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NCT01948973
A Randomised, Controlled Crossover Study of Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome
NA trial testing Subsensory in Irritable Bowel Syndrome in 21 participants. Completed in 1 March 2018.
1 March 2018
Quick facts
| Lead sponsor | University of Aarhus |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 1 September 2013 |
| Primary completion | 1 March 2018 |
| Estimated completion | 1 March 2018 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Subsensory
- OFF — full drug profile →
- Suprasensory — full drug profile →
Conditions studied
- Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →
Sponsor
University of Aarhus
Who can join
Adults 18 to 60, any sex, with Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version questionnaire
Time frame: Every week during the 6 weeks test period
The GRSRS-IBS questionnaire is filled in every week during the test period allowing comparison between OFF, subsensory and suprasensory stimulation
Sponsor's own description
Sacral nerve stimulation (SNS) has become a well-established treatment for patients with fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood but recent studies have shown changes in both colonic motility and rectal sensibility. We have previously shown IBS patients to benefit from sacral nerves stimulation. With the present study, we aim to evaluate if subsensory sacral nerve stimulation is as effective as suprasensory sacral nerve stimulation.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Long-term efficacy and safety of sacral neuromodulation for diarrhoea-predominant and mixed irritable bowel syndrome.
Fassov J, Høyer KL, Lundby L, Laurberg S, et al · · 2025 · cited 1× · PMID 39754648 · DOI 10.1007/s10151-024-03066-3
Verify or expand the search:
- PubMed search for NCT01948973
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Aarhus trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01948973 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Aarhus
- Last refreshed: 16 May 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01948973.
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