Clinical trial NCT03554421: Percutaneous Tibial Nerve Stimulation - an Alternative Treatment Option for Chronic Therapy Resistant Anal Fissure
Official title: Percutaneous Tibial Nerve Stimulation - PTNS: an Alternative Treatment Option for Chronic Therapy Resistant Anal Fissure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Anal Fissure
Keywords: Key Words: Anal Fissure, tibial nerve stimulation
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Only patients with chronic anal fissures treated
Primary purpose: TREATMENT

Brief summary: At a tertiary referral centre, 10 patients (4 male and 6 female; mean age 49.8 years) were given neuromodulation via the posterior tibial nerve to the sacral nerve for 30 min on 10 consecutive days. All patients had failed conventional medical treatment. The visual analogue scale (VAS), St. Marks score, Wexner's constipation score, Brief Pain Inventory (BPI - SF), bleeding and mucosal healing were evaluated before treatment, at termination, after 3 months and then yearly during three years.

Detailed description: Between October 2013 and January 2014, 10 patients diagnosed with chronic anal fissure at the Pelvic Floor Centre - University Hospital of Malmo, Sweden were treated with percutaneous tibial nerve stimulation. Ethical clearance to use the results in a scientific setting was obtained from the ethics committee of the University of Lund, Sweden (Dnr 2016/998). Pre-treatment evaluation included detailed medical history and anorectal examination. All patients presented with pain and/or bleeding and the presence of a chronic anal fissure was confirmed by clinical examination.

Patients were included in the study if they were older than 18 years and had symptoms of chronic anal fissure for at least 6 months. All patients must have been on high fiber diet and stool softeners and in addition failed all conservative pharmacological treatment with topical application of anaesthetic creams, muscle relaxants (nitroglycerin or diltiazem) and/or botulinum toxin injection. We excluded patients with pregnancy, pacemaker device, low molecular heparin or warfarin treatment, neurological disease, inflammatory bowel disease and radiation proctitis. The Visual Analog Scale (VAS), St. Marks Incontinence Score, Wexner´s Constipation Score, Brief Pain Inventory - Short form (BPI-SF), symptom relief, bleeding and mucosal fissure healing were evaluated before and after treatment. VAS and BPI-SF were used to measure subjective pain characteristics and symptoms of patients at baseline, after two weeks (end of treatment), three months and then after one, two and three years. St. Marks Score and Wexner´s Constipation Score were evaluated in the same way though only up to one year after completion of treatment. The patients were given percutaneous tibial nerve stimulation after obtaining informed consent. The procedure was performed by two experienced pelvic floor therapists. Patients retained their high fiber diet and stool softeners during the procedure. Percutaneous tibial nerve stimulation was performed by using the Urgent PC Neuromodulation System ® (Uroplasty, Holland) on an outpatient basis. A stimulator provides electrical current with a fixed pulse frequency of 20Hz, pulse width 200 µ seconds and current setting between 0.5 and 9 mA (amplitude). A surface electrode was placed at the medial arch of the midfoot and a needle electrode was inserted through the skin posterior to the medial malleolus and advanced towards the posterior tibial nerve. Stimulation was gradually increased until a tingling sensation was perceived in the foot, or a motor flexor response was observed at the big toe. All patients received the treatment for 30 minutes 5 days a week, during 2 consecutive weeks. The clinical state of the fissure was evaluated before and after the last treatment session as well at three months and one year (though at the 3 month follow up one patient declined clinical examination since he felt completely symptom free). The fissure wound was characterized as not healed, partially healed when the healing process was visible but not totally complete and healed when no sign of the fissure was visible. At two and three years all patients were contacted by phone, and those who had symptoms where chronic anal fissure could not be ruled out underwent a clinical examination.

Statistical analyses:

The clinical outcome i.e. none healed, partially or totally healed fissure was analysed in relation to VAS, mean of St. Marks Incontinence Score and sum of Wexners's Constipation Score. These questions were chosen due to their clinical importance and high response rate. All analyses were calculated with descriptive statistics due to the few amount of patients. All analyses were performed with SPSS 22.

Eligibility criteria: Inclusion Criteria:

* 1. Chronic anal fissure for at least 6 months. 2. Above 18 years old. 3. Failed all previous conservative therapy. 4. On high fibre diet.

Exclusion Criteria:

* 1.Pregnancy 2. Pacemaker device. 3. Blood thinners - Heparin or Warfarin 4. Neurological disease 5. Inflammatory bowel disease 6. Radiation proctitis

Primary outcomes:
measure: Rate of wound healing by clinical examination
timeFrame: 3 years
Secondary outcomes:
measure: Pain Intensity assessed by Visual Analogue Scale (VAS)
timeFrame: 3 years
measure: Pain Inventory as assessed by Brief Pain Inventory (BPI-SF)
timeFrame: 3 years
measure: Bleeding of fissure wound as assessed by patient
timeFrame: 3 years
measure: Bowel control as assessed by St. Marks Incontinence Score
timeFrame: 1 year
measure: Bowel movements assessed by Constipation Score
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Region Skane
name: Bengt Jeppsson, Professor
role: STUDY_CHAIR
References: