| CTRI Number |
CTRI/2026/02/105054 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randomised controlled trial comparing the efficacy of intravesical instillation of combination therapy and pentosan polysulfate sodium in management of bladder pain syndrome. |
|
Scientific Title of Study
|
A randomised controlled trial comparing the efficacy of intravesical pentosan polysulfate sodium with intravesical combination therapy in patients with bladder pain syndrome |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preeti Gurjar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of obstetrics and gynaecology
South
DELHI
110029
India |
| Phone |
9174436551 |
| Fax |
|
| Email |
preeti.gurjar2302@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajesh Kumari |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of obstetrics and gynaecology
South
DELHI
110029
India |
| Phone |
9911226176 |
| Fax |
|
| Email |
drrajeshkumari@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajesh Kumari |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of obstetrics and gynaecology
South
DELHI
110029
India |
| Phone |
9911226176 |
| Fax |
|
| Email |
drrajeshkumari@yahoo.com |
|
|
Source of Monetary or Material Support
|
| AIIMS,Ansari Nagar, New Delhi, Delhi ,110029, India |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Department of Obstetrics and Gynaecology, AIIMS, Ansari Nagar New Delhi,Delhi ,110029, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Preeti Gurjar |
AIIMS New delhi |
Department of Obstetrics and gynaecology
South
DELHI |
09174436551
preeti.gurjar2302@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N33||Bladder disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
combination cocktail therapy |
2%lignocaine 40ml, Sodium Bicarbonate 20ml, heparin 20000IU , Dexamethasone 4mg , Gentamycin 80mg
Route:Intravesical
Duration :weekly for 6weeks |
| Intervention |
Pentosan Polysulfate |
Pentosan Polysulfate is an oral glycosaminoglycan analogue used in the treatment of BPS, helps to restore the defective bladder mucosal barrier , reducing urothelial permeability, inflammation and pain.
Route: Intravesical
dose 30ml
Retention for 30min
duration weekly for 6 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
•Women above 18yrs of age with clinical diagnosis of BPS
•Negative urine culture at screening
•Willing to undergo intravesical instillation therapy
•Able comply with follow up
|
|
| ExclusionCriteria |
| Details |
Active urinary tract infection.
Known bladder malignancy or prior pelvic radiation active genital infection
Known allergy to study drugs PPS
Urethral stricture or significant bladder outlet obstruction
Prior intravesical therapy in last 3 months
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of intravesical instillation of Pentosan Polysulfate Sodium (PPS) with combination therapy comprising 2% Lignocaine, Sodium Bicarbonate, Heparin, Dexamethasone, and Gentamicin in patients with Bladder Pain Syndrome (BPS) |
Baseline and 7th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare changes in psychosocial wellbeing between the two group
To determine the rate of treatment discontinuation & analyse reasons for discontinuations in both groups.
To evaluate & compare the occurrence of adverse effects in patients receiving intravesical Pentosan Polysulphate Sodium & combination therapy
|
Baseline & 7th week |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
14/08/2026 |
| 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="6"
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
|
The literature up to 2024 substantiates the therapeutic role of intravesical treatment in refractory BPS/IC and elucidates complementary mechanisms for PPS and multimodal cocktails. PPS targets long-term urothelial repair and may sustain symptom improvement, whereas alkalinised lidocaine-heparin regimens offer rapid relief and short-term functional benefit. However, the absence of large, adequately powered head-to-head RCTs comparing intravesical PPS with combination therapy constitutes a significant evidence gap. The present randomised controlled trial aims to address this by providing comparative efficacy data using validated outcomes, defined instillation protocols, stratified randomisation, and rigorous safety monitoring—ultimately informing future guideline recommendations and optimising intravesical therapy for BPS/IC. |