A Case of Fecal Incontinence: Medical and Interventional Treatment Options

Transcription

1 A Case of Fecal Incontinence: Medical and Interventional Treatment Options

2 HPI JP is a 69 year-old F with a 12-month history of FI. Her symptoms began after a colonoscopy She has been experiencing passive accidents 3-4x/week consisting of the loss of 1.5 teaspoons -1/4 cup of pasty Bristol 5 stool She denies urge, stress, and overflow components. She is passing 1 Bristol 4 BM daily

3 HPI Obstetric History; 2 vaginal deliveries (+) episiotomies with each delivery No acute episodes of FI Prior Diagnostics: Colonoscopy x2 Normal Prior Therapeutics: PEG 3350 taken on an intermittent basis

4 PMH: GERD, Hyperlipidemia PSH: Ventral hernia repair Meds: Zocor, Prilosec Allergies: Sulfa FHx: (-) GI disorders/malignancies SHx: Widowed, RN, (-) tobacco/etoh ROS: 10/14 (-)

5 Physical Exam General Exam: No abnormalities External perianal exam: (-) EH; (-) fissures/fistulae (-) excoriations/rashes; (+) anal wink (+) appropriate descent (-) prolapse identified DRE: (+) weakened resting tone and squeeze pressure, normal strain maneuver, no stool palpated

6 JP: Resting Pressure IAS Function IAS Function Normal Weak Changes concerning for passive incontinence

7 JP: Maximum Squeeze Pressure EAS Function EAS Function Normal Weak Changes concerning for urge incontinence

8 History Continued: What treatment options are available for JP?

9 Non-pharmacologic Management of Fecal Incontinence Intervention Incontinence pads/cotton balls/butterfly pad Mechanism of Action Provides skin protection; prevents soiling; conduct moisture away from skin Anal plugs Provides a barrier to fecal incontinence; can be difficult to tolerate. Type can impact performance Enemas Voluntarily and selectively evacuates rectum Anorectal biofeedback Improves rectal sensation and compliance; coordinates external anal sphincter contraction; may increase anal sphincter tone Whitehead WE, Bharucha AE. Gastroenterology. 2010;138: Deutekom M, Dobben AC. Plugs for containing faecal incontinence. Cochrane Database of Systematic Reviews 2012, Issue 4. Art. No.: CD DOI: / CD pub3.

10 Percentage Long-term Results of Biofeedback for Solid Stool Fecal Incontinence ,6,36,60 MONTHS Group A Group B Group C Group D Group A: Continence fully recovered Group B: >75% reduction in # of incontinence episodes Group C: <75% reduction in # of incontinence episodes Group D: No improvement or worse than before therapy Biofeedback No treatment Lacima G et al. Colorectal Dis. 2010;12(8):

11 Pharmacologic Management of Fecal Incontinence Anti-diarrheals Tricyclic antidepressants Bile acid binding resins Topical phenylephrine gel No pharmacologic treatments have been adequately evaluated in large, randomized, controlled studies in patients with fecal incontinence

12 History Continued: Based on ARM findings JP referred to the Rehabilitation Institute of Chicago for PFPT/BF She undergoes 6 sessions of PFPT/BF but decides to stop because she finds it ineffective What other options are available? Injectable bulking agents Sacral Nerve Stimulation (SNS)

13 Cochrane: Injectables for 5 trials: the Treatment of FI Silicone biomaterial Collagen Carbon-coated microbeads Dextranomer-hyaluronic acid One large randomized controlled trail has shown that this form of treatment using dextranomer in stabilized hyaluronic acid (NASHADx) improves continence for a little over half of patients in the short term. However, the number of identified trials was limited and most had methodological weakness. Maeda Y, Laurberg S, Norton C. Perianal injectable bulking agents as treatment for faecal incontinence in adults. Cochrane Database of Systematic Reviews 2013, Issue 2. Art. No.: CD DOI: / CD pub3.

14 Injectable Bulking Agents for FI Biocompatible gel of dextranomer microspheres in hyaluronic acid (Solesta ) Administration Done in physician office or hospital outpatient department w/o anesthesia Four 1 cc injections through an anoscope into submucosal layer of the anal canal Bulks and approximates anal mucosa closing anal canal or increasing pressure 2011:FDA-approved for the treatment of fecal incontinence in patients aged 18 years who have failed conservative therapy Solesta [package insert]. Oceana Therapeutics, Edison NJ, Accessed April 1, 2013 at:

15 NASHA Dx 60% 50% Decrease in FI 6 months 52% p= NNT=5 50% 40% 30% 20% 10% 0% N=136 Solesta Sham 31% N=70 Solesta Sham. Graf W et al. Lancet. 2011; 377:

16 Median number of episodes/14 days Proportion responders Secondary Endpoints: Decrease in FI Episodes After Solesta Treatment MONTHS Graf W et al. Lancet. 2011; 377: Baseline 3 months 6 months 9 months 12 months

17 Mean number of FI-free days over 14 days NASHA Dx: Improvement in Number of FI-Free Days Months since treatment Almost 2-fold increase (4.4 to 7.8 days) of incontinence-free days 1 1. Graf W et al Lancet. 2011; 377:

18 NASHA Dx: Adverse Events Dextranomer Microspheres (n=136) Sham (n=70) Proctalgia 19 (14%) 2 (3%) Rectal hemorrhage 10 (7%) 1 (1%) Diarrhea 7 (5%) 3 (4%) Injection site bleeding 7 (5%) 12 (17%) Rectal discharge 5 (4%) Anal pruritis 2 (2%) Proctitis 4 (3%) Painful defecation 2 (2%) Fever 11 (8%) Rectal abscess* 1 (1%) Prostate abscess* 1 (1%) Others 22 (16%) 5 (7%) *Serious adverse events Graf W et al. Lancet. 2011; 377:

19 % Responders NASHA Dx: Long-Term Efficacy Open-Label 12 & 24 Month Follow-UP 62.70% 63.00% 62.00% 61.00% 60.00% 59.00% 58.00% 57.00% 56.00% 55.00% 54.00% 57.40% 12 Months 24 Months Responder defined as >50 % reduction in FI episodes Solesta [package insert]. Oceana Therapeutics, Edison NJ, Accessed January 1, 2014 at: La Torre F et al. Colorectal Dis 2013;15(5):569.

20 Sacral Nerve Stimulation (SNS) System 3 1. Tined lead is placed parallel to the sacral (S2, S3, or S4) nerve 2. Neurostimulator generates electrical pulses delivered through the leads Clinician and patients set the parameters of the electrical pulses 4. FDA approved 2011 InterStim II Neuromodulator [manual]. Medtronic, Inc. Minneapolis, MN

21 SNS Placement

22 Percent of Patients Sacral Nerve Stimulation System: 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Bowel Control Study Months (n=113) 6 Months (n=107) Wexner SD, Coller JA et al. Ann Surg. 2010;251: Improvement in Weekly Incontinent Episodes 12 Months (n=106) Follow-up Interval 24 Months (n=67) 36 Months (n=30) <=0% (0%, 50%) (50%, 75%) (75%, 100%) 100%

23 Sacral Nerve Stimulation System: Bowel Control Study Most common adverse events ( 5%) reported during the implant phase: 1 Adverse Event Frequency (%) Implant site pain 25.8% Paresthesia 12.5% Implant site infection 10.8% 2 Change in sensation of stimulation 8.3% Urinary incontinence 6.7% Diarrhea 5.0% 26 SAEs: 13 (10.8%) experienced implant site infection. 5 infections treated with medication; 7 (5.8%) required surgical intervention (5 device explants and 2 device replacements) Wexner SD, Coller JA et al. Ann Surg. 2010;251:

24 Cochrane: PFPT/BF/SNS for the Treatment of FI 21 trials: 1525 patients The limited number of identified trials together with methodological weakness of many do not allow a definitive assessment of the role of anal sphincter exercises and biofeedback therapy in the management of people with faecal incontinence. We found some evidence that biofeedback and electrical stimulation may enhance the outcome of treatment compared to electrical stimulation alone or exercises alone. Exercises appear to be less effective than an implanted sacral nerve stimulator. While there is a suggestion that some elements of biofeedback therapy and sphincter exercise may have a therapeutic effect, this is not certain. Larger well-designed trails are needed to enable safe conclusions Norton C, Cody JD. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults. Cochrane Database of Systematic Reviews 2012, Issue 7. Art. No.: CD DOI: / CD pub3.

25 History Completed: Risks, benefits, and contraindications of interventional procedures discussed JP chooses Solesta as initial intervention and this is injected without complications 3 months later she continues to experience significant improvement Mild leakage 1-2x/week 1 cc of liquid stool in her undergarment Barrier devices recommended PRN

26 Review: Treatment Options for Fecal Incontinence Least Invasive Pharmacology/Nonpharmacological Interventions Decision based on balance between risk & likelihood of positive outcome Dextranomer Microsphere Injections SNS Most Invasive Other Surgical Interventions