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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-12-31

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.

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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.

Conditions

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Fissure in Ano

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective non-randomized trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PTNS

Treatment with PTNS for chronic anal fissure, treatment to be given for 30 minutes during 10 consecutive work Days.

Group Type EXPERIMENTAL

PTNS

Intervention Type DEVICE

Patients meeting the criteria are treated with PTNS and are evaluated at 3 months and 1 year after end of treatment.

Interventions

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PTNS

Patients meeting the criteria are treated with PTNS and are evaluated at 3 months and 1 year after end of treatment.

Intervention Type DEVICE

Other Intervention Names

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Percutaneous Tibial Nerve Stimulation

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No