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CTRI Number  CTRI/2026/01/100762 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 09/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   A Comparative Study of Silodosin vs Silodosin with Tadafil in Reducing Symptoms like Frequency of urine , Urgency of urine , Frequent urination during night and Poor Urinary Flow 
Scientific Title of Study   A Comparative Study Of Silodosin vs Silodosin With Tadalafil For Relieving Lower Urinary Tract Symptoms Due To Benign Prostatic Hyperplasia 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pulluru Bala Susheeth Kumar 
Designation  Mch Urology 1st Year  
Affiliation  Dr Pinnamaneni Siddhartha Institute Of Medical Sciences And Research Foundation  
Address  Room No 113 Urology Department Dr Psims Rf Chinna Avutapalli Gannavaram Krishna Dist 521101

Krishna
ANDHRA PRADESH
521101
India 
Phone  8096600946  
Fax    
Email  sushipbsk101@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suryakumari Uppalapati 
Designation  Guide and Head of Urology 
Affiliation  Dr Pinnamaneni Siddhartha Institute Of Medical Sciences And Research Foundation 
Address  Room No 113 Urology Department Dr Psims Rf Chinna Avutapalli Gannavaram Krishna Dist 521101

Krishna
ANDHRA PRADESH
521101
India 
Phone  8519886774  
Fax    
Email  hod.urology@drpinnamanenisimsrf.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Pulluru Bala Susheeth Kumar 
Designation  Mch Urology 1st Year  
Affiliation  Dr Pinnamaneni Siddhartha Institute Of Medical Sciences And Research Foundation  
Address  Room No 113 Urology Department Dr Psims Rf Chinna avutapalli Gannavaram Krishna Dist AP 521101
Chinna Avutapalli Gannavaram Krishna Dist 521101 Andhra Pradesh
Krishna
ANDHRA PRADESH
521101
India 
Phone  8096600946  
Fax    
Email  sushipbsk101@gmail.com  
 
Source of Monetary or Material Support  
Dr Pinnamaneni Siddhartha Institute Of Medical Sciences And Research Foundation Chinna Avutapallu Gannavaram Krishna Dist 521101 Andhra Pradesh India 
 
Primary Sponsor  
Name  Dr Pulluru Bala Susheeth Kumar 
Address  Room No 113 Urology Department Dr Psims Rf Chinna Avutapalli Gannavaram Krishna Dist 521101 Andhra Pradesh India 
Type of Sponsor  Other [Mch 1st Year Student] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Pulluru Bala Susheeth Kumar  Dr Pinnamaneni Siddhartha Institute Of Medical Sciences And Research Foundation  Chinna Avutapallu Gannavaram Krishna Dist AP-521101
Krishna
ANDHRA PRADESH 
8096600946

sushipbsk101@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Dr PSIMS and RF  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Comparator Agent  Silodosin  Silodosin 8mg once daily at night time 
Intervention  Tadalafil  Combination Therapy of Silodosin 8mg plus Tadalafil 5mg once daily at night time 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  IPSS Score greater than 8
qmax less tham 10ml per sec
PVR less than 150ml per sec 
 
ExclusionCriteria 
Details  1 Presence of prostate cancer or bladder carcinoma
2 Associated Urethral Stricture
3 Complicated BPH (patients with refractory urinary retention, renal insufficiency, recurrent urinary tract infections, recurrent bladder stones or gross hematuria secondary to BPH)
4 Insufficient renal function (serum creatinine
concentration greater than 2 mgper dL)
5 Cardiac patients
6 Patients with history of hypersensitivity to these drugs
7 Patients who are not able to understand IPSS Questionnaire 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study analyse and compare Efficacy of Silodosin versus silodosin with Tadalafil for Lower Urinary tract symptoms
in Benign Prostatic Hyperplasia 
2 weeks 1 month 2 months
3 months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Lower Urinary Tract Symptoms(LUTS) are symptomatic complex of Benign Prostatic Hyperplasia(BPH). LUTS due to BPH includes obstructive symptoms (hesitancy poor stream sense of incomplete emptying straining) and irritative symptoms (frequency urgency nocturia) 

LUTS severity doesn’t correlate with Prostate size.  LUTS are evaluated by international prostate symptoms score (IPSS). IPSS is most important tool to evaluate BPH patients before initiation of treatment and monitor treatment response

BPH patient is diagnosed on the basis of history, digital rectal examination, IPSS scores, USG KUB, prostate with PVR and uroflowmetry.

Ultra sonography is used to detect prostate size and amount of urine left in the urinary bladder after voiding (PVR). Prostate size below 20 ml, and PVR below 50 ml is considered as normal

Uroflowmetry is a method for observing urination. Maximum flow of urine (Qmax) is measured by uroflowmetry. Qmax more than 15 ml/sec is considered as normal

Treatment options for BPH include watchful waiting and medical treatment and surgery

Medical therapy for symptomatic BPH currently consist of alpha 1 blockers, 5 alpha reductase inhibitors and phosphodiesterase 5 inhibitors or combination therapy. For optimal management of symptomatic BPH patient medications should be chosen based on age, disease progression, need for long-term management and other clinical parameters Clinical guidelines for LUTS due to BPH proposed alpha 1 adrenoreceptor antagonists (a 1 blockers) as first-line drug therapy for LUTS due to BPH

Tadalafil is a Phosphodiesterase type 5 inhibitor (PDE 5 inhibitors) was approved for treating LUTS due to BPH in 2014, which is routinely used for erectile dysfunction. The inhibition of PDE5 isoenzymes relaxes smooth muscle in the prostate and bladder neck (via cGMP)  increases blood perfusion to the prostate and bladder and decreases bladder afferent nerve activity. resulting in relaxation and alleviation of the symptoms of LUTS due to BPH.

Osamu et al 2015(8) stated that clinical studies carried out in Asian and non-Asian countries have demonstrated that Tadalafil 5 mg once daily is an efficacious treatment for men with BPH-LUTS and has a safety profile consistent with the known safety profile of Tadalafil for ED.

Yoshida, M et al(7)., 2017 study showed that men with BPH have demonstrated improvements in IPSS with tadalafil .  Tadalafil can cause headache, dizzines 

Lee J.Y et al(9)., 2012 stated that Silodosin is the most efficacious alpha 1 blocker with rapid onset of action. It significantly improves IPSS maximum flow rate and quality of life than other alpha 1 blocker  But a very few studies in the literature, compared the newer molecule silodosin (alpha 1 blocker) and silodosin with tadalafil (phosphodiesterase 5 inhibitor) in the treatment of BPH 

So this study is designed to compare the safety and efficacy of silodosin monotherapy and silodosin with tadalafil add on therapy in patient with symptomatic BPH.

 


 
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