Faecal Incontinence With Faecal UrgencyHiPLARSNCT07862673
Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
A study testing Percutaneous Tibial Nerve Stimulation in people with Faecal Incontinence With Faecal Urgency and Rectal Cancer, run by Region Skane at 1 site in Sweden.
Trial summary
This study aims to assess and evaluate the clinical efficacy of an intensified form of Percutaneous tibial nerve stimulation (PTNS) compared to standard conservative treatment for low anterior resection syndrome (LARS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Faecal Incontinence With Faecal Urgency, Rectal Cancer, Radiotherapy Side Effects
- What is being tested?
- Percutaneous Tibial Nerve Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 5 Oct 2026to 1 Dec 2029
- 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
- The presence of Faecal incontinence sufficiently severe to warrant intervention
- Have undergone low anterior resection and with low anterior resection syndrome (LARS) score >20
- The presence of incontinence for >6 months before inclusion in the study, failure of conservative treatment (e.g. fiber plus loperamide, biofeedback, bulking agents or TAI - transanal irrigation).
Who cannot join
- Inability to be able to communicate both verbally and in written Swedish language
- Patients with neurological diseases such as multiple sclerosis, diabetic neuropathy and Parkinson's disease.
- Medical conditions precluding stimulation, for example bleeding disorders, novel oral anticoagulants (NOACs), cardiac pacemaker or implantable defibrillator, peripheral vascular disease or ulcer, lower leg cellulitis.
- Severe cardiopulmonary disease with severe distal venous insufficiency, local skin lesion, low molecular heparin or
- Chronic bowel diseases such as inflammatory bowel disease with chronic uncontrolled diarrhoea
- Pregnancy or intention to become pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Department of Surgery. Pelvic Floor Centre
Malmö, Skåne County, 20502
Victor J Verwaal, Associate Professor of Surgery, +46 40333019, victor.verwaal@med.lu.se
Mikael Ekelund, Associate Professor of Surgery, +46 46171896, mikael.ekelund@skane.se
About this study
Official title: Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery.
This study aims to assess and evaluate the clinical efficacy of an intensified form of Percutaneous tibial nerve stimulation (PTNS) compared to standard conservative treatment for low anterior resection syndrome (LARS). A syndrome with symptoms such as faecal incontinence (FI), urgency to defecate and frequent bowel movements. Focus will be mainly on patients with significant faecal incontinence.
Participants will be randomized into 2 groups: Standard Care with bowel regulation or to High Intensive PTNS for 6 weeks.
Read more
Every treatment session will be at the clinic and take 30 minutes.
Standard care PTNS participants will have nurse contact once per week for 6 weeks
High Intensive PTNS participants will start with 5 sessions per week, which will the be phased out to 2 sessions per weeks during the 6 week period.
Follow up visits to the clinic will be at 3, 6 and 12 months after completion of study.
Patients in the Standard group whose symtoms have not improved significantly, will be given the option to try the High Intensive treatment option.
Read the detailed description
The HIPLARS study is a Swedish clinical research project investigating whether an intensive form of Percutaneous Tibial Nerve Stimulation (PTNS) can improve faecal incontinence (FI) in patients who develop Low Anterior Resection Syndrome (LARS) after rectal cancer surgery. LARS commonly causes frequent bowel movements, urgency, and faecal incontinence, which can significantly reduce quality of life.
All participants receive the current standard treatment for FI, including bowel management, pelvic floor exercises, biofeedback, and, if needed, mini-enemas. The study compares this standard treatment with an intensified PTNS treatment, a minimally invasive nerve stimulation therapy that may provide longer-lasting symptom relief. Participants whose symptoms persist after six months may also be offered PTNS.
The study will include approximately 60 participants across three Swedish clinics and lasts 12 months. Depending on the assigned study group, participants will attend 17-29 clinic visits and receive 12-24 PTNS treatment sessions, each lasting about 30 minutes. Assessments include medical examinations, ultrasound, questionnaires, quality-of-life surveys, and bowel diaries.
Participation is voluntary, and participants may withdraw at any time without affecting their future medical care. Researchers may also end participation for medical reasons or if study procedures are not followed.
PTNS is already an established treatment with a low risk of side effects. Possible risks include mild discomfort from the needle insertion and occasional minor bleeding at the insertion site. Serious side effects are uncommon.
Personal and medical information will be kept confidential, stored securely, and handled in accordance with GDPR and Swedish law. Study results may be published, but participants' identities will remain confidential.
The study is conducted by the Pelvic Floor Centre, Department of Surgery, Skåne University Hospital (SUS) Malmö, has been approved by the Swedish Ethical Review Authority, and is covered by standard patient and pharmaceutical insurance. Participants can contact the study team at any time with questions or concerns.
