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NOT YET RECRUITING
NCT07862673
NA

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

Sponsor: Region Skane

View on ClinicalTrials.gov

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). 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.

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-10-05

Completion Date

2029-12-01

Last Updated

2026-10-16

Healthy Volunteers

No

Interventions

PROCEDURE

Percutaneous Tibial Nerve Stimulation

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.

Locations (1)

Department of Surgery. Pelvic Floor Centre

Malmö, Skåne County, Sweden