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NCT04020510
Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder
Phase 4 trial testing onaBoNT-A in Overactive Bladder in 184 participants. Currently enrolling.
1 July 2021
Quick facts
| Lead sponsor | Walter Reed National Military Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 184 |
| Start date | 1 July 2019 |
| Primary completion | 1 July 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- onaBoNT-A — full drug profile →
Conditions studied
- Overactive Bladder — all drugs for Overactive Bladder →
Sponsor
Walter Reed National Military Medical Center
Who can join
18 and older, any sex, with Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
OnabotulinumtoxinA is an effective treatment for both idiopathic and neurogenic overactive bladder and was FDA approved for this indication in 2013. The standard technique for injecting onabotulinumtoxinA into the detrusor is mixing 100 units of onabotulinumtoxinA into 10mL of injectable normal saline and injecting 20 sites with 0.5mL in the posterior wall of hte bladder for idiopathic overactive bladder and mixing 200 units into 30mL and injecting 30 sites with 1mL for neurogenic overactive bladder. The purpose of this study is to compare the efficacy of a technique using a reduced number of injections with the same dosage of onabotulinumtoxinA to the standard technique. The hypothesis is that the reduced technique will not be inferior in terms of efficacy as the standard technique and that there will be a lower incidence of urinary tract infections and urinary retention requiring catheterization post-procedure.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Reduced versus standard intradetrusor OnabotulinumtoxinA injections for treatment of overactive bladder.
DiCarlo-Meacham AM, Dengler KL, Welch EK, Brooks DI, et al · · 2023 · cited 14× · PMID 36455284 · DOI 10.1002/nau.25107
Verify or expand the search:
- PubMed search for NCT04020510
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of onaBoNT-A
Trials testing the same drug.
- NCT06101160 — Botulinum Toxin Injection for Sialorrhea in Cerebral Palsy · completed
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 Walter Reed National Military Medical Center trials
Trials by the same sponsor.
- NCT07151417 — Use of Corticosteroid in Intraopertive Injections in Total Knee Replacement Surgery. · Phase 2, PHASE3 · not yet recruiting
- NCT06636136 — Transtibial Osseointegration · NA · recruiting
- NCT06808347 — Difference in Serum Estrogen Level Based on Methods of Vaginal Estrogen Application (fingertip Vs Applicator Use) in Pos · Phase 4 · not yet recruiting
- NCT06731348 — Patient Satisfaction With Opioid Restriction After Urogynecologic Surgery · Phase 4 · enrolling by invitation
- NCT06729151 — Effect of Intradetrusor onabotulinumtoxinA Injection Versus Conservative Management on Female Sexual Function in Patient · recruiting
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 NCT04020510 (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 Walter Reed National Military Medical Center
- Last refreshed: 28 April 2020
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/NCT04020510.
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