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

Primary Purpose

Fissure in Ano

Status
Not yet recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
PTNS
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fissure in Ano focused on measuring Anal fissure, Percutaneous Tibial Nerve Stimulation, PTNS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Skåne University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PTNS

Arm Description

Treatment with PTNS for chronic anal fissure, treatment to be given for 30 minutes during 10 consecutive work Days.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Bowel movements
Changes in frequency of bowel emptying and consistency of bowel contents Before and after treatment
Bowel movements
Changes in frequency of bowel emptying and consistency of bowel contents Before and after treatment
Adverse effects
Reports of adverse effects (subjective/objective)
Adverse effects
Reports of adverse effects (subjective/objective)
Smoking
Differences in healing rates between smokers and non-smokers
Smoking
Differences in healing rates between smokers and non-smokers

Full Information

First Posted
October 14, 2020
Last Updated
February 17, 2021
Sponsor
Region Skane
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1. Study Identification

Unique Protocol Identification Number
NCT04604483
Brief Title
Percutaneous Tibial Nerve Stimulation (PTNS) for the Treatment of Chronic Anal Fissure
Official Title
Percutaneous Tibial Nerve Stimulation for Chronic Anal Fissure - a Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fissure in Ano
Keywords
Anal fissure, Percutaneous Tibial Nerve Stimulation, PTNS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective non-randomized trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PTNS
Arm Type
Experimental
Arm Description
Treatment with PTNS for chronic anal fissure, treatment to be given for 30 minutes during 10 consecutive work Days.
Intervention Type
Device
Intervention Name(s)
PTNS
Other Intervention Name(s)
Percutaneous Tibial Nerve Stimulation
Intervention Description
Patients meeting the criteria are treated with PTNS and are evaluated at 3 months and 1 year after end of treatment.
Primary Outcome Measure Information:
Title
Healing rate
Description
Healing of anal fissure from assessement of clinical and/or data from patient form
Time Frame
3 months after treatment
Title
Healing rate
Description
Healing of anal fissure from assessement of clinical and/or data from patient form
Time Frame
12 months after treatment
Secondary Outcome Measure Information:
Title
Bowel movements
Description
Changes in frequency of bowel emptying and consistency of bowel contents Before and after treatment
Time Frame
3 months after treatment
Title
Bowel movements
Description
Changes in frequency of bowel emptying and consistency of bowel contents Before and after treatment
Time Frame
12 months after treatment
Title
Adverse effects
Description
Reports of adverse effects (subjective/objective)
Time Frame
3 months after treatment
Title
Adverse effects
Description
Reports of adverse effects (subjective/objective)
Time Frame
12 months after treatment
Title
Smoking
Description
Differences in healing rates between smokers and non-smokers
Time Frame
3 months after treatment
Title
Smoking
Description
Differences in healing rates between smokers and non-smokers
Time Frame
12 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Lindsten, MD
Phone
+4640331000
Email
martin.lindsten@skane.se
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Strandberg
Phone
+4640331000
Email
sara.strandberg@skane.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis B Johnson, PhD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skåne University Hospital
City
Malmo
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No intention to make individual participant data available to other researchers
Citations:
PubMed Identifier
22336789
Citation
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.
Results Reference
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Percutaneous Tibial Nerve Stimulation (PTNS) for the Treatment of Chronic Anal Fissure

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