Chronic Interstitial CystitisNCT06299683
Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment
A study testing Psychosocial Treatment and Pelvic Floor Physical Therapy in people with Chronic Interstitial Cystitis and Bladder Pain Syndrome, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Interstitial Cystitis, Bladder Pain Syndrome, Painful Bladder Syndrome
- What is being tested?
- Psychosocial Treatment and Pelvic Floor Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 4 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 indicated by structured assessments;
- Capable of giving written informed consent;
- Able to enroll for the duration of the study period;
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, active 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 13Show fewer
- Difficulties or limitations communicating over the telephone or via teleconferencing systems;
- 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 pregnant;
- Currently being treated for cancer;
- Cancer-related pain;
- Recently or actively participating in treatment similar to those being investigated (e.g. individual psychotherapy or pelvic floor pt).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt Urology Cool Springs
Franklin, Tennessee, 37067
Lindsey McKernan, PhD, MPH
About this study
Official title: Mechanistic-Based Treatment of Interstitial Cystitis/Bladder Pain Syndrome
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. Individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. Supported by our preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS.
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. Treatment advances in IC/BPS have stalled due to a lack of clear understanding of the condition, as symptoms and presentations vary widely. For these reasons, national organizations have prioritized the need to improve both treatment options and understanding of IC/BPS. Leading multi-institutional research networks have now identified that individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. At the same time, the chronic pain field is adopting a new approach driven by mechanisms of illness and treatment. Growing evidence suggests that different phenotypes of patients with IC/BPS respond differently to medical intervention. The overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS. The investigator is proposing a randomized mechanistic trial to evaluate which participants may benefit from each treatment (Aim 1) and evaluate whether neurobiological mechanisms may moderate outcomes and change with treatment (Aim 2). The investigator hypothesizes that a prediction of which participants will respond preferentially to either form of treatment based on reported bodily pain distribution (pelvic pain primarily, pain outside of the pelvis). This project has great potential to tailor treatment and improve future IC/BPS precision-medicine care efforts.
- Conditions
- Chronic Interstitial Cystitis, Bladder Pain Syndrome, Painful Bladder Syndrome, Cystitis, Interstitial, Cystitis, Chronic Interstitial, Interstitial Cystitis
- Being tested
- Psychosocial Treatment, Pelvic Floor Physical Therapy
- 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, pelvic floor physical 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 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.
Pelvic Floor Physical TherapyOther
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
| 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 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. Receives: Behavioral: Psychosocial Treatment |
| Pelvic Floor Physical Therapy | Active comparator | 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 Receives: Other: Pelvic Floor Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in response to treatment by phenotype measured by the Global Response Assessment (GRA) scale.
GRA provides a global index used to rate the response of a condition to an intervention. The GRA is a 7-point centered scale that assesses patient impression of change in IC/BPS symptoms since entering the study ranging from 7= "very much worse" to 1= "very much improved." This scale will be administered at post-treatment and at follow-up. Global improvement is a core domain recommended for conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain according to Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). We will examine the mean differences in GRA scores by phenotype in each treatment condition, and we will then calculate the percentage of patients classified as treatment responders (GRA<3) within each treatment and phenotype.
Measured: Post-treatment (either Week 8 or 10)
Secondary outcomes (7)
Chronic Overlapping Pain Condition-Screener (COPCS)
The COPCS is designed to identify up to 10 chronic overlapping pain conditions that often occur together in the same individual. The first part of the survey presents a body map, inquiring about pain locations. Based on participant responses to the body map, additional questions about symptoms are asked to determine the type of pain conditions that are experienced. Endorsed pain locations are collapsed into "regions" to reflect the number of zones in the body with pain (1-7 pain regions). Participants will be categorized into "peripheral" or "centralized" pain types based on the number of pain regions endorsed. This information will be used to examine the role of pain type in treatment response, and to assess how treatment outcomes may differ within pain phenotypes.
Measured: Baseline (Week 0)
Quantitative Sensory Testing - Tolerance Average (QST-TOL)
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 10 = "Worst Possible Pain", with higher scores indicating a higher pain tolerance. This information will inform both how pain tolerance may predict treatment response, and change in response to treatment.
Measured: Baseline (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
Quantitative Sensory Testing - Threshold Average (QST-THR)
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 10 = "Worst Possible Pain", with higher scores indicating a higher pain threshold. This information will inform both how pain threshold may predict treatment response, and change in response to treatment.
