Changing paradigm of sacral neuromodulation and external anal sphincter repair for faecal incontinence in specialist centres.

AIM: The aim of this study was to determine whether the paradigm of surgical intervention for faecal incontinence (FI) has changed between 2000 and 2013. METHOD: This was a multi-centre retrospective study of patients who had undergone either sacral neuromodulation (SNM) or delayed sphincter repair or sphincteroplasty (SR) as a primary surgical intervention for FI in five centres in Europe and one in the United States. The flow of patients according to the intervention, sustainability of the treatment at a minimum follow-up of 5 years, complications and requirement for further interventions were recorded. RESULTS: A total of 461 patients (median age 56 years, range 24-90 years, 41 men) had either SNM or SR as an index operation during the study period [SNM 284 (61.6%), SR 177 (38.4%)]. Among SNM patients, there were 169 revisional operations (change of battery and/or lead, re-siting or removal). At the time of last follow-up 203 patients (71.4%) continued to use SNM. Among SR patients, 30 (16.9%) had complications, most notably wound infection (22, 12.4%). During follow-up 32 patients (18.1%) crossed over to SNM. Comparing two 4-year periods (2000-2003 and 2007-2010), the proportion of patients operated on who had a circumferential sphincter defect of less than 90° was 48 (68%) and 45 (46%), respectively (P = 0.03), while those who had SNM as the primary intervention increased from 29% to 89% (P < 0.05). CONCLUSION: The paradigm of surgical intervention for FI has changed with increasing use of SNM.

Sacral neuromodulation for combined faecal and urinary incontinence following obstetric anal sphincter injury.

AIM: The aim of this study was to investigate the efficacy of sacral neuromodulation (SNM) in the treatment of faecal incontinence and concomitant urinary incontinence in women with a history of obstetric anal sphincter injury (OASIS). METHOD: In this prospective study, consecutive women with faecal incontinence following OASIS accepted for SNM were screened for concomitant urinary incontinence. The primary outcome was the change in urinary incontinence score on the International Consultation on Incontinence Questionnaire for Urinary Incontinence, Short Form (ICIQ-UI-SF), between baseline and 12 months. Secondary outcomes included the change in St Mark's score, sexual function and quality of life, change in grade of urinary incontinence and disappearance of urgency. RESULTS: From March 2012 to September 2014, 39 women with combined faecal incontinence and urinary incontinence received SNM. Thirty-seven women were available for analysis after 12 months. The mean reduction in the ICIQ-UI-SF score between the baseline and 12 months was 5.8 (95% CI 3.7-8.0, P < 0.001). ICIQ-UI-SF was reduced in 29 (78%) women, urinary incontinence resolved in 13/37 (35%, 95% CI 20%-50%) patients, and urgency disappeared in 14/33 (42%, 95% CI 26%-59%). The mean reduction in the St Mark's score was 10.6 (95% CI 8.6-12.7, P < 0.001). Disease-specific quality of life, Euroqual 5-dimension visual analogue scale (EQ-5D VAS) and several areas of sexual function changed significantly for the better. CONCLUSION: More than three-quarters of the women with combined faecal and urinary incontinence following OASIS reported a successful outcome with reduction in ICIQ-UI-SF at 12 months after SNM.

Sacral neuromodulation compared with injection of bulking agents for faecal incontinence following obstetric anal sphincter injury - a randomized controlled trial.

