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

Drugs

EvaluationDrugModalityDoseRoute
Background Amitriptyline Small molecule 10 mg
Background Amitriptyline Small molecule 50 mg
Background Estradiol Other / unclassified Topical
Background Gabapentin Small molecule 100 mg Oral
Background Gabapentin Small molecule 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 Small molecule
Background Triamcinolone Acetonide Other / unclassified Other
Background Trospium Small molecule
Background sodium bicarb Unknown Other