Effects of Combining Music Therapy, Light Therapy, and Chromotherapy in the Treatment of Chronic Pain Patients: A Pilot Study.

Background: It is currently considered that around 30% of chronic pain patients are totally refractory to medical treatment. Among patients who remain responsive to medical treatment, it is estimated that between 20% and 50% are likely to discontinue treatment due to severe side effects. Given these therapeutic difficulties, a significant number of patients turn to complementary therapies. Objective: The LineQuartz® is a medical device that combines 3 complementary therapies, namely, music therapy, light therapy, and chromotherapy. We propose to evaluate its effectiveness in chronic pain patients. Methods: Between October 2021 and October 2022, 44 patients aged between 23 and 85 years (mean: 55.4 years) were included in a prospective study. All patients had background pain intensity greater than 4/10 on the Numerical Pain Scale (NS). Treatment consisted of 4 half-hour sessions, divided into one session per week for 3 weeks (21 days). Patients were assessed by the Brief Pain Inventory (BPI) and the Hospital Anxiety and Depression scale (HAD) the day before starting treatment (Day 0) and the day after the end of treatment (Day 22). Results: Apart from the BPI item, "relationship with others," all items improved significantly (p < 0.050). Background pain intensity (NS) and frequency of painful attacks improved very significantly (p < 0.001). The HAD anxiety subscore was also significantly improved (p < 0.001). Discussion. This open pilot study supports the idea that LineQuartz® has a place among complementary therapies dedicated to the treatment of chronic pain. However, these results need to be confirmed by a controlled study.

Ten-year Evaluation of a Large Retrospective Cohort Treated by Sacral Nerve Modulation for Fecal Incontinence: Results of a French Multicenter Study.

OBJECTIVE: The aim of this study was to assess the effectiveness of sacral nerve modulation (SNM) in a large cohort of patients implanted for at least 10 years, quantify adverse event rates, and identify predictive factors of long-term success. SUMMARY BACKGROUND DATA: Few studies have evaluated the long-term success of SNM. METHODS: Data collected prospectively from patients implanted for fecal incontinence (FI) in 7 French centers between January 1998 and December 2008 were retrospectively analyzed. Patient FI severity scores were assessed before and 10 years after implantation. The main evaluation criterion was the success of SNM defined by the continuation of the treatment without additional therapies. The secondary evaluation criteria were the rate of device revisions and explantations. Preoperative predictors of success at 10 years were sought. RESULTS: Of the 360 patients (27 males, mean age: 59 ± 12 years) implanted for FI, 162 (45%) had a favorable outcome 10 years post-implantation, 115 (31.9%) failed, and 83 (23.1%) were lost to follow-up. The favorable outcome derived from the time-to-event Kaplan-Meier curve at 10 years was 0.64 (95% CI 0.58-0.69). FI severity scores were significantly better 10 years post-implantation compared to preimplantation (7.4 ± 4.3 vs 14.0 ± 3.2; P < 0.0001). During the 10-year follow-up, 233 patients (64.7%) had a surgical revision and 94 (26.1%) were explanted. A history of surgery for FI and sex (male) were associated with an increased risk of an unfavorable outcome. CONCLUSIONS: Long-term efficacy was maintained in approximately half of the FI patients treated by SNM at least 10 years post-implantation.

A European snapshot of psychosocial characteristics and patients' perspectives of faecal incontinence-do they correlate with current scoring systems?

PURPOSE: To compare the current clinical scoring systems used to quantify the severity of symptoms of faecal incontinence (FI) to patients' subjective scoring of parameters of psychosocial well-being. METHODS: Patients referred to six European centres for investigation or treatment of symptoms of FI between June 2017 and September 2019 completed a questionnaire that captured patient demographics, incontinence symptoms using St. Mark's Incontinence score (SMIS) and ICIQ-B, psychological well-being (HADS, Hospital Anxiety and Depression Scale), and social interaction (a three-item loneliness scale). RESULTS: Three hundred eighteen patients completed questionnaires (62 men, mean age 58.7). Sixty percent of the respondents were aged under 65. Median SMIS was 15 (11-18), ICIQ-B bowel pattern was 8 (6-11) and bowel control was 17 (13-22), similar across all demographic groups; however, younger patients were more likely to experience symptoms of depression and anxiety (HADS score > 10, 65.2% of patients age < 65 vs 54.9% of those ages > = 65, p = 0.03) with lower quality of life (ICIQ-B QoL, median score 19 (14-23)) vs age > = 65 (16 (11-21) (p < 0.005)). On loneliness score 25.5% reported often feeling isolated from others. One of the most significant concerns by patients was the fear and embarrassment related to unpredictable episodes of incontinence. CONCLUSION: The SMIS remains a useful tool for quantifying incontinence symptoms but may underestimate the psychosocial morbidity associated with unpredictable episodes of incontinence. Interventions aimed at decreasing anxiety and to address feelings of disgust may be helpful for a significant number of patients requiring treatment for FI.

Efficacy and safety of sacral nerve modulation for faecal incontinence after pelvic radiotherapy.

OBJECTIVE: To assess the efficacy and safety of sacral nerve modulation (SNM) in patients with faecal incontinence (FI) after pelvic radiotherapy in comparison with results of SNM for FI related to other conditions. METHODS: Prospectively collected data from patients who underwent SNM therapy between January 2010 and December 2015 at 7 tertiary colorectal units were reviewed retrospectively. Patients with FI following pelvic radiotherapy were identified and matched (1:2) for age and sex with 38 patients implanted over the same period for FI without previous radiotherapy. The treatment was considered favourable if the patient reported any therapeutic benefit from SNM, had no further complaints or interventions and did not consider stopping the treatment. Long-term results, surgical revision and definitive explantation rates were compared. RESULTS: Among 352 patients who received a permanent SNM implant, 19 (5.4%) had FI following pelvic radiotherapy. After a mean follow-up of 3.5 ± 1.9 years, the cumulative successful treatment rates were similar between the groups (p = 0.60). For patients with FI following pelvic radiotherapy, the cumulative success rates were 99.4% [85.4-99.8], 96.7% [78.1-99.6], 91.7% [70.4-98.1] and 74.6% [48.4-94.8] at 1, 2, 3 and 5 years respectively. The revision and definitive explantation rates for infection did not differ significantly. CONCLUSION: The long-term success rate of SNM for FI after pelvic radiotherapy is similar to that of SNM for FI related to other more frequent conditions. Our study suggests that FI after pelvic radiotherapy could be improved with SNM without an increased risk of complication.

Is Sacral Nerve Modulation a Good Option for Fecal Incontinence in Men?

OBJECTIVE: The objective was to assess the efficacy and the safety of sacral nerve modulation (SNM) in men with fecal incontinence (FI) compared with those of SNM in women. METHOD: Prospectively collected data from patients from seven tertiary colorectal units who underwent an implant procedure between January 2010 and December 2015 were reviewed retrospectively. Outcomes and surgical revision and definitive explantation rates were compared between men and women. RESULTS: A total of 469 patients (60 men [12.8%]; mean age = 61.4 ± 12.0 years) were included in the study, 352 (78.1%) (31 men [8.8%]) of whom received a permanent implant. The ratio of implanted/tested men was significantly lower than the ratio of implanted/tested women (p = 0.0004). After a mean follow-up of 3.4 ± 1.9 years, the cumulative successful treatment rates tended to be less favorable in men than in women (p = 0.0514): 88.6% (75.6-95.1), 75.9% (60.9-86.4), 63.9% (48.0-77.3), and 43.9% (26.7-62.7) at one, two, three, and five years, respectively, in men; 92.0% (89.1-94.2), 84.2% (80.3-87.4), 76.8% (72.3-80.7), and 63.6% (57.5-69.3) at one, two, three, and five years, respectively, in women. The revision rate for infection and the definitive explantation rate for infection were higher in men than in women (p = 0.0001 and p = 0.0024, respectively). CONCLUSION: Both short- and long-term success rates of SNM for FI were lower in men than in women. The revision and definitive explantation for long-term infection rates were significantly higher in men.

