Voiding Disorders Clinical Trial
Official title:
Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation: Prospective Randomized Controlled Trial
A randomized controlled study to compare the efficacy of mirabegron, solifenacin and propevirine for treatment of Lower urinary tract symptoms during intravesical BCG installation
Status | Recruiting |
Enrollment | 100 |
Est. completion date | October 2023 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients older than age 18 years. - Able to provide an informed consent. - Denovo or recurrent cases with intermediate and high risk NMIBC eligible for intravesical BCG immunotherapy. - Persistent LUTS after intravesical BCG induction. Exclusion Criteria: - International Prostate symptom score (IPSS) greater than 20. - Post-void residual (PVR) volume greater than 50 ml. - Use of medications for overactive bladder. - Pelvic surgery within the previous 6 months. - Hypersensitivity for BCG or any of the above mentioned drugs. - Tumor recurrence during follow up period. - Other medical conditions that would be adversely affected by anticholinergics such as history of urinary retention due to BPH(Benign prostatic hyperplasia), constipation and history of narrow angle glaucoma. |
Country | Name | City | State |
---|---|---|---|
Egypt | Urology and Nephrology Center, Mansoura University | Mansoura |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dysuria | Compare the percentage of reduction of dysuria as measured by Pain Visual Analouge Score at 3 month follow up after using propiverine, mirabegron and solifenacin versus placebo. | 3 months |
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