Effects of temporary sacral nerve stimulation on gastrointestinal motility and function in patients with chronic refractory slow-transit constipation.

BACKGROUND: The efficacy of sacral nerve stimulation (SNS) on patients with chronic refractory slow-transit constipation is controversial and its mechanism of action on gastrointestinal motility and transit is not fully understood. The aim of this study was to document the effects of temporary SNS on the gastrointestinal and biliary tract motility and on gastrointestinal transit in patients with refractory slow-transit constipation. METHODS: This was a prospective interventional study. Patients with slow-transit chronic constipation, unresponsive to any conservative treatment, were enrolled between January 2013 and December 2018. Patients' quality of life [patient assessment of constipation quality of life (PAC-QOL) questionnaire], constipation scores (Cleveland Clinic Constipation Score) colonic transit time (CTT), orocecal transit time (OCTT), gastric and gallbladder kinetics, together with the assessment of the autonomic nerve function were evaluated before and during temporary SNS. RESULTS: 14 patients (12 females, median age 38 years, range 24-42 years) had temporary SNS. The Cleveland Clinic Constipation Score did not change compared to baseline (23 ± 3 vs 21.4; p = 070). The PAC-QOL did not improve significantly during the stimulation period. Gallbladder/stomach motility (half-emptying time) did not change significantly before and after SNS. OCTT was delayed at baseline, as compared to standard internal normal values, and did not change during SNS. CTT did not improve significantly, although in two patients it decreased substantially from 97 to 53 h, and from 100 to 65 h. CONCLUSIONS: Temporary SNS did not have any effect on upper/lower gastrointestinal motility and transit in patients with severe constipation.

Short-term outcome of percutaneous tibial nerve stimulation for low anterior resection syndrome: results of a pilot study.

AIM: Percutaneous tibial nerve stimulation (PTNS) is a minimally invasive procedure which has been demonstrated to be effective in faecal/urinary incontinence but has never been tested in low anterior resection syndrome (LARS). The severity of LARS may be evaluated by the LARS score, but rectal cancer treatments may also affect urinary and sexual function, which are not explored by the LARS score. The Three Axial Perineal Evaluation (TAPE) score is a new validated index addressing the overall pelvic floor functions. This study aims to assess the efficacy of PTNS in LARS patients and to evaluate the results by the LARS and TAPE scores. METHODS: Twenty-one patients operated on for rectal cancer between 2009 and 2014 complaining of LARS underwent PTNS (12 sessions of 30 min each). Six patients reported urinary incontinence and all except two (men) were sexually inactive. The LARS score and the TAPE score questionnaires were administered at baseline and after 6 months of follow-up. RESULTS: At 6 months' follow-up, nine patients reported a significant improvement of faecal incontinence and 3/6 an improvement of urinary incontinence after PTNS. Median LARS score significantly decreased from 32 to 27 (P = 0.009), while the median TAPE score improved significantly from 55 to 58 (P = 0.004). CONCLUSIONS: PTNS may be a further option in the treatment of selected patients with LARS and in addition may improve associated urinary incontinence. The severity of LARS can be detected by the LARS score; however, the adoption of the TAPE score is preferred in the case of concomitant urinary and/or sexual problems not explored by the LARS score.

