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Procedure

Pelvic Floor Physical Therapy + Psychosocial Treatment for Bladder Pain Syndrome

N/A

Recruiting

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

18 years of age or older

Diagnosis of IC/BPS as indicated by structured assessments

Must not have

Current or history of diagnosis of primary psychotic or major thought disorder within the past five years

Comorbid neurological conditions including spinal cord injury or systematic neurologic illnesses, or central nervous system diseases such as brain tumor or stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 0), post-treatment (either week 8 or 10), follow-up (week 24)

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to understand how different subgroups of patients with interstitial cystitis/bladder pain syndrome respond to two common treatments - pelvic floor physical therapy and cognitive-behavioral therapy. The goal

Who is the study for?

This trial is for adults over 18 with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), who can consent to participate and stay for the whole study. It's not suitable for those who don't meet the specific diagnostic criteria or cannot commit to the duration of the trial.

What is being tested?

The study tests how different IC/BPS patient 'phenotypes' respond to pelvic floor physical therapy and cognitive-behavioral therapy, without considering their specific pain distribution patterns.

What are the potential side effects?

While not explicitly stated, common side effects of pelvic floor PT may include temporary soreness or increased pain. Cognitive-behavioral therapy typically does not have physical side effects but may cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with interstitial cystitis/bladder pain syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been diagnosed with a major thought disorder in the past 5 years.

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I have a neurological condition like a spinal injury or brain tumor.

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I do not speak English.

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I do not have thoughts of harming myself or experiencing delusions.

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I am currently receiving treatment for cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0), post-treatment (either week 8 or 10), follow-up (week 24)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 0), post-treatment (either week 8 or 10), follow-up (week 24)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), post-treatment (either week 8 or 10), follow-up (week 24) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Differences in response to treatment by phenotype measured by the Global Response Assessment (GRA) scale.

Secondary study objectives

Chronic Overlapping Pain Condition-Screener (COPCS)

Interleukin-6, whole blood stimulated (IL6-LPS)

Quantitative Sensory Testing - Temporal Summation (QST-TS)

+4 more

Side effects data

From 2019 Phase 4 trial • 288 Patients • NCT01843023

37%

Drug withdrawal syndrome

24%

Insomnia

19%

Headache

16%

Anxiety

13%

Injection site pain

13%

Myalgia

13%

Depression

10%

Nausea

10%

Irritability

Vomitting

Abdominal Pain

Injection site mass

Overdose

Decreased appetite

Cough

Dark urine

Pain

Nervousness

Rhinitis

Multiple Allergies

Injection site bruising

Injection site swelling

Athralgia

Dizziness

Rash

Contusion

Diarrhea

Unintended Pregnancy

Liver function test

Suicidal Ideation

Acute Hepatitis

Fracture

Chest Pain

Hypoglycemia

Amputation

Seizure

Constipation

Root Canal Infection

Injection site erythema

Injection site pruritus

Toothache

Hot flush

Tingling in arm

Cold stimulus headache

Hospitalized for observation

Shortness of Breath

Acne

Pruritus

Epistaxis

Hypertension

Hepatitis C

Jaundice

Infection

100%

80%

60%

40%

20%

Study treatment Arm

Extended Release Naltrexone

Treatment as Usual

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

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 and tested in a prior study. Treatment modules are individualized and include topics such as pain coping strategies, relaxation training, education on IC/BPS, and communication strategies.

Group II: Pelvic Floor Physical TherapyActive Control1 Intervention

The pelvic floor physical therapy condition consists of 10 weekly 45-minute individual visits with an assigned trained physical therapist. In IC/BPS, pelvic floor physical therapy (PT) uses manual manipulation to release localized muscle tension, trigger points, and correct other scars and restrictions to reduce pain and urgency symptoms. Specific techniques will include external connective tissue manipulation to the abdominal wall, back, buttocks and thighs, myofascial trigger point release, and internal transvaginal/transrectal treatment of the soft tissues of the pelvic floor with connective tissue and myofascial manipulation to pelvic floor musculature

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psychosocial Treatment

2020

Completed Phase 4

~440

0 / 7Eligibility criteria met