- Conditions
- Faecal Incontinence With Faecal Urgency, Rectal Cancer, Radiotherapy Side Effects, Low Anterior Resection Syndrome (LARS>20)
- Being tested
- Percutaneous Tibial Nerve Stimulation
- Keywords
- Rectal Cancer, Percutaneous Tibialis Nerve Stimulation (PTNS), Low Anterior Resection Syndrome
- Medical subject headings
- Rectal Neoplasms, Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Tibial Nerve StimulationProcedure or surgery
Also called PTNS
A total of PTNS 24 sessions, with 5 PTNS sessions per week (30 min each) for 4 weeks, thereafter 2 sessions per week for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Conservative treatment for faecal incontinence. Mainly bowel regulation |
| Percutaneous Tibial Nerve Stimulation | Experimental | 24 treatment sessions av Percutaneous Tibial Nerve Stimulation Receives: Procedure: Percutaneous Tibial Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Low Anterior Resection Syndrome Score
The primary outcome classifies patients as responders or non-responders, with a responder defined as someone having a change of the LARS score from Major LARS to Minor or No LARS
Measured: Outcome measures to be assessed at baseline, after 6 weeks, 3 months and 6 month treatment being the primary end point.
Secondary outcomes (1)
Improvement or change of at least 50 per cent in the number faecal incontinence episodes
An achievement of ≥ 50% change in weekly faecal incontinence episodes (FIEs) for secondary outcome
Measured: Outcome measures to be assessed at baseline, after 6 weeks, 3 months and 6 month treatment being the primary end point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start5 Oct 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Faecal Incontinence With Faecal UrgencyStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Crossover option included for Control Arm participants without significantly improved symtoms.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louiis B Johnson, Associate Professor of Surgery, Principal investigator, Region Skåne - University of Malmö / Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862673
- Sponsor's protocol ID
- Dnr 2024-05072-01
- Acronym
- HiPLARS
- Status last verified
- Sep 2026
- First submitted
- 1 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Basically the Ethical clearance for the study does not accomodate sharing of IPD. Further, the study focuses mainly on cancer patients which is a sensitive patient group with regards to symtoms being examined in the study.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery.
- ClinicalTrials.gov ID
- NCT07862673
- Acronym / sponsor ID
- HiPLARS / Dnr 2024-05072-01
- Conditions
- Faecal Incontinence With Faecal Urgency, Rectal Cancer, Radiotherapy Side Effects, Low Anterior Resection Syndrome (LARS>20)
- Keywords
- Rectal Cancer, Percutaneous Tibialis Nerve Stimulation (PTNS), Low Anterior Resection Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 7 Oct 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.
This study aims to assess and evaluate the clinical efficacy of an intensified form of Percutaneous tibial nerve stimulation (PTNS) compared to standard conservative treatment for low anterior resection syndrome (LARS). A syndrome with symptoms such as faecal incontinence (FI), urgency to defecate and frequent bowel movements. Focus will be mainly on patients with significant faecal incontinence.
Participants will be randomized into 2 groups: Standard Care with bowel regulation or to High Intensive PTNS for 6 weeks.
Every treatment session will be at the clinic and take 30 minutes.
Standard care PTNS participants will have nurse contact once per week for 6 weeks
High Intensive PTNS participants will start with 5 sessions per week, which will the be phased out to 2 sessions per weeks during the 6 week period.
Follow up visits to the clinic will be at 3, 6 and 12 months after completion of study.
Patients in the Standard group whose symtoms have not improved significantly, will be given the option to try the High Intensive treatment option.
Detailed description
The HIPLARS study is a Swedish clinical research project investigating whether an intensive form of Percutaneous Tibial Nerve Stimulation (PTNS) can improve faecal incontinence (FI) in patients who develop Low Anterior Resection Syndrome (LARS) after rectal cancer surgery. LARS commonly causes frequent bowel movements, urgency, and faecal incontinence, which can significantly reduce quality of life.
All participants receive the current standard treatment for FI, including bowel management, pelvic floor exercises, biofeedback, and, if needed, mini-enemas. The study compares this standard treatment with an intensified PTNS treatment, a minimally invasive nerve stimulation therapy that may provide longer-lasting symptom relief. Participants whose symptoms persist after six months may also be offered PTNS.
The study will include approximately 60 participants across three Swedish clinics and lasts 12 months. Depending on the assigned study group, participants will attend 17-29 clinic visits and receive 12-24 PTNS treatment sessions, each lasting about 30 minutes. Assessments include medical examinations, ultrasound, questionnaires, quality-of-life surveys, and bowel diaries.
Participation is voluntary, and participants may withdraw at any time without affecting their future medical care. Researchers may also end participation for medical reasons or if study procedures are not followed.
PTNS is already an established treatment with a low risk of side effects. Possible risks include mild discomfort from the needle insertion and occasional minor bleeding at the insertion site. Serious side effects are uncommon.
Personal and medical information will be kept confidential, stored securely, and handled in accordance with GDPR and Swedish law. Study results may be published, but participants' identities will remain confidential.
The study is conducted by the Pelvic Floor Centre, Department of Surgery, Skåne University Hospital (SUS) Malmö, has been approved by the Swedish Ethical Review Authority, and is covered by standard patient and pharmaceutical insurance. Participants can contact the study team at any time with questions or concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover option included for Control Arm participants without significantly improved symtoms.
