Acupuncture for Painful Bladder Syndrome

Overseen By Gabriella Rustia, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: David Sheyn

Must not be taking: Anticoagulants

Disqualifiers: Recurrent UTIs, Overactive bladder, Bleeding disorder, others

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

Compensation: Varies

Number of Visits: 22

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding acupuncture to behavioral changes can better alleviate bladder pain in women with bladder pain syndrome, also known as interstitial cystitis. Researchers aim to determine if acupuncture improves pain symptoms more effectively than behavioral changes alone. Participants will make lifestyle changes, undergo acupuncture, and then have physical therapy sessions. Women who have experienced bladder pain for more than six weeks without a clear cause and have not tried other treatments might be a good fit for this study. As an unphased trial, this study offers participants the opportunity to explore innovative treatment combinations that could enhance their quality of life.

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 might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that acupuncture is safe for treating bladder pain syndrome?

Research shows that acupuncture is generally safe and well-tolerated for treating interstitial cystitis, also known as bladder pain syndrome. Studies have found that acupuncture can help reduce symptoms like pain and discomfort associated with this condition. Importantly, these studies report few negative side effects, indicating that most patients experience minimal problems. This suggests that acupuncture is a safe option for managing bladder pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using acupuncture for Painful Bladder Syndrome because it offers a unique, non-pharmaceutical approach to managing symptoms. Unlike standard treatments like medications or surgery, acupuncture targets the nervous system directly through needle stimulation, potentially reducing bladder pain and inflammation without significant side effects. Additionally, acupuncture is combined with dietary and urinary habit changes, which may enhance its effectiveness and provide a holistic approach to treatment. This method could be particularly appealing to patients looking for alternatives to medication-based therapies.

What evidence suggests that acupuncture is effective for bladder pain syndrome?

Research has shown that acupuncture might help with bladder pain syndrome, also known as interstitial cystitis. Studies have found that both electroacupuncture and manual acupuncture can reduce pain and improve symptoms like frequent and urgent urination. Electroacupuncture, in particular, has proven effective for severe cases. One study found that acupuncture improved the worst pain levels and made the pain less disruptive to daily life. In this trial, participants in the acupuncture arm will receive six weekly one-hour acupuncture sessions, indicating that acupuncture could be a promising treatment option for managing bladder pain syndrome. ^{2 3 4 5 6}

Who Is on the Research Team?

David Sheyn, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

This trial is for women with bladder pain syndrome, also known as interstitial cystitis, who meet the American Urological Association criteria and have not been treated before. They should have had symptoms for over six weeks without any other identified cause and must have completed a cystoscopic evaluation.

Inclusion Criteria

Has completed cystoscopic evaluation for IC/BPS

Negative urine culture

I have bladder pain or discomfort for over 6 weeks with no other known cause.

Exclusion Criteria

I've had multiple urinary tract infections in the past year.

Post-void residual >100mL

Currently pregnant (if applicable, based on self-report)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Behavioral Management

Participants receive instruction on recommended changes to diet and urinary habits to treat bladder pain

6 weeks

6 visits (in-person)

Acupuncture

Participants attend weekly acupuncture sessions to improve bladder pain symptoms

6 weeks

6 visits (in-person)

Physical Therapy

Participants attend weekly physical therapy sessions after finishing acupuncture

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Every 4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acupuncture

Trial Overview The study tests if acupuncture combined with behavioral management can improve bladder pain symptoms better than just behavioral changes alone. Participants will answer surveys, make lifestyle adjustments, undergo six weekly acupuncture sessions followed by physical therapy sessions.

How Is the Trial Designed?

Group I: Acupuncture Experimental Treatment 3 Interventions

Participants will receive instruction (verbal and written) on recommended changes to diet and urinary habits to treat bladder pain. They will complete six (6) weekly one hour acupuncture sessions followed by pelvic floor physical therapy.

Group II: Behavioral Management Active Control 2 Interventions

Participants will receive instruction (verbal and written) on recommended changes to diet and urinary habits to treat bladder pain for six (6) weeks before starting pelvic floor physical therapy.

Who Is Running the Clinical Trial?

David Sheyn

Lead Sponsor

Trials

5

Recruited

390+

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Published Research Related to This Trial

In a study of 98 women with recurrent cystitis, those diagnosed with Kidney yang/qi deficiency showed the most significant improvement from acupuncture treatment, with 78% remaining cystitis-free over 6 months compared to only 17% in the untreated group.

Acupuncture not only reduced the number of cystitis episodes but also significantly decreased residual urine in the Kidney group, indicating a potential physiological benefit linked to this specific Traditional Chinese Medicine diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of prophylactic acupuncture treatment in women with recurrent cystitis: kidney patients fare better. Alraek, T., Baerheim, A.[2006]

A systematic review of 11 studies involving women with bladder pain syndrome found that dietary management, acupuncture, and physical therapy may provide symptom relief, although the studies were small and varied in quality.

The review highlights the need for larger, well-designed multicenter randomized controlled trials to better assess the effectiveness of these complementary therapies for bladder pain syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary therapies for bladder pain syndrome: a systematic review. Verghese, TS., Riordain, RN., Champaneria, R., et al.[2018]

In a study involving 21 women with interstitial cystitis/bladder pain syndrome, both electro-acupuncture (EA) and minimal acupuncture (MA) were found to improve worst pain scores after 6 weeks, with no adverse events reported, indicating safety and tolerability.

Electro-acupuncture demonstrated greater effectiveness in reducing pain interference and pelvic floor muscle tenderness compared to minimal acupuncture, suggesting it may be a more beneficial treatment option for managing pain in this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for female bladder pain syndrome: a randomized controlled trial. Bresler, L., Westbay, LC., Hekman, L., et al.[2022]

In a study of 20 patients with lower urinary tract symptoms, 77% experienced symptomatic relief from bladder instability after receiving traditional Chinese acupuncture, indicating its potential efficacy.