Long-term Outcome of Hirschsprung Disease: Impact on Quality of Life and Social Condition at Adult Age.

BACKGROUND: Hirschsprung disease is a rare congenital disease typically requiring surgical treatment during childhood. Quality of life and social condition at adult age can be impaired by disease-specific sequelae. OBJECTIVE: This study aimed to assess the quality of life and social outcome of adult patients operated on for Hirschsprung disease during childhood. DESIGN: Patients operated on for Hirschsprung disease during childhood were identified and specific questionnaires were sent to them. SETTINGS: Data from 2 referral centers were used. PATIENTS: Patients who completed the questionnaires regarding quality of life and social condition were included. MAIN OUTCOME MEASURES: The Hirschsprung's Disease and Anorectal Malformations Quality of Life disease-specific questionnaire (8 dimensions explored; each scored from 0 to 100 maximum score) and a sociodemographic questionnaire were sent to identified patients. Sociodemographic data were compared with those of the French general population. RESULTS: Thirty-four patients had Hirschsprung disease (men, 76%; mean age, 32 years) were included in the study. Mean total Hirschsprung's Disease and Anorectal Malformations Quality of Life score was 611 of 800 (maximum score 800). The 2 most impaired dimensions were "physical symptoms" and "diarrhea" (62.9/100 and 73.6/100). Fecal continence was only marginally affected (mean score, 89/100). Patients with Hirschsprung disease achieved better educational levels than the French general population. Parental and marital status did not differ between the 2 groups. LIMITATIONS: This study had the limitations inherent to a retrospective study. CONCLUSION: The quality of life of adult patients with Hirschsprung disease sequelae is marginally impaired in this study. Despite the consequences of this congenital abnormality, the condition eventually achieved can be considered as satisfactory. See Video Abstract at http://links.lww.com/DCR/A917.

Functional Results and Quality of Life Following Magnetic Anal Sphincter Augmentation in Severely Incontinent Patients.

OBJECTIVE: Magnetic anal sphincter augmentation is a novel surgical option in the treatment of severe fecal incontinence. This study aimed to analyze functional results, quality of life, and satisfaction after implantation in the mid-term, and to identify factors associated with success of this new treatment. METHODS: All patients, who underwent magnetic anal sphincter augmentation procedure at a single center between December 2008 and January 2016, were consecutively included. Symptom severity [Cleveland Clinic Incontinence Score (CCIS)], quality of life [Fecal-Incontinence Quality of Life Questionnaire (FIQL)], bowel diary data, and patients' satisfaction were assessed before and after implantation. RESULTS: Forty-five patients (43 female), mean (s.d.) age 66.82 (±10.07), were followed for a median of 36 months (range 6-84). Two patients were explanted and 1 lost to follow-up. On a 3-week diary, major leakage rate significantly improved as did CCIS and FIQL. No significant difference was seen for flatus and minor leaks. Postoperative decrease of CCIS by ≥5.5 points correlated best with satisfaction, expressed by 22 patients (48% in intention-to-treat analysis). An independent predictive factor for success after implantation was no previous fecal incontinence surgical treatment. CONCLUSIONS: Satisfaction, functional, and quality of life outcomes improve significantly following magnetic anal sphincter augmentation.

Long-Term Outcome Following Implanted Pulse Generator Change in Patients Treated With Sacral Nerve Modulation for Fecal Incontinence.

