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NCT05013541
Effect of Bladder Filling on Rectal Contractions During Cystometry
trial testing No intervention in Bladder Dysfunction in 50 participants. Completed in 30 September 2021.
31 August 2021
Quick facts
| Lead sponsor | Gérard Amarenco |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 10 March 2021 |
| Primary completion | 31 August 2021 |
| Estimated completion | 30 September 2021 |
| Sites | 1 location across France |
Drugs / interventions tested
- No intervention
Conditions studied
- Bladder Dysfunction — all drugs for Bladder Dysfunction →
Sponsor
Gérard Amarenco
Who can join
18 and older, any sex, with Bladder Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Increasing knowledge on rectal motility and bladder-rectum cross-talk has been published in recent years. However, whether bladder filling factors during multichannel urodynamic studies affect rectal contraction (RC) parameters has not been studied. The primary aim of this study is to assess the impact of bladder filling and desire to void on rectal contraction amplitude or frequency. Secondary objectives are to determine any significant change in rectal parameters depending on clinical and urodynamic factors or treatment. All patients referred for urodynamic assessment and with studies positive for rectal contractions as defined by the international continence society (ICS) will be included. Abdominal pressure will be measured using a T-doc air charged abdominal catheter inserted 10 cm from the anal margin. Standardized urodynamic evaluation will be conducted following ICS guidelines. Mean amplitude, maximal amplitude (cmH20) and mean frequency of rectal contractions on all urodynamic studies will be visually measured on the recording software and compared depending on bladder sensation (First Desire to void (FDV), Strong Desire to Void (SDV) and filling volume (200ml, 400ml). Demographic data (age, sex, BMI), underlying neurological disease, clinical symptoms, and scores (Neurogenic Bladder Symptom Score, Bristol Score, Cleveland Score), urodynamic parameters and treatments will be collected. Time since last defecation and meal will also be collected. This prospective observational study will be conducted in a Neuro-Urology department of a French university hospital. All the patients included are referred for multichannel urodynamic assessment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05013541
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Other Gérard Amarenco trials
Trials by the same sponsor.
- NCT04409054 — The Guarding Reflex Anal, Study of the Modulation Function of Rectal Distension · 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 NCT05013541 (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 Gérard Amarenco
- Last refreshed: 18 February 2022
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/NCT05013541.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing