. ARP may be useful if bowel dysfunction persists beyond 12 months.

Reprogramming Sacral Neuromodulation for Sub-Optimal Outcomes: Evidence and Recommendations for Clinical Practice.

OBJECTIVES: In some patients treated for urinary or fecal incontinence with sacral neuromodulation (SNM) persistence of symptoms, a reduction in efficacy or adverse effects of stimulation can occur. In such situations, further programming of the SNM device can help resolve problems. Infrequently hardware failure is detected. This article aims to provide practical guidance to solve sub-optimal outcomes (troubleshooting) occurring in the course of SNM therapy. MATERIALS AND METHODS: A systematic literature review was performed. Collective clinical experience from an expert multidisciplinary group was used to form opinion where evidence was lacking. RESULTS: Circumstances in which reprogramming is required are described. Actions to undertake include changes of electrode configuration, stimulation amplitude, pulse frequency, and pulse width. Guidance in case of loss of efficacy and adverse effects of stimulation, developed by a group of European experts, is presented. In addition, various hardware failure scenarios and their management are described. CONCLUSIONS: Reprogramming aims to further improve patient symptoms or ensure a comfortable delivery of the therapy. Initial changes of electrode configuration and adjustment of stimulation parameters can be performed at home to avoid unnecessary hospital visits. A logical and stepwise approach to reprogramming can improve the outcome of therapy and restore patient satisfaction.

Programming Algorithms for Sacral Neuromodulation: Clinical Practice and Evidence-Recommendations for Day-to-Day Practice.

BACKGROUND: In sacral neuromodulation (SNM), stimulation programming plays a key role to achieve success of the therapy. However to date, little attention has been given to the best ways to set and optimize SNM programming during the test and chronic stimulation phases of the procedure. OBJECTIVE: Standardize and make SNM programming easier and more efficient for the several conditions for which SNM is proposed. METHODS: Systematic literature review and collective clinical experience report. RESULTS: The basic principles of SNM programming are described. It covers choice of electrode configuration, stimulation amplitude, pulse frequency and pulse widths, while use of cycling is also briefly discussed. Step-by-step practical flow charts developed by a group of 13 European experts are presented. CONCLUSIONS: Programming of SNM therapy is not complex. There are few programming settings that seem beneficial or significantly impact patient outcomes. Only four basic electrode configurations could be identified according to four different options to define the cathode. In a majority of patients, the proposed stimulation parameters will allow a satisfactory improvement for long periods of time. A regular follow-up is, however, necessary to assess and eventually optimize results, as well as to reassure patients.

Pudendal nerve stimulation for bowel dysfunction in complete cauda equina syndrome.

OBJECTIVE: Pudendal nerve stimulation (PNS) aims to maximize afferent or efferent stimulation from the sacral plexus. BACKGROUND: We hypothesized this may be a promising new treatment for patients with bowel dysfunction in complete cauda equina syndrome (CES). METHODS: Thirteen patients with complete CES [8 constipation predominant (group 1) and 5 incontinence predominant (group 2)] had a 3-week trial of PNS. Patients who showed a 50% or more improvement in symptoms during the trial phase proceeded to permanent neurostimulator implantation. RESULTS: Five (63%) of the 8 patients in group 1 showed a 50% or more improvement in bowel symptoms during the trial phase and were permanently implanted. The mean Cleveland Clinic constipation score, sense of incomplete evacuation (%), and straining during defecation (%) improved from 17 ± 3.2 to 10 ± 4.5, 94 ± 18% to 30 ± 35%, and 81 ± 23% to 44 ± 38%, respectively. All 5 patients in group 2 showed a 50% or more reduction in incontinent episodes during the trial phase. The mean St Mark's score, ability to defer defecation, and the number of incontinent episodes per week improved from 18 ± 1.0 to 3.8 ± 2.5, 2.2 ± 1.8 to 11 ± 5.5 minutes, and 9.4 ± 10.7 to 0.4 ± 0.5 episodes, respectively, per week. During a median follow-up of 12 (10-22) months of permanent implantation, one patient lost efficacy at 6 months due to lead migration and another required removal and reimplantation of the neurostimulator due to wound infection. CONCLUSIONS: PNS is an effective treatment in the short term for bowel dysfunction in some patients with complete CES.

Bilateral transcutaneous posterior tibial nerve stimulation for the treatment of fecal incontinence.

