NCT02700438

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

Perianal Application of Glyceryl Trinitrate 0.4% Ointment vs Percutaneous Posterior Tibial Nerve Stimulation in the Treatment of Chronic Anal Fissure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Hospital General Universitario Elche · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Glyceryl trinitrate ointment	Application of 375 mg of ointment to the distal anal canal, every 12 hours for an 8-week period.
PROCEDURE	Urgent PC Neuromodulation System®	Subjects underwent one 30-min session of percutaneous posterior tibial nerve stimulation 2 days per week for 8 consecutive weeks in an outpatient clinic, with a Urgent PC Neuromodulation System®. 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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2016-03-07
• Last updated: 2016-03-07