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NCT04547816
Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
Phase 3 trial testing Biofeedback therapy in Pelvic Floor Prolapse in 100 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 July 2020 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 May 2026 |
| Sites | 2 locations across Russia |
Drugs / interventions tested
- Biofeedback therapy
- Tibial neuromodulation
- Pelvic floor muscles training
- Diet modification
Conditions studied
- Pelvic Floor Prolapse — all drugs for Pelvic Floor Prolapse →
- Functional Constipation — all drugs for Functional Constipation →
- Rectocele — all drugs for Rectocele →
Sponsor
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Who can join
Adults 18 to 70, female only, with Pelvic Floor Prolapse or Functional Constipation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is planned to evaluate the efficacy of complex conservative treatment (including tibial neuromodulation, biofeedback therapy, special pelvic floor training and diet modification) in women with pelvic organ prolapse
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04547816
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Biofeedback therapy
Trials testing the same drug.
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Other Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology trials
Trials by the same sponsor.
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- NCT05543811 — The Influence of Food for Special Dietary Use - Spread Enriched With 5-hydroxytryptophan, Theanine and Gamma-aminobutyri · NA · completed
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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 NCT04547816 (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 Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
- Last refreshed: 3 August 2025
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/NCT04547816.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing