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

Fissure in Ano Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04604483
• Other study ID #: PTNS for anal fissure
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Region Skane
• Contact: Martin Lindsten, MD
• Phone: +4640331000
• Email: martin.lindsten[@]skane.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fissure in Ano

Intervention

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

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Malmo

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing rate	Healing of anal fissure from assessement of clinical and/or data from patient form	3 months after treatment
Primary	Healing rate	Healing of anal fissure from assessement of clinical and/or data from patient form	12 months after treatment
Secondary	Bowel movements	Changes in frequency of bowel emptying and consistency of bowel contents Before and after treatment	3 months after treatment
Secondary	Bowel movements	Changes in frequency of bowel emptying and consistency of bowel contents Before and after treatment	12 months after treatment
Secondary	Adverse effects	Reports of adverse effects (subjective/objective)	3 months after treatment
Secondary	Adverse effects	Reports of adverse effects (subjective/objective)	12 months after treatment
Secondary	Smoking	Differences in healing rates between smokers and non-smokers	3 months after treatment
Secondary	Smoking	Differences in healing rates between smokers and non-smokers	12 months after treatment