CLINICAL OUTCOMES: BOWEL CONTROL Sacral neuromodulation
Chronic fecal incontinence often causes profound emotional distress leading to social withdrawal and isolation.1 The InterStim™ Therapy for Bowel Control Prospective Clinical Study demonstrates that Sacral Neuromodulation for Bowel Control delivered by the InterStim system is safe, effective, and may offer your patients improved quality of life.2,3
Clinical studies offer proof positive that Sacral Neuromodulation effectively helps patients, who have failed or could not tolerate more conservative treatments, gain control of their fecal incontinence symptoms.
The InterStim Therapy for Bowel Control Prospective Clinical Study shows no unanticipated adverse device effects, no patient deaths related to the neurostimulator or therapy, and no surgical injuries during the test or implant procedures.2,3
Most adverse events are successfully treated with medication or device reprogramming. The most common adverse events (n=120) are implant site pain, paraesthesia, implant site infection, change in sensation of stimulation, urinary incontinence, and diarrhea. The probability of the patient having surgical revision (including device replacement) within the first year is about 10%.3
For additional safety information, please refer to Indications, Safety, and Warnings.
The InterStim Therapy for Bowel Control Prospective Clinical Study demonstrates a statistically significant decline in fecal incontinence 12 months post implant.
This study uses two statistical analyses: per-protocol analysis and intent-to-treat analysis (see below for definition). Results are similar, demonstrating a statistically significant and clinically relevant reduction in fecal incontinence severity for subjects implanted with the InterStim Therapy system (p<0.0001).
Per-protocol analysis (also referred to as completers analysis): conducted with patients who had complete data at baseline and annual follow-up visits.
Intent-to-treat analysis (also referred to as modified worst case analysis): Assumed no improvement for patients who were missing bowel diaries (tool used to measure symptom improvement from baseline) at follow-up visits, unless a subsequent bowel diary was available.
Adverse events which occurred in at least 5% of patients after implantation included implant site pain, paresthesias, implant site infection, change in sensation of stimulation, urinary incontinence, and diarrhea.
A randomized controlled trial by Tjandra et al. demonstrates that the InterStim system at 12 months post implant (n=53) is more effective than supervised optimal medical therapy consisting of bulking agents, pelvic floor exercises, and dietary management. Fecal continence was greatly improved with chronic sacral neuromodulation after implantation and was sustained during the follow-up period.4
In the supervised optimal medical therapy group, there are no significant improvements in fecal incontinence symptoms, Wexner scores, FIQOL Index, and SF-12 scores.
Adverse events included pain at implant site, seroma, and excessive tingling in the vaginal region.
Sacral Neuromodulation may offer patients freedom from the embarrassing and socially isolating symptoms of fecal incontinence. Study data demonstrate significant improvement in patient quality of life, including physical and psychological well-being, as determined by a variety of accepted measures.5
In the Tjandra study, InterStim Therapy patients show sustained improvement post implant for FIQOL Index scores (n=53, p<0.0001).4 InterStim Therapy significantly improves all domains of the FIQOL Index (see table below), whereas optimal medical therapy (n=60) shows no effect at 12 months.
Adverse events with the InterStim system in this study include implant site pain, especially in slimmer patients; seroma, resolved after percutaneous aspiration; and excessive tingling in the vaginal region.3
A study by Hetzer et al. demonstrates significant improvement across all QOL scores. InterStim Therapy significantly improves median Wexner scores at 6 months (69%, p<0.001). Patients show a reduction of incontinence symptoms—thus dramatically enhancing QOL, including social lives.6
In addition, InterStim Therapy significantly improves generic and incontinence-specific QOL at 6-month follow-up:6
Complications reported in patients with long-term stimulation included infection/seroma, pain/sleeping disturbance, and loss of effect/dislocation.
InterStim Therapy improves all subscores of the Bowel-Specific Royal London Hospital QOL Questionnaire at 6-month follow-up (p<0.05).6 Score range 0-100.
41% in per-protocol analysis (n=106) and 36% for intent-to-treat analysis (n=120) for complete continence
83% in per-protocol analysis (n=106) and 73% for intent-to-treat analysis (n=120) for both weekly incontinent episodes and days per week (p < 0.0001)
80% in per-protocol analysis (n=106) and 71% for intent-to-treat analysis (n=120) for urge incontinent episodes per week (p < 0.0001)
PNE: Peripheral Nerve Evaluation, a temporary test stimulation.
Brown HW, Wexner SD, Segall MM, Brezoczky KL, Lukacz ES. Quality of life impact in women with accidental bowel leakage. Int J Clin Pract. 2012;66(11):1109-1116.
Wexner SD, Coller JA, Devroede G, Hull T, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. 2010 Mar; 251(3):441-449.
Medtronic InterStim Clinical Summary (2014).
Tjandra JJ, Chan MKY, Yeh CH, Murray-Green C. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: a randomized, controlled study. Dis Colon Rectum. 2008;51(5):494-502.
Hull T, Giese C, Wexner SD, et al. Longterm durability of sacral nerve stimulation therapy for chronic fecal incontinence. Dis Colon Rectum. 2013;56(2):234-245.
Hetzer F, Hahnloser D, Clavien P, Demartines N. Quality of life and morbidity after permanent sacral nerve stimulation for fecal incontinence. Archives of Surgery. 2007;142:8-13.