Glyceryl Trinitrate Ointment vs Posterior Tibial Nerve Stimulation in the Treatment of Anal Fissure

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: Glyceryl trinitrate ointment; Procedure: Urgent PC Neuromodulation System®

• Registration Number: NCT02700438
• Lead Sponsor: Hospital General Universitario Elche

Brief Summary

A prospective randomized study was performed. Compliance with the treatment and healing rate of chronic anal fissure in patients receiving glyceryl trinitrate ointment (GTO) and subjects undergoing percutaneous posterior tibial nerve stimulation (PPTNS) were evaluated .

Detailed Description

Patients were randomly assigned to experimental and control groups: those patients undergoing PPTNS (Experimental Group - EG) and those receiving glyceryl trinitrate ointment (Control Group - CG).

Treatments:

Glyceryl trinitrate ointment (GTO): Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.

PPTNS: The Urgent PC Neuromodulation System® (Uroplasty, Minnetonka, MN, USA) was used. Subjects underwent one 30-min session 2 days per week for 8 consecutive weeks in an outpatient clinic. Patients were placed in the supine position without anesthesia. PPTNS was delivered using a needle electrode that was inserted 3-4cm cephalad and 2 cm posterior to the medial malleolus at a 60º angle towards the ankle joint to a depth of approximately 0.5-1cm. Successful placement was confirmed by the presence of electric sensation 5 cm above and below the insertion site or a digital plantar flexion. PPTNS was undertaken at the highest amplification (0-20 mA) at a frequency of 20 Hz, causing neither a motor response nor pain.

Compliance with the treatment and healing rate of chronic anal fissure was investigated.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Study First Submitted: 2016-02-25
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-01
• Last Update Submitted: 2016-03-01
• Study First Posted: 2016-03-07
• Last Update Posted: 2016-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• persistent anal fissure after the failure of hygienic and dietary measures over at least a 6-week period

Exclusion Criteria

• associated anal pathologies
• intestinal inflammation disorders
• fissures secondary to underlying diseases
• patients with previous history of headaches

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glyceryl trinitrate ointment	Glyceryl trinitrate ointment	Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.
Urgent PC Neuromodulation System®	Urgent PC Neuromodulation System®	The Urgent PC Neuromodulation System® (Uroplasty, Minnetonka, MN, USA) was used for percutaneous posterior tibial nerve stimulation. Subjects underwent one 30-min session 2 days per week for 8 consecutive weeks in an outpatient clinic. Patients were placed in the supine position without anesthesia. PPTNS was delivered using a needle electrode that was inserted 3-4cm cephalad and 2 cm posterior to the medial malleolus at a 60º angle towards the ankle joint to a depth of approximately 0.5-1cm. Successful placement was confirmed by the presence of electric sensation 5 cm above and below the insertion site or a digital plantar flexion. PPTNS was undertaken at the highest amplification (0-20 mA) at a frequency of 20 Hz, causing neither a motor response nor pain.

Primary Outcome Measures

Name	Time	Method
Number of participants who discontinued the assigned treatment	8 weeks	The discontinuity with each treatment will be evaluated by means of face-to-face interviews in the Outpatient Clinic every week, investigating the compliance with the prescribed therapy (correct administration of the ointment and performance of the percutaneous posterior tibial nerve stimulation sessions). The number of patients who stop the therapy will be considered as a treatment withdrawal.

Secondary Outcome Measures

Name	Time	Method
Healing, defined as disappearance of symptoms and evidence of fissure reepithelization	8 weeks	Healing will be defined as disappearance of symptoms and evidence of fissure reepithelization