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Clinical Trials in Sweden / NCT04604483
Starting soon Not applicable

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

NCT04604483 · tracked via the Priya Life Science Sweden tracker
Sponsor
Region Skane
Phase
Not applicable
Started
2024-10-01
Last updated
2024-03-01

Condition(s) studied

Fissure in Ano

Investigational drug(s) / intervention(s)

PTNS

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Healing rate — 3 months after treatment
    Healing of anal fissure from assessement of clinical and/or data from patient form
  • Healing rate — 12 months after treatment
    Healing of anal fissure from assessement of clinical and/or data from patient form

Trial sites (1)

FacilityCityRegionStatus
Skåne University Hospital Malmö Sweden

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04604483 on ClinicalTrials.gov ↗ ← All trials in Sweden