Pelvic Floor Physical Therapy + Psychosocial Treatment for Bladder Pain Syndrome

Overseen By Lindsey McKernan, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Neurological conditions, Psychotic disorders, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 8-10 weeks

220 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators to get a clear answer.

What data supports the effectiveness of the treatment Pelvic Floor Physical Therapy + Psychosocial Treatment for Bladder Pain Syndrome?

Research shows that pelvic floor physical therapy (PFPT) is effective for treating various pelvic floor disorders, improving symptoms and quality of life in women with pelvic pain and other symptoms. It is also a key part of managing urogenital dysfunction, which often includes bothersome bladder symptoms. ^{1 2 3 4 5}

Is pelvic floor physical therapy safe for humans?

Pelvic floor physical therapy (PFPT) is generally considered safe for humans and is commonly used to treat various pelvic floor disorders, including urinary incontinence and pelvic organ prolapse. It involves methods like exercise, manual therapy, and biofeedback, which are non-invasive and have a low risk of adverse effects. ^{1 3 4 5 6}

How is the treatment of Pelvic Floor Physical Therapy and Psychosocial Treatment for Bladder Pain Syndrome different from other treatments?

This treatment is unique because it combines physical exercises to strengthen the pelvic floor muscles with psychological support to address emotional and behavioral aspects, which may help manage bladder pain more holistically compared to treatments focusing solely on physical or psychological aspects. ^{1 3 4 5 6}

Research Team

Lindsey McKernan, PhD, MPH

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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.

Inclusion Criteria

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

Capable of giving written informed consent

Able to enroll for the duration of the study period

Exclusion Criteria

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

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

Any major active medical issues that could preclude participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either pelvic floor physical therapy or cognitive-behavioral therapy based on their IC/BPS phenotype

8-10 weeks

8-10 weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

14-16 weeks

1 visit (in-person) at Week 24

Treatment Details

Interventions

• Pelvic Floor Physical Therapy
• Psychosocial Treatment

Trial Overview 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.

Participant Groups

Group I: Psychosocial Treatment Experimental Treatment 1 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 Therapy Active Control 1 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

Pelvic Floor Physical Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Pelvic Floor Physical Therapy for:

• Urinary incontinence
• Fecal incontinence
• Pelvic organ prolapse
• Chronic pelvic pain

Approved in European Union as Pelvic Floor Physical Therapy for:

• Urinary incontinence
• Fecal incontinence
• Pelvic organ prolapse
• Sexual dysfunction

Approved in Canada as Pelvic Floor Physical Therapy for:

• Urinary incontinence
• Fecal incontinence
• Pelvic organ prolapse

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

Pelvic floor physiotherapy (PFPT) is an essential part of conservative treatment for women experiencing urogenital issues like urinary incontinence and pelvic organ prolapse, helping to improve their quality of life.

PFPT employs various techniques such as behavioral therapy, exercise, manual therapy, biofeedback, and electrical stimulation, making it a versatile approach to managing pelvic and sexual pain disorders linked to bladder symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor physiotherapy for women with urogenital dysfunction: indications and methods. Rosenbaum, TY.[2017]

In a study of 474 women undergoing pelvic floor physical therapy (PFPT), significant improvements were observed in validated symptom scores, particularly for pelvic pain, with median scores on the Pelvic Floor Distress Inventory (PFDI) dropping from 77.3 to 41.8 after treatment (P < 0.0001).

Women with pelvic pain showed notable enhancements in their quality of life and pain levels, meeting the minimal clinically important difference for multiple measures, indicating that PFPT is an effective intervention for alleviating pelvic floor symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom and Quality of Life Improvements After Pelvic Floor Physical Therapy in a Clinical Population of Women With Pelvic Pain and Other Symptoms. Killinger, KA., Henrichsen, JL., Han, E., et al.[2021]

Approximately 66% of women prescribed pelvic floor physical therapy (PFPT) initiated treatment, but only 29% completed the full course, indicating a significant drop-off in adherence.

The study suggests potential racial disparities in PFPT attendance, as Hispanic patients were less likely to initiate therapy compared to non-Hispanic patients, highlighting a need for targeted interventions to improve access and adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attendance at Prescribed Pelvic Floor Physical Therapy in a Diverse, Urban Urogynecology Population. Shannon, MB., Genereux, M., Brincat, C., et al.[2019]

In a study of 49 women undergoing vaginal reconstruction, pelvic floor physical therapy (PFPT) showed initial improvements in muscle function at 12 weeks, but these benefits did not persist by the 24-week follow-up.

Overall quality of life and bladder symptoms improved for all participants by 24 weeks post-surgery, indicating that while PFPT did not provide additional long-term benefits, patients experienced ongoing improvements in their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor physical therapy: impact on quality of life 6 months after vaginal reconstructive surgery. Pauls, RN., Crisp, CC., Novicki, K., et al.[2022]

In a study of 26 women with high-tone pelvic floor dysfunction, 22 completed 6 sessions of pelvic floor physical therapy (PFPT), which led to significant improvements in genitourinary symptoms, pain, and quality of life, despite no significant change in vaginal closure force.

After 6 weeks of PFPT, the levator hiatal area increased, indicating muscle lengthening, but this did not translate into a measurable increase in pelvic floor muscle strength as assessed by intravaginal closure force.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objective Changes in Pelvic Floor Muscle Strength and Length in Women With High-Tone Pelvic Floor Dysfunction After Pelvic Floor Physical Therapy (RELAX Trial). Volpe, LJ., Zugelder, M., Kotarinos, R., et al.[2023]

In a study of 64 females aged 6 and older undergoing Pelvic Floor Biofeedback Therapy (PFBT), there was a significant reduction in bladder symptom scores, indicating that PFBT can effectively improve lower urinary tract symptoms (LUTS).

However, only 31% of patients showed a silencing of EMG activity during voiding after treatment, suggesting that while PFBT is beneficial for symptom relief, not all patients achieve the expected physiological response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor biofeedback therapy in children: Assessment of symptom scores in responders and non-responders. Taylor, AS., Cabo, JJ., Lauderdale, C., et al.[2020]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Pelvic floor physiotherapy for women with urogenital dysfunction: indications and methods. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Symptom and Quality of Life Improvements After Pelvic Floor Physical Therapy in a Clinical Population of Women With Pelvic Pain and Other Symptoms. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Attendance at Prescribed Pelvic Floor Physical Therapy in a Diverse, Urban Urogynecology Population. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Pelvic floor physical therapy: impact on quality of life 6 months after vaginal reconstructive surgery. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Objective Changes in Pelvic Floor Muscle Strength and Length in Women With High-Tone Pelvic Floor Dysfunction After Pelvic Floor Physical Therapy (RELAX Trial). [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Pelvic floor biofeedback therapy in children: Assessment of symptom scores in responders and non-responders. [2020]