Overactive Bladder Clinical Trial
— OABOfficial title:
Multi-site, Randomized, Opened and Controlled Comparison Study on the Effectiveness and Safety of Solifenacin Succinate Tablets and Solifenacin Succinate Tablets + Estrogen for Overactive Bladder in the Post-menopausal Women
Verified date | March 2014 |
Source | Peking Union Medical College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
This study is a multi-site, randomized, opened and parallel-controlled clinical study.
The patients up to the inclusion criteria are randomly treated with Solifenacin Succinate
Tablets (5mg/d) or Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks.
Before the dosing and at Week 4, 8 and 12 of the dosing, various examinations are made, and
various indices are evaluated.
Status | Completed |
Enrollment | 200 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Post-menopausal women aged =75. - Signing of ICF. - Willing to and able to correctly complete the urination diary. - Complications of OAB for =12 weeks (including: urgent micturition, frequent urination (=8 times in the daytime, and =2 times at the night) and/or urgent urinary incontinence). - No dosing of other drugs of same kind within 14d. -=8 urination times (24h) in the 1d urination diary. Exclusion Criteria: - Clinically-significant dysuria(at the investigators' viewpoints). - Serious stress urinary incontinence or mixed stress/urgent urinary incontinence (mainly stress one) confirmed by the investigators. - At the ongoing intubatton or the intermittent self-intubatton. - Evidence-based urinary tract infection or chronic inflammation in the recent 2 weeks (e.g. interstitial cystitis), bladder calculus, past pelvic radiotherapy, and past or existing pelvic malignant tumors. - Uncontrolled narrow-angle glaucoma, urinary/gastric retention, intestinal obstruction and other medical symptoms forbidden for anti-cholinergic drugs at the investigators' viewpoints. - Non-pharmacotherapy (including electrotherapy) or bladder training within 2 weeks before the study initiation (or during the study). - Dosing of diuretics and drugs with the cholinergic or anti-cholinergic adverse reactions - Known or suspicious allergy to Solifenacin Succinate, other anti-cholinergic drugs or lactose. - Clinically-significant symptoms inapplicable for clinical study at the investigators' viewpoints. - Participation in other clinical studies within 30d before the random grouping. - No completion of urination diary according to relevant instructions. - Potentially clinically significant abnormalities (PCSA) inapplicable for clinical study at the investigators' viewpoints. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital | Astellas Pharma China, Inc., Beijing CAT Science Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference between the mean urination times (24h) at the end of treatment and the baseline value | 12 weeks | No | |
Secondary | Difference between the mean urgent micturition times (24h) and the baseline value | on week 12 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04578899 -
"The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"
|
N/A | |
Active, not recruiting |
NCT03556891 -
Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence
|
N/A | |
Not yet recruiting |
NCT05977634 -
Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder
|
N/A | |
Completed |
NCT01955408 -
Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment
|
N/A | |
Recruiting |
NCT06201013 -
Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children
|
N/A | |
Recruiting |
NCT03727711 -
TPTNS: Home vs Hospital Treatment for Overactive Bladder
|
N/A | |
Completed |
NCT00768521 -
A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)
|
Phase 1 | |
Completed |
NCT03625843 -
Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing
|
N/A | |
Completed |
NCT02211846 -
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder
|
Phase 1 | |
Completed |
NCT02835846 -
Investigation of the Effect of the Female Urinary Microbiome on Incontinence
|
Phase 4 | |
Completed |
NCT02857816 -
PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB
|
N/A | |
Withdrawn |
NCT02320201 -
Foot Neuromodulation for Overactive Bladder in Children
|
N/A | |
Completed |
NCT02202031 -
Controlling Urgency Through Relaxation Exercises
|
N/A | |
Not yet recruiting |
NCT01423838 -
Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder
|
Phase 4 | |
Completed |
NCT01458197 -
A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder.
|
Phase 2 | |
Not yet recruiting |
NCT01409512 -
Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder
|
N/A | |
Completed |
NCT01437670 -
Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin
|
N/A | |
Withdrawn |
NCT01210859 -
Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents
|
N/A | |
Terminated |
NCT01758848 -
Physical Therapy for Overactive Bladder
|
N/A | |
Terminated |
NCT01003249 -
Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen
|
Phase 4 |