NCT07632196Recruiting
Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia
Randomized Clinical Trial Assessing the Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 6 Feb 2026
- Start date
- 6 Feb 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Diseases
- Colorectal cancer
- NCT number
- NCT07632196
What you commit to
- Study type: Interventional
- Planned participants: 84
- From 6 Feb 2026 to the primary completion date, 31 Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with contraindications to the use of the neurostimulator:
- Pacemaker / Defibrillator / Other electronic devices
- History of heart problems
- Propensity to excessive bleeding (coagulopathies)
- Damage to the nervous system (epilepsy)
- Current pregnancy
- Infections or skin lesions
- Severe vascular disorders
- Active neoplasms.
Other
- Patients not operated or within active surveillance strategy programs (watch \& wait)
- Patients with ostomy
Who the study is looking for
- \- Adult patients diagnosed with rectal neoplasia and who have undergone a high anterior rectal resection regardless of the surgical approach (open, laparoscopic, laparoscopic+TaTME or robotic+TaTME).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xarxa Assistencial Universitària de Manresa, Althaia Coordinator of this site? Confirm its status | Manresa | Spain | Recruiting |
| ALTHAIA, Xarxa Assistencial Universitaria de Manresa. Coordinator of this site? Confirm its status | Manresa | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.