Percutaneous Tibial Nerve Stimulation (PTNS) for the Treatment of Chronic Anal Fissure

Study Overview
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Brief Summary
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Chronic anal fissure rarely heals spontaneously. About 50% heal on administration om topical muscle relaxants (e.g. diltiazem) and/or injection of Botulinum toxin, but for the remainder of patients surgery (with lateral internal sphincterotomy or fissurectomy) with subsequent risks of anal incontinence has been the golden standard. Treatment with PTNS (percutaneous tibial nerve stimulation) has been showed to produce healing of chronic anal fissures not responding to topical treatment, thus avoiding the risk for debilitating anal incontinence.

Detailed Description
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This study will prospectively include 52 patients with chronic anal fissure that have received topical treatment and stool softeners and have all been evaluated by experienced proctological surgeons. The treatment will be given for 10 consecutive work days and then evaluated at 3 and 12 months. If the patients symptoms are unimproved at 3 months alternative treatments will be offered.

Official Title
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Percutaneous Tibial Nerve Stimulation for Chronic Anal Fissure - a Prospective Study

Conditions
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Fissure in Ano

Intervention / Treatment
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* Device: PTNS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Verified anal fissure (Clinical assessement by experienced proctological surgeon) Full conservative treatment has been given Exclusion Criteria: Inflammatory bowel disease Fistula and/or anal abscess Patients with compromised immunity Pregnancy Treatment with anti-coagulants (not aspirin) Previous irradiation towards pelvic floor Pacemaker or implanted defibrillator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective non-randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTNS<br>Treatment with PTNS for chronic anal fissure, treatment to be given for 30 minutes during 10 consecutive work Days. | Device: PTNS<br>* Patients meeting the criteria are treated with PTNS and are evaluated at 3 months and 1 year after end of treatment.<br>* Other names: Percutaneous Tibial Nerve Stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing rate | Healing of anal fissure from assessement of clinical and/or data from patient form | 3 months after treatment | 
| Healing rate | Healing of anal fissure from assessement of clinical and/or data from patient form | 12 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel movements | Changes in frequency of bowel emptying and consistency of bowel contents Before and after treatment | 3 months after treatment | 
| Bowel movements | Changes in frequency of bowel emptying and consistency of bowel contents Before and after treatment | 12 months after treatment | 
| Adverse effects | Reports of adverse effects (subjective/objective) | 3 months after treatment | 
| Adverse effects | Reports of adverse effects (subjective/objective) | 12 months after treatment | 
| Smoking | Differences in healing rates between smokers and non-smokers | 3 months after treatment | 
| Smoking | Differences in healing rates between smokers and non-smokers | 12 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anal fissure, Percutaneous Tibial Nerve Stimulation, PTNS