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CTRI Number  CTRI/2025/07/091024 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 13/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Single Arm Study 
Public Title of Study   Evaluating the Safety and Potential Efficacy of Platelet-Rich Plasma (PRP) Therapy in Patients with Detrusor Underactivity (DUA) 
Scientific Title of Study   A Single-Arm Feasibility Study Evaluating the Safety and Potential Efficacy of Platelet-Rich Plasma (PRP) Therapy in Patients with Detrusor Underactivity (DUA) 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Satyadeo Sharma 
Designation  Assistant Professor Urology 
Affiliation  All India Institute of Medical Sciences Raipur 
Address  Department of urology and renal transplant Ground floor, C block, Gate no.4 AIIMS Raipur, Tatibandh

Raipur
CHHATTISGARH
492099
India 
Phone  7772967744  
Fax    
Email  satyadeo2004@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Satyadeo Sharma 
Designation  Assistant Professor Urology 
Affiliation  All India Institute of Medical Sciences Raipur 
Address  Department of urology and renal transplant ground floor, c block, gate no.4 AIIMS Raipur, Tatibandh


CHHATTISGARH
492099
India 
Phone  7772967744  
Fax    
Email  satyadeo2004@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Satyadeo Sharma 
Designation  Assistant Professor Urology 
Affiliation  All India Institute of Medical Sciences Raipur 
Address  Department of urology and renal transplant Ground floor, C block, Gate no.4 AIIMS Raipur, Tatibandh


CHHATTISGARH
492099
India 
Phone  7772967744  
Fax    
Email  satyadeo2004@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences AIIMS Raipur 
Address  Department of Urology and Renal Transplant, AIIMS Raipur. Tatibandh, Raipur.Chhattisgarh. PIN 492001 
Type of Sponsor  Government medical college 
 
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 
Satyadeo Sharma  All India Institute of Medical Sciences, AIIMS Raipur  Department of Urology, Ground floor, C block, Near gate no. 4, AIIMS Tatibandh, Raipur(Chhattisgarh), India. PIN 492099
Raipur
CHHATTISGARH 
7772967744

satyadeo2004@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS RAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: N318||Other neuromuscular dysfunction ofbladder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  PRP platelet rich plasma  Patients own platelet rich plasma after activation with calcium chloride will be given intravesical(10 intra detrusor injections of 1 mL PRP via cystoscopy injection needle). Frequency: Single session with repeat session at 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients of detrusor underactivity 
 
ExclusionCriteria 
Details  Exclusion Criteria
Active urinary tract infection
Bladder malignancy
Coagulopathy or platelet dysfunction disorders
Pregnancy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary Outcomes:
Improvement in detrusor contractility (measured as PdetMax maximum detrusor pressure on urodynamics)

Reduction in post-void residual (PVR) volume (mL) by MSCD/minimal significant clinical difference of at least 10% over previous value.

 

measured at 1, 3, 6, and 12 months.
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in patient reported symptoms (IPSS, VAS) MSCD/minimal significant clinical difference of at least 2 points in IPSS & one in VAS.
- Reduction in catheterization frequency by at least 2 .
- Improvement in bladder compliance & Qmax (uroflowmetry) MSCD/minimal significant clinical difference of at least by 2 points
 

Patient reported outcome measures (IPSS, VAS, QoL)
At 1, 3, 6, & 12 months

 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   Phase 2 
Date of First Enrollment (India)   28/07/2025 
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)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

The bladder’s function is to store and release urine. In some individuals, the bladder muscle becomes weak and cannot contract properly, leading to a condition called Detrusor Underactivity (DUA). This results in difficulty in emptying urine, urinary retention, and dependence on catheters for voiding. Current treatments such as intermittent catheterization or medications are only partially effective and carry risks like infections.

Platelet-Rich Plasma (PRP) is a biological product prepared from a person’s own blood, containing platelets that release multiple growth factors known to promote healing and regeneration of muscles and nerves. PRP has been successfully used in other medical fields to repair tissues but has limited research in bladder muscle repair.

In this study, we propose to use PRP therapy to improve bladder muscle function in patients with DUA. After taking a small blood sample from the participant, PRP will be prepared, activated, and injected into the bladder muscle through a minor cystoscopic procedure. This process will be done once, with a possible booster injection after 3 months if needed.

Participants will be followed up at 1, 3, 6, and 12 months to assess improvement in urination, bladder emptying, bladder pressures, symptom scores, and any side effects. No participant will be charged for participation, and all safety measures will be in place.

The goal of this study is to explore whether PRP therapy can provide a safer, less invasive regenerative treatment option for DUA patients, potentially improving their quality of life and reducing dependency on catheters.

Participation is voluntary, and patients can withdraw from the study at any time without affecting their routine medical care.

 
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