to Evaluate Efficacy and Safety of FDC of Silodosin 8mg and Solifenacin succinate 5mg Tablets in Comparison to Silodosin 8mg Tablets in Male Patients Having Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms with Overactive Bladder
- Conditions
- Health Condition 1: N390- Urinary tract infection, site notspecified
- Registration Number
- CTRI/2024/06/069574
- Lead Sponsor
- SAVI HEALTH SCIENCE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1 Male patient aged between 50 to 75 years having Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms and with residual Overactive Bladder symptoms despite treatment with Silodosin 8 mg or other alpha blockers Alfuzosin 10 mg Tamsulosin 0.4 mg for more than equal to 4 weeks prior to screening
2 Patient with International Prostate Symptom Score more than equal to 13 with urgency item score more than 1 during screening
3 Patient with IPSS-QoL item score of greater than 2 during screening
4 Patient with number of micturition more than equal to 8 times per 24 hours and at least 2 urgency episodes per 24 hours in a 3-day bladder diary during screening
5 Patient with Post Void Residual volume less than equal to 150 ml and maximum urinary flow rate (Qmax) between 5 to 15 mL/s during screening
6 Patient is willing to give informed consent
7 Patient must agree to use adequate contraception from study entry till the last dose of the study medication
1.Patient taking anti-muscarinics (other than Solifenacin) antispasmodics any substances to influence voiding function at the time of screening or planning to take during study
2.Patient with history of prostate cancer and/or previous prostatic/ bladder neck surgery
3 Patient with history of urethral obstruction due to stricture, valves, sclerosis or tumour and patient with previous urethral surgery
4 Patient with autonomic neuropathy neurologic bladder conditions (multiple sclerosis spinal cord injury Parkinson disease)
5.Patient with clinically significant bladder outflow obstruction other than BPH, as judged by investigator Patients receiving Miconazole
6.Patient with chronic inflammation bladder stones bladder neck stricture sclerosis severe vesical diverticulum urethral stricture
7.Patient with history of cancer or undergoing chemotherapy
8.Patient with history of severe cardiac diseases including angina requiring certain treatment with nitrates or any clinically significant conditions
9.Patient with a history of esophageal or intestinal or gastric pylorus obstruction or gastrointestinal disorders (including gastric retention and toxic megacolon) which is associated with decreased gastrointestinal motility at the time of screening
10.Patient with hiatus hernia/gastro-oesophageal reflux and/or who is concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis
11.Patient with irradiation to the pelvis interstitial cystitis, prostatitis
12.Patient who is likely to require catheterization within next 3 months
13.Patient with history of symptomatic orthostatic hypotension or recurrent dizziness vertigo loss of consciousness or syncope
14.Patient with history of any condition that is a contraindication for anticholinergic treatment including narrow angle glaucoma, urinary retention and myasthenia gravis
15.Patient who started with a 5-alpha reductase inhibitor within 3 months prior to screening or planning to take during the study
16.Patient undergoing haemodialysis
17.Patient with symptomatic acute Urinary Tract Infection (UTI) during the screening period or recurrent UTI (more than equal to 2 episodes within the last 6 months from the screening).
18.Patient with moderate to severe renal impairment (Creatinine clearance less than 50 mL/min) and severe hepatic impairment (AST and ALT more than 3 x ULN)
19.Patient with serum Prostate Specific Antigen (PSA) beyond 4 ng/ ml at screening
20.Patient with uncontrolled hypertension (BP more than equal to 140/90 mm of Hg) and type 2 diabetes (HbA1c more than 9%)
21.Patient has a clinically significant disorder that in the opinion of the investigator would result in the patient’s inability to understand and comply with the requirements of the study
22.Patient with history of HIV and/or Hepatitis B and/or Hepatitis C
23.Patient with history of angioedema with airway obstruction
24.Patient with rare hereditary problems of galactose intolerance the Lapp lactase deficiency or glucosegalactose malabsorption
25.Patient planning cataract surgery during the study.
26.Patients having history of QT prolongation or patients who are taking medications known to prolong QT interval
27.Patient using any nitrates, androgens estrogens luteinizing hormone-releasing hormone (LH
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in IPSS Storage sub scoreTimepoint: baseline to Week 4 week 8 and Week 12 (end of treatment)
- Secondary Outcome Measures
Name Time Method 1 Change in Total International Prostate Symptom Score <br/ ><br>2 Change in mean number of micturition’s per 24 hrs <br/ ><br>3 Change in mean number of urgency episodes per 24 hrs <br/ ><br>4 Change in post void residual volume <br/ ><br>5 Change in IPSS Voiding (Obstructive) subscore <br/ ><br>6 Change in IPSS- QoL <br/ ><br>7 Overall Treatment Efficacy (OTE) at the end of 12 weeks <br/ ><br>treatment period- Global assessment will be done by patients using a questionnaire This will be scored on a seven point Likert scaleTimepoint: from baseline [Time frame: 4, 8 and 12 weeks] <br/ ><br>