Percutaneous Tibial Nerve Stimulation (PTNS) for the Treatment of Chronic Anal Fissure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PTNS.
- Who it may be relevant to
- Registry conditions: Fissure in Ano. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Percutaneous Tibial Nerve Stimulation for Chronic Anal Fissure - a Prospective Study
Overview
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.
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.
Interventions
- Device PTNS
Patients meeting the criteria are treated with PTNS and are evaluated at 3 months and 1 year after end of treatment.
Primary outcome measures
- Healing rate [Time frame: 3 months after treatment]
- Healing rate [Time frame: 12 months after treatment]
Secondary outcome measures (6)
- Bowel movements [Time frame: 3 months after treatment]
- Bowel movements [Time frame: 12 months after treatment]
- Adverse effects [Time frame: 3 months after treatment]
- Adverse effects [Time frame: 12 months after treatment]
- Smoking [Time frame: 3 months after treatment]
- Smoking [Time frame: 12 months after treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Skåne University Hospital — Malmö
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. PMID 22336789
Identifiers
NCT: NCT04604483 · PTNS for anal fissure