BACKGROUND: Long-term outcome of sacral nerve modulation (SNM) patients after implanted pulse generator (IPG) change for fecal incontinence (FI) is unknown. This study reported the outcome and long-term satisfaction after a change of an exhausted IPG, questioning the need to concurrently change the electrode and looking for factors involved in the maintenance of treatment efficiency. METHODS: Patients with fecal incontinence and with a Medtronic IPG implanted in a single center (2001-2016) were prospectively followed up. Satisfaction was graded according to a patient-reported outcome measure from 0 to 10. A pre- and postreplacement FI severity score (Cleveland Clinic Fecal Incontinence Score) and Fecal Incontinence Quality of Life questionnaire were also collected. RESULTS: In 170 patients with SNM, 39 had an IPG replacement. At a median of 29 month after replacement, 32 and 7 patients reported respectively a similar and reduced satisfaction (7.6 ± 1.62 vs. 5.5 ± 0.87), p < .001. Satisfied patients were younger (65 years vs. 76 years, p < .001). Cleveland Clinic Fecal Incontinence Scores were not significantly different, but the satisfied group had a significantly better Fecal Incontinence Quality of Life score (p = .047). Only 5 patients needed an electrode change at the time of the IPG replacement or later. CONCLUSIONS: Patient satisfaction and efficiency remain high after IPG replacement. Older age has a negative impact on the outcome. Electrode replacement is rarely required and does not need to be performed routinely when an IPG is exhausted. CONFLICT OF INTEREST: Paul-Antoine Lehur has a consulting agreement with Medtronic SA. This had no impact with the results of the study. The other authors have no conflict of interests to declare.

Sacral Nerve Stimulation for Fecal Incontinence: How Long Should the Test Phase Be?

BACKGROUND: Decision-making for pulse generator implantation for sacral nerve stimulation in the management of fecal incontinence is based on the results of a test phase. Its duration is still a matter of debate. OBJECTIVE: The purpose of this study was to determine whether an early positive response during the test phase could predict implantation of a permanent sacral nerve pulse generator. DESIGN: This was a short-term observational cohort study. A positive response was defined as a >50% decrease of fecal leaks compared with baseline. A multivariate logistic regression was computed to predict pulse generator implantation after the first week of the test phase. SETTINGS: The study was conducted in 3 national referral centers. PATIENTS: From January 2006 to December 2012, 144 patients with fecal incontinence enrolled in a prospectively maintained database completed a 2- to 3-week bowel diary, at baseline and during test phase. MAIN OUTCOME MEASURES: The primary outcome was the clinical decision to implant a pulse generator. The primary predictor was a calculated score including the number of leak episodes, bowel movements, and urgencies and the time to defer defecation expressed in minutes during the first screening test week. RESULTS: After the first, second and third week of the test phase, 81 (56%) of 144, 96 (67%) of 144, and 93 (70%) of 131 patients had a positive test. A permanent pulse generator was implanted in 114. Time to defer defecation increased during the 3 weeks of screening. Urgencies were unchanged. The computed score was predictive of a permanent pulse generator implantation (Se = 72.6% (95% CI, 59.8-83.1); Sp = 100% (95% CI, 78.2-100); c-index = 0.86 (95% CI, 0.78-0.94)). LIMITATIONS: No cost analysis or projection based on our proposal to reduce the test phase has been made. CONCLUSIONS: Permanent pulse generator implantation can be safely proposed early (1-week screening) to fast responders. Nonetheless, permanent implantation may be decided as well in patients exhibiting a delayed response. Whether a rapid response to sacral nerve stimulation could be predictive of a long-term response remains to be determined. See Video Abstract at http://links.lww.com/DCR/A452.

Exhausted implanted pulse generator in sacral nerve stimulation for faecal incontinence: What next in daily practice for patients?

