Acupuncture for Prevention of Recurrent Urinary Tract Infections.
Condition: Recurrent Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Recurrence
Study type: Interventional

Summary: 
      In this multi-centre prospective randomized controlled trial the efficacy of segmental
      acupuncture in the prevention of recurrent urinary tract infections will be assessed. The
      study (acupuncture) group will receive 12 acupuncture treatments according to a standardized
      protocol, plus recommendation for use of cranberry products. The control group will receive
      recommendation for use of cranberry products only.
    

Detailed description: 
      1. Background 1.1. Urinary tract infection

           Urinary tract infections (UTI) are considered to be the most common bacterial
           infections, with approximately 80% of all UTIs occurring in women (1). Nearly one in
           three women is expected to have at least one episode of UTI by the age of 24 years and
           almost half of all women will experience one UTI during their lifetime (2). Recurrence
           affect approximately 20-30% of women with initial UTI, although recurrence rates vary
           widely (3).

           Recurrent UTIs are a common problem seen in clinical practice with important medical,
           social and financial implications. Prophylaxis of recurrent UTI is an ongoing challenge
           with several different management strategies being used (4). Low dose antibiotic
           prophylaxis for several months is effective, but fosters the development of antibiotic
           resistance of the causative microorganisms, but also the commensal flora.(4-8). In
           postmenopausal women vaginal estrogen therapy reduces symptomatic UTI episodes (1, 7).
           Further prevention strategies include the oral immunostimulant OM-89, the vaginal
           vaccine Urovac, lactobacilli prophylaxis, cranberry products and acupuncture (5, 7, 9).

           1.2.Cranberry products Cranberries have been used in the prevention of UTIs for many
           years. Cranberries contain two compounds with antiadherence properties that prevent
           fimbriated Escherichia coli from adhering to uroepithelial cells in the urinary tract
           (10). A recent review of 24 studies showed that the use of various cranberry products
           may have a small benefit for women with recurrent UTIs, although differences were not
           statistically significant (11).

           1.3. Acupuncture treatment The effectiveness of acupuncture has been established for a
           series of different conditions (12, 13). Up to date there are only two clinical trials
           studying the effect of acupuncture on the prevention of recurrent UTI, both conducted
           from the same research group. In one controlled trial of 67 adult women acupuncture was
           significantly more effective in preventing recurrent UTI compared to sham acupuncture
           than no treatment over an observation period of 6 months (14). In the second trial of
           100 women acupuncture, administered twice weekly for 4 weeks, was significantly more
           effective in reducing the number of UTIs, but also in reducing the volume of residual
           urine. Acupuncture points were chosen according to patients´ individual diagnoses
           following traditional Chinese medical patterns. (15)

        2. Study aims The present study aims to compare acupuncture treatment with standard
           treatment (recommendation for cranberry intake) in the treatment of uncomplicated
           recurrent UTIs in women and is designed as a prospective randomized controlled trial. We
           will assess the number of acute lower UTIs and subsequent treatment, the type and amount
           of self medication (cranberry products and others), health related quality of life and
           treatment satisfaction within a defined period of time.

           The results from this study will help to guide clinical practice with level I evidence
           and allow for effective treatment with regard to patient needs.

        3. Methods/ Workplan This patient oriented non-profit clinical study is designed as a
           randomised controlled trial (6 months) with a follow-up period of 12 months.

      Active recruitment: 12 months Randomised controlled trial: 6 months Short-term Follow-up: 12
      months 3.1. Active recruitment After Ethics Committee approval patient recruitment will be
      started. Information material about the study, including contact details, will be provided at
      the outpatient clinics of the Dep. of Gynecology, the Dep. of Urology, and other local health
      care providers. During an initial visit patients will be informed about the study and
      inclusion and exclusion criteria will be evaluated. A structured medical history, including
      assessment of previous UTIs and other urogenital tract symptoms, will be obtained. After
      written informed consent is obtained participants will be randomized.

      3.2. Randomized Controlled Trial (6 months)

      At the time of randomization patients must not have signs or symptoms of an acute UTI, and
      must not currently receive antibiotic treatment. Randomizing will be done electronically
      (www.randomizer.at). Patients will be randomized in one of two treatment groups without
      stratification with a planned ratio of 1:1:

        -  Acupuncture treatment group 12 acupuncture treatments according to a standardized
           protocol plus recommendation for use of cranberry products

        -  Standard treatment group Recommendation for use of cranberry products only

      Participants will be contacted bimonthly by telephone and asked about occurrence of UTIs,
      adverse events, study adherence and completion of study diary. At 6 months a control visit
      will be scheduled, the RCT will be completed and the main outcome parameter (number of women
      with no acute UTIs) and secondary outcome parameters (9.2.) will be assessed.

      This will be followed by a 12 months short-term Follow-up. 3.3. Short-term Follow-up (12
      months) Patients of both treatment groups may use any prophylactic treatment. Participants
      will be contacted bimonthly by telephone and asked about occurrence of UTIs, adverse events,
      and use of prophylactic and therapeutic treatments for UTIs.

      The study is designed according to the 2010 CONSORT guidelines(16) and the STRICTA (Standards
      for Reporting Interventions in Clinical Trials of Acupuncture) guidelines (17).
    

Intervention name(s): acupuncture; Cranberry products
Intervention type(s): Other; Drug
Intervention description(s): Acupuncture will be performed according to the physiological concept of segmental acupuncture. A fixed schema of acupuncture points will be used irrespective of TCM diagnosis. Needles will be inserted approximately 10 mm under the skin. The "deqi sensation" (a sensation described as numbness, heaviness, and distension) may be obtained, but will not be specifically aimed for. The acupuncture protocol includes body and ear acupuncture.; Participants will receive Cranberry products (Urgenin Blasenkapseln® and/or Alpinamed Preiselbeer Granulat ®) - use is recommended but not obligatory.
Other intervention name(s): Cranberry tablets and juice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention