Low Anterior Resection Syndrome (LARS)NCT07632196
Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia
A study testing Posterior tibial nerve stimulation intervention group in people with Low Anterior Resection Syndrome (LARS) and Rectal Neoplasm Malignant, run by Althaia Xarxa Assistencial Universitària de Manresa at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Anterior Resection Syndrome (LARS), Rectal Neoplasm Malignant, Quality of Life (QOL)
- What is being tested?
- Posterior tibial nerve stimulation intervention group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 2 sitesSpain
- Study dates
- 6 Feb 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 11Show fewer
- Damage to the nervous system (epilepsy)
- Current pregnancy
- Infections or skin lesions
- Severe vascular disorders
- Active neoplasms.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Althaia Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, 08243
Anna Arnau, PhD, +34 93 875 93 00 ext. 3414, aarnau@althaia.cat
Meritxell Font Prat, MD
- Recruiting
Xarxa Assistencial Universitària de Manresa, Althaia
Manresa, Barcelona, 08243
Meritxell Font, Medical doctor, +34 676131774, meritxell.fontprat@gmail.com
Ignasi Puig, Medical doctor
About this study
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
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
- Low Anterior Resection Syndrome (LARS), Rectal Neoplasm Malignant, Quality of Life (QOL), Fecal Incontinence (FI), Disorder of Ejaculation
- Being tested
- Posterior tibial nerve stimulation intervention group, Control group
- Keywords
- total mesorectum excision, rectal neoplasm, randomised clinical trial, posterior tibial nerve stimulation, low anterior resection syndrome (LARS), life quality, Fecal Incontinence (FI)
- Medical subject headings
- Low Anterior Resection Syndrome, Rectal Neoplasms, Fecal Incontinence, Ejaculatory Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior tibial nerve stimulation intervention groupDevice
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 groupDevice
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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Posterior tibial nerve stimulation with Beurer EM-49 digital neuroestimulator at complete doses Receives: Device: Posterior tibial nerve stimulation intervention group |
| Control group | Sham comparator | Posterior tibial nerve stimulation with Beurer EM-49 digital neuroestimulator at subtherapeutic doses Receives: Device: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12th month post-surgery
Secondary outcomes (10)
Sexual impairment 1st month
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)
Measured: 1st month post-surgery
Sexual impairment - 6th month
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)
Measured: 6th month post-surgery
Sexual impairment - 12th month
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)
Measured: 12th month post-surgery
Quality of life (QoL) - FIQLS 1st month
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.
Measured: 1st month post-surgery
Quality of life (QoL) - FIQLS 6th month
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
Measured: 6th month post-surgery
Quality of life (QoL) - FIQLS 12th month
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
Measured: 12th month post-surgery
Quality of life (QoL) - QLQ-CR 38 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
Measured: 1st month
Quality of life (QoL) - QLQ-CR38 6th 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
Measured: 6th month post-surgery
Quality of life (QoL) - QLQ-CR38 12th 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
Measured: 12th month post-surgery
Patient global impression of improvement (PGI-I)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start6 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Anterior Resection Syndrome (LARS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial (1:1) with two arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meritxell Font Prat, Althaia Xarxa Assistencial Universitària de Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632196
- Sponsor's protocol ID
- CEIm 25/080
- Status last verified
- May 2026
- First submitted
- 6 Feb 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is planned to publish the complete result data without providing specific participant data.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07632196
- Acronym / sponsor ID
- CEIm 25/080
- Conditions
- Low Anterior Resection Syndrome (LARS), Rectal Neoplasm Malignant, Quality of Life (QOL), Fecal Incontinence (FI), Disorder of Ejaculation
- Keywords
- total mesorectum excision, rectal neoplasm, randomised clinical trial, posterior tibial nerve stimulation, low anterior resection syndrome (LARS), life quality, Fecal Incontinence (FI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de ManresaUniversity, hospital or other
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial (1:1) with two arms
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Posterior tibial nerve stimulation intervention groupPosterior tibial nerve stimulation with Beurer EM-49 digital neuroestimulator at complete doses |
| Control group | Sham comparator | Device: Control groupPosterior tibial nerve stimulation with Beurer EM-49 digital neuroestimulator at subtherapeutic doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (11 listed)
- Patients not operated or within active surveillance strategy programs (watch \& wait)
- Patients with ostomy
- Patients with contraindications to the use of the neurostimulator:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior tibial nerve stimulation intervention groupIn 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 | Device | Intervention group |
| Control groupIn 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 | Device | Control group |
Primary outcome
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).
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).
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).
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.
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.
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Sociedad Española de Oncología Médica (SEOM). Las cifras del càncer en España. 2024.Link provided by the sponsor.
- El cáncer en España, datos y estadísticas. Epdata.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No. It is planned to publish the complete result data without providing specific participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior tibial nerve stimulation intervention group in people with Low Anterior Resection Syndrome (LARS) and Rectal Neoplasm Malignant, run by Althaia Xarxa Assistencial Universitària de Manresa at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meritxell Font (+34 676131774, meritxell.fontprat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faecal incontinence (FI) - LARS 1st month (time frame: 1st month post-surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.