Surgery for faecal incontinence in adults

Brown, S. R.; Wadhawan, Himanshu; Nelson, Richard L.

doi:10.1002/14651858.cd001757.pub4

Cited by 65 publications

(52 citation statements)

References 63 publications

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“…Surgical procedures are invasive and have, at best, variable success rates with significant risk of morbidity. [18][19][20][21] Neuromodulation is a relatively new treatment modality for FI which is bridging the gap between conservative strategies and invasive surgery in centres where expertise exists. It is based on recruitment of residual anorectal neuromuscular function pertinent to continence by electrical stimulation of the peripheral nerve supply, without the need for surgery to the anus itself.…”

Section: Management Of Faecal Incontinencementioning

confidence: 99%

Double-blind randomised controlled trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in the treatment of faecal incontinence: CONtrol of Faecal Incontinence using Distal NeuromodulaTion (the CONFIDeNT trial)

Horrocks

Bremner

Stevens

et al. 2015

Health Technol Assess

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BackgroundFaecal incontinence (FI) is a common condition which is often under-reported. It is distressing for those suffering from it, impacting heavily on their quality of life. When conservative strategies fail, treatment options are limited. Percutaneous tibial nerve stimulation (PTNS) is a minimally invasive outpatient treatment, shown in preliminary case series to have significant effectiveness; however, no randomised controlled trial has been conducted.ObjectivesTo assess the effectiveness of PTNS compared with sham electrical stimulation in the treatment of patients with FI in whom initial conservative strategies have failed.DesignMulticentre, parallel-arm, double-blind randomised (1 : 1) controlled trial.SettingEighteen UK centres providing specialist nurse-led (or equivalent) treatment for pelvic floor disorders.ParticipantsParticipants aged > 18 years with FI who have failed conservative treatments and whose symptoms are sufficiently severe to merit further intervention.InterventionsPTNS was delivered via the Urgent®PC device (Uroplasty Limited, Manchester, UK), a hand-held pulse generator unit, with single-use leads and fine-needle electrodes. The needle was inserted near the tibial nerve on the right leg adhering to the manufacturer’s protocol (and specialist training). Treatment was for 30 minutes weekly for a duration of 12 treatments. Validated sham stimulation involved insertion of the Urgent PC needle subcutaneously at the same site with electrical stimulation delivered to the distal foot using transcutaneous electrical nerve stimulation.Main outcome measuresOutcome measures were assessed at baseline and 2 weeks following treatment. Clinical outcomes were derived from bowel diaries and validated, investigator-administered questionnaires. The primary outcome classified patients as responders or non-responders, with a responder defined as someone having achieved ≥ 50% reduction in weekly faecal incontinence episodes (FIEs).ResultsIn total, 227 patients were randomised from 373 screened: 115 received PTNS and 112 received sham stimulation. There were 12 trial withdrawals: seven from the PTNS arm and five from the sham arm. Missing data were multiply imputed. For the primary outcome, the proportion of patients achieving a ≥ 50% reduction in weekly FIEs was similar in both arms: 39 in the PTNS arm (38%) compared with 32 in the sham arm (31%) [odds ratio 1.28, 95% confidence interval (CI) 0.72 to 2.28;p = 0.396]. For the secondary outcomes, significantly greater decreases in weekly FIEs were observed in the PTNS arm than in the sham arm (beta –2.3, 95% CI –4.2 to –0.3;p = 0.02), comprising a reduction in urge FIEs (p = 0.02) rather than passive FIEs (p = 0.23). No significant differences were found in the St Mark’s Continence Score or any quality-of-life measures. No serious adverse events related to treatment were reported.ConclusionsPTNS did not show significant clinical benefit over sham electrical stimulation in the treatment of FI based on number of patients who received at least a 50% reduction in weekly FIE. It would be difficult to recommend this therapy for the patient population studied. Further research will concentrate on particular subgroups of patients, for example those with pure urge FI.Trial registrationCurrent Controlled Trials ISRCTN88559475.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 77. See the NIHR Journals Library website for further project information.

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Section: Management Of Faecal Incontinencementioning

confidence: 99%

Double-blind randomised controlled trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in the treatment of faecal incontinence: CONtrol of Faecal Incontinence using Distal NeuromodulaTion (the CONFIDeNT trial)

Horrocks

Bremner

Stevens

et al. 2015

Health Technol Assess

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“…The strength of the present study is its prospective design with systematic assessment of faecal incontinence, urinary incontinence, sexual function and quality of life in a homogeneous group of women with faecal incontinence and a history of OASIS, representing the largest subgroup of patients with faecal incontinence [34]. A limitation of this study is its small dataset.…”

