Last reviewed · How we verify
NCT06345677: XAVIER
Clinical Trial for the Assessment of Safety, Usability and Efficacy of the Vixe Combination for OAB in Female Subjects
NA trial testing ViXe Xombination in Overactive Bladder in 48 participants. Completed in 1 February 2024.
1 February 2024
Quick facts
| Lead sponsor | Vensica Therapeutics Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 9 June 2023 |
| Primary completion | 1 February 2024 |
| Estimated completion | 1 February 2024 |
| Sites | 8 locations across Portugal |
Drugs / interventions tested
- ViXe Xombination
- Placebo + Sham
Conditions studied
- Overactive Bladder — all drugs for Overactive Bladder →
Sponsor
Vensica Therapeutics Ltd.
Who can join
Adults 18 to 80, female only, with Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this interventional clinical trial is to assess the safety, usability and initial efficacy of Xeomin and Vibe combination (ViXe) compared to placebo + sham in female subjects with idiopathic Overactive Bladder. The main question\[s\] it aims to answer are: • The rate of device and drug related serious adverse events during treatment and throughout the follow up period • Investigator, subject and technician satisfaction from treatment, and • Assess the initial efficacy of the drug-device combination compared to placebo-sham combination. Participants will be treated a single time with the ViXe combination and will be followed up for a period of 12 weeks, during which they will visit the clinic after 2, 6 and 12 weeks. Participants will complete a 3-day voiding diary prior to the 6- and 12-week FU visit.
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 NCT06345677
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Overactive Bladder
Currently open trials in the same condition.
- NCT06201013 — Vitamin D Treat-to-Target Strategy for Children With Overactive Bladder-Wet · NA · recruiting
- NCT05895045 — Yoga for Treatment of Overactive Bladder in Pediatric Patients · NA · recruiting
- NCT07209397 — Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women · NA · recruiting
- NCT06921746 — Changes in the Urinary Microbiome and Metabolome During Treatment of the Overactive Bladder in Female Patients · recruiting
- NCT06935240 — Investigation of Effects of Electrical Stimulation in Women With Vaginal Laxity · NA · recruiting
Other Vensica Therapeutics Ltd. trials
Trials by the same sponsor.
- NCT03874780 — Vibe First In Human Study for the Assessment of Safety and Initial Performance of the Vibe Delivery System in Subjects W · NA · completed
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 NCT06345677 (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 Vensica Therapeutics Ltd.
- Last refreshed: 9 April 2024
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/NCT06345677.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing