Chronic Interstitial CystitisNCT04275297

Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome

A study testing Psychosocial Treatment in people with Chronic Interstitial Cystitis and Bladder Pain Syndrome, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Interstitial Cystitis, Bladder Pain Syndrome, Cystitis, Interstitial
What is being tested?: Psychosocial Treatment
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 78 participants
Where: 1 siteUnited States
Study dates: 13 Jul 2020to 16 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years of age or older
Diagnosis of IC/BPS as given by providers or indicated by assessments

Who cannot join

Comorbid neurological conditions including spinal cord injury or systematic neurologic illnesses, or central nervous system diseases such as brain tumor or stroke
Current or history of diagnosis of primary psychotic or major thought disorder within the past five years
Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, and/or PTSD (within the past 5 years)
Psychiatric or behavioral conditions in which symptoms are unstable or severe (e.g. current delirium, mania, psychosis, suicidal ideation, homicidal ideation, substance abuse dependency) reported within the past six months
Non-English speaking
Presenting symptoms at time of screening that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking

Show all 12Show fewer

Difficulties or limitations communicating over the telephone
Any planned life events that would interfere with participating in the key elements of the study
Any major active medical issues that could preclude participation
Currently being treated for cancer
Cancer-related pain
Currently engaged in individual counseling/psychotherapy or unwilling to pause this treatment for the trial duration

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37212

Other trials in United States

About this study

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. By creating and testing a psychosocial intervention specific to IC/BPS, we will learn if this intervention improves patient wellness, who the intervention works best for, and how the body's pain processing influences outcomes.

Read the detailed description

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a debilitating, incurable, and costly pain condition affecting approximately 3-8 million individuals in the United States and is extremely challenging to treat. Evidence suggests psychosocial factors accompany and intensify the illness.

Unaddressed psychosocial co-morbidities are associated with reduced functionality and poorer outcomes, which suggests that psychosocial symptoms and bladder-specific symptoms reinforce each other. While psychosocial self-management interventions have demonstrated efficacy for other pain conditions, the IC/BPS field lacks the gold standard - randomized controlled trials - studying these interventions. At the same time, the chronic pain field is adopting a new approach driven by mechanisms of illness and treatment. Growing evidence suggests that subgroups (called "phenotypes") of patients with IC/BPS respond differently to medical intervention. Presence of central sensitization (CS) largely defines patient subgroups and may be a biological factor affecting response to medical treatment. The overall goal of this project is to fully develop, optimize, and evaluate a patient-centered CBT self-management intervention specific to IC/BPS. To achieve this goal, we will develop (Aim 1) and test (Aim 2) an empirically-based psychosocial treatment for IC/BPS compared to attention control, while examining pain mechanisms and subgroup characteristics that may alter treatment response (Aim 3). We hypothesize that a) inclusion of a self-management intervention will be more effective than a control treatment for IC/BPS, and that b) treatment effects will be moderated by degree of psychological co-morbidity, presence of chronic overlapping pain conditions, and elevated central sensitization. Successful completion of these aims will determine whether the addition of a tailored self-management intervention for IC/BPS will improve outcomes compared to control, whether particular subgroups are more responsive to this intervention, and whether a biological mechanism (CS) influences treatment responsiveness.

Conditions: Chronic Interstitial Cystitis, Bladder Pain Syndrome, Cystitis, Interstitial, Painful Bladder Syndrome, Cystitis, Chronic Interstitial, Interstitial Cystitis
Being tested: Psychosocial Treatment, Attention Control
Keywords: interstitial cystitis, bladder pain syndrome, clinical trial, psychosocial intervention, pelvic pain, therapy, urological chronic pelvic pain syndrome, chronic prostatitis, self-management, cognitive behavioral therapy
Medical subject headings: Cystitis, Interstitial, Bronchiolitis Obliterans Syndrome, Prostatitis, Pelvic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Psychosocial TreatmentBehavioural
The psychosocial intervention will consist of 8 weekly 50-minute individual visits with the assigned therapist.
Attention ControlBehavioural
The Attention Control will reflect a similar visit pattern and duration as intervention sessions.