Section: Discussionmentioning

confidence: 99%

Sacral neuromodulation for combined faecal and urinary incontinence following obstetric anal sphincter injury

et al. 2018

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Aim The aim of this study was to investigate the efficacy of sacral neuromodulation (SNM) in the treatment of faecal incontinence and concomitant urinary incontinence in women with a history of obstetric anal sphincter injury (OASIS).Method In this prospective study, consecutive women with faecal incontinence following OASIS accepted for SNM were screened for concomitant urinary incontinence. The primary outcome was the change in urinary incontinence score on the International Consultation on Incontinence Questionnaire for Urinary Incontinence, Short Form (ICIQ-UI-SF), between baseline and 12 months. Secondary outcomes included the change in St Mark's score, sexual function and quality of life, change in grade of urinary incontinence and disappearance of urgency.Results From March 2012 to September 2014, 39 women with combined faecal incontinence and urinary incontinence received SNM. Thirty-seven women were available for analysis after 12 months. The mean reduction in the ICIQ-UI-SF score between the baseline and 12 months was 5.8 (95% CI 3.7-8.0, P < 0.001). ICIQ-UI-SF was reduced in 29 (78%) women, urinary incontinence resolved in 13/37 (35%, 95% CI 20%-50%) patients, and urgency disappeared in 14/33 (42%, 95% CI 26%-59%). The mean reduction in the St Mark's score was 10.6 (95% CI 8.6-12.7, P < 0.001). Disease-specific quality of life, Euroqual 5-dimension visual analogue scale (EQ-5D VAS) and several areas of sexual function changed significantly for the better.Conclusion More than three-quarters of the women with combined faecal and urinary incontinence following OASIS reported a successful outcome with reduction in ICIQ-UI-SF at 12 months after SNM.Keywords Faecal incontinence, urinary incontinence, pelvic floor disorders/dysfunction, obstetric anal sphincter injury, sacral neuromodulation What does this paper add to the literature? A high prevalence of concomitant urinary incontinence was found in a selected group of women with faecal incontinence following obstetric anal sphincter injury treated with sacral neuromodulation. Faecal incontinence and concomitant urinary incontinence were treated successfully in the majority of women.

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“…Accidental bowel leakage (ABL), the patient-preferred term for fecal incontinence (FI) affects 12-15% of community-dwelling women [1][2][3][4][5]. Recent community-based studies estimate that as many as 17 million women in the U.S. suffer from some form of ABL, with over 3 million severe cases [6].…”

Section: Introductionmentioning

confidence: 99%

“…Current non-surgical treatment options that include behavioral and dietary modifications, physical therapy, biofeedback, and medications often fall short of achieving adequate relief from ABL episodes [11,12]. Additionally, surgical options are challenged with cost, medical and surgical complexity, and sub-optimal overall treatment success rates [2,[13][14][15][16][17]. Alternative treatments that provide long-term efficacy with minimal risk are needed.…”

Section: Introductionmentioning

confidence: 99%

A Staged Feasibility Study of a Novel Vaginal Bowel Control System for the Treatment of Accidental Bowel Leakage in Adult Women

Takase-Sanchez¹

2017

SOJGOW

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BackgroundAccidental bowel leakage, or fecal incontinence, impacts the quality of life in women of all ages. A minimallyinvasive vaginal bowel control system was designed to reduce accidents and provides a new health care option for women. MethodsA feasibility study was conducted to evaluate fit, patient comfort, and ease-of-use of this novel vaginal bowel control therapy at home to better inform device design, treatment delivery, and the design of a subsequent pivotal clinical trial protocol. Staged evaluations were performed in women without and with self-reported accidental bowel leakage of any severity. Wear duration progressed from an initial one-time, in-office fitting to extended-wear periods at home. Device-related adverse events were collected in all subjects exposed to the device. Treatment responses were collected at baseline and after 1-month wear in women with accidental bowel leakage. Additionally, device comfort and satisfaction were assessed. ResultsEighty-six women were fitted with forty-five women continuing to wear the vaginal bowel control system for ≥ 1 week. Fifteen women with fecal incontinence were extended to ≥ 1-month wear. Nine minor devicerelated adverse events were reported. Eight of 9 women who completed diaries experienced ≥ 50% reduction in episodes at 1-month wear. Device comfort and satisfaction were high.

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Surgery for faecal incontinence in adults

Abstract: Analysis 10.7. Comparison 10 Gluteus maximus transposition (adynamic) versus total pelvic floor repair, Outcome 7 Maximum resting anal pressure (cm/water

Cited by 65 publications

References 63 publications

Double-blind randomised controlled trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in the treatment of faecal incontinence: CONtrol of Faecal Incontinence using Distal NeuromodulaTion (the CONFIDeNT trial)

Double-blind randomised controlled trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in the treatment of faecal incontinence: CONtrol of Faecal Incontinence using Distal NeuromodulaTion (the CONFIDeNT trial)

Sacral neuromodulation for combined faecal and urinary incontinence following obstetric anal sphincter injury

A Staged Feasibility Study of a Novel Vaginal Bowel Control System for the Treatment of Accidental Bowel Leakage in Adult Women

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