Acupuncture for Painful Bladder Syndrome

Overseen By Gabriella M 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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if acupuncture in addition to behavioral changes can better treat in women with bladder pain syndrome (also known as interstitial cystitis) that have not received other treatments. The main question it aims to answer is: Does acupuncture improve pain symptoms on the Interstitial Cystitis Index? Researchers will compare six (6) weeks behavioral management alone to behavioral management and acupuncture. Participants will * complete surveys about their bladder pain symptoms * make behavioral changes that have been shown to improve bladder pain symptoms * attend six (6) weekly acupuncture sessions * attend six (6) weekly physical therapy sessions after finishing acupuncture

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 data supports the effectiveness of the treatment Acupuncture for Painful Bladder Syndrome?

Research shows that acupuncture can be effective for conditions similar to painful bladder syndrome, such as interstitial cystitis and overactive bladder, by reducing symptoms and improving quality of life. ^{1 2 3 4 5}

Is acupuncture safe for treating bladder-related conditions?

Research indicates that acupuncture, including electro-acupuncture, is generally safe for treating bladder-related conditions, with minimal side effects reported. ^{3 6 7 8 9}

How does acupuncture treatment differ from other treatments for painful bladder syndrome?

Acupuncture is unique for painful bladder syndrome as it is a non-invasive treatment that may help reduce pain by stimulating specific points on the body, unlike conventional treatments that often involve medications or invasive procedures. It is considered a complementary therapy with minimal side effects and has shown promise in patients who do not respond to standard treatments. ^{3 5 7 10 11}

Research Team

David Sheyn, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

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]

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 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 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]

References

1. United States 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Complementary therapies for bladder pain syndrome: a systematic review. [2018]

3. Poland pubmed.ncbi.nlm.nih.gov

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

4. Germany pubmed.ncbi.nlm.nih.gov

Acupuncture for overactive bladder in female adult: a randomized controlled trial. [2022]

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

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

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

Acupuncture for adults with overactive bladder: A systematic review and meta-analysis of randomized controlled trials. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Electro-Acupuncture for Bladder Pain Syndrome: A Protocol of a Randomized Controlled Trial and Study for Central Mechanism. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Acupuncture in the treatment of bladder instability. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Electroacupuncture to treat with Overactive Bladder in Postmenopausal Women: study protocol for a multicenter, randomized, controlled, parallel clinical trial. [2019]

10. Canada pubmed.ncbi.nlm.nih.gov

Acupuncture for female bladder pain syndrome: a randomized controlled trial. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

[Effectiveness of acupuncture and moxibustion therapy for the treatment of refractory interstitial cystitis]. [2013]