Actively Recruiting
Randomized Clinical Trial Assessing the Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia
Led by Althaia Xarxa Assistencial Universitària de Manresa · Updated on 2026-06-08
84
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Rectal neoplasia is a common cancer in Spain, and the preferred treatment is total mesorectal excision (TME), which improves cancer outcomes but can lead to complications such as altered bowel function known as low anterior resection syndrome (LARS) and erectile dysfunction. This trial aims to study the effects of posterior tibial nerve stimulation on fecal incontinence, sexual dysfunction, and quality of life in patients who have had rectal surgery for rectal neoplasia. Participants will be randomly assigned to one of two groups: one receiving posterior tibial nerve stimulation at therapeutic doses, and the other receiving stimulation at subtherapeutic doses using a Beurer EM-49 digital neurostimulator. Both groups will learn how to use the device with a pelvic floor rehabilitator and will perform sessions at home following a schedule that decreases in frequency over the first year after surgery. Throughout the 12 months after surgery, participants will be assessed at one, six, and twelve months using questionnaires that measure fecal incontinence (LARS and Wexner scales), sexual function, and quality of life (FIQLS and QLQ-CR38). Researchers will monitor safety and effectiveness through these evaluations and a patient global impression of improvement at one year, ensuring comprehensive follow-up during the study period.
CONDITIONS
Brief Title
Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients diagnosed with rectal neoplasia
- Have undergone high anterior rectal resection regardless of surgical approach
- Willing and able to follow the study procedures and use the neurostimulator device at home
You will not qualify if you...
- Patients not operated or under active surveillance (watch & wait) strategy
- Patients with an ostomy
- Contraindications to neurostimulator use including:
- Presence of pacemaker, defibrillator, or other electronic devices
- History of heart problems
- Coagulopathies or tendency to excessive bleeding
- Nervous system damage such as epilepsy
- Current pregnancy
- Infections or skin lesions
- Severe vascular disorders
- Active neoplasms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo surgery for rectal neoplasia before starting the nerve stimulation intervention.
1 visit (in-person)
Duration - Up to 12 months post-surgery
Participants use a neurostimulator device at home for posterior tibial nerve stimulation according to a scheduled program post-surgery.
Initial training session with rehabilitator followed by home-based sessions 3 times a week for months 1 to 3, 2 times a week for months 4 to 6, and once a week for months 7 to 12
Trial Site Locations
Total: 2 locations
1
Althaia Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, Spain, 08243
Actively Recruiting
2
Xarxa Assistencial Universitària de Manresa, Althaia
Manresa, Barcelona, Spain, 08243
Actively Recruiting
Research Team
M
Meritxell Font
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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