Electrical stimulation of the dorsal clitoral nerve in the treatment of idiopathic defecatory urgency. A pilot study.

PURPOSE: To investigate the effect of dorsal clitoral nerve stimulation (DCNS) on bothersome urgency to defecate with or without fecal incontinence and the patient-reported discomfort or adverse effect with the method. METHODS: For dorsal clitoral nerve stimulation, a battery powered, handheld stimulator was used, set to a pulse width of 200 µs and a frequency of 20 Hz. One electrode was placed at the preputium of the clitoris and acted as cathode while an anode electrode was placed on the belly. Prior to stimulation the patients were asked to complete a bowel habit diary throughout 14 consecutive days before and during stimulation. RESULTS: Fourteen out of the 16 patients included completed the study. A decrease in the number of episodes (per day) with strong urgency declined in eight patients but increased in four cases during the stimulation period. An increase in episodes with moderate or mild urgency was observed in 11 and 6 cases, respectively, and a decrease in defecation without the feeling of urgency or passive incontinence decreased in two thirds of the patients. Two patients discontinued the study prematurely, on due to worsening in symptoms and one due to pelvic pain. CONCLUSION: Although the results may be promising, much still must be learned about the method including mode and duration of stimulation, better electrodes and more patient friendly equipment together with the development of better questionnaires to assess the patient burden of urgency.

Comparison of long-term outcome of sacral nerve stimulation for constipation and faecal incontinence with focus on explantation rate, additional visits, and patient satisfaction.

BACKGROUND: The aim of the present study was to compare sacral nerve stimulation (SNS) for constipation (SNS-C) with SNS for idiopathic faecal incontinence (SNS-IFI) regarding explantation rate, additional visits, and improvement of patient satisfaction 5 years after implantation. METHODS: From our prospective database (launched in 2009), we extracted all SNS-C patients 5 years post-implantation, and the SNS-IFI patients implanted just before and just after each SNS-C patient. We retrospectively evaluated the explantation rate, number of additional visits, and patient satisfaction using a visual analogue scale (VAS). We hypothesized that compared with those in the SNS-IFI group: (1) the explantation rate would be higher in SNS-C patients, (2) the number of additional visits would be higher in SNS-C patients, and (3) in patients with an active implant at 5 years, the improvement in VAS would be the same. RESULTS: We included 40 SNS-C patients and 80 SNS-IFI patients. In the SNS-C group 7/40 (17.5%), patients were explanted, compared to 10/80 (12.5%) patients in the SNS-IFI group (p = 0.56). The mean number of additional visits in the SNS-C group was 3.5 (95% CI 2.8-4.1)) and 3.0 (95% CI 2.6-3.6)) in the SNS-IFI group (p = 0.38). Additional visits due to loss of efficacy were significantly higher in the SNS-C patients (p = 0.03). The reduction in VAS score (delta VAS) at 5 years was 37.1 (95% CI 20.9-53.3) in the SNS-C group, and 46.0 (95% CI 37.9-54.0) in the SNS-IFI group (p = 0.27). CONCLUSIONS: No significant difference was found regarding explantation rate, number of additional visits, or improvement of VAS at 5 years after SNS implantation between SNS-C patients and SNS-IFI patients.

Improved longevity and efficacy of sacral nerve stimulation by simple adjustments at follow-up.

