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Psychosocial Treatment for Interstitial Cystitis

N/A

Waitlist Available

Led By Lindsey McKernan, PhD MPH

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months (after treatment is complete), 5 months

Awards & highlights

Study Summary

This trial will help to improve understanding and treatment of IC/BPS, a severe pain condition that lacks effective treatments.

Eligible Conditions

Interstitial Cystitis
Chronic Prostatitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months (after treatment is complete), 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 months (after treatment is complete), 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months (after treatment is complete), 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in the Genitourinary Pain Index (GUPI) 2 Months

Change in the Genitourinary Pain Index (GUPI) 5 Months

Secondary outcome measures

Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder (GAD-7) Questionnaire

Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-8)

Change in Posttraumatic Stress Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) With Criterion A

+6 more

Other outcome measures

The RAND Interstitial Cystitis Epidemiology (RICE) scale

Side effects data

From 2019 Phase 4 trial • 288 Patients • NCT01843023

37%

Drug withdrawal syndrome

24%

Insomnia

19%

Headache

16%

Anxiety

13%

Myalgia

13%

Injection site pain

13%

Depression

10%

Nausea

10%

Irritability

Cough

Abdominal Pain

Vomitting

Injection site mass

Overdose

Decreased appetite

Dark urine

Pain

Rhinitis

Nervousness

Multiple Allergies

Injection site swelling

Athralgia

Dizziness

Rash

Contusion

Injection site bruising

Diarrhea

Unintended Pregnancy

Liver function test

Suicidal Ideation

Fracture

Hot flush

Root Canal Infection

Constipation

Epistaxis

Hypertension

Chest Pain

Injection site pruritus

Amputation

Seizure

Cold stimulus headache

Shortness of Breath

Acne

Pruritus

Acute Hepatitis

Toothache

Hypoglycemia

Injection site erythema

Tingling in arm

Hospitalized for observation

Hepatitis C

Jaundice

Infection

100%

80%

60%

40%

20%

Study treatment Arm

Extended Release Naltrexone

Treatment as Usual

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Psychosocial TreatmentExperimental Treatment1 Intervention

The psychosocial self-management intervention consists of 8 weekly 50-minute individual visits with an assigned trained therapist. Sessions follow a structured protocol that has been developed with the patient population. Treatment modules are individualized and include topics such as pain coping strategies, relaxation training, education on IC/BPS, and communication strategies.

Group II: Attention ControlPlacebo Group1 Intervention

The attention control condition consists of 8 weekly telephone calls with a study interventionist. Sessions will occur via scheduled telephone calls and follow a structured procedure. Telephone calls are designed to monitor symptoms and overall wellness. Each week, participants will be asked about current symptoms, flare patterns, and physical and emotional wellbeing.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psychosocial Treatment

2020

Completed Phase 4

~440

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,315,417 Total Patients Enrolled

13 Trials studying Interstitial Cystitis

2,539 Patients Enrolled for Interstitial Cystitis

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,119 Total Patients Enrolled

1 Trials studying Interstitial Cystitis

220 Patients Enrolled for Interstitial Cystitis

Lindsey McKernan, PhD MPHPrincipal InvestigatorVanderbilt University Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project currently open to enrolment?

"According to the data on clinicaltrials.gov, this medical trial is not currently enrolling participants. The study was initially uploaded July 13th 2020 and its last update occurred on July 25th 2022; however, there are 1536 other trials seeking candidates at present."

Answered by AI

Is there an age restriction pertaining to eligibility for this investigation?

"The requisite age parameters for enrollment into this trial are 18 as the lower limit and 100 as the upper boundary."

Answered by AI

What is the intended outcome of this medical experiment?

"The primary goal of this study, evaluated over a 5-month period, is to measure any changes in the Genitourinary Pain Index (GUPI) score at 2 months. Secondary objectives include analyzing modifications in depressive symptoms as assessed through the Patient Health Questionnaire (PHQ-8), gauging variation in patient reported outcomes with PROMIS®-29 and finally quantifying response rate/perceived improvement and quality of life via the Patient Global Impression of Change Scale (PGIC)."

Answered by AI

Is it possible to participate in this clinical experiment?

"This research project is seeking 78 individuals aged between 18 and 100 who suffer from bladder pain syndrome. To be considered for enrollment, potential participants must meet the age requirement of 18 or older as well as have a provider-confirmed diagnosis of IC/BPS."

Answered by AI