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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how individuals with interstitial cystitis/bladder pain syndrome (IC/BPS) respond to two treatments: pelvic floor physical therapy and cognitive-behavioral therapy. The researchers seek to understand if the type of IC/BPS affects treatment effectiveness. Participants will receive either hands-on physical therapy to relieve muscle tension or therapy sessions to aid in pain management and emotional well-being. Suitable candidates for this trial include those diagnosed with IC/BPS who do not have other major health issues or ongoing similar treatments. As an unphased trial, this study provides a unique opportunity to enhance understanding of treatment options for IC/BPS and potentially improve personal health outcomes.

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 prior data suggests that these treatments are safe for individuals with bladder pain syndrome?

Research has shown that both pelvic floor physical therapy and psychosocial treatments are generally well-tolerated by people with interstitial cystitis/bladder pain syndrome (IC/BPS).

Pelvic floor physical therapy uses hands-on techniques to relieve muscle tension and pain. Studies indicate that this therapy gently and supportively manages IC/BPS symptoms. It involves working on muscles both outside and inside the body to reduce discomfort, with no major side effects reported.

Psychosocial treatment includes therapy sessions that help manage pain and stress. This treatment also teaches relaxation and communication skills. Research suggests that these cognitive therapies are safe and can effectively support those with IC/BPS.

Both treatments aim to provide relief without significant side effects, making them suitable options for many people. However, individual experiences may vary, so discussing options with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for Bladder Pain Syndrome (BPS) because they offer a comprehensive approach that targets both physical and psychological aspects of the condition. Unlike standard treatments like medication or surgery, Pelvic Floor Physical Therapy uses hands-on techniques to directly address muscle tension and trigger points in the pelvic region, potentially reducing pain and urgency symptoms more effectively. Meanwhile, the Psychosocial Treatment provides personalized sessions focusing on pain coping strategies and relaxation training, which are not typically part of conventional treatments. This dual approach could lead to more holistic relief for patients.

What evidence suggests that this trial's treatments could be effective for bladder pain syndrome?

Research has shown that pelvic floor physical therapy, one of the treatments in this trial, can greatly benefit people with interstitial cystitis or bladder pain syndrome (IC/BPS). One study found that women who received deep tissue physical therapy experienced better symptom relief compared to other treatments. This therapy eases muscle tension and trigger points, reducing pain and the urgency to urinate.

Another treatment option in this trial is psychosocial treatment, including cognitive-behavioral therapy (CBT). Studies have shown that CBT can improve anxiety and treatment outcomes when combined with other bladder treatments. This therapy teaches pain management techniques and relaxation exercises to help control symptoms. Both therapies have shown promise in enhancing the quality of life for individuals with IC/BPS. ^{2 5 6 7 8}

Who Is on the Research Team?

Lindsey McKernan, PhD, MPH

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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]

Citations

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Improvement in Quality of Life with Pelvic Floor Muscle ... Improvement in quality of life with pelvic floor muscle training and biofeedback in patients with painful bladder syndrome/interstitial cystitis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3351550/

Randomized Multicenter Clinical Trial of Myofascial Physical ... Randomized multicenter clinical trial of myofascial physical therapy in women with interstitial cystitis/painful bladder syndrome (IC/PBS) and pelvic floor ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02870738

Bladder Directed vs. Pelvic Floor Therapy in IC/BPS This clinical trial will test a bladder directed therapy (bladder instillations) compared to a course of pelvic floor physical therapy (PFPT) to assess the role ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022534712002595

Randomized Multicenter Clinical Trial of Myofascial ... A significantly higher proportion of women with interstitial cystitis/painful bladder syndrome responded to treatment with myofascial physical therapy than to ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/nau.70106

Global Consensus on Interstitial Cystitis/Bladder Pain ... 3.1 Pelvic Floor Physical Therapy. Hypertonic pelvic floor muscles can exacerbate pain and urinary urgency through peripheral and central ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK570588/

Interstitial Cystitis/Bladder Pain Syndrome - NCBI - NIH Avoidance of behaviors and activities that are known to exacerbate bladder irritability, such as: Pelvic floor muscle strengthening exercises (Kegels).

7. auanet.org auanet.org/guidelines-and-quality/guidelines/diagnosis-and-treatment-interstitial-of-cystitis/bladder-pain-syndrome-(2022)

Diagnosis and Treatment of Interstitial Cystitis/Bladder Pain ... The purpose of this clinical guideline is to provide a clinical framework for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome (IC/ ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429507002993

Prevalence of Pelvic Floor Dysfunction in Patients with ... Our data demonstrate an association between IC and pelvic floor dysfunction in the majority of our IC patients, with 87% experiencing levator pain during ...