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

BACKGROUND: Sacral nerve stimulation (SNS) has proven short- to medium-term effectiveness for the treatment of faecal incontinence (FI); fewer long-term outcomes have been presented and usually in small series. Here, the long-term effectiveness of SNS was evaluated in a large European cohort of patients with a minimum of 5 years' follow-up. METHODS: Prospectively registered data from patients with FI who had received SNS for at least 5 years from ten European centres were collated by survey. Daily stool diaries, and Cleveland Clinic and St Mark's incontinence scores were evaluated at baseline, after implantation and at the last follow-up. SNS was considered successful when at least 50 per cent symptom improvement was maintained at last follow-up. RESULTS: A total of 407 patients underwent temporary stimulation, of whom 272 (66·8 per cent) had an impulse generator implanted; 228 (56·0 per cent) were available for long-term follow-up at a median of 84 (i.q.r. 70-113) months. Significant reductions in the number of FI episodes per week (from median 7 to 0·25) and summative symptom scores (median Cleveland Clinic score from 16 to 7, St Mark's score from 19 to 6) were recorded after implantation (all P < 0·001) and maintained in long-term follow-up. In per-protocol analysis, long-term success was maintained in 71·3 per cent of patients and full continence was achieved in 50·0 per cent; respective values based on intention-to-treat analysis were 47·7 and 33·4 per cent. Predictive analyses determined no significant association between pretreatment variables and successful outcomes. Risk of long-term failure correlated with minor symptom score improvement during the temporary test phase. CONCLUSION: SNS remains an effective treatment for FI in the long term for approximately half of the patients starting therapy.

The Three Axial Perineal Evaluation (TAPE) score: a new scoring system for comprehensive evaluation of pelvic floor function.

AIM: Abnormalities of one pelvic floor compartment are usually associated with anomalies in the other compartments. Therapies which specifically address one clinical problem may potentially adversely affect other pelvic floor activities. A new comprehensive holistic scoring system defining global pelvic function is presented. METHOD: A novel scoring system with a software program is presented expressing faecal, urinary and gynaecological functions as a geometric polygon based on symptom-specific questionnaires [the three axial pelvic evaluation (TAPE) score] where differences in overall geometric area vary from normal. After validation in healthy volunteers, its clinical performance was tested on patients with obstructed defaecation, genital prolapse and urinary/faecal incontinence treated by the stapled transanal rectal resection (STARR) procedure, colpo-hysterectomy and sacral nerve modulation, respectively. The TAPE score was correlated with the Pelvic Floor Impact Questionnaire 7 quality of life score. RESULTS: There was good inter-observer variation and internal consistency between two observers recording the TAPE score in normal volunteers. In the STARR patients, constipation improved but the TAPE score was unchanged because of deterioration in other pelvic floor functions leading to an unchanged overall postoperative recorded quality of life. Conversely, incontinent patients treated with sacral nerve stimulation improved their function showing concomitant improvements in TAPE scores and quality of life indices. Similar correlative improvements were noted in patients undergoing hysterectomy for genital prolapse. CONCLUSION: The TAPE score defines the impact of symptom-specific treatments on the pelvic floor and may provide an opportunity for comparison of clinical data between units and in clinical trials of specific medical and surgical pelvic floor management.

Sacral neuromodulation for bowel dysfunction: a consensus statement from the Italian group.

BACKGROUND: Representatives from the Italian centers experienced in sacral neuromodulation (SNM) for the treatment of bowel dysfunction met in order to define the current clinical practice in Italy and to produce a consensus statement regarding indications for this therapy and patient management. METHODS: Fifty Italian colonproctologists were asked to complete a questionnaire concerning their clinical practice in SNM (290 questions, grouped within 4 broad areas). Physicians expressed their opinion by completing the questionnaire, assigning to each statement their level of agreement according to the 5-point Likert scale; the data were analyzed by attributing to each expert's answers a weight proportional to the degree of experience. During a meeting held 2 months later, the critical aspects of the therapy were re-examined and discussions held with the goal of reaching an agreement on controversial topics. The available literature was reviewed. RESULTS: Patient selection criteria, etiology, diagnostic investigations, test procedures and implantation, follow-up and evaluation of results have been reviewed. The aim was to achieve an algorithm for patient management, showing the place of SNM in the treatment of bowel dysfunction. The approach in case of treatment failure was also discussed. CONCLUSIONS: Analysis of the data collected reveals substantial consensus at the national level concerning all the main points with regard to the therapy. The recommendations expressed in this article can be considered as national guidelines and taken into account by the principal international implantation centers.

