Www.ncbi.nlm.nih.gov
Table F6. KQ 2: Adverse effects of nonsurgical treatments for fecal incontinence in randomized controlled trials Author, YearStudy AimN Randomized; n Analyzed; % Female; FI Etiology; Treatment and Followup DurationStudy Groups (n per group)Patient-Reported Outcomes (primary outcome bolded if known)Reported Harms Attrition*Dietary fiberBliss, 2014 ADDIN EN.CITE <EndNote><Cite><Author>Bliss</Author><Year>2014</Year><RecNum>1486</RecNum><DisplayText><style face="superscript" font="Times New Roman">54</style></DisplayText><record><rec-number>1486</rec-number><foreign-keys><key app="EN" db-id="s95ra9wxt05e2ue5wp3pfz5da29tt9p9xt9s">1486</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Bliss, D. Z.</author><author>Savik, K.</author><author>Jung, H. J.</author><author>Whitebird, R.</author><author>Lowry, A.</author><author>Sheng, X.</author></authors></contributors><auth-address>School of Nursing, University of Minnesota, 5-140 Weaver-Densford Hall, 308 Harvard St. SE, Minneapolis, MN, 5545.</auth-address><titles><title>Dietary fiber supplementation for fecal incontinence: a randomized clinical trial</title><secondary-title>Res Nurs Health</secondary-title><alt-title>Research in nursing & health</alt-title></titles><periodical><full-title>Research in Nursing & Health</full-title><abbr-1>Res Nurs Health</abbr-1></periodical><alt-periodical><full-title>Research in Nursing & Health</full-title><abbr-1>Res Nurs Health</abbr-1></alt-periodical><pages>367-78</pages><volume>37</volume><number>5</number><dates><year>2014</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>1098-240X (Electronic)
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ADDIN EN.CITE.DATA 57Does fiber supplement and loperamide improve FI over low residue diet and loperamideN: 63n: 47F: 91%MixedT: 12 wk (6 + 6)FU: 6 wk, 12 wkCrossoverT: balanced fiber diet + fiber supplement + loperamide (32)C: low residue diet + placebo fiber + loperamide (31)FISI, FIQLNo AEs occurred25%T: 22%C: 29%Drugs: Sphincter function enhancersPark, 2007PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QYXJrPC9BdXRob3I+PFllYXI+MjAwNzwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 58Efficacy of 30% phenylephrine gel for FI after low anterior resection for rectal cancerN=35n=29 F: 37%Postsurgical T: 4 wkFU: 4 wk T: 30% topical phenylephrine (17) 2x/dayC: placebo 2x/d (12)FISI, FIQL, Global EfficacyOverall: 35% nonserious AEsT: 41% nonserious AEs; local allergic dermatitis 29%, headache 12%C: 17% nonserious AEsExcluded post-randomization data from 17% with poor compliance Carapeti, 2000PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DYXJhcGV0aTwvQXV0aG9yPjxZZWFyPjIwMDA8L1llYXI+
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ADDIN EN.CITE.DATA 64Effectiveness of 10% topical phenylephrine in FI patients with IAS dysfunctionN=36n=36F: 61%NRT: 4 wk eachFU: 4 wk, 8 wkCrossover, 1 wk washoutT: topical 10% phenylephrine gel (anus) 2x/d (36)C: placebo gel (36)Vaizey score, subjective improvementOverall: No serious AEsT: 8% nonserious AEs; mild dermatitis (erythema & pruritus) most commonC: NoneNot reportedDrugs: AntidiarrhealsSun, 1997PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TdW48L0F1dGhvcj48WWVhcj4xOTk3PC9ZZWFyPjxSZWNO
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ADDIN EN.CITE.DATA 27Effectiveness of loperamide oxide for chronic diarrhea with FIN=11n=11F: 73%MixedT: 1 wk eachFU: 2 wk 4 wkCrossover, 1wk run-in, washoutT: loperamide 8mg/d (11)C: placebo(11)FI episodes, % fully continent, stool freq/consistency, urgency, FI severity, diarrhea, abdominal painOverall: NRT: 55% nonserious AEsC: 27% nonserious AEsAbdominal pain, headache & nausea most commonNoneHallgren, 1994PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IYWxsZ3JlbjwvQXV0aG9yPjxZZWFyPjE5OTQ8L1llYXI+