PURPOSE: The efficacy of sacral nerve stimulation in faecal incontinence relies on an implanted pulse generator known to have a limited lifespan. The long-term use of sacral nerve stimulation raises concerns about the true lifespan of generators. The aim of the study was to assess the lifespan of sacral nerve stimulation implanted pulse generators in daily practice, and the outcome of exhausted generator replacement, in faecal incontinent patients. METHODS: Faecal incontinent patients with pulse generators (Medtronic Interstim™ or InterstimII™) implanted in a single centre from 2001 to 2014 were prospectively followed up. Generator lifespan was measured according to the Kaplan-Meier method. Patients with a generator explanted/turned off before exhaustion were excluded. Morbidity of exhausted generator replacement and the outcome (Cleveland Clinic Florida Faecal Incontinence (CCF-FI) and Faecal Incontinence Quality of Life (FIQL) scores) were recorded. RESULTS: Of 135 patients with an implanted pulse generator, 112 (InterstimII 66) were included. Mean follow-up was 4.9 ± 2.8 years. The generator reached exhaustion in 29 (26%) cases. Overall median lifespan of an implanted pulse generator was approximately 9 years (95% CI 8-9.2). Interstim and InterstimII 25th percentile lifespan was 7.2 (CI 6.4-8.3) and 5 (CI 4-not reached) years, respectively. After exhaustion, generators were replaced, left in place or explanted in 23, 2 and 4 patients, respectively. Generator replacement was virtually uneventful. CCF-FI/FIQL scores remained unchanged after generator replacement (CCF-FI 8 ± 2 vs 7 ± 3; FIQL 3 ± 0.6 vs 3 ± 0.5; p = ns). CONCLUSION: In this study, the implanted pulse generator observed median lifespan was 9 years. After exhaustion, generators were safely and efficiently replaced. The study also gives insight into long-term needs and costs of sacral nerve stimulation (SNS) therapy.

Sacral nerve stimulation for faecal incontinence - efficacy confirmed from a two-centre prospectively maintained database.

INTRODUCTION: Sacral nerve stimulation (SNS) has been recognised as an effective treatment for faecal incontinence. Many unresolved questions could be answered when comparing large data-series from different centres providing prospective data. AIM: To present data, from an international two-centre SNS prospective database (SNSPD) on functional outcome and management of surgical complications in patients treated with SNS for faecal incontinence. METHOD: The SNSPD was designed in order to gather detailed pre- and perioperative information followed by a close follow-up in all patients undergoing SNS for bowel dysfunction. The SNSPD was open for inclusion of newly SNS implanted patients in May 2009, and closed on 31 December 2013. Two-centres Aarhus, Denmark, and Nantes, France, included and monitored all patients implanted due to bowel dysfunction according to database criteria. RESULTS: In total, 164 faecal incontinent patients with a median follow-up of 22 (range 1-50) months were implanted. The Wexner incontinence score improved from 15 (range, 3-20) at baseline to 9 (range, 0-20) at latest follow-up (P < 0.001) and VAS impact on daily life improved from 85.5 (range, 3-100) to 20 (range, 0-100) (P < 0.001). Additional surgical intervention was required in 19.5 % during follow-up. Repositioning of the pacemaker due to pain or migration was the most common complication in 12.1 %. Infections leading to explantation occurred in 3.0 %.

Surgery for 'asymptomatic' mild primary hyperparathyroidism improves some clinical symptoms postoperatively.

OBJECTIVE AND BACKGROUND: Most primary hyperparathyroidism (pHPT) patients do not conform to the guidelines for parathyroidectomy established by an international panel of specialists and have a mild pHPT. This group is typically defined as 'asymptomatic'. The primary aim of this study was to determine symptom improvement in this 'asymptomatic' group after parathyroidectomy. Secondly, we aimed to create a preoperative clinical score predicting postoperative symptom resolution. DESIGN: A prospective nonrandomized study included patients with mild pHPT. METHODS: A questionnaire (22 items) was given to 'asymptomatic' patients preoperatively and at 3, 6, and 12 postoperative months. A logistic regression was performed to create a preoperative clinical score. RESULTS: One hundred and sixteen patients were included. Postoperatively, HPT was resolved in 98% of patients. Twelve of 22 nonspecific symptoms were improved at 1 year. Subgroups analysis showed a greater improvement in patients <70 years and those with a serum calcium level ≥2.6 mmol/l preoperatively. A clinical score, based on age and five symptoms, was established to predict the clinical improvement after surgery in mild pHPT patients with a positive predictive value of 81%. CONCLUSION: Patients with asymptomatic pHPT have clinical improvement of their symptoms postoperatively even after 1 year. Younger patients and those with higher preoperative calcium levels show the best improvement.