Study groups in NCT04275297
Study group	Role	What they receive
Psychosocial Treatment	Experimental	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. Receives: Behavioral: Psychosocial Treatment
Attention Control	Placebo comparator	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. Receives: Behavioral: Attention Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Genitourinary Pain Index (GUPI) 2 Months
The Genitourinary Pain Index measures genitourinary symptom severity in both men and women. It is comprised of three subscales: pain, urinary symptoms, and impact on quality of life. The total score ranges from 0-35, with 0 being the lowest severity of symptoms and 35 being the highest.
Measured: baseline to 2 months
Change in the Genitourinary Pain Index (GUPI) 5 Months
The Genitourinary Pain Index measures genitourinary symptom severity in both men and women. It is comprised of three subscales: pain, urinary symptoms, and impact on quality of life. The total score ranges from 0-35, with 0 being the lowest severity of symptoms and 35 being the highest.
Measured: baseline to 5 months

Secondary outcomes (9)

Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-8)
The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies. It consists of 8 questions where participants indicate on a Likert scale the extent to which they have experienced symptoms of depression within the past two weeks, with 0 being "not at all" and 3 being "nearly every day." Cumulative scores range from 0-24, with cutoff points for none, mild, moderate, moderately severe, and severe marked at 5, 10, 15, and 20.
Measured: baseline, 2 months (after treatment is complete), 5 months
The Widespread Pain Index (Derived From CHOIR Bodymap)
The Widespread Pain Index measures the location(s) of chronic pain complaints and widespread body pain. Widespread pain was assessed using the Collaborative Health Outcomes Information Registry (CHOIR) bodymap, condensed into a Widespread Pain Index (WPI) score assessing 19 potential body pain areas. Scores on the WPI range from 0-19, with one point given for each potential body pain area endorsed; higher scores indicate higher widespread pain. The WPI was coupled with the Fibromyalgia Symptom Scale (FSS) below, a 7-item questionnaire, to calculate the American College of Rheumatology classification criteria for fibromyalgia, and assess fibromyalgia symptom severity (higher scores indicate higher symptom severity). The WPI total (0-19) can be combined with the FSS (0-12) in a sum total score (0-31) to assess the degree of a person's widespread pain and fibromyalgia symptom severity, with higher scores indicating a worse outcome.
Measured: baseline, 2 months (after treatment is complete), 5 months
Fibromyalgia Symptom Scale (FSS)
7-item questionnaire assessing modified 2010 American College of Rheumatology diagnostic criteria for fibromyalgia and includes a) an index of widespread pain and b) an index of symptom severity via patient self-report. The FSS is the index of symptom severity and can range from 0-12. Higher scores indicate higher symptom severity, a worse outcome. When combined with the WPI score above, a total score on this scale (WPI + FSS) ranges from 0-31, with scores ≥ 13 indicating a high likelihood of fibromyalgia.
Measured: baseline, 2 months (after treatment is complete), 5 months
Change in Posttraumatic Stress Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) With Criterion A
The PTSD Checklist for the DSM-5 measures post-traumatic stress. It utilizes the symptom checklist for PTSD in the DSM-5 and inquires about trauma-induced thoughts and behaviors in the past month. The total score ranges from 0-80, with 31-33 and above indicating probable diagnosis of PTSD.
Measured: baseline, 2 months (after treatment is complete), 5 months
Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder (GAD-7) Questionnaire
The Generalized Anxiety Disorder (GAD-7) questionnaire is a self-administered 7 item instrument that uses some of the DSM-V criteria for GAD to identify probable cases of GAD along with measuring anxiety symptom severity. Questions are on a 4-point Likert scale, with 0 being "not at all sure" and 3 being "nearly every day." Cumulative scoring is tiered from minimal anxiety (0-4) to mild anxiety (5 to 9) to moderate anxiety (10-14) to severe anxiety (15-21).
Measured: baseline, 2 months (after treatment is complete), 5 months
Difference in Response to Treatment/Perceived Improvement and Quality of Life Between Groups as Measured by the Patient Global Impression of Change Scale (PGIC)
Patient Global Impression of Improvement measures the response of a condition to an intervention. Patients rate their impression of change on a Likert scale ranging from 1-7 with 1 being "No change/condition has gotten worse" to 7 being "a great deal better and a considerable improvement that has made all the difference." This scale was administered at post-treatment and follow-up only.
Measured: 2 months (after treatment is complete), 5 months
Quantitative Sensory Testing (Optional) - Threshold Average
Psychophysical testing methods replicated existing protocols used at VUMC and include the following elements: 1) an evaluation of temporal summation (as a biomarker for central sensitization), 2) thermal pain threshold and tolerance. Thermal measures involved four pain threshold trials, followed by four pain tolerance trials, with the probe applied to slightly different target sites for each trial to avoid local sensitization. Means for the four threshold and tolerance trials are separately derived, and threshold is reported here. Scores range from 0 = "No Pain or Warmth" to 100 = "Worst Possible Pain", with higher scores indicating a higher pain threshold.
Measured: baseline
Quantitative Sensory Testing (Optional) - Tolerance Average
Psychophysical testing methods replicated existing protocols used at VUMC and include the following elements: 1) an evaluation of temporal summation (as a biomarker for central sensitization), 2) thermal pain threshold and tolerance. Thermal measures involved four pain threshold trials, followed by four pain tolerance trials, with the probe applied to slightly different target sites for each trial to avoid local sensitization. Means for the four threshold and tolerance trials are separately derived, and tolerance is reported here. Scores range from 0 = "No Pain or Warmth" to 100 = "Worst Possible Pain", with higher scores indicating a higher pain tolerance.
Measured: baseline
Quantitative Sensory Testing - Temporal Summation (Slope)
Psychophysical testing methods will replicate existing protocols used at VUMC and include the following elements: 1) an evaluation of temporal summation (as a biomarker for central sensitization), 2) thermal pain threshold and tolerance. Regarding temporal summation: in each sequence, immediately after each heat pulse, subjects provide a verbal numeric pain intensity rating on a 0-100 scale (0 = "No Pain or Warmth" and 100 = "Worst Possible Pain"). The standardized slope of the line fitted to the series of 10 pulses at each temperature indexes temporal summation and serves as a quantitative marker of central sensitization. These slopes reflected the relationship between pain and pulse, representing average pain increase for each unit increase in pulse.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 202016 Jun 2023

First posted19 Feb 2020
Study start13 Jul 2020
Primary completion16 Jun 2022
Study completion16 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Chronic Interstitial CystitisStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The study involves a two group parallel design, with one group receiving individual psychosocial intervention online/in person and another individual symptom monitoring and discussion via telephone.
Masking: None (open label)
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04275297
Sponsor's protocol ID: 193461
Other IDs: K23DK118118
Status last verified: Jul 2023
First submitted: 11 Feb 2020
Last updated: 8 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: This study is occurring via a career development award mechanism through the NIDDK. The PI will establish an IPD sharing plan following consultation with study team mentors at a bi-annual mentorship team meeting in April. The information will be updated in the system accordingly.

