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

NCT07632196 | Recruiting

• 1 other identifier: CEIm 25/080
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Rectal Neoplasm Malignant; Quality of Life (QOL); Fecal Incontinence (FI); Disorder of Ejaculation; Low Anterior Resection Syndrome (LARS)

Keywords

total mesorectum excision; rectal neoplasm; randomised clinical trial; posterior tibial nerve stimulation; low anterior resection syndrome (LARS); life quality; Fecal Incontinence (FI)

Outcome Measures

Primary Outcomes (6)

• Faecal incontinence (FI) - LARS 1st month

  Assessed by LARS questionnaire Low anterior resection syndrome (LARS): LARS scale consists of 5 questions: gas incontinence (0,4,7 points), liquid incontinence (0,3,3 points), stool frequency (4,2,0,5 points), defecation fractionation (0,9,11 points) and defecatory urgency (0, 11,16 points). The score range is between 0 and 42 points. Patients are categorized into three groups: no LARS (0 to 20 points), mild LARS (21 to 29 points) and severe LARS (30 to 42 points).

  1st month post-surgery

• Faecal incontinence (FI) - LARS 6th month

  Assessed by LARS questionnaire Low anterior resection syndrome (LARS): LARS scale consists of 5 questions: gas incontinence (0,4,7 points), liquid incontinence (0,3,3 points), stool frequency (4,2,0,5 points), defecation fractionation (0,9,11 points) and defecatory urgency (0, 11,16 points). The score range is between 0 and 42 points. Patients are categorized into three groups: no LARS (0 to 20 points), mild LARS (21 to 29 points) and severe LARS (30 to 42 points).

  6th month post-surgery

• Faecal incontinence (FI) - LARS 12th month

  Assessed by LARS questionnaire Low anterior resection syndrome (LARS): LARS scale consists of 5 questions: gas incontinence (0,4,7 points), liquid incontinence (0,3,3 points), stool frequency (4,2,0,5 points), defecation fractionation (0,9,11 points) and defecatory urgency (0, 11,16 points). The score range is between 0 and 42 points. Patients are categorized into three groups: no LARS (0 to 20 points), mild LARS (21 to 29 points) and severe LARS (30 to 42 points).

  12th month post-surgery

• Feacal incontinence (FI) - Wexner 1st month

  Assessed by Wexner questionnaire. Wexner scale consists of 5 questions (range 0-4): incontinence of solid stools, incontinence of liquid stools, incontinence of gases, use of pads or diapers and alteration of social life. Depending on the frequency, a score of 0 to 4 is assigned. The score can range from 0 to 20 points, considering no incontinence as 0 to 2 points, mild incontinence as a result of 3 to 6 points, moderate incontinence as 7 to 11 points and severe incontinence as a result greater than or equal to 12 points.

  1st month post-surgery

• Faecal incontinence (FI) - Wexner 6th month

  Assessed by Wexner questionnaire. Wexner scale consists of 5 questions (range 0-4): incontinence of solid stools, incontinence of liquid stools, incontinence of gases, use of pads or diapers and alteration of social life. Depending on the frequency, a score of 0 to 4 is assigned. The score can range from 0 to 20 points, considering no incontinence as 0 to 2 points, mild incontinence as a result of 3 to 6 points, moderate incontinence as 7 to 11 points and severe incontinence as a result greater than or equal to 12 points.

  6th month post-surgery

• Faecal incontinece (FI) - Wexner 12th month

  Assessed by Wexner questionnaire. Wexner scale consists of 5 questions (range 0-4): incontinence of solid stools, incontinence of liquid stools, incontinence of gases, use of pads or diapers and alteration of social life. Depending on the frequency, a score of 0 to 4 is assigned. The score can range from 0 to 20 points, considering no incontinence as 0 to 2 points, mild incontinence as a result of 3 to 6 points, moderate incontinence as 7 to 11 points and severe incontinence as a result greater than or equal to 12 points.

  12th month post-surgery

Secondary Outcomes (10)

• Sexual impairment 1st month

  1st month post-surgery

• Sexual impairment - 6th month

  6th month post-surgery

• Sexual impairment - 12th month

  12th month post-surgery

• Quality of life (QoL) - FIQLS 1st month

  1st month post-surgery

• Quality of life (QoL) - FIQLS 6th month

  6th month post-surgery

Other Outcomes (7)

• Patient's characteristics

  At the enrollment

• Concomitant medication for stool

  At the enrollment

• Tumor characteristics

  At the enrollment

Study Arms (2)

Intervention group

EXPERIMENTAL

Posterior tibial nerve stimulation with Beurer EM-49 digital neuroestimulator at complete doses

Device: Posterior tibial nerve stimulation intervention group

Control group

SHAM COMPARATOR

Posterior tibial nerve stimulation with Beurer EM-49 digital neuroestimulator at subtherapeutic doses

Device: Control group

Interventions

Posterior tibial nerve stimulation intervention group DEVICE

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 sessions will be carried out at home. In both groups, a program for carrying out sessions will be indicated according to the following scheme: * From the 1st month to the 3rd month post-surgery: stimulation 3 times a week * From the 4th month to the 6th month post-surgery: stimulation 2 times a week * From the 7th to the 12th month post-surgery: 1 time a week

Intervention group

Control group DEVICE

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 time. The first session will be carried out with the rehabilitator to learn how it works and resolve doubts about its use, and later the sessions will be carried out at home. In both groups, a program for carrying out sessions will be indicated according to the following scheme: * From the 1st month to the 3rd month post-surgery: stimulation 3 times a week * From the 4th month to the 6th month post-surgery: stimulation 2 times a week * From the 7th to the 12th month post-surgery: 1 time a week

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Althaia Xarxa Assistencial Universitària de Manresa: lead

Study Sites (2)

Althaia Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, 08243, Spain

RECRUITING

Xarxa Assistencial Universitària de Manresa, Althaia

Manresa, Barcelona, 08243, Spain

RECRUITING

Related Links

• Sociedad Española de Oncología Médica (SEOM). Las cifras del càncer en España. 2024.
• El cáncer en España, datos y estadísticas. Epdata.
• Ma B, Gao P, Song Y, Zhang C, Zhang C, Wang L, et al. Transanal total mesorectal excision (taTME) for rectal cancer: A systematic review and meta-analysis of oncological and perioperative outcomes compared with laparoscopic total mesorectal excision.
• Muratore A, Mellano A, Marsanic P, De Simone M. Transanal total mesorectal excision (taTME) for cancer located in the lower rectum: Short- and mid-term results. European Journal of Surgical Oncology. 2015; 41(4): 478-83.
• Color II Study Group, Buunen M, Bonjer HJ, Hop WCJ, Haglind E, Kurlberg G, et al. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer. Danish Medical Bulletin. 2009; 56(2): 89-91.
• Van der Pas MH, Haglind E, Cuesta MA, Fürst A, Lacy AM, Hop WC, et al. Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncology. 2013; 14(3): 210-8.
• Sanchon L., Bardají M., Labró M., Curto J., Soto C., Puig A., et al. Oncological monitoring after transanal total mesorectal excision (TaTME) for rectal neoplàsia. Techniques in Coloproctology. 2023: 27(9):739-746.
• Grass J. K., Chen C-C., Melling N., Lingala B., Kemper M., Scognamiglio P., et al. Robotic rectal resection preserves anorectal function: systematic review and meta-analysis. Int J Med Robot. 2021; 17(6):e2329.
• Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Annals of Surgery. 2012; 255(5): 922-8.
• Sörensson M, Asplund D, Matthiessen P, Rosenberg J, Hallgren T, Rosander C, et al. Self-reported sexual dysfunction in patients with rectal cancer. Color Disease. 2020; 22(5): 500-12.
• Carrillo A, Enríquez-Navascués JM, Rodríguez A, Placer C, Múgica JA, Saralegui Y, et al. Incidencia y caracterización del síndrome de resección anterior de recto mediante la utilización de la escala LARS (low anterior resection score). Cirugía Españo
• Kauff DW, Roth YDS, Bettzieche RS, Kneist W. Fecal incontinence after total mesorectal excision for rectal cancer-impact of potential risk factors and pelvic intraoperative neuromonitoring. World Journal of Surgical Oncology. 2020; 18(1).
• Zhang, L., Hu C., Zhao J., Wu C., Zhang Z., Li R., et al. The effect of robotic surgery on low anterior resection syndrome in patients with lower rectal cancer: a propensity score-matched analysis. Surgical Endoscopy 2024; 38(4): 1912-1921.
• Vidal C., Romero G., Jané C., Vidal L., Arnau A., Rosal A., et al. Intervención no farmacològica para mejorar la calidad de vida de los pacientes intervenidos de resección anterior de recto. Revista Sociedad Española de Enfermería en Estomaterapia. 2
• Rosen H., Sebesta C.G., Sebesta C. Cancers (Basel). 2023; 15(3): 778
• Nguyen TH, Chokshi R V. Low Anterior Resection Syndrome. Current Gastroenterology Reports. Springer; 2020; 22(10): 48.
• Ciriza de los Ríos C, Ruiz de León A, García Durán F, Tomás Moros E, Carneros Martín JA, Muñoz Yagüe T, et al. Calidad de vida en pacientes con incontinencia fecal y su relación con la gravedad de la misma.Gastroenterología Hepatología. 2010; 33(9):621-8
• Efisioterapia. T.E.N.S. Estimulación nerviosa transcutánea. eFisioterapia.net. 2007.
• Medicina del Dolor. Hospital VITHAS Valencia.

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Rectal Neoplasms; Fecal Incontinence; Ejaculatory Dysfunction

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Meritxell Font

CONTACT

+34 676131774; meritxell.fontprat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Model Details: Randomized clinical trial (1:1) with two arms

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: June 8, 2026
• Study Start: February 6, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)