drugset / Trial / NCT05658874

A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain

NCT05658874 ↗

Phase 3 Terminated 26 enrolled Jocelyn Fitzgerald
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to compare two different treatment patterns in patients with chronic bladder pain. The main questions the investigators are seeking to answer is if bladder pain improves before and after treatment using a painful bladder scale. The participant will have 5 visits to evaluate your symptoms with questionnaires, at least one procedural visit, and must participate in physical therapy and some kind of behavioral health therapy. This study will assess participant response to a bundled-care approach to chronic bladder pain both pre-and post intervention as well as compared to a group of participants receiving typical care.

Timeline

Start
2022-12-06
Primary completion
2024-12-30
Completion
2025-12-30

Outcome

Outcome not reported

Stopped (Enrollment): “unable to reach the recruitment numbers required to power our primary outcome”

Drugs

EvaluationDrugModalityDoseRoute
Background Amitriptyline Small molecule 10 mg —
Background Amitriptyline Small molecule 50 mg —
Background Estradiol Other / unclassified — Topical
Background Gabapentin Unknown 100 mg Oral
Background Gabapentin Unknown 600 mg Oral
Background Gentamicin Small molecule — Other
Background Heparin Other / unclassified — Other
Background Lidocaine Other / unclassified — Other
Background Methenamine Unknown — —
Background Mirabegron Other / unclassified — —
Background Oxybutynin Small molecule — —
Background Tolterodine Unknown — —
Background Triamcinolone Acetonide Other / unclassified — Other
Background Trospium Small molecule — —
Background sodium bicarb Unknown — Other