NCT04604483

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Fissure in Ano

Interventions

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

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-10-27
• Last updated: 2024-03-01

Locations

1 site across 1 country: Sweden