AIM: Sacral nerve stimulation (SNS) for faecal incontinence (FI) at subsensory amplitudes as low as 50% of the sensory threshold has been found to be effective at 3 months' follow-up. Furthermore, alternative pacemaker settings may improve functional outcome in patients with suboptimal treatment efficacy. In this work we aim to explore if sub-sensory stimulation as low as 50% of sensory threshold is effective at 1-year follow-up. We also aimed to investigate if 31 Hz (frequency) or 90 µs (pulse width) stimulation improved treatment efficacy in dissatisfied patients. METHOD: All patients in whom the stimulation was effective in controlling FI (satisfied group) were encouraged to have the stimulation amplitude reduced. Those in whom the device was less effective (dissatisfied group) were offered alternative frequency settings or pulse width (31 Hz or 90 µs). Patients were follow-up after 12 months and evaluated by a visual analogue scale (VAS) for patient satisfaction, the Cleveland Clinic Continence Score (CCCS), Rockwood Faecal Incontinence Quality of Life Scale (QoL) and a bowel habit diary. RESULTS: Two hundred and nineteen patients were contacted, with a response rate of 71% (n = 155). Those who were successfully contacted comprised 110 (71%) patients classed as satisfied and 45 (29%) as dissatisfied. Seventy-five (68%) of the satisfied patients agreed to have their stimulation amplitude reduced. At 1-year follow-up the median amplitude had reduced from 1.5 V [interquartile range (IQR) 0.85-2.0 V] to 0.75 V (IQR 0.45-1.4 V) (P-value < 0.001) representing an overall reduction of 39% (6.6-62.5%). There were no significant differences in VAS, CCCS or QoL despite subsensory stimulation at 1-year follow-up. In 28% of the dissatisfied patients alternative pacemaker settings improved VAS to satisfactory levels. CONCLUSION: Subsensory stimulation is as effective as stimulation at or above the sensory threshold. High-frequency stimulation (31 Hz) can improve functional outcome in patients with loss of efficacy.

The functional outcome of sacral nerve stimulation for faecal incontinence can be improved by using lead model 3889 and a standardized implantation technique.

AIM: Sacral nerve stimulation has been recognized as an effective treatment option for faecal incontinence when conservative therapy has failed. Refinement of the procedural technique and the use of a curved stylet may improve the functional outcome. Our aim was to explore the relationship between lead model, functional outcome, stimulation amplitude and the need for extra visits during the first year of follow-up. METHOD: Patient data from May 2009 to February 2017, which were prospectively collected in a local database, were extracted and analysed for differences between lead model and improvement in incontinence scores, stimulation amplitude and the need for additional visits during the first year of follow-up. RESULTS: A foramen lead model 3093(straight stylet) was used in 134 patients and lead model 3889(curved stylet) was used in 40 patients. There were no differences in baseline characteristics or incontinence scores. Comparing results between the two lead models we found that the improvement (delta value) in the Wexner score at 6 months' follow-up (P = 0.05) and the St Mark's score at 12 months' follow-up (P = 0.02) was greater in patients implanted with lead model 3889(curved stylet) compared with patients implanted with lead model 3093(straight stylet). Patients implanted with lead model 3889 (curved stylet) were less likely to have to alter the stimulation amplitude or pole configuration during the first year of follow-up (P = 0.04). No difference was found for stimulation amplitude (P = 0.170) or the need for additional visits (P = 0.663). CONCLUSION: Lead model 3889 (curved stylet) improves functional results compared with lead model 3093 (straight stylet) during the first year of follow-up. Lead model 3889 (curved stylet) reduces the need for reprogramming but has no influence on stimulation amplitude or the number of additional visits required.

Is the efficacy of sacral nerve stimulation for faecal incontinence dependent on the number of active electrode poles achieved during permanent lead insertion?

AIM: Sacral nerve stimulation (SNS) is effective for faecal incontinence (FI). Little is known about the relationship between the implantation technique and the functional outcome. This study aimed to explore the relationship between the numbers of active electrode poles (AEP) achieved during permanent lead placement and subsequent function, therapeutic amplitude and the need for extra appointments between scheduled follow-up visits. METHOD: One hundred and eighty-six patients with FI who underwent permanent implantation between May 2009 and March 2015 with a tined (barbed) lead (3093/3080, Medtronic) using the straight stylet were registered on the European two-centre SNS prospective database (SNSPD). Correlation between the number of AEP, function, stimulation amplitude and the need for extra visits was analysed. RESULTS: The numbers of patients having an intra-operative motor response on stimulation of one, two, three and four poles were 18 (9.7%), 75 (40.3%), 61 (32.8%) and 32 (17.2%). The Wexner incontinence score was significantly reduced from 15 (±2.8) at baseline to 9.2 (±4.8) at the latest follow-up after a mean 878 ± 561 days (SD; P < 0.001). No correlation was found between the number of AEP and the functional outcome (P > 0.05). Patients with four-AEP had a reduced therapeutic amplitude up to 289 (±146) days of follow-up (P < 0.03). The number of AEP did not influence the need for extra follow-up visits (P < 0.223). CONCLUSION: The functional outcome and number of extra visits after SNS for FI did not depend on the number of AEP achieved. The therapeutic amplitude was reduced during the first postoperative year if four AEP were achieved during lead placement.

