Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlthaia Xarxa Assistencial Universitària de Manresa

About this trial

Rectal neoplasia is one of the most prevalent cancers in Spain, and the treatment of choice is total mesorectal excision (TME), as it has demonstrated significant oncological improvements. However, mesorectal excision is not without complications, and patients often experience altered bowel function in the form of low anterior resection syndrome (LARS), as well as erectile dysfunction. However, few studies evaluate faecal incontinence, as most focus on oncological outcomes.

The aim of our study is to evaluate the efficacy and safety of posterior tibial nerve stimulation on fecal incontinence, sexual dysfunction, and quality of life in patients who underwent to rectal surgery for rectal neoplasia.

It will be conducted a randomized clinical trial (1:1) with two arms: half of the patients will receive posterior tibial nerve stimulation, while the other half will undergo stimulation with subtherapeutic doses. Faecal incontinence will be assessed using the LARS and Wexner questionnaires, and quality of life and sexual function will be assessed using the Fecal Incontinence Quality of Life Scale (FIQLS) and the Colorectal Cancer Quality of Life Questionnaire (QLQ-CR38), at one month, six months and one year after surgery.

Eligibility criteria

Qualifiers

None

Disqualifiers

Patients not operated or within active surveillance strategy programs (watch & wait)

Patients with ostomy

Pacemaker / Defibrillator / Other electronic devices

History of heart problems

Trial design

Treatments tested in this trial

  • Posterior tibial nerve stimulation intervention group
  • Control group

Treatment groups

84 Participants
are divided into 2 treatment groups