Sphincter training or anal injections of dextranomer for treatment of anal incontinence: a randomized trial

Dehli, Trond; Stordahl, Arvid; Vatten, Lars J.; Romundstad, Pål Richard; Mevik, Kjersti; Sahlin, Ylva; Lindsetmo, Rolv-Ole; Vonen, Barthold

doi:10.3109/00365521.2012.758770

Cited by 41 publications

(27 citation statements)

References 23 publications

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“…Treatment did not significantly improve FI quality of life; data for complete continence and effects on anorectal physiology or imaging were not provided 80, 81 . Another controlled trial with 126 patients reported significant improvement in FI symptom severity and QOL in patients who were randomized to pelvic floor biofeedback therapy and separately to NASHA Dx 82 ; the efficacy of these approaches was not different. Biofeedback therapy increased anal squeeze pressure but NASHA Dx did not increase anal resting or squeeze pressre.…”

Section: Fecal Incontinencementioning

confidence: 99%

An Update on Anorectal Disorders for Gastroenterologists

2014

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Gastroenterologists frequently encounter pelvic floor disorders, which affect 10–15% of the population. The anorectum is a complex organ that collaborates with the pelvic floor muscles to preserve fecal continence and enable defecation. A careful clinical assessment is critical for the diagnosis and management of defecatory disorders and fecal incontinence. Newer diagnostic tools (e.g., high resolution manometry and magnetic resonance defecography) provide a refined understanding of anorectal dysfunctions and identify phenotypes in defecatory disorders and fecal incontinence. Conservative approaches including biofeedback therapy are the mainstay for managing these disorders; new minimally-invasive approaches may benefit a subset of patients with fecal incontinence but more controlled studies are needed. This mini-review highlights these advances, current concepts and controversies in the area.

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Section: Fecal Incontinencementioning

confidence: 99%

An Update on Anorectal Disorders for Gastroenterologists

2014

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“…NASHA Dx has been evaluated in several trials (Table 3),108–119 including a randomized, double-blind sham-controlled study in adults who had failed conservative therapies. Patients received NASHA Dx (n=136) or sham treatment (n=70) in an outpatient setting without anesthesia; patients with no persistent AEs but persistent FI after 1 month were offered 1 retreatment procedure 109.…”

Section: Resultsmentioning

confidence: 99%

“…Efficacy and long-term durability have been reported in open-label studies110–114 and a comparative study versus biofeedback training (∼20 min daily, 5 d a week, for 6 mo; Table 3). 108…”

Section: Resultsmentioning

confidence: 99%

Current and Emerging Treatment Options for Fecal Incontinence

Rao

2014

Journal of Clinical Gastroenterology

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Fecal incontinence (FI) is a multifactorial disorder that imposes considerable social and economic burdens. The aim of this article is to provide an overview of current and emerging treatment options for FI. A MEDLINE search was conducted for English-language articles related to FI prevalence, etiology, diagnosis, and treatment published from January 1, 1990 through June 1, 2013. The search was extended to unpublished trials on ClinicalTrials.gov and relevant publications cited in included articles. Conservative approaches, including dietary modifications, medications, muscle-strengthening exercises, and biofeedback, have been shown to provide short-term benefits. Transcutaneous electrical stimulation was considered ineffective in a randomized clinical trial. Unlike initial studies, sacral nerve stimulation has shown reasonable short-term effectiveness and some complications. Dynamic graciloplasty and artificial sphincter and bowel devices lack randomized controlled trials and have shown inconsistent results and high rates of explantation. Of injectable bulking agents, dextranomer microspheres in non-animal stabilized hyaluronic acid (NASHA Dx) has shown significant improvement in incontinence scores and frequency of incontinence episodes, with generally mild adverse effects. For the treatment of FI, conservative measures and biofeedback therapy are modestly effective. When conservative therapies are ineffective, invasive procedures, including sacral nerve stimulation, may be considered, but they are associated with complications and lack randomized, controlled trials. Bulking agents may be an appropriate alternative therapy to consider before more aggressive therapies in patients who fail conservative therapies.