Bilateral compared with unilateral sacral nerve stimulation for faecal incontinence: results of a randomized, single-blinded crossover study.

AIM: This randomized single-blinded crossover study aimed to investigate whether bilateral sacral nerve stimulation (SNS) is more efficient than unilateral stimulation for faecal incontinence (FI). METHOD: Patients with FI who responded during a unilateral test stimulation, with a minimum improvement of 50% were eligible. Twenty-seven patients who were accepted to enter the trial were bilaterally implanted with two permanent leads and pacemakers. Patients were randomized into three periods of 4 weeks' stimulation including unilateral right, unilateral left and bilateral stimulation. Symptoms scores and bowel habit diaries were collected at baseline and in each study period. A 1-week washout was introduced between each study period. RESULTS: Twenty-seven (25 female) patients with a median age of 63 (36-84) years were bilaterally implanted from May 2009 to June 2012. The median number of episodes of FI per 3 weeks significantly decreased from 17 (3-54) at baseline to 2 (0-20) during stimulation on the right side, 2 (0-42) during stimulation on the left side and 1 (0-25) during bilateral stimulation. The Wexner incontinence score improved significantly from a median of 16 (10-20) at baseline to 9 (0-14) with right-side stimulation, 10 (0-15) with left-side stimulation and 9 (0-14) with bilateral stimulation. The differences between unilateral right or unilateral left and bilateral stimulation were non-significant, for FI episodes (P = 0.3) or for Wexner incontinence score (P = 0.9). CONCLUSION: Bilateral SNS therapy for FI is not superior to standard unilateral stimulation in the short term. Equal functional results can be obtained regardless of the side of implantation.

A double-blinded randomized multicentre study to investigate the effect of changes in stimulation parameters on sacral nerve stimulation for constipation.

AIM: Sacral nerve stimulation (SNS) may be offered to patients with constipation who have failed to improve with conservative treatment. The response to SNS is variable, with a significant loss of efficacy in some patients. An increased frequency of stimulation may improve the efficacy of SNS for faecal incontinence. This study aimed to see if alteration of the pulse width or frequency improved the outcome for those with constipation. METHOD: Eleven patients with constipation currently being treated by SNS were recruited from three centres. They were randomized to five different protocols of stimulation each applied for 5 weeks. Group 1 used standard settings (pulse width 210 µs, frequency 14 Hz); in the other four groups (Groups 2-5) the pulse width and/or frequency were halved or doubled. Patients and investigators were blinded to the group allocation. RESULTS: The Cleveland Clinic constipation score varied significantly between the five groups. Group 1 achieved the lowest score mean (± SD) 13.4 (± 4.4) (P = 0.03). The number of digitations per defaecation was the lowest in Group 4, 90 µs and 14 Hz (P < 0.01). No other variable changed significantly. Standard settings were the most preferred by the recruited patients. CONCLUSION: Alteration of pulse width or frequency of stimulation had no significant effect on the outcome of SNS for constipation.

Nurse-led clinics can manage faecal incontinence effectively: results from a tertiary referral centre.

