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Clinical Trials/ISRCTN49693042
ISRCTN49693042
Completed
Not Applicable

aparoscopic trans-peritoneal pudendal nerve stimulation for management of faecal incontinence in adults

niversity of Leeds (UK)0 sites10 target enrollmentApril 20, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Faecal incontinence
Sponsor
niversity of Leeds (UK)
Enrollment
10
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 20, 2016
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Leeds (UK)

Eligibility Criteria

Inclusion Criteria

  • 1\. Patients with moderate to severe faecal incontinence for more than 6 months and suffering \= two incontinence episodes per week
  • 2\. Patients should have had a trial of conservative management plus either be suitable for trial of sacral nerve stimulation (SNS) or have had unsuccessful outcome with trial of SNS
  • 3\. Patients willing to participate in this study
  • 4\. Age \=18 years
  • 5\. Able to provide written and informed consent
  • 6\. Suitable candidate for surgery
  • 7\. Able and willing to comply with terms of the protocol including filling in questionnaires

Exclusion Criteria

  • 1\. Presence of anal sphincter augmentation device i.e. FENIX or ABS
  • 2\. Chronic gastro\-intestinal motility disorder causing incontinence due to diarrhoea
  • 3\. Active anorectal sepsis or disease such as cancer
  • 4\. External rectal prolapse
  • 5\. Pregnancy
  • 6\. Suspected or known allergy to titanium
  • 7\. Multiply scarred abdomen precluding laparoscopic surgery

Outcomes

Primary Outcomes

Not specified

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