Acupuncture for Female IC/PBSyndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial

NCT02232282 | Completed Results

• 1 other identifier: 206129
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Painful Bladder Syndrome; Interstitial Cystitis

Keywords

Painful Bladder Syndrome; Interstitial Cystitis; Suprapubic Pain; Urinary Urgency

Outcome Measures

Primary Outcomes (1)

• 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.

  0 weeks, 6 weeks

Secondary Outcomes (2)

• Tolerability of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrom

  0 weeks, 6 weeks

• Safety of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrome

  0 weeks, 12 weeks

Other Outcomes (1)

• Change in Urinary Microbiome

  0 weeks, 6 weeks

Study Arms (2)

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.

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.

Device: standard acupuncture treatment

Interventions

standard acupuncture treatment DEVICE

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.

Standard acupuncture treatment

Control Sham/Minimal Acupuncture DEVICE

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.

Minimal Acupuncture

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Loyola University: lead
• Interstitial Cystitis Association (ICA): collaborator

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (38)

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MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Larissa Bresler, MD
• Organization: Loyola University Chicago

lbresler@lumc.edu

7086433827

Study Officials

• Larissa Bresler, MD

  Loyola University Medical Center Dept of Urology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 5, 2014
• Study Start: October 1, 2014
• Primary Completion: August 16, 2017
• Study Completion: August 16, 2017
• Last Updated: April 14, 2022
• Results First Posted: March 25, 2021

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)