Acupuncture was found to be safe with no complications or side effects, making it a viable non-invasive treatment option for patients with idiopathic bladder instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture in the treatment of bladder instability. Philp, T., Shah, PJ., Worth, PH.[2019]

Acupuncture treatment showed significant short-term effectiveness in reducing symptoms of refractory Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) in a study of 12 female patients, with improvements noted in various symptom scores after the first month.

However, the long-term benefits diminished over time, with only 33.3% of patients responding positively at six months and 16.6% at twelve months, suggesting that while acupuncture is a promising non-invasive option, its effects may not be sustained without ongoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complete response to acupuncture therapy in female patients with refractory interstitial cystitis/bladder pain syndrome. Sönmez, MG., Kozanhan, B.[2018]

Acupuncture, particularly electroacupuncture (EA), may effectively reduce nocturia episodes and improve quality of life in adults with overactive bladder (OAB), based on a systematic review of 10 randomized controlled trials involving 794 patients.

The treatment was found to be safe, with only 15 out of 794 patients reporting mild adverse reactions, but more high-quality studies are needed to confirm its efficacy compared to standard drug treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for adults with overactive bladder: A systematic review and meta-analysis of randomized controlled trials. Zhao, Y., Zhou, J., Mo, Q., et al.[2021]

This study will evaluate the efficacy and safety of electroacupuncture in treating overactive bladder in postmenopausal women, involving 290 participants over a 10-week period.

Participants will be randomly assigned to receive either electroacupuncture or traditional acupuncture, with the primary outcome measured by the average number of urinations per day, providing a clear comparison of treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroacupuncture to treat with Overactive Bladder in Postmenopausal Women: study protocol for a multicenter, randomized, controlled, parallel clinical trial. Nam, EY., Park, JY., Jo, J., et al.[2019]

In a double-blind randomized controlled trial involving 30 female patients with overactive bladder (OAB), laser acupuncture significantly reduced OAB symptoms, as measured by the Overactive Bladder Symptom Score (OABSS), with notable improvements after 3, 6, and 9 treatments.

The study also found that laser acupuncture improved quality of life indicators, with significant decreases in the Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6) scores, suggesting that this noninvasive treatment could be an effective option for women suffering from OAB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser Acupuncture Alleviates Symptoms and Improves Quality of Life in Women with Overactive Bladder: A Double-Blind, Pilot Randomized Controlled Trial. Chang, YW., Lo, TS., Chang, HN., et al.[2022]

In a study involving 240 female patients with overactive bladder, both acupuncture and the medication tolterodine significantly improved symptoms like urinary urgency and incontinence after 4 weeks of treatment.

Acupuncture was found to be a safe treatment option with no serious adverse events reported, suggesting it could be a viable alternative for managing overactive bladder symptoms in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for overactive bladder in female adult: a randomized controlled trial. Yuan, Z., He, C., Yan, S., et al.[2022]

In a study of eight female patients with refractory interstitial cystitis, acupuncture and moxibustion treatment led to a 38% response rate, with three patients showing significant improvement after three months, including one patient remaining symptom-free for over 48 months.

The treatment was well-tolerated and considered relatively noninvasive, suggesting that acupuncture and moxibustion could serve as a complementary therapy for patients who have not responded to conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of acupuncture and moxibustion therapy for the treatment of refractory interstitial cystitis]. Katayama, Y., Nakahara, K., Shitamura, T., et al.[2013]

This study will evaluate the efficacy and safety of electro-acupuncture (EA) for bladder pain syndrome (BPS) in a randomized controlled trial involving 84 participants, comparing EA to medication and sham treatments over a 4-week period.

The primary outcome will be measured using the Visual Analog Scale (VAS), with additional assessments including anxiety and depression scales, aiming to provide insights into the central mechanisms of EA in treating BPS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electro-Acupuncture for Bladder Pain Syndrome: A Protocol of a Randomized Controlled Trial and Study for Central Mechanism. Xu, Y., Chen, Y., Shi, Y., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12164251/

Research Methodology in Acupuncture for Managing ... Acupuncture and moxibustion are being explored as complementary therapies with promising potential in managing interstitial cystitis/bladder pain syndrome ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1550830723002720

Effects of electroacupuncture on refractory interstitial ... Electroacupuncture has proven to be an effective management method for IC/BPS, as evidenced by the patient's alleviated lower urinary system symptoms and ...

3. urotoday.com urotoday.com/index.php?option=com_content&view=article&id=160258:research-methodology-in-acupuncture-for-managing-interstitial-cystitis-bladder-pain-syndrome-a-scoping-review&catid=1149&utm_source=newsletter_14165&utm_medium=email&utm_campaign=uroalerts-voiding-dysfunction-weekly&acm=_14165

Research Methodology in Acupuncture for Managing ... The most frequently reported outcome was pain, followed by quality-of-life impact (symptom burden), urinary frequency and urgency, nocturia, and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02232282

Study Details | NCT02232282 | Acupuncture for Female IC/ ... The investigators central hypothesis is that women with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) will benefit from acupuncture compared with sham ...

5. canjurol.com canjurol.com/html/subscriber/Spdf/V29I03/09_DrBreslerS.pdf

Acupuncture for female bladder pain syndrome Conclusions: Both EA and MA showed improvement in worst pain scores, however EA showed greater improvement in pain interference and pelvic floor muscle.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40313170/

Research Methodology in Acupuncture for Managing ... Acupuncture and moxibustion are being explored as complementary therapies with promising potential in managing interstitial cystitis/bladder pain syndrome (IC/ ...