Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Posterior tibial nerve stimulation intervention group, Control group.
- Who it may be relevant to
- Registry conditions: Low Anterior Resection Syndrome (LARS), Rectal Neoplasm Malignant, Quality of Life (QOL), Fecal Incontinence (FI). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Clinical Trial Assessing the Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia
Overview
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.
Interventions
- Device Posterior tibial nerve stimulation intervention group
In the intervention group, Beurer EM-49 digital neurostimulator will be used, with CE marking, and a dose of 20 Hertz (Hz) - 200 microseconds (μs) will be applied. As the control group and the intervention group, the pelvic floor rehabilitator will program the neurostimulator for each case and then they will be trained on how to perform the neurostimulation. The first session will be carried out with the rehabilitator to learn how it works and resolve doubts about its use, and later the sessio - Device Control group
In the intervention group, Beurer EM-49 digital neurostimulator will be used, with CE marking; and a dose of 80 Hertz (Hz) - 150 microseconds (μs) will be applied. As the control group and the intervention group, the pelvic floor rehabilitator will program the neurostimulator for each case and then they will be trained on how to perform the neurostimulation. In order to apply the therapy, the patient must sit down for the placement of the electrodes. It will be performed on 2 feet at the same
Primary outcome measures
- Faecal incontinence (FI) - LARS 1st month [Time frame: 1st month post-surgery]
- Faecal incontinence (FI) - LARS 6th month [Time frame: 6th month post-surgery]
- Faecal incontinence (FI) - LARS 12th month [Time frame: 12th month post-surgery]
- Feacal incontinence (FI) - Wexner 1st month [Time frame: 1st month post-surgery]
- Faecal incontinence (FI) - Wexner 6th month [Time frame: 6th month post-surgery]
- Faecal incontinece (FI) - Wexner 12th month [Time frame: 12th month post-surgery]
Secondary outcome measures (10)
- Sexual impairment 1st month [Time frame: 1st month post-surgery]
- Sexual impairment - 6th month [Time frame: 6th month post-surgery]
- Sexual impairment - 12th month [Time frame: 12th month post-surgery]
- Quality of life (QoL) - FIQLS 1st month [Time frame: 1st month post-surgery]
- Quality of life (QoL) - FIQLS 6th month [Time frame: 6th month post-surgery]
- Quality of life (QoL) - FIQLS 12th month [Time frame: 12th month post-surgery]
- Quality of life (QoL) - QLQ-CR 38 1st month [Time frame: 1st month]
- Quality of life (QoL) - QLQ-CR38 6th month [Time frame: 6th month post-surgery]
- Quality of life (QoL) - QLQ-CR38 12th month [Time frame: 12th month post-surgery]
- Patient global impression of improvement (PGI-I) [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
\- 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).
Exclusion criteria
- Patients not operated or within active surveillance strategy programs (watch \& wait)
- Patients with ostomy
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Spain · 2 centers
- Althaia Xarxa Assistencial Universitària de Manresa — Manresa
- Xarxa Assistencial Universitària de Manresa, Althaia — Manresa
Identifiers
NCT: NCT07632196 · CEIm 25/080