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A randomised controlled trial comparing the efficacy of intravesical instillation of combination therapy and pentosan polysulfate sodium in management of bladder pain syndrome.

A randomised controlled trial comparing the efficacy of intravesical pentosan polysulfate sodium with intravesical combination therapy in patients with bladder pain syndrome - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/105054
Enrollment
40
Registered
2026-02-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N33- Bladder disorders in diseases classified elsewhere

Interventions

Intervention1: Pentosan Polysulfate: Pentosan Polysulfate is an oral glycosaminoglycan analogue used in the treatment of BPS, helps to restore the defective bladder mucosal barrier , reducing urotheli

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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)Timepoint: Baseline and 7th week—

Secondary

MeasureTime frame
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 Timepoint: Baseline & 7th week—

Countries

India

Contacts

Public ContactRajesh Kumari

AIIMS New Delhi

drrajeshkumari@yahoo.com9911226176

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026