Transcutaneous Posterior Tibial Nerve Stimulation for Treatment of Chronic Anal Fissure

Chronic Anal Fissure Clinical Trial

Official title:

Randomized Clinical Trial of Transcutaneous Electrical Posterior Tibial Nerve Stimulation Versus Lateral Internal Sphincterotomy for Treatment of Chronic Anal Fissure.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02395809
• Other study ID #: MFM201215
• Status: Completed
• Phase: N/A
• First received: March 9, 2015
• Last updated: March 17, 2015
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: March 2015
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Mansoura Faculty of medicine
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Anal Fissure
• Fissure in Ano

Intervention

Procedure:
• lateral internal sphincterotomy

• TENS

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with clinical improvement of symptoms	Resolution of anal pain after the procedure	one year	Yes
Secondary	number of patients with post-procedure anal incontinence according to Pescatory grading and scoring index for anal incontinence		one year	Yes
Secondary	Number of patients with improvement of constipation according to Wexner constipation score		one year	Yes
Secondary	Anal pain scores on VAS		one month	Yes
Secondary	Post-procedure patient satisfaction on VAS		one year	Yes
Secondary	Number of patients with healed anal fissure	Complete epithelialization of the fissure	one month	Yes