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NCT05026970
Validation of a Multimodal Algorithm for the Treatment of Fecal Incontinence
NA trial testing Biofeedback+Electrostimulation+Kegel in Fecal Incontinence in 150 participants. Status unknown.
1 December 2022
Quick facts
| Lead sponsor | Hospital de Mataró |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 1 February 2019 |
| Primary completion | 1 December 2022 |
| Estimated completion | 1 May 2023 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Biofeedback+Electrostimulation+Kegel
- Biofeedback+Tibial Neuromodulation+Kegel
- Biofeedback+Kegel
Conditions studied
- Fecal Incontinence — all drugs for Fecal Incontinence →
Sponsor
Hospital de Mataró
Who can join
18 and older, female only, with Fecal Incontinence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Thisi is a pragmatical clinical trial with the main aim of main aim of evaluating the effectiveness of the combination of treatments for the management of fecal incontinence (FI), on profiles of patients with IF based on pathophysiological criteria, measuring physiological, clinical and quality of life outputs. Secondary: 1. Evaluate the presence of SIBO, gluten-sensitive enteropathy, malabsorption of bile salts or sugars in patients with Bristol stools ≥5 that condition the fecal continuity. 2. Effect of change in fecal consistency on IF symptoms. 3. To evaluate the effect of the combination of treatments on anorectal physiology and neurophysiology (motor and sensory), clinical severity and quality of life. 4. Evaluate the persistence of the treatments to the three months of end of the same.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05026970
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Hospital de Mataró 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 NCT05026970 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital de Mataró
- Last refreshed: 30 August 2021
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/NCT05026970.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing