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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fissure in Ano
• Intervention / Treatment: Device: PTNS

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Lindsten, MD; Phone Number: +4640331000; Email: martin.lindsten@skane.se
• Study Contact Backup: Name: Sara Strandberg; Phone Number: +4640331000; Email: sara.strandberg@skane.se

Study Locations

• Sweden
  • Malmo, Sweden
    • Skåne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Louis B Johnson, PhD, Lund University

Publications and helpful links

General Publications

• Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003431. doi: 10.1002/14651858.CD003431.pub3.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Anal fissure; PTNS; Percutaneous Tibial Nerve Stimulation
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Anus Diseases; Fissure in Ano
• Other Study ID Numbers: PTNS for anal fissure

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No intention to make individual participant data available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No