BACKGROUND: Unilateral posterior tibial nerve stimulation has been shown to improve fecal incontinence in the short term. Posterior tibial nerve stimulation is believed to work by stimulation of the ascending afferent spinal pathways. Bilateral stimulation may activate more of these pathways. This may lead to an improved therapeutic effect. OBJECTIVE: The aim of this study was to assess the efficacy of bilateral transcutaneous posterior tibial nerve stimulation for fecal incontinence. DESIGN: This was a single-group pilot prospective study. SETTING: The study was conducted from June 2012 to September 2012 at the authors' institution. PATIENTS: Twenty patients with fecal incontinence were recruited consecutively. Conservative therapy had failed to improve the fecal incontinence in all 20 patients. INTERVENTION: All patients received 30 minutes of daily bilateral stimulation for 6 weeks. The bilateral stimulation was administered by each patient at home. No further stimulation was given after 6 weeks, and the patients were followed up until their symptoms returned to the prestimulation state (baseline). MAIN OUTCOME MEASURE: The primary outcome measure was a change in the frequency of incontinent episodes per week. RESULTS: Seventeen patients completed 6 weeks of treatment. Two patients achieved complete continence. Ten (59%) achieved a ≥50% reduction in frequency of incontinent episodes. Overall, there was a significant reduction in median (interquartile range) frequency of incontinent episodes per week of 6 (8.25) to 2 (7.25) (p = 0.03). There was a significant improvement in the ability to defer defecation from 3 (4) to 5 (8) minutes (p = 0.03). There was no change in the St Mark's incontinence score. One domain of the Rockwood fecal incontinence quality-of-life score and of the Medical Outcomes Study Short Form 36 score improved significantly. LIMITATIONS: This study was limited by its small size and its lack of blinding and control. CONCLUSIONS: Bilateral transcutaneous posterior tibial nerve stimulation appears to be a cheap and effective treatment for fecal incontinence. It can easily be used by the patient at home.

Long-term outcomes of sacral nerve stimulation for fecal incontinence.

BACKGROUND AND OBJECTIVE: In patients with fecal incontinence who do not benefit from medical or behavioral treatments sacral nerve stimulation is now considered a first-line procedure. Although the efficacy of treatment appears to be sustained in the short and medium term, the long-term results of therapy are relatively unknown. OBJECTIVE: We report the results of chronic sacral nerve stimulation in patients who have had more than 8 years of therapy. DESIGN AND SETTINGS: All patients who underwent sacral nerve stimulation for fecal incontinence from 1996 to 2002 were followed up prospectively. Data were collected prospectively by the use of bowel habit diaries and St Mark's continence scores. Treatment success was defined as >50% reduction in episodes of fecal incontinence with sacral nerve stimulation in comparison with baseline symptoms. RESULTS: Between January 1996 and December 2002, 25 patients (male/female 2:23; median age, 54 years (range, 35-68 years) underwent temporary sacral nerve stimulation. Twenty-three (92%) patients had a greater than 50% improvement in their ability to defer defecation during the trial phase and were considered suitable for chronic stimulation. Over a median follow-up of 114 months (range, 96-164 months), full continence was maintained in 12 (48%) of the 23 patients who received a neurostimulator implant. Two patients lost efficacy at 48 and 60 months after permanent implant for unknown reasons and had the device removed. Three patients died at 3, 8, and 9 years after permanent implant because of unrelated comorbidities. Nine patients required a change of battery at a mean (SD) of 87 (13.5) months. CONCLUSIONS: Sacral nerve stimulation can maintain a persistent clinical benefit in the long term for the majority of patients. Some patients will experience deterioration in their symptoms over time, for reasons yet unknown.

Sacral nerve stimulation for intractable constipation.

