Acupuncture for Painful Bladder Syndrome
Recruiting in Palo Alto (17 mi)
Overseen byDavid Sheyn, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: David Sheyn
Must not be taking: Anticoagulants
Disqualifiers: Recurrent UTIs, Overactive bladder, Bleeding disorder, others
No Placebo Group
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.
12345Is 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.
36789How 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.
3571011Eligibility 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)
+7 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: AcupunctureExperimental Treatment3 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 ManagementActive Control2 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University HospitalsCleveland, OH
Loading ...
Who Is Running the Clinical Trial?
David SheynLead Sponsor
University Hospitals Cleveland Medical CenterLead Sponsor
References
Laser Acupuncture Alleviates Symptoms and Improves Quality of Life in Women with Overactive Bladder: A Double-Blind, Pilot Randomized Controlled Trial. [2022]The aim of this study was to investigate the clinical efficacy of laser acupuncture for the treatment of women with overactive bladder (OAB) in Taiwan.
Complementary therapies for bladder pain syndrome: a systematic review. [2018]Bladder pain syndrome is a difficult condition to treat. The purpose of this systematic review is to assess the effectiveness of various complementary therapies available for treatment.
Complete response to acupuncture therapy in female patients with refractory interstitial cystitis/bladder pain syndrome. [2018]Interstitial Cystitis/Bladder Pain syndrome (IC/BPS) is a considerable issue in urology and gynecology and unfortunately, the treatment options recommended are not fully efficient. Therefore, in this study we aimed to determine the effectiveness of acupuncture treatment in patients with refractory IC/BPS.
Acupuncture for overactive bladder in female adult: a randomized controlled trial. [2022]To assess the effectiveness of acupuncture in treating female adult with overactive bladder.
The effect of prophylactic acupuncture treatment in women with recurrent cystitis: kidney patients fare better. [2006]To evaluate how the effect of acupuncture treatment in recurrent cystitis relates to Traditional Chinese Medicine (TCM) diagnostic categories and physiologic measurements.
Acupuncture for adults with overactive bladder: A systematic review and meta-analysis of randomized controlled trials. [2021]Overactive bladder is stated as the occurrence of urinary urgency which will cause negative impacts and decrease patients' health-related quality of life. The aim of this systematic review is to assess the efficiency and safety of acupuncture for adults with overactive bladder (OAB) comparing with sham-acupuncture, drugs, and acupuncture plus drugs.
Electro-Acupuncture for Bladder Pain Syndrome: A Protocol of a Randomized Controlled Trial and Study for Central Mechanism. [2022]The efficacy of conventional treatments for treating bladder pain syndrome (BPS) remains unsatisfactory. Electro-acupuncture (EA) is one of the complementary treatments with great analgesic effect and minimal side effect, but evidence of the efficacy of EA on BPS is limited. Thus, this study aims to investigate the efficacy and safety of EA for treating BPS and study on central mechanism of patients with BPS.
Acupuncture in the treatment of bladder instability. [2019]Twenty patients with lower urinary tract symptoms attributable to bladder instability or sensory urgency were treated with traditional Chinese acupuncture; 77% of patients with idiopathic detrusor instability were symptomatically cured. Urodynamic assessment after treatment showed no consistent changes and instability was abolished in only 1 patient. Bladder capacity rose in those who responded. Acupuncture is safe and free of complications and side effects. In patients with diurnal symptoms associated with idiopathic bladder instability it offers a therapy as effective as other non-invasive treatments.
Electroacupuncture to treat with Overactive Bladder in Postmenopausal Women: study protocol for a multicenter, randomized, controlled, parallel clinical trial. [2019]Electroacupuncture has been used for treatment in patients with overactive bladder. This study was conducted to evaluate the efficacy and safety of electroacupuncture for treating overactive bladder of postmenopausal women.
Acupuncture for female bladder pain syndrome: a randomized controlled trial. [2022]Growing evidence supports acupuncture for several pain conditions including chronic prostatitis. This study aimed to determine the safety, tolerability, and effectiveness of acupuncture in reducing pain in women with interstitial cystitis/bladder pain syndrome (IC/BPS).
[Effectiveness of acupuncture and moxibustion therapy for the treatment of refractory interstitial cystitis]. [2013]The efficacy of acupuncture and moxibustion treatment was examined on eight female patients with refractory interstitial cystitis (IC) who had been treated conservatively with hydrodistension, intravesical instillation of dimethyl sulfoxide, or oral medication. These patients had received hydrodistension on an average of 2.3±1.8 times. Moxa needles were applied to Ciliao in bladder meridian 32 and Xialiao in bladder meridian 34, and electroacupuncture was performed on Zhongliao in bladder meridian 33 at 3 Hz for 20 min once a week. The bladder condition was assessed by the visual analogue scale (VAS) score, the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI), the Interstitial Cystitis Problem Index (ICPI), and the maximum voided volume (MVV). After 3 months, patients who showed a reduction of >2 in their VAS score, reduction of 100 ml MVV were considered responders. There were three responders, and after repeated therapy to maintain these effects, they no longer required hydrodistension. Two responders had no recurrence for 48 months or more. Acupuncture and moxibustion resulted in improvement in 38% of the patients (3/8) with refractory IC, and repeated therapy maintained the therapeutic effects. This therapy is traditional and relatively noninvasive. Although its precise mechanism of action is unclear, this study suggests that acupuncture and moxibustion treatment may be a complementary and alternative therapeutic option for refractory IC.