Publications

Hanno PM, Burks DA, Clemens JQ, Dmochowski RR, Erickson D, Fitzgerald MP, Forrest JB, Gordon B, Gray M, Mayer RD, Newman D, Nyberg L Jr, Payne CK, Wesselmann U, Faraday MM; Interstitial Cystitis Guidelines Panel of the American Urological Association Education and Research, Inc. AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. J Urol. 2011 Jun;185(6):2162-70. doi: 10.1016/j.juro.2011.03.064. Epub 2011 Apr 16.
PubMed 21497847
Berry SH, Bogart LM, Pham C, Liu K, Nyberg L, Stoto M, Suttorp M, Clemens JQ. Development, validation and testing of an epidemiological case definition of interstitial cystitis/painful bladder syndrome. J Urol. 2010 May;183(5):1848-52. doi: 10.1016/j.juro.2009.12.103. Epub 2010 Mar 29.
PubMed 20303099
Brummett CM, Bakshi RR, Goesling J, Leung D, Moser SE, Zollars JW, Williams DA, Clauw DJ, Hassett AL. Preliminary validation of the Michigan Body Map. Pain. 2016 Jun;157(6):1205-1212. doi: 10.1097/j.pain.0000000000000506.
PubMed 26835782
Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB. Fibromyalgia criteria and severity scales for clinical and epidemiological studies: a modification of the ACR Preliminary Diagnostic Criteria for Fibromyalgia. J Rheumatol. 2011 Jun;38(6):1113-22. doi: 10.3899/jrheum.100594. Epub 2011 Feb 1.
PubMed 21285161
Kratz AL, Schilling SG, Goesling J, Williams DA. Development and initial validation of a brief self-report measure of cognitive dysfunction in fibromyalgia. J Pain. 2015 Jun;16(6):527-36. doi: 10.1016/j.jpain.2015.02.008. Epub 2015 Mar 4.
PubMed 25746197
Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
PubMed 10782451
Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0.
PubMed 9187685
Desrochers G, Bergeron S, Khalife S, Dupuis MJ, Jodoin M. Fear avoidance and self-efficacy in relation to pain and sexual impairment in women with provoked vestibulodynia. Clin J Pain. 2009 Jul-Aug;25(6):520-7. doi: 10.1097/AJP.0b013e31819976e3.
PubMed 19542801
Amtmann D, Cook KF, Jensen MP, Chen WH, Choi S, Revicki D, Cella D, Rothrock N, Keefe F, Callahan L, Lai JS. Development of a PROMIS item bank to measure pain interference. Pain. 2010 Jul;150(1):173-182. doi: 10.1016/j.pain.2010.04.025.
PubMed 20554116
Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce B, Rose M; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007 May;45(5 Suppl 1):S3-S11. doi: 10.1097/01.mlr.0000258615.42478.55.
PubMed 17443116
Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
PubMed 18752852
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171
Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
PubMed 26606250
Rampakakis E, Ste-Marie PA, Sampalis JS, Karellis A, Shir Y, Fitzcharles MA. Real-life assessment of the validity of patient global impression of change in fibromyalgia. RMD Open. 2015 Sep 14;1(1):e000146. doi: 10.1136/rmdopen-2015-000146. eCollection 2015.
PubMed 26535150
Sherman AL, Morris MC, Bruehl S, Westbrook TD, Walker LS. Heightened Temporal Summation of Pain in Patients with Functional Gastrointestinal Disorders and History of Trauma. Ann Behav Med. 2015 Dec;49(6):785-92. doi: 10.1007/s12160-015-9712-5.
PubMed 25967582

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
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All Chronic Interstitial Cystitis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome
ClinicalTrials.gov ID: NCT04275297
Acronym / sponsor ID: 193461
Conditions: Chronic Interstitial Cystitis, Bladder Pain Syndrome, Cystitis, Interstitial, Painful Bladder Syndrome, Cystitis, Chronic Interstitial, Interstitial Cystitis
Keywords: interstitial cystitis, bladder pain syndrome, clinical trial, psychosocial intervention, pelvic pain, therapy, urological chronic pelvic pain syndrome, chronic prostatitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 13 Jul 2020 (actual)
Primary completion: 16 Jun 2022 (actual)
Study completion: 16 Jun 2023 (actual)
First posted: 19 Feb 2020 (actual)
Results: Posted 8 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: The study involves a two group parallel design, with one group receiving individual psychosocial intervention online/in person and another individual symptom monitoring and discussion via telephone.