Measured: Baseline (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
Quantitative Sensory Testing - Temporal Summation (QST-TS)
Psychophysical testing methods will replicate existing protocols used at VUMC and include an evaluation of temporal summation (as a biomarker for central sensitization). Temporal summation includes a series of 10 sequential heat pulses applied to the forearm. In each sequence, after each heat pulse, subjects provide a verbal numeric pain intensity rating on a 0-10 scale (0 = "No Pain or Warmth" and 10 = "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. Two slopes will be calculated from two sequences. These slopes reflect the relationship between pain and pulse, representing average pain increase for each unit increase in pulse. This information will inform both how temporal summation may predict treatment response, and change in response to treatment.
Measured: Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
Urinary Nerve Growth Factor (NGF)
Urinalysis will be used to assess for infection and urinary biomarkers associated with pain phenotype. Urinary Nerve Growth Factor will be collected to assess the potential impact of inflammation detected in the urine on treatment response, and whether any change in this biomarker may occur following treatment.
Measured: Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
Urinary Interleukin-6 (IL6)
Urinalysis will be used to assess for infection and urinary biomarkers associated with pain phenotype. Urinary Interleukin-6 will be collected to examine the potential impact of pro-inflammatory cytokines detected in the urine on treatment response, and whether any change in this biomarker may occur following treatment.
Measured: Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
Interleukin-6, whole blood stimulated (IL6-LPS)
Blood samples will be taken and stimulated with lipopolysaccharide (LPS) to assess for the presence of low-grade inflammation in the blood. Changes in blood samples will be taken to assess for inflammatory biomarkers, including LPS-stimulated cytokines to facilitate patient phenotyping and assess whether IL6-LPS may predict treatment response and change in response to treatment.
Measured: Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 May 2024
- Primary completion5 Apr 2027 (estimated)
- Study completion4 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 and another pelvic floor physical therapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsey Mckernan, Vanderbilt University Medical Center
- Investigators
- Lindsey McKernan, PhD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299683
- Sponsor's protocol ID
- 230487
- Other IDs
- 1R01DK133415-01A1
- Status last verified
- Jan 2026
- First submitted
- 29 Feb 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 21497847Rampakakis 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 26535150Sherman 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 25967582Starkweather AR, Heineman A, Storey S, Rubia G, Lyon DE, Greenspan J, Dorsey SG. Methods to measure peripheral and central sensitization using quantitative sensory testing: A focus on individuals with low back pain. Appl Nurs Res. 2016 Feb;29:237-41. doi: 10.1016/j.apnr.2015.03.013. Epub 2015 Apr 8.
PubMed 26856520Li J, Simone DA, Larson AA. Windup leads to characteristics of central sensitization. Pain. 1999 Jan;79(1):75-82. doi: 10.1016/S0304-3959(98)00154-7.
PubMed 9928779Shy ME, Frohman EM, So YT, Arezzo JC, Cornblath DR, Giuliani MJ, Kincaid JC, Ochoa JL, Parry GJ, Weimer LH; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Quantitative sensory testing: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2003 Mar 25;60(6):898-904. doi: 10.1212/01.wnl.0000058546.16985.11.
PubMed 12654951Ezenwa MO, Molokie RE, Wang ZJ, Yao Y, Suarez ML, Pullum C, Schlaeger JM, Fillingim RB, Wilkie DJ. Safety and Utility of Quantitative Sensory Testing among Adults with Sickle Cell Disease: Indicators of Neuropathic Pain? Pain Pract. 2016 Mar;16(3):282-93. doi: 10.1111/papr.12279. Epub 2015 Jan 12.
PubMed 25581383Schrepf A, Maixner W, Fillingim R, Veasley C, Ohrbach R, Smith S, Williams DA. The Chronic Overlapping Pain Condition Screener. J Pain. 2024 Jan;25(1):265-272. doi: 10.1016/j.jpain.2023.08.009. Epub 2023 Aug 24.
PubMed 37633574
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic-Based Treatment of Interstitial Cystitis/Bladder Pain Syndrome
- ClinicalTrials.gov ID
- NCT06299683
- Acronym / sponsor ID
- 230487
- Conditions
- Chronic Interstitial Cystitis, Bladder Pain Syndrome, Painful Bladder Syndrome, Cystitis, Interstitial, 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
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 5 Apr 2027 (estimated)
- Study completion
- 4 Apr 2028 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. Supported by our preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS.
