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

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 .

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glyceryl trinitrate ointment

Drug

Application of 375 mg of ointment to the distal anal canal, every 12 hours for an 8-week period.

Other names: Rectogesic

Urgent PC Neuromodulation System®

Procedure

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.

Other names: PTNS

Primary outcomes

Number of participants who discontinued the assigned treatment

Time frame: 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 outcomes

Healing, defined as disappearance of symptoms and evidence of fissure reepithelization

Time frame: 8 weeks

Healing will be defined as disappearance of symptoms and evidence of fissure reepithelization

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Mar 7, 2016
Registry last updated: Mar 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed