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NCT01824420
Flexibly adding-on Second Antimuscarinic Agent to the First Antimuscarinics for Refractory Overactive Bladder Syndrome - A Prospective Randomized Controlled Comparative Study With Mono-antimuscarinic Therapy
Phase 4 trial testing Detrusitol 4mg QD and Oxybutynin ER 5mg QD in Overactive Bladder in 129 participants. Completed in 1 February 2017.
1 February 2017
Quick facts
| Lead sponsor | Buddhist Tzu Chi General Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 129 |
| Start date | 1 March 2013 |
| Primary completion | 1 February 2017 |
| Estimated completion | 1 February 2017 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Detrusitol 4mg QD and Oxybutynin ER 5mg QD — full drug profile →
- Detrusitol 4mg QD — full drug profile →
Conditions studied
- Overactive Bladder — all drugs for Overactive Bladder →
Sponsor
Buddhist Tzu Chi General Hospital
Who can join
Adults 20 to 65, any sex, with Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change from Baseline in the Perception of Bladder Condition (PPBC) at different time points
Time frame: 1 month, 2 months and 3 months
Efficacy: Change from Baseline in the Perception of Bladder Condition (PPBC) at different time points (1 month, 2 months and 3 months). If patients have a PPBC improved by two scales, they are considered as successfully treated, otherwise failed treatment. Safety: Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness
Sponsor's own description
To investigate if oxybutynin ER adding on antimuscarinics is more effective than mono-antimuscarinic treatment for patients with refractory OAB
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 NCT01824420
- 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 Buddhist Tzu Chi General Hospital trials
Trials by the same sponsor.
- NCT06141902 — The Effects of Jing Si Herbal Tea on Physical and Psychological Symptoms in Peripheral Blood Hematopoietic Stem Cell Don · NA · enrolling by invitation
- NCT06818526 — Huandao Conditioning Application for Allergic Rhinitis Treatment · NA · not yet recruiting
- NCT06744478 — Assessing the Magnitude of Anisometropia in Patients Wearing Misight 1 Day Contact Lens · enrolling by invitation
- NCT07287657 — Exploring the Effects of Transcutaneous Electrical Acupoint Stimulation Therapy on Patients After Video-Assisted Thoraco · NA · enrolling by invitation
- NCT07334938 — Effects of Far Infrared Rays and Transcutaneous Electrical Nerve Stimulation on Short Term Prognosis of Head and Neck Ca · NA · active not 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 NCT01824420 (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 Buddhist Tzu Chi General Hospital
- Last refreshed: 7 March 2017
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/NCT01824420.
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