Painful Bladder SyndromeNCT02232282
Acupuncture for Female IC/PBSyndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial
A study testing standard acupuncture treatment in people with Painful Bladder Syndrome and Interstitial Cystitis, run by Loyola University at 1 site in United States.
Trial summary
The investigators central hypothesis is that women with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) will benefit from acupuncture compared with sham treatment and acupuncture responders will have a differential urinary microbiome. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Painful Bladder Syndrome, Interstitial Cystitis
- What is being tested?
- standard acupuncture treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 16 Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females, age 21 to 65 years
- Symptoms of urinary frequency, urgency and suprapubic/bladder pain for > 6 months
- Generally stable health
- An average bladder pain score of at least >3/10
Who cannot join
- Patients with pacemaker or other neurostimulator (gastric/spinal)
- History or current symptomatic urethral stricture, cystitis caused by tuberculosis, radiation therapy or Cytoxan/cyclophosphamide therapy
- Prior augmentation cystoplasty or cystectomy
- Systemic autoimmune disorder (such as Crohn's Disease, Ulcerative Colitis, Lupus, Rheumatoid Arthritis, or Multiple Sclerosis)
- Systemic neuromuscular disease known to affect the lower urinary tract
- History of urogenital cancer (with the exception of minor skin cancer)
Show all 10Show fewer
- Current or imminent planned pregnancy/recent delivery <6 months
- Current pelvic floor physical therapy
- Current use of opioid medications (short or long acting) for pain
- Abdominal or pelvic surgery within the last 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: Acupuncture for Female Interstitial Cystitis/Painful Bladder Syndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial
The investigators central hypothesis is that women with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) will benefit from acupuncture compared with sham treatment and acupuncture responders will have a differential urinary microbiome.
Read the detailed description
The Urinary Microbiota. Within internal surfaces, which are defined as existing outside the body (e.g. the intestinal epithelium or the vaginal epithelium), there exist commensal microbial communities. These microbiota are believed to be beneficial to human health, facilitating efficient removal of improperly functioning immune cells and protecting the host from pathogen infection13-15. The human bladder is a core component of the human urinary tract. It is a hollow muscular organ lined with transitional epithelium, which functions as the storage site for metabolic wastes in the form of urine. Given that the bladder's luminal space is also considered outside the body, it would seem reasonable that a urinary microbiota would be present. Yet, the historic dogma has maintained that urine is "sterile," based on culture-dependent methods of bacterial detection. This paradigm is shifting, however, based on our newly published data noting the presence of a urinary microbiota in adult women without clinical urinary tract infections16,17. Furthermore, we have recently discovered that the microbiota of women with overactive bladder (specifically with associated urgency incontinence) is distinguishable from the microbiota of women with stress urinary incontinence. These findings suggest that IC/PBS may be influenced by an alteration to the urinary microbiota. Indeed, recent evidence reports a difference in the urinary microbiome dominated by Lactobacillus in subjects with IC/PBS compared with healthy controls18. This work is limited by lack of correlative clinical symptomatology, small sample size and urinary samples that may have been contaminated.
The investigators long term goal is to determine pelvic pain mechanisms that will inform clinically-relevant classification and evidence-based treatment of women with IC/PBS and CPP. The short term goal of this application is to determine the safety, tolerability and efficacy of acupuncture in women with IC/PBS as a neuromodulative treatment and to correlate the urinary microbiome with acupuncture responders. Our approach will advance the understanding of the contribution and consequences of peripheral pelvic nociception in IC/PBS.
- Conditions
- Painful Bladder Syndrome, Interstitial Cystitis
- Being tested
- standard acupuncture treatment, Control Sham/Minimal Acupuncture
- Keywords
- Painful Bladder Syndrome, Interstitial Cystitis, Suprapubic Pain, Urinary Urgency
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard acupuncture treatmentDevice
A standardized acupuncture treatment will be assigned, and both groups will receive 7 acupuncture treatments that follow a standardized protocol on classical acupuncture points, with or without mild electrical stimulation versus sham/minimal acupuncture. Acupuncture needles are single use, sterile and disposable. Standard acupuncture treatment protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied.
Control Sham/Minimal AcupunctureDevice
Control group will receive sham/minimal acupuncture with low level electrical stimulation. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including "minimal acupuncture", therefore, the control group will not be aware of receiving sham acupuncture. These described acupuncture treatments are well accepted treatment protocols for women with pelvic pain and bladder complaints.
| Study group | Role | What they receive |
|---|---|---|
| Minimal Acupuncture | Sham comparator | Fifteen (15) will be allocated in the control sham/minimal acupuncture + standard medical treatments of IC. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including "minimal acupuncture", therefore, the control group will not be aware of receiving sham acupuncture. Receives: Device: Control Sham/Minimal Acupuncture |
| Standard acupuncture treatment | Active comparator | Fifteen (15) will be allocated in the standard acupuncture treatment + medical management of IC. Standard acupuncture treatment protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied. Receives: Device: standard acupuncture treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Acupuncture to Reduce Pain in Women With Interstitial Cystitis/Painful Bladder Syndrome
Change in worst pain as measured by the Brief Pain Inventory-Short Form. Scores range from 0 to 10 and higher scores indicate more pain. Change is calculated as the 6 weeks score minus the baseline score.
