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

NCT04604483 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-03-01

No results posted yet for this study

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

Interventions

DEVICE

PTNS

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

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Louis B Johnson, PhD · Lund University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04604483 on ClinicalTrials.gov