A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain

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.

Conditions

• Interstitial Cystitis
• Levator Spasm
• Bladder Pain Syndrome

Interventions

DRUG

Multimodal Bundle Drugs

multimodal pain therapy

PROCEDURE

Operative Cystoscopy

Evaluate bladder and treat Hunner lesions with kenalog or fulguration as appropriate

BEHAVIORAL

Behavioral health consultation/therapy

Patient to see behavioral health/psychiatric care

OTHER

Pelvic floor physical therapy

Patient to have evaluation and treatment by a trained pelvic floor physical therapist

OTHER

Usual Urogynecologic care

Usual care from practicing academic Urogynecologist

DRUG

Bladder Instillation

Intravesical lidocaine, heparin, sodium bicarb, Kenalog, gentamicin

DRUG

Vaginal estrogen

Topical vaginal estradiol application

DRUG

Methenamine

UTI prevention/bladder therapeutic

DRUG

Amitriptyline/Gabapentin

Part of multimodal pain therapy

Sponsors & Collaborators

• Jocelyn Fitzgerald

  lead OTHER

Principal Investigators

• Jocelyn J Fitzgerald, MD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-06

Primary Completion

2024-12-30

Completion

2025-12-30

FDA Drug

Yes

Countries

• United States

Study Locations