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

NCT04604483 | Not Yet Recruiting

• 1 other identifier: PTNS for anal fissure
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fissure in Ano

Keywords

Anal fissure; Percutaneous Tibial Nerve Stimulation; PTNS

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Bowel movements

  3 months after treatment

• Bowel movements

  12 months after treatment

• Adverse effects

  3 months after treatment

• Adverse effects

  12 months after treatment

• Smoking

  3 months after treatment

Study Arms (1)

PTNS

EXPERIMENTAL

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

Device: PTNS

Interventions

PTNS DEVICE

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

Also known as: Percutaneous Tibial Nerve Stimulation

PTNS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Verified anal fissure (Clinical assessement by experienced proctological surgeon)
• Full conservative treatment has been given

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skåne University Hospital

Malmo, Sweden

Location

Related Publications (1)

• 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.

  PMID: 22336789 BACKGROUND

MeSH Terms

Conditions

Fissure in Ano

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Louis B Johnson, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Lindsten, MD

CONTACT

+4640331000; martin.lindsten@skane.se

Sara Strandberg

CONTACT

+4640331000; sara.strandberg@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective non-randomized trial

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 27, 2020
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)