Arm	Type	Receives
Psychosocial Treatment	Experimental	Behavioral: Psychosocial TreatmentThe 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.
Attention Control	Placebo comparator	Behavioral: Attention ControlThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

18 years of age or older
Diagnosis of IC/BPS as given by providers or indicated by assessments

Key exclusion criteria (12 listed)

Comorbid neurological conditions including spinal cord injury or systematic neurologic illnesses, or central nervous system diseases such as brain tumor or stroke
Current or history of diagnosis of primary psychotic or major thought disorder within the past five years
Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, and/or PTSD (within the past 5 years)
Psychiatric or behavioral conditions in which symptoms are unstable or severe (e.g. current delirium, mania, psychosis, suicidal ideation, homicidal ideation, substance abuse dependency) reported within the past six months
Non-English speaking

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Psychosocial TreatmentThe psychosocial intervention will consist of 8 weekly 50-minute individual visits with the assigned therapist.	Behavioural	Psychosocial Treatment
Attention ControlThe Attention Control will reflect a similar visit pattern and duration as intervention sessions.	Behavioural	Attention Control

Primary outcome

Change in the Genitourinary Pain Index (GUPI) 2 Months
Time frame: baseline to 2 months
The Genitourinary Pain Index measures genitourinary symptom severity in both men and women. It is comprised of three subscales: pain, urinary symptoms, and impact on quality of life. The total score ranges from 0-35, with 0 being the lowest severity of symptoms and 35 being the highest.
Change in the Genitourinary Pain Index (GUPI) 5 Months
Time frame: baseline to 5 months
The Genitourinary Pain Index measures genitourinary symptom severity in both men and women. It is comprised of three subscales: pain, urinary symptoms, and impact on quality of life. The total score ranges from 0-35, with 0 being the lowest severity of symptoms and 35 being the highest.

9 secondary outcomes

Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-8)
Time frame: baseline, 2 months (after treatment is complete), 5 months
The Widespread Pain Index (Derived From CHOIR Bodymap)
Time frame: baseline, 2 months (after treatment is complete), 5 months
Fibromyalgia Symptom Scale (FSS)
Time frame: baseline, 2 months (after treatment is complete), 5 months
Change in Posttraumatic Stress Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) With Criterion A
Time frame: baseline, 2 months (after treatment is complete), 5 months
Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder (GAD-7) Questionnaire
Time frame: baseline, 2 months (after treatment is complete), 5 months
Difference in Response to Treatment/Perceived Improvement and Quality of Life Between Groups as Measured by the Patient Global Impression of Change Scale (PGIC)
Time frame: 2 months (after treatment is complete), 5 months
Quantitative Sensory Testing (Optional) - Threshold Average
Time frame: baseline
Quantitative Sensory Testing (Optional) - Tolerance Average
Time frame: baseline
Quantitative Sensory Testing - Temporal Summation (Slope)
Time frame: Baseline

Results and safety

Results posted to the registry on 8 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Psychosocial Treatment	52	51
Attention Control	26	25

Primary outcome: Change in the Genitourinary Pain Index (GUPI) 2 Months

Time frame: baseline to 2 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Psychosocial Treatment n = 52	Attention Control n = 25
Value	6.6 (6.9)	4.8 (9.0)

Population analysed: We analyzed a total of N=77 individuals from baseline to post-treatment. Below is the change in the total genitourinary pain index (GUPI) score between both timepoints.

