Prospective randomized double-blind study of temporary sacral nerve stimulation in patients with rectal evacuatory dysfunction and rectal hyposensitivity.

OBJECTIVE: Prospective randomized double-blind placebo-controlled crossover trial of 14 female patients (median age 52 [30-69] years) with proctographically defined evacuatory dysfunction (ED) and demonstrable rectal hyposensitivity (elevated thresholds to balloon distension in comparison with age- and sex-matched controls). BACKGROUND: Sacral nerve stimulation (SNS) is an evolving treatment for constipation. However, variable outcomes might be improved by better patient selection. Evidence that the effect of SNS may be mediated by modulation of afferent signaling promotes a role in patients with ED associated with rectal hyposensation. METHODS: SNS was performed by the standard 2-stage technique (temporary then permanent implantation). During a 4-week period of temporary stimulation, patients were randomized ON-OFF/OFF-ON for two 2-week periods. Before insertion (PRE), and during each crossover period, primary (rectal sensory thresholds) and secondary (bowel diaries, constipation, and GIQoL [gastrointestinal quality of life] scores) outcome variables were blindly assessed. RESULTS: Thirteen patients completed the trial. Following stimulation, defecatory desire volumes to rectal balloon distension were normalized in 10 of 13 patients (PRE: mean 277 mL [234-320] vs ON: 163 mL [133-193] vs OFF: 220 mL [183-257 mL]; P = 0.006) and maximum tolerable volume in 9 of 13 (PRE: mean 350 mL [323-377] vs ON: 262 mL [219-305] vs OFF: 298 mL [256-340 mL]; P = 0.012). There was a significant increase in the percentage of successful bowel movements (PRE: median 43% [0-100] vs ON: 89% [11-100] vs OFF: 83% [11-100]; P = 0.007) and Wexner constipation scores improved (PRE: median 19 [9-26] vs ON: 10 [6-27] vs OFF: 13 [5-29]; P = 0.01). There were no significant changes in disease-specific or generic quality of life measures. Eleven patients progressed to permanent stimulation (9/11 success at 19 months). CONCLUSIONS: Most patients with chronic constipation secondary to ED with rectal hyposensitivity responded to temporary SNS. The physiological results presented support a mechanistic role for rectal afferent modulation.

Efficacy of sacral nerve stimulation for the treatment of fecal incontinence.

BACKGROUND: Sacral nerve stimulation has been shown to be an effective treatment for fecal incontinence and early studies reported success rates of 67% to 100%. However, "success" has been arbitrarily set at a 50% reduction in symptoms, and data are rarely reported with "intention to treat." OBJECTIVE: This study aimed to assess the true efficacy of sacral nerve stimulation for fecal incontinence compared with the published literature. DESIGN: This prospective 5-year study was conducted to assess 50 patients with fecal incontinence treated with sacral nerve stimulation. All analyses were performed on an intention-to-treat basis. SETTINGS: This study took place in a single tertiary referral colorectal department. PATIENTS: Fifty consecutive patients with fecal incontinence refractory to conservative management were included in the study. INTERVENTIONS: The interventions performed were temporary evaluation with or without permanent sacral nerve stimulation. MAIN OUTCOME MEASURES: : Primary outcome measures were 1) attainment of continence, 2) reduction in fecal incontinence episodes, 3) improvement in Cleveland Clinic Fecal Incontinence scores, and 4) improvement in the ability to defer defecation. RESULTS: Thirteen patients (26%) did not respond at the temporary evaluation stage or were dissatisfied with the result. Ten further patients (20%) did not achieve a 50% reduction in symptoms following permanent implantation. The median follow-up was 17 months (range, 2-55), at which time 27 patients (54%) experienced a 50% or more reduction in symptoms, including 13 (26%) who achieved apparent continence. Median fecal incontinence episodes per fortnight reduced from 14 (range, 0-53) to 2 (range, 0-20; P < .0001). Median Cleveland Clinic Fecal Incontinence scores reduced from 15 (range, 3-20) to 8 (range, 0-17; P < .0001). The ability to defer defecation improved significantly (P < .0001). These results compare favorably with the published literature. LIMITATIONS: Quality of life was not assessed. CONCLUSIONS: This study demonstrates that sacral nerve stimulation can be an effective treatment for patients with fecal incontinence; however, when analyzed by intention to treat, the symptoms of fecal incontinence continue in the majority (74%) of patients.

Advancement anoplasty and sacral nerve stimulation: an effective combination for radiation-induced anal stenosis.

INTRODUCTION: Pelvic radiotherapy can cause anal stenosis. Patients can be left with severe rectal evacuatory difficulties, anal fissuring and resistant faecal incontinence. The management of such patients is difficult since surgical treatment can worsen faecal incontinence. CASE STUDY: We report a patient who was treated for recurrent fissuring and faecal incontinence secondary to severe anal stenosis caused by external beam radiotherapy to his prostate. A 74-year-old male patient underwent excision of the fissuring, fibrotic anal mucosa and internal sphincter and was then treated with a broad-based House advancement anoplasty. The patient's fissuring was successfully treated but he still suffered from faecal incontinence. The patient underwent sacral nerve stimulation with significant improvement in all faecal incontinence symptoms. CONCLUSION: The use of a novel combination of a House advancement anoplasty and sacral nerve stimulation is a safe and effective treatment rationale for treatment of radiation-induced anal stenosis.