Translation and validation of the international consultation on incontinence questionnaire-Bowel in Danish men and women with pelvic floor disorders.

BACKGROUND: We lack a comprehensive validated Danish questionnaire to evaluate symptoms and bother regarding anal incontinence (AI). The International Consultation on Incontinence Questionnaire-Bowel (ICIQ-B) is an internationally recommended questionnaire containing 21 items, of which 17 are scored in three subscales: bowel pattern, bowel control, and quality of life. AIMS: To translate the ICIQ-B into Danish and to validate the Danish version in pelvic floor disorder (PFD) patients with and without AI. METHODS: The ICIQ-B was translated by a panel of healthcare professionals followed by cognitive interviews with PFD patients attending an outpatient clinic. Revisions were undertaken using an iterative process, and a backward translation was performed for the final version. Pretesting and test-retest of the ICIQ-B were done online and administrated together with the St. Mark's score. Content, structural, convergent and discriminant validity were assessed, followed by an evaluation of relative and absolute reliability, including the smallest real difference (SRD). RESULTS: Thirty cognitive patient interviews were performed, resulting in three revisions. The Danish ICIQ-B was found to be comprehensible and relevant but lacked items addressing the psychological impact of bowel problems. The ICIQ-B was completed online by 227 PFD patients with and without AI. The structural validity of the bowel pattern subscale could not be retrieved. Patients indicating AI had significantly higher ICIQ-B and St. Mark's scores than patients without AI, and ICIQ-B subscale scores correlated moderately with St. Mark's scores. Internal consistency was good except for the bowel pattern subscale. Seventy-six patients completed test-retest. Relative reliability was excellent for subscale scores and moderate or good for single items except for the item concerning stool consistency, which was weak. The SRD was found to be 2.8 for the bowel pattern subscale, 4.3 for bowel control subscale, and 3.6 for the quality-of-life subscale. CONCLUSION: The Danish version of the ICIQ-B can be used for Danish patients with PFD, and discriminant validity is good. The structural validity and the internal consistency of the bowel pattern subscale are questionable, indicating that some items do not represent the underlying construct. Test-retest reliability of the ICIQ-B is acceptable, but the change needed to reflect a real change above the measurement error in each subscale is three to four points.

One-stage implant in sacral neuromodulation for faecal incontinence - short-term outcome from a prospective study.

AIM: Sacral neuromodulation (SNM) is approved for the treatment of faecal incontinence (FI) in a two-stage technique. With standardized implantation, approximately 90% of patients undergo successful Stage I operation and proceed to a permanent implant (Stage II). The aim of this work was to explore the feasibility of SNM as a one-stage procedure and report the 24-week efficacy. METHOD: This study included patients diagnosed with idiopathic FI or FI due to an external anal sphincter defect ≤160° and one or more episodes of FI per week despite maximal conservative therapy. Patients were offered a one-stage procedure if a motor response of the external anal sphincter was achieved in three or more poles with at least one at ≤1.5 mA at lead placement. Patients were followed for 24 weeks. Their evaluation included the Wexner/St Mark's Incontinence Score, Faecal Incontinence Quality of Life score (FIQoL), a visual analogue scale (VAS) for assessing patient satisfaction and a bowel habit diary. RESULTS: Seventy-three patients with a median age of 60 years (interquartile range 50-69 years) completed this prospective study. Episodes of FI were significantly reduced at the 24-week follow-up, from 13 (8-23) at baseline to 2 (0-5) (p-value = 0002). A ≥50% reduction in the number of FI episodes was achieved in 92% of participants. The Wexner score improved significantly from 16 (14-17) at baseline to 9 (5-13) (p-value < 0.001), and the St Mark's score improved significantly from 18 (16-20) to 11 (7-16) (p-value < 0.001). All domains in the FIQoL score and VAS for patient satisfaction improved significantly following the one-stage procedure. CONCLUSION: A one-stage implantation procedure is feasible in selected patients with FI, significantly improving continence, quality of life and patient satisfaction after 24 weeks of follow-up.

Functional Outcome after Laparoscopic Posterior Sutured Rectopexy Versus Ventral Mesh Rectopexy for Rectal Prolapse: Six-year Follow-up of a Double-blind, Randomized Single-center Study.

BACKGROUND: Laparoscopic ventral mesh rectopexy (LVMR) for rectal prolapse has been implemented to reduce postoperative bowel symptoms. The preoperative-to-postoperative change in a double-blinded, randomized study comparing it to laparoscopic posterior sutured rectopexy (LPSR) found no significant difference between the two procedures after one year. The aim of this study was to investigate the long-term functional outcomes. METHODS: From November 2006-January 2014, 75 patients were randomized to LVMR (n = 37) or LPSR (n = 38). In March 2017, questionnaires containing constipation symptom score (PAC-SYM), quality of life score (PAC-QoL), obstructed defecation score (ODS), Cleveland clinic constipation and incontinence scores (CCCS, CCIS) were mailed to all the patients included in the RCT. Prolapse recurrences and mesh complications were recorded. FINDING: Sixty-nine patients were available for long-term follow-up. Questionnaires were completed by 64 patients (94.4%). The median follow-up was 6.1 years. The total PAC-QoL was significantly lower in the LVMR group 0.26 (0.14-0.83) compared to the LPSR group 0.93(0.32-1.61)(P = 0.008). The total PAC-SYM was significantly lower in the LVMR group 0.5 (0.21-0.87) compared to the LPSR group 1.0 (0.5-1.5)(P = 0.031). Except for CCIS, the ODS and the CCCS significantly favored the LVMR group at six years (P = 0.011 & 0.017). Only three(8.82%) patients in the LVMR group developed recurrence compared to seven(23.33%) in the LPSR group (P = 0.111). INTERPRETATION: The long-term functional outcome after LVMR is superior to that after LPSR. Larger multicenter studies are warranted. FUNDING: None.

Management of patients with faecal incontinence.

Faecal incontinence, defined as the involuntary loss of solid or liquid stool, is a common problem affecting 0.8-8.3% of the adult population. Individuals suffering from faecal incontinence often live a restricted life with reduced quality of life. The present paper is a clinically oriented review of the pathophysiology, evaluation and treatment of faecal incontinence. First-line therapy should be conservative and usually include dietary adjustments, fibre supplement, constipating agents or mini enemas. Biofeedback therapy to improve external anal sphincter function can be offered but the evidence for long-term effect is poor. There is good evidence that colonic irrigation can reduce symptoms and improve quality of life, especially in patients with neurogenic faecal incontinence. Surgical interventions should only be considered if conservative measures fail. Sacral nerve stimulation is a minimally invasive procedure with high rate of success. Advanced surgical procedures should be restricted to highly selected patients and only performed at specialist centres. A stoma should be considered if other treatment modalities fail.

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 %.

Baseline factors predictive of patient satisfaction with sacral neuromodulation for idiopathic fecal incontinence.

PURPOSE: Sacral neuromodulation (SNM) is an established treatment for fecal incontinence (FI). A recent study from our group found that the relationship between patient satisfaction and clinical outcome is complex and does not match the traditional used success criteria. Therefore, the ability to predict patient satisfaction must be given priority. The aim of the present study is to identify baseline factors predictive of patient satisfaction, with SNM, for idiopathic FI. METHODS: We analyzed data from patients treated with SNM for idiopathic FI in Aarhus, Denmark, and Maastricht, The Netherlands. A questionnaire considering self-reported satisfaction was mailed to these patients and compared to baseline characteristics. Logistic regression was used to determine the predictive value of baseline demographic and diagnostic variables. RESULTS: In total, 131 patients were included in the analysis. Patient satisfaction with the current treatment result was reported in 75 patients. Fifty-six patients were dissatisfied with SNM treatment, after median 46 months (range 11-122) with permanent implantation. Pudendal nerve terminal motor latency (PNTML) was the solely identified predictor for long-term patient satisfaction. A subgroup univariate-logistic regression analysis showed that PNTML ≤ 2.3 ms at the side of lead implantation was a statistically significant predictor for patient satisfaction (odds ratio (OR) 2.3, 95% confidence interval (CI) 1.01-5.24, p = 0.048). CONCLUSION: Baseline PNTML measurement may be predictive of long-term satisfaction with SNM therapy for idiopathic FI. Further studies are needed to confirm this result.

Sacral nerve stimulation at subsensory threshold does not compromise treatment efficacy: results from a randomized, blinded crossover study.

BACKGROUND AND OBJECTIVE: : Stimulation amplitude used in sacral nerve stimulation (SNS) is at or just above the sensory threshold (ST). This randomized, blinded crossover study aimed to document if stimulation at 75% or 50% of the ST would be as effective as stimulation at the ST for fecal incontinence (FI). METHOD: : FI patients treated with SNS, who were satisfied with current treatment results and had a minimum symptom reduction of 75%, were eligible. Patients were randomized into 3 periods of 4-week stimulation: ST, 75% of the ST, and 50% of the ST. Patients completed a bowel habit diary and questionnaires on bowel functions and patient satisfaction at the study baseline and in each study period. RESULTS: : Nineteen patients (18 females) with a mean follow-up of 51.7 ± 29.9 months were included from January to April 2010. The mean FI episodes per 3 weeks decreased from pre-SNS therapy 33.6 ± 31.6 to 1.1 ± 2.2 at the study baseline (P < 0.001). Decreasing the stimulation amplitude to as low as 50% of the ST did not affect the overall number of incontinent episodes (P = 0.078). The Wexner incontinence score dropped from 16.5 ± 2.5 for pre-SNS therapy to 7.4 ± 3.1 at the study baseline (P < 0.001). Decreasing the stimulation amplitude to ST, 75% of the ST or 50% of the ST, did not change the Wexner score when compared with the study baseline (P = 0.581). In general, patient satisfaction was high at the study baseline and did not deteriorate as the stimulation amplitude was decreased to 50% of the ST (P = 0.932). CONCLUSIONS: : Subsensory stimulation as low as 50% of the ST is as effective as stimulation at or above the ST. The study was approved by the Regional Committee on Biomedical Research Ethics, Denmark, and registered at ClinicalTrials.gov (NCT01130870).

Management of fecal incontinence after treatment for rectal cancer.

PURPOSE OF REVIEW: Anorectal dysfunction constitutes a major problem in patients surviving rectal cancer. In this review, the current options for management of fecal incontinence after treatment for rectal cancer are discussed. RECENT FINDINGS: First line therapy should be conservative measures aimed at symptomatic control. Dietary regiments, fibers, constipating agents and enemas may be tried. Biofeedback is an option to strengthen the external anal sphincter, improve rectal sensitivity and coordinate pelvic floor muscles. Colonic irrigation has been successful to reduce symptoms and improve quality of life. Surgical interventions may be considered if conservative management fails. Sacral nerve stimulation is a successful minimal invasive procedure for the treatment of fecal incontinence; however, evidence of the method after treatment for rectal cancer is still limited. Complex surgical procedures should be limited to only highly selected patients. A stoma should be considered when other treatment modalities have failed. SUMMARY: Systematic evaluation of the postoperative anorectal function in patients treated for rectal cancer should be a standard practice at every follow-up. An individually tailored treatment should be offered to the severely affected patients to minimize their symptoms. The evidence on the most commonly used treatments is sparse, therefore, further randomized controlled studies are needed.