The effects of sacral nerve stimulation on continence are temporarily maintained after turning the stimulator off.

AIM: Sacral nerve stimulation is an effective treatment for urinary and faecal incontinence even though its mechanism of action is uncertain. Central nervous system involvement by 'setting-up' neurological mechanisms appointed to control pelvic function has been hypothesized. The study aimed to evaluate whether the effects of long-term sacral nerve stimulation are memorized and therefore maintained after switching off the stimulator. METHOD: Patients having sacral nerve stimulation for faecal and/or urinary incontinence for at least 1 year had the stimulator turned off and the results monitored. Data recorded with the stimulator off were compared with post-implant data. If symptoms recurred the stimulator was switched back on. Nineteen patients entered the study. Fourteen had faecal and/or urinary incontinence and five had faecal incontinence alone. The symptoms were assessed by means of a bowel function diary and dedicated questionnaire. RESULTS: In 10 patients symptoms recurred at different intervals after a median off period of 3.4 months with a probability of symptom relapse of 55%. The Fecal Incontinence Quality of Life (FIQL) score did not show any significant difference in nine patients with the stimulator off for at least 1 year. No factors predictive of symptom recurrence were identified although an idiopathic aetiology, severity of disease and urinary incontinence had higher hazard ratios. During the off period, none of the scores and episodes of incontinence showed significant changes compared with the on period. CONCLUSION: The effects of sacral nerve stimulation on faecal and urinary incontinence were maintained in about half of patients after switching the stimulator off, but in some symptoms returned after different periods of time. The data shed new light on possible effects of sacral nerve stimulation on brain neuroplasticity in the control of continence.

Factors affecting the outcome of temporary sacral nerve stimulation for faecal incontinence. The value of the new tined lead electrode.

AIM: Sacral nerve stimulation (SNS) is an effective but expensive treatment for faecal incontinence. About 50% of the patients are unresponsive for unknown reasons, hence knowledge of any factors predictive of success would be highly desirable. The aim of this study was to analyse the potential factors associated with a successful outcome of the temporary test of electrostimulation. METHOD: Eighty-five patients with faecal incontinence were tested for SNS. The cause was idiopathic in 45, iatrogenic or obstetric in 28, spinal lesion or neurological diseases in nine and anal malformation in three patients; 43 were tested with a unipolar electrode and 42 with a quadripolar electrode. The severity of faecal incontinence was evaluated using the American Medical System (AMS) score and Wexner's score. RESULTS: A positive response was obtained in 45 patients (53%); 40 (47%) were implanted with a permanent pulse generator. Responders and nonresponders were comparable in age, duration of incontinence, anal manometry, pudendal nerve terminal motor latency and diabetes. Unipolar electrode test (PNE test) was able to elicit positive responses in 18 of 43 (42%) and the quadripolar in 27 of 42 patients (P < 0.001). Type of incontinence and gender did not affect the success rate. Patients with idiopathic incontinence had a significantly higher response rate (P =0.022). Multivariate regression analysis indicated use of a quadripolar electrode as the only independent variable predicting the success of SNS (OR = 5.58, P = 0.009). CONCLUSION: Use of the quadripolar electrode is the only factor significantly related to the success of SNS.

Fecal incontinence: up to date on pathophysiology and treatment.

This study analyzes the most recent insight into the pathophysiology of fecal incontinence considering each of the factors contributing to the mechanism of fecal continence both during urgency to defecate and in resting state. In fact different types of incontinence are caused by different damage to one or more of these physiologic factors. The second part of the study focuses on the therapeutic choices of fecal incontinence. The recent introduction of sacral nerve electrostimulation and the progressive broadening of its clinical indications is progressively replacing and challenging other traditional surgical techniques because of their disappointing long-term results and because they are much more invasive. An emerging new treatment based on the injection of anal bulking agents is nowadays even more preferred for the less severe cases of fecal incontinence. An increasing number of materials is now proposed by the industry in order to identify the best biocompatible material to be injected trans-anally. Traditional surgery could be reserved for patients non-responding to these new treatments.

