Transcutaneous Posterior Tibial Nerve Stimulation for Treatment of Chronic Anal Fissure

Mansoura University

Status: Completed

Conditions: Chronic Anal Fissure

Treatments: Procedure: TENS; Procedure: lateral internal sphincterotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02395809

MFM201215

Details and patient eligibility

About

Lateral internal sphinterotomy (LIS) is the gold standard against which all treatments are compared with a healing rate over 92%. However, the most serious complication of this procedure is anal incontinence. To overcome these problems, continued efforts are being tried to find less invasive treatments modalities for anal fissure that is as effective as surgical therapy with lower morbidity.

Full description

Sacral nerve stimulation has been recently tried for management of chronic anal fissure with promising results. However, the technique described is invasive with the need for surgically implantable expensive stimulator electrodes.

The aim of this study was to evaluate the efficacy of posterior tibial nerve stimulation (PTN) by transcutaneous electrical nerve stimulation (TENS) and to compare it to the conventional LIS. This non-invasive technique has been proved to be of acceptable results in treatment of fecal incontinence and urinary incontinence.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consecutive symptomatic adults affected by chronic anal fissure were enrolled in the study.

Exclusion criteria

1. patients younger than 18 years;
2. patients with laterally located or painless fissures;
3. concurrent fistula or significant hemorrhoidal disease;
4. inflammatory bowel disease;
5. Diabetes mellitus;
6. pregnancy;
7. neurological disease;
8. spinal cord lesions,
9. use of cardiac pacemaker. Males and females were considered for inclusion.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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94 participants in 2 patient groups

LIS group

Active Comparator group

Description:

Lateral internal shincterotomy: A blade knife (No 11) was inserted between internal and external sphincter. The tip of the blade was angled medially pointing just above the dentate line and IS was divided. When the knife was felt beneath the intact mucosa, it was withdrawn.

Treatment:

Procedure: lateral internal sphincterotomy

TENS group

Active Comparator group

Description:

Posterior tibial nerve stimulation by transcutaneous electrical nerve stimulation by through a stimulating TENS unit.

Treatment:

Procedure: TENS