A randomised controlled trial comparing the efficacy of intravesical pentosan polysulfate sodium with intravesical combination therapy in patients with bladder pain syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
研究者
Preeti Gurjar
AIIMS New Delhi