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NCT Number: NCT07632196

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

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.

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Key information

Conditions

Low Anterior Resection Syndrome (LARS) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disorder of Ejaculation Ejaculatory Dysfunction Fecal Incontinence Fecal Incontinence (FI) Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Intestinal Diseases Intestinal Neoplasms Low Anterior Resection Syndrome Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Quality of Life (QOL) Rectal Diseases Rectal Neoplasm Malignant Rectal Neoplasms Sexual Dysfunction, Physiological Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Althaia Xarxa Assistencial Universitària de Manresa, Manresa, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Faecal incontinence (FI) - LARS 1st month

    Time frame: 1st month post-surgery

    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).

  2. Faecal incontinence (FI) - LARS 6th month

    Time frame: 6th month post-surgery

    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).

  3. Faecal incontinence (FI) - LARS 12th month

    Time frame: 12th month post-surgery

    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).

  4. Feacal incontinence (FI) - Wexner 1st month

    Time frame: 1st month post-surgery

    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.

  5. Faecal incontinence (FI) - Wexner 6th month

    Time frame: 6th month post-surgery

    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.

  6. Faecal incontinece (FI) - Wexner 12th month

    Time frame: 12th month post-surgery

    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.

Secondary outcomes

  1. Sexual impairment 1st month

    Time frame: 1st month post-surgery

    Assessed by QLQ-CR38 questionnaire (question 17-18 for both sexes, 20-21 for men and 22-23 for women).

    Each question can be answered from 1 to 4 points. And then is it calculated in the sexual impairment analysis (symptoms area)

  2. Sexual impairment - 6th month

    Time frame: 6th month post-surgery

    Assessed by QLQ-CR38 questionnaire (question 17-18 for both sexes, 20-21 for men and 22-23 for women). Each question can be answered from 1 to 4 points. And then is it calculated in the sexual impairment analysis (symptoms area)

  3. Sexual impairment - 12th month

    Time frame: 12th month post-surgery

    Assessed by QLQ-CR38 questionnaire (question 17-18 for both sexes, 20-21 for men and 22-23 for women). Each question can be answered from 1 to 4 points. And then is it calculated in the sexual impairment analysis (symptoms area)

  4. Quality of life (QoL) - FIQLS 1st month

    Time frame: 1st month post-surgery

    Assessed by:

    -Fecal Incontinence Quality of Life Scale(FIQLS):composed of 29 items that evaluate 4 health dimensions:lifestyle(10 items),behavior(9 items),depression/self-esteem(7 items) and shame(3 items).Each item has a range from 1 to 5,with 1 being the minimum value for the quality of life state.

  5. Quality of life (QoL) - FIQLS 6th month

    Time frame: 6th month post-surgery

    Assessed by:

    -Fecal Incontinence Quality of Life Scale(FIQLS):composed of 29 items that evaluate 4 health dimensions:lifestyle(10 items),behavior(9 items),depression/self-esteem(7 items) and shame(3 items).Each item has a range from 1 to 5,with 1 being the minimum value for the quality of life state

  6. Quality of life (QoL) - FIQLS 12th month

    Time frame: 12th month post-surgery

    Assessed by:

    -Fecal Incontinence Quality of Life Scale(FIQLS):composed of 29 items that evaluate 4 health dimensions:lifestyle(10 items),behavior(9 items),depression/self-esteem(7 items) and shame(3 items).Each item has a range from 1 to 5,with 1 being the minimum value for the quality of life state

  7. Quality of life (QoL) - QLQ-CR 38 1st month

    Time frame: 1st month

    Assessed by:

    -Colorectal Cancer Quality of Life Questionnaire(QLQ-CR38):organized into 2 areas: 1.Functioning area,which includes the body image and sexual functioning scales and the items on enjoying sex and worrying about the future.2.Symptom area with scales for problems with urination,gastrointestinal symptoms,chemotherapy side effects,problems with defecation,problems with the stoma,sexual problems in men and women,and the weight loss item. All scores ranged 1 to 4, and then are lineal transformation is done (0 to 100). In the functioning area,a higher score indicates a better quality of life,while in the symptom area, a higher score indicates a worse quality

  8. Quality of life (QoL) - QLQ-CR38 6th month

    Time frame: 6th month post-surgery

    Assessed by:

    -Colorectal Cancer Quality of Life Questionnaire(QLQ-CR38):organized into 2 areas: 1.Functioning area,which includes the body image and sexual functioning scales and the items on enjoying sex and worrying about the future.2.Symptom area with scales for problems with urination,gastrointestinal symptoms,chemotherapy side effects,problems with defecation,problems with the stoma,sexual problems in men and women,and the weight loss item. All scores ranged 1 to 4, and then are lineal transformation is done (0 to 100). In the functioning area,a higher score indicates a better quality of life,while in the symptom area, a higher score indicates a worse quality

  9. Quality of life (QoL) - QLQ-CR38 12th month

    Time frame: 12th month post-surgery

    Assessed by:

    -Colorectal Cancer Quality of Life Questionnaire(QLQ-CR38):organized into 2 areas: 1.Functioning area,which includes the body image and sexual functioning scales and the items on enjoying sex and worrying about the future.2.Symptom area with scales for problems with urination,gastrointestinal symptoms,chemotherapy side effects,problems with defecation,problems with the stoma,sexual problems in men and women,and the weight loss item. All scores ranged 1 to 4, and then are lineal transformation is done (0 to 100). In the functioning area,a higher score indicates a better quality of life,while in the symptom area, a higher score indicates a worse quality

  10. Patient global impression of improvement (PGI-I)

    Time frame: 1 year

    Assessed by PGI-I questionnaire.

    The Patient Global Improvement Visual Analogue Scale (PGI-I) will be used to allow patients to comparatively assess their degree of global improvement after undergoing posterior tibial nerve stimulation therapy. The scale in question has only one question that asks the patient to classify the degree of symptom relief obtained with the treatment according to the 7-point Likert scale. The higher the score, the better the perception of quality of life.

Other outcomes

  1. Patient's characteristics

    Time frame: At the enrollment

    Age at diagnosis (years), sex (man/woman), height (m), weight (kg), BMI (kg/m2), prior anorectal disease (yes and not, if yes should specify)

  2. Concomitant medication for stool

    Time frame: At the enrollment

    methylcellulose, loperamide, ... (yes or no, if yes should specify)

  3. Tumor characteristics

    Time frame: At the enrollment

    Date of diagnosis (exact day), clinical TNM stage (TNM), tumour height from the anal verge by colonoscopy (cm) and proctoscopy (cm) magnetic resonance imaging findings (TNM, cm to anal verge), neadjuvant treatment (yes or no, which type), CEA values (ng/mL), neutrophil and lymphocyte values pre and post-chemotherapy (absolut value x10e9)

  4. Surgical details

    Time frame: At the enrollment

    Date of surgery, surgical approach (laparoscopic (LAP), robotic (ROB), LAP + transanal (TaTME), ROB + TaTME), transanal extraction of the specimen (yes or no), intraoperative complications (specify), type of anastomosis (mechanic, manual), height of anastomosis (cm), protective ileostomy (yes or no)

  5. Follow-up

    Time frame: From the surgical day (day 1) to the end of the study (day 360)

    Days of hospital stay (days), days until intake (days), postoperative complications (yes or no, if yes specify and complete Clavien-Dindo clasification), treatment of postoperative complication (need of new surgery, yes or no, if yes specify surgical procedure), readmission (yes or no, specify why)

  6. Esphinteric funcionality

    Time frame: At 1st month and 12th month from day 1 (surgery day)

    Rectal examination with basal tone and transperineal ultrasound (normal, insufficient expulsive maneuver, sphincter defect, anism, rectal hypersensitivity, rectal hyposensitivity, not performed), Oxford classification of esphinteric muscular strenght (0 to 5, being 5 good function).

  7. Compliance diary

    Time frame: 1 year

    Registration of the sessions done and observations

Study contacts

Contact information is provided by the study sponsor or research team.

Meritxell Font

CONTACT

[email protected]

+34 676131774

Sponsors and collaborators

Lead sponsor

Althaia Xarxa Assistencial Universitària de Manresa

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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