Primary outcome: Change in the Genitourinary Pain Index (GUPI) 5 Months

Time frame: baseline to 5 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Psychosocial Treatment n = 52	Attention Control n = 25
Value	8.1 (9.9)	6.6 (7.3)

Population analysed: We analyzed a total of N=77 individuals from baseline to follow-up. Below is the change in the total genitourinary pain index (GUPI) score between both timepoints.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From date of randomization up to 97 days post-treatment, an average of 5.5 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Psychosocial Treatment	0 of 52 (0%)	1 of 52 (1.9%)	0 of 52
Attention Control	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Limitations and caveats (from the sponsor): As this trial was conducted at the outset of the COVID-19 pandemic, the psychological intervention that was planned for in-person sessions transitioned entirely to telehealth for the duration of the study. Second, the in-person assessment which included quantitative sensory testing was made optional.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21497847Hanno PM, Burks DA, Clemens JQ, Dmochowski RR, Erickson D, Fitzgerald MP, Forrest JB, Gordon B, Gray M, Mayer RD, Newman D, Nyberg L Jr, Payne CK, Wesselmann U, Faraday MM; Interstitial Cystitis Guidelines Panel of the American Urological Association Education and Research, Inc. AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. J Urol. 2011 Jun;185(6):2162-70. doi: 10.1016/j.juro.2011.03.064. Epub 2011 Apr 16.
Background: PubMed 20303099Berry SH, Bogart LM, Pham C, Liu K, Nyberg L, Stoto M, Suttorp M, Clemens JQ. Development, validation and testing of an epidemiological case definition of interstitial cystitis/painful bladder syndrome. J Urol. 2010 May;183(5):1848-52. doi: 10.1016/j.juro.2009.12.103. Epub 2010 Mar 29.
Background: PubMed 26835782Brummett CM, Bakshi RR, Goesling J, Leung D, Moser SE, Zollars JW, Williams DA, Clauw DJ, Hassett AL. Preliminary validation of the Michigan Body Map. Pain. 2016 Jun;157(6):1205-1212. doi: 10.1097/j.pain.0000000000000506.
Background: PubMed 21285161Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB. Fibromyalgia criteria and severity scales for clinical and epidemiological studies: a modification of the ACR Preliminary Diagnostic Criteria for Fibromyalgia. J Rheumatol. 2011 Jun;38(6):1113-22. doi: 10.3899/jrheum.100594. Epub 2011 Feb 1.
Background: PubMed 25746197Kratz AL, Schilling SG, Goesling J, Williams DA. Development and initial validation of a brief self-report measure of cognitive dysfunction in fibromyalgia. J Pain. 2015 Jun;16(6):527-36. doi: 10.1016/j.jpain.2015.02.008. Epub 2015 Mar 4.
Background: PubMed 10782451Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
Background: PubMed 9187685Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0.
Background: PubMed 19542801Desrochers G, Bergeron S, Khalife S, Dupuis MJ, Jodoin M. Fear avoidance and self-efficacy in relation to pain and sexual impairment in women with provoked vestibulodynia. Clin J Pain. 2009 Jul-Aug;25(6):520-7. doi: 10.1097/AJP.0b013e31819976e3.
Background: PubMed 20554116Amtmann D, Cook KF, Jensen MP, Chen WH, Choi S, Revicki D, Cella D, Rothrock N, Keefe F, Callahan L, Lai JS. Development of a PROMIS item bank to measure pain interference. Pain. 2010 Jul;150(1):173-182. doi: 10.1016/j.pain.2010.04.025.
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Background: PubMed 18752852Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
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Individual participant dataSharing planned: No. This study is occurring via a career development award mechanism through the NIDDK. The PI will establish an IPD sharing plan following consultation with study team mentors at a bi-annual mentorship team meeting in April. The information will be updated in the system accordingly.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lindsey McKernan, PhD MPH principal investigator

Vanderbilt University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Psychosocial Treatment in people with Chronic Interstitial Cystitis and Bladder Pain Syndrome, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Genitourinary Pain Index (GUPI) 2 Months (time frame: baseline to 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04275297, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.