The artificial bowel sphincter: a single institution experience over a decade.

OBJECTIVE: A report on the long-term results of a consecutive series of patients implanted with the Acticon Neosphincter. METHOD: Data were reviewed from a prospective database. From May 1996 to Jan 2010, 52 patients (46 women), mean age 51.5 ± 14.8 years, with severe fecal incontinence for a mean of 10.6 ± 10.5 years, were implanted with 85 devices. All patients had failed conservative management, including 13 with unsuccessful prior surgical treatments. Indications for implantation were sphincter destruction (45), pudendal neuropathy (12), congenital malformation (7), and perineal colostomy (4). Preoperative assessment included anal endosonography, anorectal manometry, and electrophysiologic testing. Incontinence (Wexner) and Quality of Life scores were recorded prior to the procedure and at each follow-up visit, together with annual anal physiology assessments. Cumulative risks of device revision and explantation were evaluated using Kaplan-Meier survival curves. RESULTS: Mean follow-up was 64.3 ± 46.5 months (range, 2-169); 26 patients (50%) required revisions after a mean of 57.7 ± 35.0 months, with 73.1% due to a leaking cuff from a microperforation; 14 patients (26.9%) required definitive explantation after a mean of 14.6 ± 7.9 months, with the majority (42.9%) due to infection; and 9 patients were lost to follow-up. In 35 patients (67.3%) with an activated device, there were significant improvements in both median Wexner (P < 0.0001) and Quality-of-life scores (P = 0.0286). There was a significant difference between preoperative resting anal pressures and closed pressures at activation (P < 0.0001) and latest follow-up (P < 0.0001). CONCLUSION: With careful patient selection, meticulous surgical technique, and dedicated surveillance, favorable long-term results can be achieved with acceptable rates of revision and explantation.

Outcome and management of patients in whom sacral nerve stimulation for fecal incontinence failed.

BACKGROUND: Sacral nerve stimulation fails in 30% to 50% of patients, the outcome that remains largely unreported. OBJECTIVE: We report on the management and outcome of this cohort of patients. DESIGN AND INTERVENTIONS: Ninety-one patients (88 females) with fecal incontinence, median age 63 years (range, 37-81), were candidates for sacral nerve stimulation. The follow-up protocol comprised incontinence and quality-of-life scores. MAIN OUTCOME MEASURES: Failure was defined on an intention-to-treat basis: after the test (<50% decrease of fecal incontinence episodes) or after permanent implantation (Wexner score >8). Subsequent management and functional results were recorded. RESULTS: The mean Wexner score for the cohort decreased from 14.3 at baseline to 7.6 after a median follow-up of 31 months (range, 11-69). Sixty-one (67.0%) patients were implanted with a permanent pacemaker; 36 (39.6%) achieved success (group 1). Failure after permanent implantation occurred in 25 (27.5%) patients after a mean of 34.5 months (group 2). Failure after the test occurred in 30 (33.0%) patients, 12 of whom underwent further surgery (group 3) (including stoma, 2; anal reconstruction, 9; and rectopexy, 1), whereas the remainder chose conservative treatment (group 4). At the end of follow-up, group 1 had significantly lower Wexner scores compared with the rest (P < .0001) and superior Fecal Incontinence Quality of Life scores compared with groups 2 and 4 (P < .0001). Group 3 achieved a greater reduction in Wexner scores compared with groups 2 and 4 (P = .04), although the improvement in Fecal Incontinence Quality of Life scores did not reach statistical significance. LIMITATIONS: This was a nonrandomized study with retrospective stratification of patients. CONCLUSIONS: On an intention-to-treat basis, success can be achieved in up to 40% of patients undergoing sacral nerve stimulation. In those in whom sacral nerve stimulation fails, further surgical treatment can yield favorable results in adequately motivated patients.