Short-term sacral nerve stimulation for functional anorectal and urinary disturbances: results in 40 patients: evaluation of a new option for anorectal functional disorders.

PURPOSE: There are several options in the treatment of fecal incontinence; it is often difficult to choose the most appropriate, adequate treatment. The consolidated experience gained in the urologic field suggests that sacral nerve stimulation may be a further option in the choice of treatment. The aim of our study was to evaluate the preliminary results of the peripheral nerve evaluation test obtained in a multicenter collaborative study on patients with defecatory and urinary disturbances. METHODS: Forty patients (9 males; mean age, 50.2; range, 26-79 years) underwent the peripheral nerve evaluation test, 28 (70 percent) for fecal incontinence and 12 (30 percent) for chronic constipation. Fourteen (35 percent) patients also had urinary incontinence; six had urge incontinence, two had stress incontinence, and six had retention incontinence. Associated diseases were scleroderma (2 patients), spinal injuries (4 patients), and syringomyelia (1 patient). All the patients underwent preliminary investigations with anorectal manometry, pudendal nerve terminal motor latency testing, anal ultrasound, defecography, and if required, urodynamic tests. The electrode for sacral nerve stimulation was positioned percutaneously under local anesthesia in the S2 (4), S3 (34), or S4 (1) foramen unilaterally (1 patient not accounted for because of no response to acute test), based on the best motor and subjective responses of paresthesia of the pelvic floor. Stimulation parameters were average amplitude, 2.8 (range, 1-6) V and average frequency, 15 to 25 Hz. RESULTS: The mean duration of the tests was 9.9 (range, 7-30) days; tests lasting fewer than seven days were not evaluated. There were four early displacements of the electrode. In 22 of the 25 evaluable patients with fecal incontinence, there was an improvement of symptoms (88 percent), and 11 (44 percent) were completely continent to liquid or solid stools, whereas in 7 symptoms were unchanged. Mean number of episodes of liquid or solid stool incontinence per week was 8.1 (range, 4-18) in the prestimulation period and 1.7 (range, 0-12) during the peripheral nerve evaluation test. (P = 0.001; Wilcoxon's signed-rank test). The most important manometric findings were: increase of maximum rest pressure (39.4 +/- 7.3 vs. 54.3 +/- 8.5 mmHg; P = 0.014, Wilcoxon's test) and maximum squeeze pressure (84.7 +/- 8.8 vs. 99.5 +/- 1.1 mmHg; P = 0.047), reduction of initial threshold (63.6 +/- 5.2 vs. 42.4 +/- 4.7 ml; P = 0.041) and urge sensation (123.8 +/- 0.6 vs. 78.3 +/- 8.9 ml; P = 0.05). An improvement was also found in patients with constipation, with reduction in difficulty emptying the rectum, with prestimulation at 7 (range, 2-21) episodes per week and end of peripheral nerve evaluation test at 2.1 (range, 0-6) episodes per week, P < 0.01) and in the number of unsuccessful visits to the toilet, which dropped from 29.2 (7-24) to 6.7 (0-28) per week (P = 0.01). The most important manometric findings in constipated patients were an increase in amplitude of maximum squeeze pressure during sacral nerve stimulation (prestimulation, 63 +/- 0 mm Hg; end of peripheral nerve evaluation test, 78 +/- 1 mm Hg; P = 0.009) and a reduction in rectal volume for urge threshold (prestimulation, 189 +/- 52 ml; end of peripheral nerve evaluation test, 139 +/- 45 ml; P = 0.004). CONCLUSIONS: In functional bowel disorders short-term sacral nerve stimulation seems to be a useful diagnostic tool to assess patients for a minor invasive therapy alternative to conventional surgical procedure.