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Conservative treatment for faecal incontinence. Mainly bowel regulation |
| Percutaneous Tibial Nerve Stimulation | Experimental | Procedure: Percutaneous Tibial Nerve Stimulation24 treatment sessions av Percutaneous Tibial Nerve Stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The presence of Faecal incontinence sufficiently severe to warrant intervention
- Have undergone low anterior resection and with low anterior resection syndrome (LARS) score >20
- The presence of incontinence for >6 months before inclusion in the study, failure of conservative treatment (e.g. fiber plus loperamide, biofeedback, bulking agents or TAI - transanal irrigation).
Key exclusion criteria (6 listed)
- Inability to be able to communicate both verbally and in written Swedish language
- Patients with neurological diseases such as multiple sclerosis, diabetic neuropathy and Parkinson's disease.
- Medical conditions precluding stimulation, for example bleeding disorders, novel oral anticoagulants (NOACs), cardiac pacemaker or implantable defibrillator, peripheral vascular disease or ulcer, lower leg cellulitis.
- Severe cardiopulmonary disease with severe distal venous insufficiency, local skin lesion, low molecular heparin or
- Chronic bowel diseases such as inflammatory bowel disease with chronic uncontrolled diarrhoea
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 |
|---|---|---|
| Percutaneous Tibial Nerve StimulationAlso: PTNSA total of PTNS 24 sessions, with 5 PTNS sessions per week (30 min each) for 4 weeks, thereafter 2 sessions per week for 2 weeks. | Procedure or surgery | Percutaneous Tibial Nerve Stimulation |
Primary outcome
Change in Low Anterior Resection Syndrome Score
Time frame: Outcome measures to be assessed at baseline, after 6 weeks, 3 months and 6 month treatment being the primary end point.
The primary outcome classifies patients as responders or non-responders, with a responder defined as someone having a change of the LARS score from Major LARS to Minor or No LARS
1 secondary outcome
Improvement or change of at least 50 per cent in the number faecal incontinence episodes
Time frame: Outcome measures to be assessed at baseline, after 6 weeks, 3 months and 6 month treatment being the primary end point.
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 23 Oct 2026.
- Br J Surg . 2014 Apr;101(5):457-68. doi: 10.1002/bjs.9391. Epub 2014 Jan 20. Systematic review of tibial nerve stimulation to treat faecal incontinence E J Horrocks 1, C H Knowles. PMID: 24446127Link provided by the sponsor.
- Br J Surg . 2013 Oct;100(11):1430-47. doi: 10.1002/bjs.9226. Systematic review of the clinical effectiveness of neuromodulation in the treatment of faecal incontinence N N Thin 1, E J Horrocks, A Hotouras, K E Matzel, C H Knowles.PMID: 24037562Link provided by the sponsor.
- Tech Coloproctol . 2019 Apr;23(4):361-365. doi: 10.1007/s10151-019-01972-5. Percutaneous tibial nerve stimulation (PTNS): an alternative treatment option for chronic therapy resistant anal fissure , Louis B Johnson. PMID: 30972649 PMCID: PMC6536470Link provided by the sponsor.
- Clin Gastroenterol Hepatol . 2017 Dec;15(12):1915-1921.e2. doi: 10.1016/j.cgh.2017.06.032. Epub 2017 Jun 21. Factors Associated With Efficacy of PTNS for Fecal Incontinence. Post-Hoc Analysis of Data. Charles H Knowles. PMID: 28647458Link provided by the sponsor.
- Colorectal Dis . 2017 Sep;19(9):851-856. doi: 10.1111/codi.13669. Short-term outcome of percutaneous tibial nerve stimulation for low anterior resection syndrome: results of a pilot study D F Altomare 1, M De Fazio 1. PMID: 28371160Link provided by the sponsor.
- Ann Rehabil Med . 2022 Jun;46(3):142-153. Efficacy of Tibial Nerve Stimulation on Fecal Incontinence in Patients With Low Anterior Resection Syndrome Following Surgery for Colorectal Cancer Aigul Tazhikova 1.PMID: 35793903 PMCID: PMC9263329Link provided by the sponsor.
- Individual participant dataSharing planned: No. Basically the Ethical clearance for the study does not accomodate sharing of IPD. Further, the study focuses mainly on cancer patients which is a sensitive patient group with regards to symtoms being examined in the study.
Related trials for Faecal Incontinence With Faecal Urgency
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
RecruitingObservational study
Understanding and Tailored Treatment of Low Anterior Resection Syndrome
Low Anterior Resection Syndrome, Faecal Incontinence With Faecal Urgency
Recruiting
Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 1
Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence
Fecal Incontinence
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.
Louiis B Johnson, Associate Professor of Surgery principal investigator
Region Skåne - University of Malmö / Lund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Tibial Nerve Stimulation in people with Faecal Incontinence With Faecal Urgency and Rectal Cancer, run by Region Skane at 1 site in Sweden.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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. 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 Louis B Johnson, Associate Professor of Surgery (+46 704951997, louis.johnson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Low Anterior Resection Syndrome Score (time frame: Outcome measures to be assessed at baseline, after 6 weeks, 3 months and 6 month treatment being the primary end point.). 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 23 Oct 2026.