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

Region Skane

Status: Not yet enrolling

Conditions: Fissure in Ano

Treatments: Device: PTNS

Study type: Interventional

Funder types: Other

Identifiers

NCT04604483

PTNS for anal fissure

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

PTNS

Experimental group

Description:

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

Treatment:

Device: PTNS