Chilaiditi's syndrome. Successful surgical correction by colopexy.

We describe the case of a patient affected by the Chilaiditi's syndrome, the interposition of the small or large bowel between the inferior face of the diaphragm and the liver, a rare anomaly, often asymptomatic. A 50-year-old man came to our outpatients clinic because of persistent pain in the right abdominal region. Two attempts to perform colonoscopy failed because of the impossibility of passing through the transverse colon. A double contrast enema indicated only sigmoid diverticulitis. Only after abdominal radiography was the abnormal position of the right colon noted. At surgery the right colon was totally intraperitoneal and positioned between the diaphragm and liver, which was smaller than normal. The right colon was repositioned and fixed to the anterior abdominal wall. The postoperative course was uneventful and the right abdominal pain disappeared completely. In conclusion, surgical treatment of Chilaiditi's syndrome may be required in cases of persistent abdominal pain.

Outcome and predictors of success of biofeedback for constipation.

BACKGROUND: A study was undertaken to determine outcome and to identify predictors of success for biofeedback for constipation. METHODS: Patients who had at least one biofeedback session were evaluated whether or not they completed a treatment course. Parameters assessed included use of cathartics, number of spontaneous bowel movements per week, presence of rectal pain, number of biofeedback sessions and results of anorectal physiology. RESULTS: A total of 194 patients (59 male, 135 female) of median age 71 (range 11-96) years, including 30 with concomitant rectal pain, were treated. The median number of spontaneous bowel movements per week before treatment was 0. Some 35 per cent of patients had complete success (three or more spontaneous bowel movements per week with discontinuation of cathartics), 13 per cent had partial success (fewer than three spontaneous bowel movements per week with continued use of cathartics) and 51 per cent had no improvement. Neither patient age, sex nor duration of symptoms significantly affected outcome. Only 18 per cent of patients who had between two and four sessions had complete success, compared with 44 per cent of those who had five or more (P < 0.001). A total of 63 per cent of patients who completed the treatment protocol experienced complete success, compared with 25 per cent of those who self-discharged (P < 0.0001). CONCLUSIONS: This large study indicates that the success rate of biofeedback for patients with constipation is less than previously reported. However, the success rate improves significantly after five or more sessions and is significantly related to the patient's willingness to complete treatment.

Biofeedback for intractable rectal pain: outcome and predictors of success.

PURPOSE: A number of modalities have been used for the treatment of intractable rectal pain, with varying degrees of success. Electromyography (EMG)-based biofeedback therapy has been used in the treatment of this condition during the past six years. MATERIALS AND METHODS: Medical records of 86 patients who completed at least one session of biofeedback for rectal pain between February 1989 and August 1995 were retrospectively reviewed. All sessions were one-hour outpatient encounters with a trained biofeedback therapist. There were 31 male and 55 female patients with a median age of 68 (range, 12-96) years. Surgery (19.8 percent) or stress (15.1 percent) were frequently cited as precipitating factors for the development of rectal pain. Eleven patients completed only one session of biofeedback and were excluded from further analysis. Of the remaining patients, 28 complained of concomitant constipation. Assessment of the benefit of therapy was based on the patients' subjective reports of the level of symptoms, aided by a linear analog scale. RESULTS: Twenty six patients (34.7 percent) reported an improvement in symptoms. Outcome was not influenced by patients' ages (P = 0.63), duration of symptoms (P = 1.0), or a prior history of surgery (P = 0.14). Alleviation of symptoms was not significantly related to the presence of paradoxical puborectalis contraction demonstrated on either EMG (P = 1) or defecography (P = 0.12). Importantly, outcome was significantly improved in patients who completed the treatment schedule compared with those who self-discharged (P < 0.001). CONCLUSIONS: Although idiopathic rectal pain is difficult to treat, EMG-based biofeedback can produce alleviation of symptoms. However, success depends on patients' willingness to pursue a full course of therapy.

