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

NCT02700438 | Completed Phase 3 DMC

• 1 other identifier: CG15-02
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Number of participants who discontinued the assigned treatment

  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.

  8 weeks

Secondary Outcomes (1)

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

  8 weeks

Study Arms (2)

Glyceryl trinitrate ointment

ACTIVE COMPARATOR

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.

Drug: Glyceryl trinitrate ointment

Urgent PC Neuromodulation System®

EXPERIMENTAL

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.

Procedure: Urgent PC Neuromodulation System®

Interventions

Glyceryl trinitrate ointment DRUG

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

Also known as: Rectogesic

Glyceryl trinitrate ointment

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.

Also known as: PTNS

Urgent PC Neuromodulation System®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital General Universitario Elche: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Eduardo Barna, MD, PhD

  Garcilaso Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 7, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 7, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share