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ADDIN EN.CITE.DATA 14Effectiveness of loperamide HCl after proctoco-lectomy for ulcerative colitisN=30n=28F: 27%PostsurgicalT: 8 d eachFU: 15 d, 30 dCrossover, 1wk run-in, washout T: loperamide HCl 12mg/d (30)C: placebo (30)Defecation freq, need for night evacuation, FI episodes, use of pads, flatus releaseNo AEs occurred7%*Read, 1982PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SZWFkPC9BdXRob3I+PFllYXI+MTk4MjwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 30Effectiveness of loperamide for chronic diarrhea with FI and urgencyN=26n=26F; 57%MixedT: 1 wk eachFU: 1 wk, 2 wkCrossover, washout NRT: loperamide 12mg/d (26)C: placebo (26)FI episodes; stool freq, weight and consistency; urgency; improvement in FI and urgency Overall: No serious AEs reported. T: 69% nonserious AEsC: 4% nonserious AEsConstipation, exacerbation of diarrhea, abdominal pain, and nausea & vomiting most commonNonePalmer, 1980PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QYWxtZXI8L0F1dGhvcj48WWVhcj4xOTgwPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 22Compare 3 drugs for chronic diarrhea (95% had urgency with FI)N=30n=25F: NRMixedT: 4 wk eachFU: outcomes every 4 wk up to 12 wk Crossover; used 3 wk data per period T1: loperamide HCl 2mg/d (30)T2: codeine phos-phate 45mg/d (30)T3: diphenoxylate 5mg/d (30)FI episodes, # of patients with FI, stool freq. and consistency, urgency episodes, dose/capsule consumptionOverall: NR T1: 22 AEs in 40% of groupT2: 29 AEs in 48% of groupT3: 39 AEs in 48% of groupAbdominal pain, vomiting, constipation most common AEs causing withdrawal.17% AEs caused discontinuation of treatment:T1: 16%* T2: 16%* T3: 20%* Abdominal pain, vomiting, constipation most common in withdrawals. 5 withdrew due to idiopathic diarrhea Drugs: OtherBharucha, 2014PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CaGFydWNoYTwvQXV0aG9yPjxZZWFyPjIwMTQ8L1llYXI+
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ADDIN EN.CITE.DATA 53Effectiveness of clonidine vs. placebo in women with FIN=44n=44F: 100%MixedT: 4 wkFU: 4 wk T: Clonidine 0.2mg/d (22)C: placebo (22)FICA, FI count, days of FI, FIQL, FISI, satisfaction, rectal urgency, loperamide useOverall: No serious AEs. T: 86% nonserious AEsC: 32% nonserious AEs Dry mouth, fatigue, light-headedness and drowsiness most common.4%*T: 4%C: NonePinedo, 2012PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QaW5lZG88L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 25Effectiveness of valproate sodium for FI after ileoanal anastomosisN=17n=17F: 24%PostsurgicalT: 1 wkFU: 1 wkCrossover, 3 d washoutT: Valproate sodium 1600mg/d (17)C: placebo (17)FI count (soiling), stool freq, perianal skin troubleOverall: No serious AEs reported. T: 47% nonserious AEs; nausea and abdominal pain most common.C: NoneNonePFMT with biofeedback (BF) PFMT-BF vs. standard careDamon, 2014PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EYW1vbjwvQXV0aG9yPjxZZWFyPjIwMTQ8L1llYXI+PFJl
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ADDIN EN.CITE.DATA 37Does PFMT-BF plus standard care improve FI outcomes over standard care only?N=157n=92-142 (varied per analysis)F: 77%MixedT: 4 moFU: 4 moT: PFMT-BF (20 sessions) plus standard care (77)C: standard care of laxative, oral bulking agent, loperamide (80)Treatment effectiveness (-5 to 5), CCFIS, FIQL, KESS, SF-12, symptom changeNo AEs occurred10%*T: 13%C: 6%PFMT-BF vs. PFMT with digital rectal feedback (DRF)Bols, 2012PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Cb2xzPC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 66Does PFMT-BF with rectal balloon improve FI over PFMT (digital rectal feedback)?N=80n=80 (ITT)F: 90%MixedT: 9 wkFU: 4.5 mo (varied)12 sessions/9 wk: T: PFMT-BF plus rectal balloon (40)C: PFMT “alone” (with DRF) (40)Vaizey (0-24); FIQL, GPE No AEs occurred13%T: 8%C: 18%Compare exercisesBartlett, 2011PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CYXJ0bGV0dDwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+