Electrostimulated gracilis neosphincter for faecal incontinence and in total anorectal reconstruction: still an experimental procedure?

The possibility of converting an easily fatiguable muscle like the gracilis muscle into a fatigue-resistant one using chronic electrostimulation has renewed interest in Pickrell's procedure. Between July 1991 and June 1996, 9 patients (2 M; 7 F) mean age = 45 y (range 14-72) underwent dynamic graciloplasty using Medtronic electrostimulators. Five patients had faecal incontinence (2 congenitally anomaly, 1 neurological, 2 post-operative) and 4 had a perineal colostomy performed either simultaneously (two cases) or at 3 to 4 years after abdominoperineal excision of the rectum. Early post-operative complications included distal tendon necrosis [1], perineal colostomy breakdown [1], detachment of the gracilis tendon [2] and seroma in the thigh [1]. Long-term complications included rectocele with faecal impaction in one patient with imperforate anus, anal stricture in one patient who had refashioning of a perineal colostomy, and displacement of the lead from the main nerve in 3 with external expulsion in 2. The patient with anal stricture was successfully treated with anoplasty but subsequently returned to an abdominal colostomy due to stricture recurrence 2 years later. The rectocele was successfully treated using a transvaginal approach. Electrical conversion of the muscle was completed in all patients but long term functional results are available for only 5 cases. Manometry revealed a significant improvement in anal pressure under electro-stimulation and the continence grading scale score significantly improved in 4 patients. The technique is applicable to a very selected group of patients with no other options but is still in the experimental phase and should not be performed outside controlled trials. Repeated hospitalisation and reoperations are often required although the complication rate may diminish and improve with experience.

Fast-to-slow muscle conversion by chronic electrostimulation: effects on mitochondrial respiratory chain function with possible implications for the gracilis neosphincter procedure.

The effects of chronic, around the clock, low-frequency electrostimulation on the respiratory chain activity and cytochrome content of freshly isolated mitochondria were evaluated in rabbit skeletal muscle before and after 30 days of continuous or cyclical electrostimulation using a totally implantable system and a training programme now used in humans. The respiratory activity measured in state III increased strongly after electrostimulation. The efficiency of the respiratory chain increased significantly after electrostimulation but the activity of complex [(reduced nicotinamide adenine dinucleotide dehydrogenase) did not increase. The amount of cytochromes a and a3, b562, and c and c1 increased clearly after electrostimulation. The respiratory activity rate of mitochondria obtained after continuous electrostimulation was apparently higher than after cyclical electrostimulation. Chronic uninterrupted low-frequency electrostimulation, using a clinical training programme, induces an increase in mitochondrial respiratory chain activity in purified mitochondria of skeletal muscle. These changes are the basis of induced resistance to fatigue in fast-to-slow muscle conversion by chronic electrostimulation.

Vaginal repair of rectocele after dynamic graciloplasty for fecal incontinence due to imperforate anus.

A 35-years-old woman developed obstructed defecation due to a large (6 cm) non-emptying rectocele one year after successful electrostimulated gracilis neosphincter operation for correction of fecal incontinence after surgery for imperforate anus. Surgical correction of the rectocele was performed by a trans-vaginal approach due to the poor elasticity of the neoanus and avoidance of possible damage to the neosphincter. After physiological investigations, including defecography, the patient had a resection of the posterior vaginal mucosal wall, a double layer plication of the muscular wall with non-absorbable suture and a longitudinal mucosal suture. The postoperative course was uneventful. Defecography, performed 3 and 6 months later, showed a marked reduction of the rectocele (2 cm) which corresponded to clinical improvement. Occurrence of disabling rectocele can be considered a possible long term complication after successful electrostimulated neosphincter procedure in patients at risk for developing a rectocele; a successful repair can be obtained using trans-vaginal approach without the risk of neosphincter damage. Transvaginal repair of rectocele in similar clinical situations may be recommended.