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. Treatment advances in IC/BPS have stalled due to a lack of clear understanding of the condition, as symptoms and presentations vary widely. For these reasons, national organizations have prioritized the need to improve both treatment options and understanding of IC/BPS. Leading multi-institutional research networks have now identified that individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. At the same time, the chronic pain field is adopting a new approach driven by mechanisms of illness and treatment. Growing evidence suggests that different phenotypes of patients with IC/BPS respond differently to medical intervention. The overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS. The investigator is proposing a randomized mechanistic trial to evaluate which participants may benefit from each treatment (Aim 1) and evaluate whether neurobiological mechanisms may moderate outcomes and change with treatment (Aim 2). The investigator hypothesizes that a prediction of which participants will respond preferentially to either form of treatment based on reported bodily pain distribution (pelvic pain primarily, pain outside of the pelvis). This project has great potential to tailor treatment and improve future IC/BPS precision-medicine care efforts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study involves a two group parallel design, with one group receiving individual psychosocial intervention online and another pelvic floor physical therapy.
| 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 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. |
| Pelvic Floor Physical Therapy | Active comparator | Other: Pelvic Floor Physical TherapyThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older;
- Diagnosis of IC/BPS as indicated by structured assessments;
- Capable of giving written informed consent;
- Able to enroll for the duration of the study period;
Key exclusion criteria (13 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, active 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 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. | Behavioural | Psychosocial Treatment |
| Pelvic Floor Physical TherapyThe 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 | Other | Pelvic Floor Physical Therapy |
Primary outcome
Differences in response to treatment by phenotype measured by the Global Response Assessment (GRA) scale.
Time frame: Post-treatment (either Week 8 or 10)
GRA provides a global index used to rate the response of a condition to an intervention. The GRA is a 7-point centered scale that assesses patient impression of change in IC/BPS symptoms since entering the study ranging from 7= "very much worse" to 1= "very much improved." This scale will be administered at post-treatment and at follow-up. Global improvement is a core domain recommended for conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain according to Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). We will examine the mean differences in GRA scores by phenotype in each treatment condition, and we will then calculate the percentage of patients classified as treatment responders (GRA<3) within each treatment and phenotype.
7 secondary outcomes
Chronic Overlapping Pain Condition-Screener (COPCS)
Time frame: Baseline (Week 0)
Quantitative Sensory Testing - Tolerance Average (QST-TOL)
Time frame: Baseline (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
Quantitative Sensory Testing - Threshold Average (QST-THR)
Time frame: Baseline (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
Quantitative Sensory Testing - Temporal Summation (QST-TS)
Time frame: Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
Urinary Nerve Growth Factor (NGF)
Time frame: Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
Urinary Interleukin-6 (IL6)
Time frame: Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
Interleukin-6, whole blood stimulated (IL6-LPS)
Time frame: Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- 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 26535150Rampakakis 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.
- Background: PubMed 25967582Sherman 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.
- Background: PubMed 26856520Starkweather AR, Heineman A, Storey S, Rubia G, Lyon DE, Greenspan J, Dorsey SG. Methods to measure peripheral and central sensitization using quantitative sensory testing: A focus on individuals with low back pain. Appl Nurs Res. 2016 Feb;29:237-41. doi: 10.1016/j.apnr.2015.03.013. Epub 2015 Apr 8.
- Background: PubMed 9928779Li J, Simone DA, Larson AA. Windup leads to characteristics of central sensitization. Pain. 1999 Jan;79(1):75-82. doi: 10.1016/S0304-3959(98)00154-7.
- Background: PubMed 12654951Shy ME, Frohman EM, So YT, Arezzo JC, Cornblath DR, Giuliani MJ, Kincaid JC, Ochoa JL, Parry GJ, Weimer LH; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Quantitative sensory testing: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2003 Mar 25;60(6):898-904. doi: 10.1212/01.wnl.0000058546.16985.11.
- Background: PubMed 25581383Ezenwa MO, Molokie RE, Wang ZJ, Yao Y, Suarez ML, Pullum C, Schlaeger JM, Fillingim RB, Wilkie DJ. Safety and Utility of Quantitative Sensory Testing among Adults with Sickle Cell Disease: Indicators of Neuropathic Pain? Pain Pract. 2016 Mar;16(3):282-93. doi: 10.1111/papr.12279. Epub 2015 Jan 12.
- Background: PubMed 37633574Schrepf A, Maixner W, Fillingim R, Veasley C, Ohrbach R, Smith S, Williams DA. The Chronic Overlapping Pain Condition Screener. J Pain. 2024 Jan;25(1):265-272. doi: 10.1016/j.jpain.2023.08.009. Epub 2023 Aug 24.
- Individual participant dataSharing planned: No
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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.
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 and Pelvic Floor Physical Therapy 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 4 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsey McKernan, PhD, MPH (615-875-9990, research.ocim@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in response to treatment by phenotype measured by the Global Response Assessment (GRA) scale. (time frame: Post-treatment (either Week 8 or 10)). 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 NCT06299683, which also lists 8 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 21 Jan 2026.