Measured: 0 weeks, 6 weeks
Secondary outcomes (2)
Tolerability of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrom
The total number of acupuncture sessions stopped due to poor tolerability of acupuncture
Measured: 0 weeks, 6 weeks
Safety of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrome
The total number of adverse events experienced by women receiving acupuncture
Measured: 0 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startOct 2014
- Primary completion16 Aug 2017
- Study completion16 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Painful Bladder SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Collaborators
- Interstitial Cystitis Association (ICA)
- Responsible party
- Principal investigator, Larissa Bresler, Loyola University
- Investigators
- Larissa Bresler, MD, Principal investigator, Loyola University Medical Center Dept of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232282
- Sponsor's protocol ID
- 206129
- Status last verified
- Mar 2022
- First submitted
- 29 Aug 2014
- Last updated
- 14 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bogart LM, Berry SH, Clemens JQ. Symptoms of interstitial cystitis, painful bladder syndrome and similar diseases in women: a systematic review. J Urol. 2007 Feb;177(2):450-6. doi: 10.1016/j.juro.2006.09.032.
PubMed 17222607Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
PubMed 11857671Suskind AM, Berry SH, Suttorp MJ, Elliott MN, Hays RD, Ewing BA, Clemens JQ. Health-related quality of life in patients with interstitial cystitis/bladder pain syndrome and frequently associated comorbidities. Qual Life Res. 2013 Sep;22(7):1537-41. doi: 10.1007/s11136-012-0285-5. Epub 2012 Oct 7.
PubMed 23054497Adams K, Denman MA. Bladder pain syndrome: a review. Female Pelvic Med Reconstr Surg. 2011 Nov;17(6):279-89. doi: 10.1097/SPV.0b013e31823a8174.
PubMed 22453222Lai HH, North CS, Andriole GL, Sayuk GS, Hong BA. Polysymptomatic, polysyndromic presentation of patients with urological chronic pelvic pain syndrome. J Urol. 2012 Jun;187(6):2106-12. doi: 10.1016/j.juro.2012.01.081. Epub 2012 Apr 12.
PubMed 22503014Hoffman D. Understanding multisymptom presentations in chronic pelvic pain: the inter-relationships between the viscera and myofascial pelvic floor dysfunction. Curr Pain Headache Rep. 2011 Oct;15(5):343-6. doi: 10.1007/s11916-011-0215-1.
PubMed 21739128Warren JW, van de Merwe JP, Nickel JC. Interstitial cystitis/bladder pain syndrome and nonbladder syndromes: facts and hypotheses. Urology. 2011 Oct;78(4):727-32. doi: 10.1016/j.urology.2011.06.014. No abstract available.
PubMed 21855966Birder L, de Groat W, Mills I, Morrison J, Thor K, Drake M. Neural control of the lower urinary tract: peripheral and spinal mechanisms. Neurourol Urodyn. 2010;29(1):128-39. doi: 10.1002/nau.20837.
PubMed 20025024Hanno PM, Burks DA, Clemens JQ, Dmochowski RR, Erickson D, Fitzgerald MP, Forrest JB, Gordon B, Gray M, Mayer RD, Newman D, Nyberg L Jr, Payne CK, Wesselmann U, Faraday MM; Interstitial Cystitis Guidelines Panel of the American Urological Association Education and Research, Inc. AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. J Urol. 2011 Jun;185(6):2162-70. doi: 10.1016/j.juro.2011.03.064. Epub 2011 Apr 16.
PubMed 21497847O'Hare PG 3rd, Hoffmann AR, Allen P, Gordon B, Salin L, Whitmore K. Interstitial cystitis patients' use and rating of complementary and alternative medicine therapies. Int Urogynecol J. 2013 Jun;24(6):977-82. doi: 10.1007/s00192-012-1966-x. Epub 2012 Nov 14.
PubMed 23149598Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654.
PubMed 22965186Capodice JL, Jin Z, Bemis DL, Samadi D, Stone BA, Kapan S, Katz AE. A pilot study on acupuncture for lower urinary tract symptoms related to chronic prostatitis/chronic pelvic pain. Chin Med. 2007 Feb 6;2:1. doi: 10.1186/1749-8546-2-1.