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“…Dextranomer microspheres in non-animal stabilized hyaluronic acid (NASHA Dx) is the only Food and Drug Administration (FDA)-approved product for FI 23 . While the implied mechanism of action is to enhance the seal of the anal canal, dextranomer did not significantly increase anal resting or squeeze pressures nor was it superior to biofeedback therapy 24 . In a randomized, double-blind sham-controlled study in adults who had failed conservative therapies, 71/136 (52%) patients in the active treatment group vs. 22/70 (31%) in the sham group had a treatment response (≥50% improvement from baseline in the number of FI episodes) at 6 months (OR: 2.36; P = 0.0089) 25 (Table 1).…”

Section: Perianal Bulking Injectionmentioning

confidence: 87%

Surgical Interventions and the Use of Device-Aided Therapy for the Treatment of Fecal Incontinence and Defecatory Disorders

Bharucha

Rao

Shin

2017

Clinical Gastroenterology and Hepatology

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Description The purpose of this clinical practice update expert review is to describe the key principles in the use of surgical interventions and device-aided therapy for managing fecal incontinence (FI) and defecatory disorders. Methods The best practices outlined in this review are based on relevant publications, including systematic reviews and expert opinion (when applicable). Best practice advice 1 A stepwise approach should be followed for management of FI. Conservative therapies (diet, fluids, techniques to improve evacuation, a bowel training program, management of diarrhea and constipation with diet and medications if necessary) will benefit approximately 25% of patients and should be tried first. Best practice advice 2 Pelvic floor retraining with biofeedback therapy is recommended for patients with FI who do not respond to the conservative measures indicated above. Best practice advice 3 Perianal bulking agents such as intraanal injection of dextranomer may be considered when conservative measures and biofeedback therapy fail. Best practice advice 4 Sacral nerve stimulation should be considered for patients with moderate or severe FI in whom symptoms have not responded after a 3 month or longer trial of conservative measures and biofeedback therapy and who do not have contraindications to these procedures. Best practice advice 5 Until further evidence is available, percutaneous tibial nerve stimulation should not be used for managing FI in clinical practice. Best practice advice 6 Barrier devices should be offered to patients who have failed conservative or surgical therapy, or in those who have failed conservative therapy who do not want or are not eligible for more invasive interventions. Best practice advice 7 Anal sphincter repair (sphincteroplasty) should be considered in postpartum women with FI and in patients with recent sphincter injuries. In patients who present later with symptoms of FI unresponsive to conservative and biofeedback therapy and evidence of sphincter damage, sphincteroplasty may be considered when perianal bulking injection and sacral nerve stimulation are not available or have proven unsuccessful. Best practice advice 8 The artificial anal sphincter, dynamic graciloplasty, may be considered for patients with medically-refractory severe FI who have failed treatment or are not candidates for barrier devices, sacral nerve stimulation, perianal bulking injection, sphincteroplasty and a colostomy. Best practice advice 9 Major anatomic defects (e.g., rectovaginal fistula, full thickness rectal prolapse, fistula in ano, or cloacalike deformity) should be rectified with surgery. Best practice advice 10 A colostomy should be considered in patients with severe FI who have failed conservative treatment and have failed or are not candidates for barrier devices, minimally invasive surgical interventions, and sphincteroplasty. Best practice advice 11 A magnetic anal sphincter device may be considered for patients with medically refractory severe FI who have failed o...

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Sphincter training or anal injections of dextranomer for treatment of anal incontinence: a randomized trial

Abstract: The efficacy of anal injections and biofeedback in treating anal incontinence did not differ in this randomized, single-blinded, controlled trial.

Cited by 41 publications

References 23 publications

An Update on Anorectal Disorders for Gastroenterologists

An Update on Anorectal Disorders for Gastroenterologists

Current and Emerging Treatment Options for Fecal Incontinence

Surgical Interventions and the Use of Device-Aided Therapy for the Treatment of Fecal Incontinence and Defecatory Disorders

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