| 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
|
|
|
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
|
|
|
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. |