PubMed 17284322Flint HJ, Scott KP, Louis P, Duncan SH. The role of the gut microbiota in nutrition and health. Nat Rev Gastroenterol Hepatol. 2012 Sep 4;9(10):577-89. doi: 10.1038/nrgastro.2012.156. eCollection 2012 Oct.
PubMed 22945443Frank DN, Zhu W, Sartor RB, Li E. Investigating the biological and clinical significance of human dysbioses. Trends Microbiol. 2011 Sep;19(9):427-34. doi: 10.1016/j.tim.2011.06.005. Epub 2011 Jul 19.
PubMed 21775143Gajer P, Brotman RM, Bai G, Sakamoto J, Schutte UM, Zhong X, Koenig SS, Fu L, Ma ZS, Zhou X, Abdo Z, Forney LJ, Ravel J. Temporal dynamics of the human vaginal microbiota. Sci Transl Med. 2012 May 2;4(132):132ra52. doi: 10.1126/scitranslmed.3003605.
PubMed 22553250
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Female Interstitial Cystitis/Painful Bladder Syndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02232282
- Acronym / sponsor ID
- 206129
- Conditions
- Painful Bladder Syndrome, Interstitial Cystitis
- Keywords
- Painful Bladder Syndrome, Interstitial Cystitis, Suprapubic Pain, Urinary Urgency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Collaborators
- Interstitial Cystitis Association (ICA)
- Study start
- Oct 2014 (actual)
- Primary completion
- 16 Aug 2017 (actual)
- Study completion
- 16 Aug 2017 (actual)
- First posted
- 5 Sep 2014 (estimated)
- Results
- Posted 25 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators central hypothesis is that women with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) will benefit from acupuncture compared with sham treatment and acupuncture responders will have a differential urinary microbiome.
Detailed description
The Urinary Microbiota. Within internal surfaces, which are defined as existing outside the body (e.g. the intestinal epithelium or the vaginal epithelium), there exist commensal microbial communities. These microbiota are believed to be beneficial to human health, facilitating efficient removal of improperly functioning immune cells and protecting the host from pathogen infection13-15. The human bladder is a core component of the human urinary tract. It is a hollow muscular organ lined with transitional epithelium, which functions as the storage site for metabolic wastes in the form of urine. Given that the bladder's luminal space is also considered outside the body, it would seem reasonable that a urinary microbiota would be present. Yet, the historic dogma has maintained that urine is "sterile," based on culture-dependent methods of bacterial detection. This paradigm is shifting, however, based on our newly published data noting the presence of a urinary microbiota in adult women without clinical urinary tract infections16,17. Furthermore, we have recently discovered that the microbiota of women with overactive bladder (specifically with associated urgency incontinence) is distinguishable from the microbiota of women with stress urinary incontinence. These findings suggest that IC/PBS may be influenced by an alteration to the urinary microbiota. Indeed, recent evidence reports a difference in the urinary microbiome dominated by Lactobacillus in subjects with IC/PBS compared with healthy controls18. This work is limited by lack of correlative clinical symptomatology, small sample size and urinary samples that may have been contaminated.
The investigators long term goal is to determine pelvic pain mechanisms that will inform clinically-relevant classification and evidence-based treatment of women with IC/PBS and CPP. The short term goal of this application is to determine the safety, tolerability and efficacy of acupuncture in women with IC/PBS as a neuromodulative treatment and to correlate the urinary microbiome with acupuncture responders. Our approach will advance the understanding of the contribution and consequences of peripheral pelvic nociception in IC/PBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal Acupuncture | Sham comparator | Device: Control Sham/Minimal AcupunctureFifteen (15) will be allocated in the control sham/minimal acupuncture + standard medical treatments of IC. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including "minimal acupuncture", therefore, the control group will not be aware of receiving sham acupuncture. |
| Standard acupuncture treatment | Active comparator | Device: standard acupuncture treatmentFifteen (15) will be allocated in the standard acupuncture treatment + medical management of IC. Standard acupuncture treatment protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Females, age 21 to 65 years
- Symptoms of urinary frequency, urgency and suprapubic/bladder pain for > 6 months
- Generally stable health
- An average bladder pain score of at least >3/10
Key exclusion criteria (10 listed)
- Patients with pacemaker or other neurostimulator (gastric/spinal)
- History or current symptomatic urethral stricture, cystitis caused by tuberculosis, radiation therapy or Cytoxan/cyclophosphamide therapy
- Prior augmentation cystoplasty or cystectomy
- Systemic autoimmune disorder (such as Crohn's Disease, Ulcerative Colitis, Lupus, Rheumatoid Arthritis, or Multiple Sclerosis)
- Systemic neuromuscular disease known to affect the lower urinary tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard acupuncture treatmentA standardized acupuncture treatment will be assigned, and both groups will receive 7 acupuncture treatments that follow a standardized protocol on classical acupuncture points, with or without mild electrical stimulation versus sham/minimal acupuncture. Acupuncture needles are single use, sterile and disposable. Standard acupuncture treatment protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied. | Device | Standard acupuncture treatment |
| Control Sham/Minimal AcupunctureControl group will receive sham/minimal acupuncture with low level electrical stimulation. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including "minimal acupuncture", therefore, the control group will not be aware of receiving sham acupuncture. These described acupuncture treatments are well accepted treatment protocols for women with pelvic pain and bladder complaints. | Device | Minimal Acupuncture |
Primary outcome
Efficacy of Acupuncture to Reduce Pain in Women With Interstitial Cystitis/Painful Bladder Syndrome
Time frame: 0 weeks, 6 weeks
Change in worst pain as measured by the Brief Pain Inventory-Short Form. Scores range from 0 to 10 and higher scores indicate more pain. Change is calculated as the 6 weeks score minus the baseline score.
2 secondary outcomes
Tolerability of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrom
Time frame: 0 weeks, 6 weeks
Safety of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrome
Time frame: 0 weeks, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17222607Bogart LM, Berry SH, Clemens JQ. Symptoms of interstitial cystitis, painful bladder syndrome and similar diseases in women: a systematic review. J Urol. 2007 Feb;177(2):450-6. doi: 10.1016/j.juro.2006.09.032.
- Background: PubMed 11857671Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
- Background: PubMed 23054497Suskind AM, Berry SH, Suttorp MJ, Elliott MN, Hays RD, Ewing BA, Clemens JQ. Health-related quality of life in patients with interstitial cystitis/bladder pain syndrome and frequently associated comorbidities. Qual Life Res. 2013 Sep;22(7):1537-41. doi: 10.1007/s11136-012-0285-5. Epub 2012 Oct 7.
- Background: PubMed 22453222Adams K, Denman MA. Bladder pain syndrome: a review. Female Pelvic Med Reconstr Surg. 2011 Nov;17(6):279-89. doi: 10.1097/SPV.0b013e31823a8174.
- Background: PubMed 22503014Lai HH, North CS, Andriole GL, Sayuk GS, Hong BA. Polysymptomatic, polysyndromic presentation of patients with urological chronic pelvic pain syndrome. J Urol. 2012 Jun;187(6):2106-12. doi: 10.1016/j.juro.2012.01.081. Epub 2012 Apr 12.
- Background: PubMed 21739128Hoffman D. Understanding multisymptom presentations in chronic pelvic pain: the inter-relationships between the viscera and myofascial pelvic floor dysfunction. Curr Pain Headache Rep. 2011 Oct;15(5):343-6. doi: 10.1007/s11916-011-0215-1.
- Background: PubMed 21855966Warren JW, van de Merwe JP, Nickel JC. Interstitial cystitis/bladder pain syndrome and nonbladder syndromes: facts and hypotheses. Urology. 2011 Oct;78(4):727-32. doi: 10.1016/j.urology.2011.06.014. No abstract available.
- Background: PubMed 20025024Birder L, de Groat W, Mills I, Morrison J, Thor K, Drake M. Neural control of the lower urinary tract: peripheral and spinal mechanisms. Neurourol Urodyn. 2010;29(1):128-39. doi: 10.1002/nau.20837.
- Background: PubMed 21497847Hanno PM, Burks DA, Clemens JQ, Dmochowski RR, Erickson D, Fitzgerald MP, Forrest JB, Gordon B, Gray M, Mayer RD, Newman D, Nyberg L Jr, Payne CK, Wesselmann U, Faraday MM; Interstitial Cystitis Guidelines Panel of the American Urological Association Education and Research, Inc. AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. J Urol. 2011 Jun;185(6):2162-70. doi: 10.1016/j.juro.2011.03.064. Epub 2011 Apr 16.
- Background: PubMed 23149598O'Hare PG 3rd, Hoffmann AR, Allen P, Gordon B, Salin L, Whitmore K. Interstitial cystitis patients' use and rating of complementary and alternative medicine therapies. Int Urogynecol J. 2013 Jun;24(6):977-82. doi: 10.1007/s00192-012-1966-x. Epub 2012 Nov 14.
- Background: PubMed 22965186Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654.
- Background: PubMed 17284322Capodice JL, Jin Z, Bemis DL, Samadi D, Stone BA, Kapan S, Katz AE. A pilot study on acupuncture for lower urinary tract symptoms related to chronic prostatitis/chronic pelvic pain. Chin Med. 2007 Feb 6;2:1. doi: 10.1186/1749-8546-2-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larissa Bresler, MD principal investigator
Loyola University Medical Center Dept of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard acupuncture treatment in people with Painful Bladder Syndrome and Interstitial Cystitis, run by Loyola University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Acupuncture to Reduce Pain in Women With Interstitial Cystitis/Painful Bladder Syndrome (time frame: 0 weeks, 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02232282, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.