Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT04604483

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Fissure in Ano Anus Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skåne University Hospital

Malmö, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PTNS

Device

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

Other names: Percutaneous Tibial Nerve Stimulation

Primary outcomes

  1. Healing rate

    Time frame: 3 months after treatment

    Healing of anal fissure from assessement of clinical and/or data from patient form

  2. Healing rate

    Time frame: 12 months after treatment

    Healing of anal fissure from assessement of clinical and/or data from patient form

Secondary outcomes

  1. Bowel movements

    Time frame: 3 months after treatment

    Changes in frequency of bowel emptying and consistency of bowel contents Before and after treatment

  2. Bowel movements

    Time frame: 12 months after treatment

    Changes in frequency of bowel emptying and consistency of bowel contents Before and after treatment

  3. Adverse effects

    Time frame: 3 months after treatment

    Reports of adverse effects (subjective/objective)

  4. Adverse effects

    Time frame: 12 months after treatment

    Reports of adverse effects (subjective/objective)

  5. Smoking

    Time frame: 3 months after treatment

    Differences in healing rates between smokers and non-smokers

  6. Smoking

    Time frame: 12 months after treatment

    Differences in healing rates between smokers and non-smokers

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Lindsten, MD

CONTACT

[email protected]

+4640331000

Sara Strandberg

CONTACT

[email protected]

+4640331000

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 27, 2020
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.