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

Condition(s) studied

Investigational drug(s) / intervention(s)

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 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: 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

Study 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.

Eligibility

Primary outcome measure(s)

• Faecal incontinence (FI) - LARS 1st month — 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).
• Faecal incontinence (FI) - LARS 6th month — 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).
• Faecal incontinence (FI) - LARS 12th month — 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).
• Feacal incontinence (FI) - Wexner 1st month — 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.
• Faecal incontinence (FI) - Wexner 6th month — 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.
• Faecal incontinece (FI) - Wexner 12th month — 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.

Trial sites (2)

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