OBJECTIVE: Traditional surgical procedures for intractable idiopathic constipation are associated with a variable outcome and substantial morbidity. The symptomatic response, physiological effect and effect on quality of life of sacral nerve stimulation (SNS) were evaluated in patients with constipation (slow transit and normal transit with impaired evacuation). METHODS: In a prospective study at five European sites patients who failed conservative treatment underwent 21 days test stimulation. Patients with >50% improvement in symptoms underwent permanent neurostimulator implantation. Primary end points were increased defecation frequency, decreased straining and decreased sensation of incomplete evacuation. RESULTS: 62 patients (55 female, median age 40 years) underwent test stimulation, of whom 45 (73%) proceeded to chronic stimulation. 39 (87%) of these 45 patients achieved treatment success. After a median 28 (range 1-55) months follow-up, defecation frequency increased from 2.3 to 6.6 evacuations per week (p<0.001). Days per week with evacuation increased from 2.3 to 4.8 (p<0.001). There was a decrease in time spent toileting (10.5 to 5.7 min, p=0.001), straining (75-46% of successful evacuations, p<0.001), perception of incomplete evacuation (71.5-46% of successful evacuations, p<0.001) and subjective rating of abdominal pain and bloating (p<0.001). Cleveland Clinic constipation score (0=no to 30=severe constipation) decreased from 18 to 10 (p<0.001). Visual analogue scale (VAS) score (0=severe to 100=no symptoms) increased from 8 to 66 (p<0.001). Patients with slow and normal transit benefited. Quality of life significantly improved. Colonic transit normalised in half of those with baseline slow transit (p=0.014). CONCLUSION: SNS is effective in the treatment of idiopathic slow and normal transit constipation resistant to conservative treatment. Clinical Trial Number NCT00200005.

Sacral nerve stimulation for the treatment of faecal incontinence related to dysfunction of the internal anal sphincter.

PURPOSE: In patients with faecal incontinence related to isolated internal anal sphincter (IAS) disruption, conservative management is the mainstay of treatment. Surgical repair of the internal sphincter is not successful. This study evaluated the use of sacral nerve stimulation (SNS) in those with faecal incontinence and IAS disruption in whom medical and behavioural treatments had failed. METHODS: Nine patients (seven women, median age 44 years, range 39-62 years), with a history of obstetric or iatrogenic anal sphincter trauma, underwent a trial of SNS. All had passive faecal incontinence, low resting anal sphincter pressure and full thickness IAS muscle disruption of greater than 30 degrees radial extent. The effect of SNS on symptoms was measured by a bowel habit diary and validated questionnaires used to assess impact on quality of life. RESULTS: Eight (89%) patients benefited from temporary stimulation and proceeded to permanent device implantation. Follow-up was at a mean of 46 months (range 2-81). Faecal incontinence decreased from a mean (SD) of 9.9 (10.9) to 1.0 (2.4) episodes per week (p = 0.031), and soiling decreased from 6.1 (1.6) to 1.7 (2.4) episodes per week (p = 0.031), with chronic stimulation. At latest follow-up, three patients had no incontinence, three patients had episodes of minor soiling only, one patient had >75% reduction of incontinent episodes, and two patients remained incontinent. CONCLUSIONS: Sacral nerve stimulation is effective in treating faecal incontinence related to a structurally and functionally abnormal internal anal sphincter. Treatment should not be refused on the basis of IAS disruption.

Comparison of clinical outcome between open and percutaneous lead insertion for permanent sacral nerve neurostimulation for the treatment of fecal incontinence.

PURPOSE: Results from early studies on sacral nerve stimulation are based on a stimulation electrode lead that was placed under direct vision during an open surgical procedure. A percutaneous inserted lead, introduced in 2002, is now widely used. This study was designed to investigate differences in clinical efficacy and adverse complications between the two methods of lead placement. METHODS: Prospectively collected data were analyzed for 48 patients who had undergone permanent sacral nerve stimulation for fecal incontinence at a single institution between 1997 and 2006. Eighteen patients had undergone open lead placement (Group 1) and 30 patients percutaneous lead placement (Group 2). RESULTS: Median follow-up was 51 (range, 22-106) months for Group 1 and 8 (range, 1-40) months for Group 2 patients. There was no difference in patient demographics, severity of incontinence, or physiologic parameters between the two groups. Lead type did not affect the outcome of chronic stimulation with reductions in total episodes of incontinence being similar between the two groups (P = 0.448). No difference in infection or lead dislocation rate between the two groups was identified. CONCLUSIONS: The percutaneously inserted lead seems to be equal to the open inserted lead in terms of clinical efficacy and complication rate in the short-term.

Sacral nerve stimulation for fecal incontinence related to obstetric anal sphincter damage.

