Fissure in AnoNCT04604483
Percutaneous Tibial Nerve Stimulation (PTNS) for the Treatment of Chronic Anal Fissure
A study testing PTNS in people with Fissure in Ano, run by Region Skane at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fissure in Ano
- What is being tested?
- PTNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Verified anal fissure (Clinical assessement by experienced proctological surgeon)
- Full conservative treatment has been given
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Percutaneous Tibial Nerve Stimulation for Chronic Anal Fissure - a Prospective Study
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.
Read the 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.
- Conditions
- Fissure in Ano
- Being tested
- PTNS
- Keywords
- Anal fissure, Percutaneous Tibial Nerve Stimulation, PTNS
- Medical subject headings
- Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTNSDevice
Also called Percutaneous Tibial Nerve Stimulation
Patients meeting the criteria are treated with PTNS and are evaluated at 3 months and 1 year after end of treatment.
| Study group | Role | What they receive |
|---|---|---|
| PTNS | Experimental | Treatment with PTNS for chronic anal fissure, treatment to be given for 30 minutes during 10 consecutive work Days. Receives: Device: PTNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing rate
Healing of anal fissure from assessement of clinical and/or data from patient form
Measured: 3 months after treatment
Healing rate
Healing of anal fissure from assessement of clinical and/or data from patient form
Measured: 12 months after treatment
Secondary outcomes (6)
Bowel movements
Changes in frequency of bowel emptying and consistency of bowel contents Before and after treatment
Measured: 3 months after treatment
Bowel movements
Changes in frequency of bowel emptying and consistency of bowel contents Before and after treatment
Measured: 12 months after treatment
Adverse effects
Reports of adverse effects (subjective/objective)
Measured: 3 months after treatment
Adverse effects
Reports of adverse effects (subjective/objective)
Measured: 12 months after treatment
Smoking
Differences in healing rates between smokers and non-smokers
Measured: 3 months after treatment
Smoking
Differences in healing rates between smokers and non-smokers
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Oct 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fissure in AnoStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective non-randomized trial
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis B Johnson, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604483
- Sponsor's protocol ID
- PTNS for anal fissure
- Status last verified
- Feb 2024
- First submitted
- 14 Oct 2020
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No intention to make individual participant data available to other researchers
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.
PubMed 22336789
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Tibial Nerve Stimulation for Chronic Anal Fissure - a Prospective Study
- ClinicalTrials.gov ID
- NCT04604483
- Acronym / sponsor ID
- PTNS for anal fissure
- Conditions
- Fissure in Ano
- Keywords
- Anal fissure, Percutaneous Tibial Nerve Stimulation, PTNS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective non-randomized trial
| Arm | Type | Receives |
|---|---|---|
| PTNS | Experimental | Device: PTNSTreatment with PTNS for chronic anal fissure, treatment to be given for 30 minutes during 10 consecutive work Days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Verified anal fissure (Clinical assessement by experienced proctological surgeon)
- Full conservative treatment has been given
Key exclusion criteria (7 listed)
- Inflammatory bowel disease
- Fistula and/or anal abscess
- Patients with compromised immunity
- Pregnancy
- Treatment with anti-coagulants (not aspirin)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTNSAlso: Percutaneous Tibial Nerve StimulationPatients meeting the criteria are treated with PTNS and are evaluated at 3 months and 1 year after end of treatment. | Device | PTNS |
Primary outcome
Healing rate
Time frame: 3 months after treatment
Healing of anal fissure from assessement of clinical and/or data from patient form
Healing rate
Time frame: 12 months after treatment
Healing of anal fissure from assessement of clinical and/or data from patient form
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 22336789Nelson 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.
- Individual participant dataSharing planned: No. No intention to make individual participant data available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louis B Johnson, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTNS in people with Fissure in Ano, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Lindsten, MD (+4640331000, martin.lindsten@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rate (time frame: 3 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04604483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.