| 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
|
|
|
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
|
|
|
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
|
|
|
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. |