PURPOSE: Sphincter repair is the standard treatment for fecal incontinence secondary to obstetric external anal sphincter damage; however, the results of this treatment deteriorate over time. Sacral nerve stimulation has become an established therapy for fecal incontinence in patients with intact sphincter muscles. This study investigated its efficacy as a treatment for patients with obstetric-related incontinence. METHODS: Fecally incontinent patients with external sphincter defects who would normally have undergone overlapping sphincter repair as a primary or repeat procedure were included. Eight consecutive women (median age, 46 (range, 35-67) years) completed temporary screening; all eventually had permanent implantation. RESULTS: Six of eight patients had improved continence at median follow-up of 26.5 (range, 6-40) months. Fecal incontinent episodes improved from 5.5 (range, 4.5-18) to 1.5 (range, 0-5.5) episodes per week (P = 0.0078). Urgency improved in five patients, with ability to defer defecation improving from a median of <1 (range, 0-5) minute to 1 to 5 (range, 1 to >15) minutes (P = 0.031, all 8 patients). There was no change in anal manometry or rectal sensation. There was significant improvement in lifestyle, coping/behavior, depression/self-perception, and embarrassment as measured by the American Society of Colon and Rectal Surgery fecal incontinence quality of life score. CONCLUSIONS: Sacral nerve stimulation is potentially a safe and effective minimally invasive treatment for fecal incontinence in patients with de novo external anal sphincter defects or defects after unsuccessful previous external anal sphincter repair, although numbers remain small.

Obstetric anal sphincter injury: incidence, risk factors, and management.

BACKGROUND AND AIMS: Obstetric sphincter damage is the most common cause of fecal incontinence in women. This review aimed to survey the literature, and reach a consensus, on its incidence, risk factors, and management. METHOD: This systematic review identified relevant studies from the following sources: Medline, Cochrane database, cross referencing from identified articles, conference abstracts and proceedings, and guidelines published by the National Institute of Clinical Excellence (United Kingdom), Royal College of Obstetricians and Gynaecologists (United Kingdom), and American College of Obstetricians and Gynecologists. RESULTS: A total of 451 articles and abstracts were reviewed. There was a wide variation in the reported incidence of anal sphincter muscle injury from childbirth, with the true incidence likely to be approximately 11% of postpartum women. Risk factors for injury included instrumental delivery, prolonged second stage of labor, birth weight greater than 4 kg, fetal occipitoposterior presentation, and episiotomy. First vaginal delivery, induction of labor, epidural anesthesia, early pushing, and active restraint of the fetal head during delivery may be associated with an increased risk of sphincter trauma. The majority of sphincter tears can be identified clinically by a suitably trained clinician. In those with recognized tears at the time of delivery repair should be performed using long-term absorbable sutures. Patients presenting later with fecal incontinence may be managed successfully using antidiarrheal drugs and biofeedback. In those who fail conservative treatment, and who have a substantial sphincter disruption, elective repair may be attempted. The results of primary and elective repair may deteriorate with time. Sacral nerve stimulation may be an appropriate alternative treatment modality. CONCLUSIONS: Obstetric anal sphincter damage, and related fecal incontinence, are common. Risk factors for such trauma are well recognized, and should allow for reduction of injury by proactive management. Improved classification, recognition, and follow-up of at-risk patients should facilitate improved outcome. Further studies are required to determine optimal long-term management.

Permanent sacral nerve stimulation for treatment of functional anorectal pain: report of a case.

PURPOSE: Patients with functional anorectal pain in the absence of an organic cause often have symptoms that are resistant to conventional medical and behavioral therapy. This study assessed the use of sacral nerve stimulation in the treatment of this condition. METHODS: A 56-year-old, female subject with an 18-month history of intermittent severe anorectal pain, in the absence of any evacuatory disorder or gross pathology, underwent temporary then subsequent permanent sacral nerve stimulation. Treatment efficacy was measured by verbal pain scores obtained at baseline, during screening, after screening, and subsequent follow-up. RESULTS: Temporary sacral nerve stimulation of the left S3 root (3-5 V; 14 Hz; 210 microsec) resulted in total alleviation of the patient's symptoms. A verbal pain score of 10/10 preoperatively was reduced to 0/10 with no adverse effects from stimulation. On completing the trial evaluation, the symptoms of pain returned with a verbal pain score of 10/10. A permanent pulse generator was implanted with a Medtronic 3093 quadripolar electrode lead, placed in the left S3 foramen. Results of chronic stimulation showed that pain symptoms were again abolished with no recurrence of symptoms seen at one-year follow-up (1.3 V; 14 Hz; 210 microsec). CONCLUSIONS: Sacral nerve stimulation may be of benefit in the treatment of functional anorectal pain resistant to conventional treatments. The mechanism of action is not known. Further prospective evaluation of a series of patients is required using pain scoring, quality of life, and psychologic assessment to aid selection.