Percutaneous Tibial Nerve Stimulation (PTNS) for the Treatment of Chronic Anal Fissure
ConditionFissure in Ano
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Verified anal fissure (Clinical assessement by experienced proctological surgeon)
Full conservative treatment has been given
Disqualifiers
Inflammatory bowel disease
Fistula and/or anal abscess
Patients with compromised immunity
Pregnancy
Trial design
Design model
Single group
Treatments tested in this trial
PTNS
DevicePatients meeting the criteria are treated with PTNS and are evaluated at 3 months and 1 year after end of treatment.
Treatment groups
52 Participants
are divided into 1 treatment groupGroup A: PTNSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Healing rate
Healing of anal fissure from assessement of clinical and/or data from patient form
Time frame
3 months after treatment2
Healing rate
Healing of anal fissure from assessement of clinical and/or data from patient form
Time frame
12 months after treatmentSecondary outcomes
1
Bowel movements
Changes in frequency of bowel emptying and consistency of bowel contents Before and after treatment
Time frame
3 months after treatment2
Bowel movements
Changes in frequency of bowel emptying and consistency of bowel contents Before and after treatment
Time frame
12 months after treatment3
Adverse effects
Reports of adverse effects (subjective/objective)
Time frame
3 months after treatment4
Adverse effects
Reports of adverse effects (subjective/objective)
Time frame
12 months after treatmentSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: