Clinical trial · Interventional
Sacral Neuromodulation (SNM) With InterStimTM for Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation
Randomized Crossover Study of the Efficacy of Sacral Neuromodulation (SNM) With InterStimTM for Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study permanently closed due to low accrual
Summary
Brief summary (as posted)
The purpose of this study is to evaluate whether a medical device/implant (InterStimTM) will help patients to have more normal bowel movements. The InterStimTM device is a neuromodulating device. Neuromodulation is a way of changing the activity of the nervous system by using electrical stimulation. InterStimTM is FDA approved to help people who have a hard time controlling their bowl movements. This is called fecal incontinence.The device is placed near a nerve root in the lower back. It works in a manner similar to a pacemaker by releasing electrical stimulation that triggers the S3 nerve root. When being placed, it is initially tested to make sure it will work using a temporary wire and then, if successful, the device is permanently implanted.
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 |
|---|---|---|---|
| for Bowel Dysfunction Following Surgery for Rectal Cancers | Rectal Neoplasm | PROBABILISTIC | 0.70 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Implantation of the InterStimTM | Device | — | UNRESOLVED |
| MSK BFI questionnaires | Behavioral | — | UNRESOLVED |
| The EuroQOL5D questionnaires | Behavioral | — | UNRESOLVED |
| The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires | Behavioral | — | UNRESOLVED |
| The Low Anterior Resection Score (LARS) questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- InterStimTM the device on
- description
- The device will be set to stimulate for 4 weeks, then off for two weeks, and then the device will be on but will not stimulate for 4 weeks.
- interventionNames
- Device: Implantation of the InterStimTM
- Behavioral: MSK BFI questionnaires
- Behavioral: The Low Anterior Resection Score (LARS) questionnaires
- Behavioral: The EuroQOL5D questionnaires
- Behavioral: The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires
- type
- EXPERIMENTAL
- label
- InterStimTM the device off
- description
- The device will be on but will not stimulate for 4 weeks, then off for two weeks, and then the device will be set to stimulate for 4 weeks.
- interventionNames
- Device: Implantation of the InterStimTM
- Behavioral: MSK BFI questionnaires
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * History of rectal cancer or neoplastic polyp (i.e. intramucosal carcinoma, carcinoma in situ) * BFI score must meet at least one of the below criteria: * Total BFI \< 50 * Dietary subscale \< 11 * Frequency subscale \< 19 * Urgency subscale \< 12 * English speaking * Patients ≥18 years old. age * Sphincter-preserving surgery and ≥ 12 months after restoration of bowel continuity Exclusion Criteria: * Locally recurrent or metastatic disease * Immune suppressive medication * Seizure disorder * Prior sacral/lower spinal surgery * Congenital Spinal defect/Paraplegia * Rectal prolapse * IBD/Crohn's * Pregnancy * Active anal/rectal abscess * Pacemaker or other electronic implanted device * Immediate need for MRI * At the time of the wire stimulation procedure, patients will be excluded if the surgeon is unable to place the temporary stimulating lead * Inability to commit to local follow up for device management.
References
Publications (0)
Data not yet available