Clinical trial · Interventional
Percutaneous Tibial Nerve Stimulation in the Treatment of Anterior Resection Syndrome After Rectal Cancer Surgery
NCT02177084CI-TRIAL-00014961unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study aims to evaluate the efficacy of percutaneous tibial nerve stimulation (PTNS) associated with conservative therapy (arm A) for the treatment of low anterior resection syndrome (LARS) compared with only conservative therapy (arm B). The secondary aims are the evaluation of the following parameters: * Effect of PTNS on manometric parameters * Effect of PTNS on quality of life * Effect of PTNS on the severity of fecal incontinence and / or obstructed defecation * Safety of PTNS
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low Anterior Resection Syndrome | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PTNS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PTNS + conservative treatment
- description
- PTNS consists in the insertion of a small electrode above the medial malleolus adjacent to the posterior tibial nerve. An adhesive surface electrode is placed under th arch of the foot. Both electrodes are connected to the neurostimulator that generates electricity. A neuromodulation session lasts 30 minutes. The treatment plan includes 12 weekly sessions, followed by two sessions at 2-week intervals and the last one after one month. Two additional sessions of reinforcement (top-up) are provided at intervals of 6 months or earlier in case of worsening of symptoms
- interventionNames
- Device: PTNS
- type
- NO_INTERVENTION
- label
- conservative treatment
Primary outcomes (1)
- measure
- LARS score
- timeFrame
- 67 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with LARS score ≥ 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer; * Age\> 18 years; * Obtaining informed consent. Exclusion Criteria: * Patients carrying ostomy; * Patients with clinical or radiological evidence of local or distant tumor recurrence; * Patients suffering from neurological disorders; * Patients with Inflammatory Bowel Disease (IBD); * Patients who have a pacemaker or defibrillator; * Patients taking antiplatelet agents or anticoagulants; * Patients unable to follow the procedures of the Protocol or to provide informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.