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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 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
8%
Vomitting
8%
Abdominal Pain
8%
Injection site mass
8%
Overdose
8%
Decreased appetite
8%
Cough
7%
Dark urine
6%
Pain
4%
Nervousness
4%
Rhinitis
4%
Multiple Allergies
3%
Injection site bruising
3%
Injection site swelling
3%
Athralgia
3%
Dizziness
3%
Rash
3%
Contusion
2%
Diarrhea
2%
Unintended Pregnancy
2%
Liver function test
2%
Suicidal Ideation
1%
Acute Hepatitis
1%
Fracture
1%
Chest Pain
1%
Hypoglycemia
1%
Amputation
1%
Seizure
1%
Constipation
1%
Root Canal Infection
1%
Injection site erythema
1%
Injection site pruritus
1%
Toothache
1%
Hot flush
1%
Tingling in arm
1%
Cold stimulus headache
1%
Hospitalized for observation
1%
Shortness of Breath
1%
Acne
1%
Pruritus
1%
Epistaxis
1%
Hypertension
1%
Hepatitis C
1%
Jaundice
1%
Infection
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,432 Previous Clinical Trials
4,323,037 Total Patients Enrolled
Vanderbilt University Medical CenterLead Sponsor
895 Previous Clinical Trials
934,559 Total Patients Enrolled
Lindsey McKernan, PhD, MPHPrincipal InvestigatorVanderbilt University Medical Center
~147 spots leftby Apr 2027
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