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ADDIN EN.CITE.DATA 19Does PFMT-BF with medium freq estim improve FI over PFMT-BF with low freq estim)?N=80n=80 (ITT)F: 81%MixedT: 6 moFU: 3 mo, 6 moT: Estim (medium freq) with PFMT-BF (39)C: Estim (low freq.) with PFMT-BF (41)CCFIS, adapted Vaizey (0-24), FIQL, ICIQ-SF, % complete respondersOverall: NRT: NoneC: 50%; pain during estim most common3 mo: 9%*T: 5%C: 12%6 mo: 11%*T: 8%C: 15%ElectrostimulationNorton, 2006PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ob3J0b248L0F1dGhvcj48WWVhcj4yMDA2PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 63Does home-based estim without PFMT improve FI over sham home-based estim?N=90n=90 (ITT)F: 90%IdiopathicT: 2 moFU: 2 moT: estim 35Hz 20 min/d x 3 wk, then 40 min/d x 5 wk (47)C: same protocol but 1Hz estim (43)Symptom change outcome rating, FI counts/w, 0-10 of bowel control & satisfaction, effectiveness Overall: Discomfort 9%22%T: 21%C: 23%Rectal irrigationChristensen, 2006PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaHJpc3RlbnNlbjwvQXV0aG9yPjxZZWFyPjIwMDY8L1ll
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ADDIN EN.CITE.DATA 52Does stepwise intervention improve bowel management & reduce FI over usual care? N: 68n: 68 (ITT)F: 34%Spinal cord injuryT: 6 wkFU: 6 wkT: Stepwise intervention (7 steps, least to most invasive) (35)C: Usual bowel management (33)Duration and level of intervention required, FI frequency, time to stool, minimum level of effective interventionOverall: No serious AEs T: 1% nonserious AEC: None26%*T: 40%C: 12%Percutaneous tibial nerve stimulation (PTNS)Thin, 2015PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UaGluPC9BdXRob3I+PFllYXI+MjAxNTwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 36Compare PTNS with SNSN=40n=3198% F; 59 yMixedT: 5 mo (PTNS)FU: 3 mo., 6 mo.T: PTNS 15 sessions: 12 in 3 mo, plus 3 over 2 mo. (16)C: SNS (15)FI episodes, CCFIS, SF-36, EQ-5D; qualitative interviewNo serious AEs occurred Nonserious:T: transient paresthesias (6%) or pain (6%).C: 20%: leg pain or site pain (resolved)NoneLocal tissue-bulking injectionsDehli, 2013PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EZWhsaTwvQXV0aG9yPjxZZWFyPjIwMTM8L1llYXI+PFJl
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ADDIN EN.CITE.DATA 65Determine if tissue bulking injections with dextranomer superior to PFMT with biofeedback (plus estim if needed) for FIN: 126n: 119 (6 mo)F: 93%MixedT: 6mo controlFU: 6 mo (RCT to 6 mo; observed successes to 2 yr) T: Dextranomer in hyaluronic acid (4 x 1ml injections to anal submucosa); repeat 1x if needed (64)C: PFMT-BF plus estim if needed x 6 sessions/6 mo (62) Vaizey (“St. Mark’s” 0-24), FIQL, EQ-5DOverall: NRT: 25%; leakage of injected agent, infection, prolonged defecation most commonC: 8%; pain using anal probe most common.3%*T: NoneC: 5%Withdrew consent after randomization:T: n=2C: n=4Graf, 2011PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HcmFmPC9BdXRob3I+PFllYXI+MjAxMTwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 40Does anal canal injection of dextranomer in stabilized hyaluronic acid improve FI over sham?N=206n=197 (6 mo); 125 (1 yr treated only)F: 89%MixedT: Injections (1 d); repeat in 1 mo if CCFIS >10FU: 3 mo, 6 mo; 1 yr for treated groupT: Total of 4-8 ml dextranomer injections in four quadrants of anal submucosa (136)C: Sham injections (no substance injected) (70)FI counts/wk (50% or more reduction from baseline)CCFIS, FIQL, number of FI-free days, decrease in FI episodesOverall: NRSerious AEs:T: rectal abscess (1%), prostate abscess (1%)C: NoneNonserious AEs:T: proctalgia (14%), rectal hemorrhage (7%), diarrhea (5%), constipation (2%), injection site bleeding (5%), rectal discharge (4%), anal pruritus (2%), proctitis (3%), painful defecation (2%), fever (8%), other (16%)C: proctalgia (3%), rectal hemorrhage (1%), diarrhea (4%), injection site bleeding (17%), others (7%)6 mo: 4%T: 3%C: 7%By 1 yr:T: 8%C: Not followed beyond 6 mo.Off-label & only 1 arm FDA approvedMorris, 2013PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb3JyaXM8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFyPjxS
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dGU+
ADDIN EN.CITE.DATA 38injected outpatient surgeryCompare injectable bulking agents: Durasphere? (off-label) vs PTQ? (not FDA approved )N=35n=34 overallF: NRNRT: 1 dFU: 6 wk, 6 mo, 1 yrT1: Durasphere?: perianal injection (18)T2: PTQ? (not-FDA approved) (17)CCFIS, SF-36Overall: NRT1: NoneT2: NR6%Tjandra, 2009PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UamFuZHJhPC9BdXRob3I+PFllYXI+MjAwOTwvWWVhcj48
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ADDIN EN.CITE.DATA 43Compare injectable bulking agents: Durasphere? (off-label) vs. PTQ? (not FDA approved)N=40n=40 overallF: 90%MixedT: 1 dFU: 2 wk, 6 wk, 6 mo, 1 yrT1: Durasphere?: perianal injection (20)T2: PTQ? (not-FDA approved) (20)CCFIS, FIQL, SF-12Overall: NRT1: Serious AEs: rectal pain (5%), erosion through rectal mucosa (10%), hypersensitivity reaction (required hospitalization & IV steroids, 5%). Nonserious AEs: bruising (20%).T2: NRNone *Attrition based on the number randomized. Attrition (n, %) was calculated by the MN EPC when study authors reported attrition only among the subset of patients who completed the study or perfectly completed the protocol. AE=Adverse Effects; AMS=American Medical System; AM=anal manometry; BDI=Beck Depression Inventory; BM=bowel movement; CCCS= Cleveland Clinic Constipation Score; CCFIS=Cleveland Clinic Fecal Incontinence Score; C=Comparator/control ; d=day; dx=diagnosis; DRF: digital rectal feedback; DYS=Dysfunctional; E-diary=Electronicdiary; EQ-5D=EuroQoL Questionnaire-5 Dimensions; F=Female; FI=Fecal incontinence; FICA=Fecal Incontinence and Continence Assessment; FIQL=Fecal Incontinence Quality of Life scale; FISI=Fecal Incontinence Severity Index; FU=Followup; FDA=Food and Drug Administration; freq=frequency; GI=gastrointestinal; g=Grams; HAD: Hospital Anxiety and Depression Scale; IAS=internal anal sphincter; IBS=irritable bowel syndrome; ITT=Intention-to-treat analysis; M=Male; mo=month; mg=milligrams; ms=microseconds; neurogenic bowel dysfunction score (NBDS); NR=Not Reported; NSD=No Significant Difference; pt=patient; PFMT=Pelvic floor muscle training; pd=period; PP=Per protocol analysis; PTQ?=injectable bulking agent not FDA approved for use in the US; QoL=Quality of Life; reps: repetitions; SMFIS=St. Mark’s Fecal Incontinence Score; s=Seconds; SAE=Serious Adverse Event; SF-12=Short-Form-12 health survey; SF-36=Medical Outcomes Study Short-Form 36-item Health Survey; surg=surgery; T1=Treatment group 1 T2=Treatment group 2 T3=Treatment group 3; TEAE=Treatment Emergent Adverse Event; Vaizey=Vaizey Fecal Incontinence Score; VAS=Visual Analogue Scale; wk=week; y=year ................
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