AIM: In May 2010, a specialist nurse-initiated assessment and treatment algorithm for faecal incontinence (FI) was introduced at the department of Anal Physiology, Aarhus University Hospital, Denmark. This study aimed to evaluate the effectiveness of and patient satisfaction with the program. METHOD: A medical file audit was preformed on patients evaluated and treated for FI and discharged after September 2010. Patients were invited to participate in a structured telephone interview. This study aimed to enrol 100 patients. Patients were asked if they were satisfied with their current level of continence status (yes/no), and a numerical satisfaction score and Wexner score were recorded. These results were compared to baseline and at time of discharge. RESULTS: One-hundred patients completed the telephone interview; 73 of these patients were satisfied after a median of 420 (range: 114-586) days following discharge from the program. A median of one outpatient consultation followed by one telephone follow-up was required before the patients were discharged. The Wexner score was significantly reduced by 3.9 (±4.4) (P < 0.001) points among the satisfied and non-significantly reduced by 0.52 (± 3.3) (P = 0.42) points among the dissatisfied patients at follow-up compared to baseline. The satisfied and dissatisfied patients at follow-up did not differ in baseline characteristics including Wexner score. CONCLUSIONS: FI can successively be evaluated and conservatively managed by specialist nurses, and these nurses achived high satisfaction rates among their patients. The concept of specialist nurse-led clinics will reduce waiting lists, and descrease the number of patients needing to be evaluated by a surgeon.

Randomized double-blind crossover study of alternative stimulator settings in sacral nerve stimulation for faecal incontinence.

BACKGROUND: Sacral nerve stimulation is an established treatment for faecal incontinence. Nearly half of all patients experience loss of efficacy at some point. Standard reprogramming restores efficacy for some, but not all, patients. This study aimed to determine whether alternative stimulator settings would increase treatment efficacy. METHODS: Patients with sustained loss of efficacy were recruited from two international specialist centres. A number of alternative stimulation parameters were tested using a double-blind randomized crossover study design. Stimulation settings tested were pulse frequencies of 6.9 and 31 Hz, and pulse widths of 90 and 330 µs, compared with one standard setting of 14 Hz/210 µs. Treatment efficacy was evaluated using a disease-specific quality-of-life score (Fecal Incontinence Quality of Life Scale, FIQLS) and a bowel habit diary completed before randomization, during the study period and after 3 months of follow-up with one preferred setting. RESULTS: Fifteen patients were analysed. With one preferred setting, three of four subdomains in the FIQLS improved significantly. The mean(s.d.) total number of incontinence episodes dropped from 11.7(10.8) to 4.8(4.5) per 3 weeks (P = 0.011) and improvements were maintained after 3 months of follow-up. Optimal pacemaker settings were individual, but a trend towards highest patient satisfaction and improved treatment outcome was evident for high-frequency stimulation (31 Hz/210 µs), which was preferred by eight of the 15 patients. CONCLUSION: Patients experiencing loss of efficacy can experience improvement if alternative pacemaker settings are tested. High-frequency stimulation (31 Hz/210 µs) was preferred by more than half of the patients, and improved treatment outcome was sustained at 3 months.

Functional results and patient satisfaction with sacral nerve stimulation for idiopathic faecal incontinence.

AIM: Sacral nerve stimulation (SNS) is an established treatment for faecal incontinence (FI) when conservative modalities have failed to restore continence. This two-centre study aimed to document functional outcome and its relationship to patient satisfaction. METHOD: Patients treated with SNS for idiopathic FI in Aarhus (Denmark) and Maastricht (The Netherlands) were included. At the most recent follow-up appointment, 127 patients (80%) were identified as receiving active SNS therapy. A questionnaire considering bowel habits, quality of life, and self-reported satisfaction and a 3-week bowel-habit diary were mailed to these patients, and 85% responded. RESULTS: Patient satisfaction was clearly related to the number of FI episodes. Patients experiencing full continence were all satisfied, and although the satisfaction rate decreased as the number of FI episodes increased, 46% of the patients with more FI episodes at follow-up than at baseline were still satisfied. Per-protocol analysis resulted in a satisfaction rate of 57.3%. In total, 74.7% of the patients receiving active SNS therapy reported a reduction of ≥ 50% in FI episodes, 10.3% of whom were dissatisfied after a median of 46 months of follow-up. CONCLUSION: There is a clear relationship between patient satisfaction and improved continence. A total of 57.3% of the patients offered SNS therapy were satisfied at follow-up. However, 46% of the patients with more FI episodes at follow-up than at baseline were also satisfied. Therefore, functional outcome of SNS therapy cannot be based only on bowel-habit diaries and bowel scores.