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Long-term efficacy of NASHA Dx injection therapy for treatment of fecal incontinence.

ABSTRACT: Injectable bulking treatment for fecal incontinence (FI) is intended to expand tissue in the anal canal and prevent fecal leakage. Use of injectable bulking agents is increasing because it can be performed in an outpatient setting and with low risk for morbidity. This study evaluated the long-term (36-month) clinical effectiveness and safety of injection of non-animal stabilized hyaluronic acid/dextranomer (NASHA Dx) on FI symptoms.In a prospective multicenter trial, 136 patients with FI received the NASHA Dx bulking agent. Treatment success defined as a reduction in number of FI episodes by 50% or more compared with baseline (Responder50 ). Change from baseline in Cleveland Clinic Florida Fecal Incontinence Score (CCFIS) and Fecal Incontinence Quality of Life Scale (FIQL), and adverse events were also evaluated.Successful decrease in symptoms was achieved in 52% of patients at 6 months and this was sustained at 12 months (57%) and 36 months (52%). Mean CCFIS decreased from 14 at baseline to 11 at 36 months (p < 0.001). Quality-of-life scores for all four domains improved significantly between baseline and 36 months of follow-up. Severe adverse events were rare and most adverse events were transient and pertained to minor bleeding and pain or discomfort.Submucosal injection of NASHA Dx provided a significant improvement of FI symptoms in a majority of patients and this effect was stable during the course of the follow-up and maintained for 3 years.

SUBMITTER: Mellgren A

PROVIDER: S-EPMC4371654 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

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Long-term efficacy of NASHA Dx injection therapy for treatment of fecal incontinence.

Mellgren A A Matzel K E KE Pollack J J Hull T T Bernstein M M Graf W W

Neurogastroenterology and motility 20140519 8

<h4>Background</h4>Injectable bulking treatment for fecal incontinence (FI) is intended to expand tissue in the anal canal and prevent fecal leakage. Use of injectable bulking agents is increasing because it can be performed in an outpatient setting and with low risk for morbidity. This study evaluated the long-term (36-month) clinical effectiveness and safety of injection of non-animal stabilized hyaluronic acid/dextranomer (NASHA Dx) on FI symptoms.<h4>Methods</h4>In a prospective multicenter ...[more]

PMID: 24837493

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Project description:PURPOSE:Injection with the bulking agent consisting of non-animal stabilized hyaluronic acid/dextranomer (NASHA(®)/Dx) is well tolerated and efficacious for the treatment of fecal incontinence (FI); however, the patient population that may derive maximum benefit has not been established. This post hoc responder analysis assessed demographic and baseline characteristics predictive of responsiveness to NASHA/Dx treatment. METHODS:Adults with a Cleveland Clinic Florida fecal incontinence score (CCFIS) ?10 were randomized to receive NASHA/Dx or sham treatment. The primary end point was response to treatment (ie, decrease from baseline of ?50% in number of FI episodes) at 6 months; a prespecified secondary end point was change in fecal incontinence quality of life (FIQL) score at 6 months. Post hoc subgroup analyses were performed for baseline and demographic characteristics and prior FI treatments. RESULTS:Overall, response to treatment was significantly greater with NASHA/Dx versus sham injection (52.7% vs 32.1%; P=0.0089). All subgroups analyzed demonstrated evidence of improvement, favoring NASHA/Dx versus sham treatment for both response to treatment and change in the FIQL coping/behavior subscale score. For the primary end point, a significantly greater percentage of patients with CCFIS ?15, FI symptoms ?5 years' duration, or obstetric causes of FI responded to NASHA/Dx treatment versus patients receiving sham treatment (51.1% vs 28.3%, P=0.0169; 55.4% vs 25.7%, P=0.0026; and 53.6% vs 23.1%, P=0.0191, respectively). The mean change in the FIQL coping/behavior score significantly favored NASHA/Dx versus sham treatment for patients with CCFIS ?15 (P=0.0371), FI symptoms ?5 years' duration (P=0.0289), or obstetric causes of FI (P=0.0384). Patients without a history of specific FI treatments (eg, antidiarrheal medications, biofeedback, surgery) were more likely to respond to NASHA/Dx versus sham treatment for both end points. CONCLUSION:Although all subgroups analyzed showed evidence of quantitative and qualitative benefit from NASHA/Dx therapy, patients with characteristics indicative of mild-to-moderate FI may exhibit the greatest benefit.

Project description:Purpose: Endoscopic dextranomer/hyaluronic acid (Dx/HA) injection is a common treatment for vesicoureteral reflux (VUR) with excellent reported short-term clinical success rates. Long-term outcomes are less well-defined. We assessed long-term outcomes and parental satisfaction after Dx/HA injection for primary VUR with >5-year follow-up. Materials and Methods: Families of all patients who underwent Dx/HA injection for primary VUR at our institution between 2008 and 2012 were contacted for telephone interview. Data collected by phone included parental satisfaction and presence and severity of UTIs pre-operatively and post-operatively. Patient demographics, radiographic VUR data, need for secondary surgery, and surgical indications were obtained through chart review. Results: Five hundred and seventy-five patients underwent Dx/HA injection for primary VUR between 2008 and 2012. Ninety-nine (17.2%) of these patients' parents were successfully contacted and interviewed. Median follow-up time from surgery to survey was 8.4 (IQR 6.8-9.6) years. Secondary surgery was performed in 13/99 (13.1%), most commonly repeat Dx/HA injection. Seven patients (7.1%) underwent secondary Dx/HA injection for persistent VUR without UTIs at a median of 0.35 (IQR 0.33-0.77) years post-operatively. Five patients (5.1%) underwent Dx/HA injection (n = 3) or ureteral reimplantation (n = 2) for VUR with febrile UTIs (fUTIs) at a median of 2.2 (IQR 1.3-5.1) years. One patient had ureteral reimplantation for symptomatic obstruction 2.8 years after initial surgery. Only 3/99 (3.0%) required open or laparoscopic surgery after Dx/HA injection. Eighty-three families (84.7%) reported ≥1 fUTIs pre-operatively. Of these, only 9/83 (10.8%) reported fUTIs post-operatively, for an overall clinical success rate of 89.2%. Clinical success was 93.1% in patients whose pre-operative fUTIs were treated outpatient and 80.0% in those hospitalized at least once for fUTI treatment pre-operatively. Ninety-four percent of parents were highly satisfied, 2.4% partially satisfied, and 3.5% dissatisfied. Conclusions: Endoscopic injection with Dx/HA for primary VUR appears to have good long-term clinical success rates and high parental satisfaction, mirroring our previously reported short-term results. Post-operative ureteral obstruction is rare but may occur years post-operatively, justifying initial sonographic surveillance, and repeat imaging in symptomatic patients.

Project description:ObjectiveDefecatory symptoms, such as a sense of incomplete emptying and straining with bowel movements, are paradoxically present in women with fecal incontinence. Treatments for fecal incontinence, such as loperamide and biofeedback, can worsen or improve defecatory symptoms, respectively. The primary aim of this study was to compare changes in constipation symptoms in women undergoing treatment for fecal incontinence with education only, loperamide, anal muscle exercises with biofeedback or both loperamide and biofeedback. Our secondary aim was to compare changes in constipation symptoms among responders and nonresponders to fecal incontinence treatment.Study designThis was a planned secondary analysis of a randomized controlled trial comparing 2 first-line therapies for fecal incontinence in a 2 × 2 factorial design. Women with at least monthly fecal incontinence and normal stool consistency were randomized to 4 groups: (1) oral placebo plus education only, (2) oral loperamide plus education only, (3) placebo plus anorectal manometry-assisted biofeedback, and (4) loperamide plus biofeedback. Defecatory symptoms were measured using the Patient Assessment of Constipation Symptoms questionnaire at baseline, 12 weeks, and 24 weeks. The Patient Assessment of Constipation Symptoms consists of 12 items that contribute to a global score and 3 subscales: stool characteristics/symptoms (hardness of stool, size of stool, straining, inability to pass stool), rectal symptoms (burning, pain, bleeding, incomplete bowel movement), and abdominal symptoms (discomfort, pain, bloating, cramps). Scores for each subscale as well as the global score range from 0 (no symptoms) to 4 (maximum score), with negative change scores representing improvement in defecatory symptoms. Responders to fecal incontinence treatment were defined as women with a minimally important clinical improvement of ≥5 points on the St Mark's (Vaizey) scale between baseline and 24 weeks. Intent-to-treat analysis was performed using a longitudinal mixed model, controlling for baseline scores, to estimate changes in Patient Assessment of Constipation Symptoms scores from baseline through 24 weeks.ResultsAt 24 weeks, there were small changes in Patient Assessment of Constipation Symptoms global scores in all 4 groups: oral placebo plus education (-0.3; 95% confidence interval, -0.5 to -0.1), loperamide plus education (-0.1, 95% confidence interval, -0.3 to0.0), oral placebo plus biofeedback (-0.3, 95% confidence interval, -0.4 to -0.2), and loperamide plus biofeedback (-0.3, 95% confidence interval, -0.4 to -0.2). No differences were observed in change in Patient Assessment of Constipation Symptoms scores between women randomized to placebo plus education and those randomized to loperamide plus education (P = .17) or placebo plus biofeedback (P = .82). Change in Patient Assessment of Constipation Symptoms scores in women randomized to combination loperamide plus biofeedback therapy was not different from that of women randomized to treatment with loperamide or biofeedback alone. Responders had greater improvement in Patient Assessment of Constipation Symptoms scores than nonresponders (-0.4; 95% confidence interval, -0.5 to -0.3 vs -0.2; 95% confidence interval, -0.3 to -0.0, P < .01, mean difference, 0.2, 95% confidence interval, 0.1-0.4).ConclusionChange in constipation symptoms following treatment of fecal incontinence in women are small and are not significantly different between groups. Loperamide treatment for fecal incontinence does not worsen constipation symptoms among women with normal consistency stool. Women with clinically significant improvement in fecal incontinence symptoms report greater improvement in constipation symptoms.

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Long-term efficacy of NASHA Dx injection therapy for treatment of fecal incontinence.

Publications

Long-term efficacy of NASHA Dx injection therapy for treatment of fecal incontinence.

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