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

PHASE3CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

January 31, 2016

Study Completion Date

January 31, 2016

Conditions
Pain
Interventions
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.

All Listed Sponsors
lead

Hospital General Universitario Elche

OTHER

NCT02700438 - Glyceryl Trinitrate Ointment vs Posterior Tibial Nerve Stimulation in the Treatment of Anal Fissure | Biotech Hunter | Biotech Hunter