AIM: The purpose of this trial was to compare the effectiveness of sacral neuromodulation (SNM) with a submucosal injection of collagen (Permacol®) in women with faecal incontinence following obstetric anal sphincter injury (OASIS). METHOD: This single-blinded randomized controlled trial at two hospital units in Norway included women with faecal incontinence following OASIS. Eligible women who had had a successful percutaneous nerve evaluation were randomly assigned to SNM or Permacol®. The primary outcome was the difference in the St Mark's incontinence score between baseline and 6 months. Secondary outcomes were changes in the disease-specific quality of life (FIQL) and urinary incontinence (ICIQ-UI-SF) scores. RESULTS: Fifty-eight women were randomly assigned to SNM (n = 30) and Permacol® (n = 28). The reduction in the St Mark's score between baseline and 6 months was 11.2 (SD 5.3) in the SNM group vs 2.3 (SD 5.0) in the Permacol® group, resulting in a difference of 8.9 (95% CI: 6.1-11.7, P < 0.0001). The differences in the four scales of FIQL (lifestyle, coping, depression, embarrassment) were 0.90 (95% CI: 0.50-1.30, P < 0.001), 1.05 (0.62-1.47, P < 0.001), 0.52 (95% CI: 0.16-0.87, P = 0.005) and 0.95 (95% CI: 0.50-1.40, P < 0.001), respectively, in favour of SNM. The difference in the ICIQ-UI-SF was 5.0 (95% CI: 1.97-8.02, P = 0.002) in favour of SNM. There were nine minor adverse events in the SNM group compared with seven in the Permacol® group (P = 0.77). CONCLUSION: SNM was superior to Permacol® in terms of reduction of St Mark's score, ICIQ-UI-SF and the change of the FIQL in women with faecal incontinence following OASIS.

Sacral neuromodulation for faecal incontinence following obstetric sphincter injury - outcome of percutaneous nerve evaluation.

AIM: The purpose of this study was to assess the efficacy of percutaneous nerve evaluation (PNE) in women with faecal incontinence (FI) following obstetric anal sphincter injury and to relate the outcomes to baseline factors, with special emphasis on the extent of the sphincter defect. METHOD: This was a prospective study at a tertiary colorectal referral unit at the University Hospital of North Norway conducted from 2012 to 2014. Sixty-three women underwent a 3-week PNE using a tined lead and the Verify® external neurostimulator. The primary outcome was efficacy, defined as the percentage reduction in weekly FI episodes, and patients with a reduction of 50% or more were defined as responders. Baseline factors affecting the primary outcome were explored. Sphincter defects were classified with a validated three-dimensional endoanal ultrasound defect score. RESULTS: Fifty-six (89%) of the 63 women were responders with a reduction in weekly FI episodes of 94.5%, from a median (interquartile range) of 4.8 (2.0-11.0) to 0.5 (0-2.0) (P < 0.001). Twenty-nine (52%) reported no weekly FI episodes, and urgency episodes disappeared in 18 (32%). In the multivariable linear regression model, efficacy was related to concomitant urinary incontinence (P = 0.04), body mass index (BMI) (P = 0.03) and pain during PNE (P = 0.046) but not to the extent of the sphincter defect (P = 0.1). Responders had a higher St Mark's score than nonresponders (P = 0.046). CONCLUSIONS: The vast majority of women had successful PNE tests. Responders had higher baseline St Mark's scores than nonresponders. Efficacy was related to concomitant urinary incontinence, BMI and pain, not to the extent of the sphincter defect.

Significance of morphometric, DNA cytometric features, and other prognostic markers on survival of endometrial cancer patients in northern Norway.

The objective of this study was to evaluate the prognostic value of nuclear morphometric features and DNA ploidy by flow cytometry next to depth of myometrial invasion and vascular invasion in endometrial cancer of all FIGO stages. A total of 123 women (103 FIGO stage I, eight stage II, and 12 stage III and IV) from northern Norway were studied. The follow-up period was between 7 and 19 years. The median age of patients was 62 years. The primary surgery was performed in the University Hospital of Tromso or in the seven different reference hospitals in the northern part of Norway after an endometrial cancer diagnosis. The histologic, morphometric,flow cytometric and immunohistochemical investigations were based on archival paraffin-embedded material. The information regarding the follow-up data and clinical information were obtained from the medical records. Thirteen (10.6%) patients from the entire group (all stages) but only three (2.7%) of the FIGO stage I and II patients died from locally recurrent or metastatic disease. FIGO substage (P = 0.0006; odds ratio [OR] =16.44, 95% confidence interval [CI] = 3.36-80.45), vascular invasion (P =0.01, OR = 6.42, CI = 1.57-26.34) and nuclear size (P = 0.025, OR = 1.3,CI = 1.05-1.61) were independently correlated with recurrence in a multivariate analysis but histologic grade and DNA ploidy were not. Vascular invasion was poorly reproducible both between and within the same observer, however. In this retrospective study of all stages of endometrial carcinoma with long follow-up periods the primary tumor characteristics nuclear perimeter and FIGO stage were of prognostic significance in addition to the poorly reproducible vessel invasion.