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Acupuncture for Prevention of Recurrent Urinary Tract Infections. (SARUTI)

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ClinicalTrials.gov Identifier: NCT02705495
Recruitment Status : Recruiting
First Posted : March 10, 2016
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Brief 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.

Condition or disease Intervention/treatment Phase
Recurrent Urinary Tract Infection Other: acupuncture Drug: Cranberry products Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Segmental and Ear Acupuncture for Prevention of Recurrent Urinary Tract Infections(SARUTI Study): a Multicenter Randomized Controlled Trial
Study Start Date : May 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: acupuncture
12 acupuncture treatments according to a standardized protocol, plus recommendation for use of cranberry products
Other: acupuncture
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.

Drug: Cranberry products
Participants will receive Cranberry products (Urgenin Blasenkapseln® and/or Alpinamed Preiselbeer Granulat ®) - use is recommended but not obligatory.
Other Name: Cranberry tablets and juice

Control
Recommendation for use of cranberry products only
Drug: Cranberry products
Participants will receive Cranberry products (Urgenin Blasenkapseln® and/or Alpinamed Preiselbeer Granulat ®) - use is recommended but not obligatory.
Other Name: Cranberry tablets and juice




Primary Outcome Measures :
  1. Urinary tract infection (UTI) [ Time Frame: 6 months ]
    Number of women with no acute UTI at 6 months


Secondary Outcome Measures :
  1. Urinary symptoms [ Time Frame: 6 months ]
    Occurrence of urinary symptoms without signs of UTI

  2. Study diary [ Time Frame: 6 months ]
    Use of cranberry products (type, length and amount) assessed by the study diary

  3. Health related quality of life [ Time Frame: 6 months ]
    Health related quality of life as measured by the Kings Health Questionnaire



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recurrent UTIs: Two or more symptomatic UTIs within the last six 6 months or 3 or more infections within the last 12 months.
  • At least two positive urine culture within this period of time
  • No evidence of current UTI at the time of inclusion
  • Women, Age 18 - 90 years
  • Informed consent

Exclusion Criteria:

  • Pregnancy
  • Urogenital anatomical abnormality
  • Evidence of kidney stones
  • Indwelling catheter
  • systemic diseases such as renal insufficiency, transplantation, diabetes, or immunodeficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705495


Contacts
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Contact: Gerda Trutnovsky, MD +4331681081 gerda.trutnovsky@medunigraz.at

Locations
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Austria
Department of Gynecology/ Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Gerda Trutnovsky, MD    +43 316 385 ext 81081    gerda.trutnovsky@medunigraz.at   
Contact: Paul Ziller-Diechler, MD    +43 316 650 ext 8207708    paul@ziller-diechler.at   
Principal Investigator: Gerda Trutnovsky, MD         
Sub-Investigator: Paul Ziller-Diechler, MD         
Sub-Investigator: Thomas Ots, MD         
Sub-Investigator: Orietta Dalpiaz, MD         
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Gerda Trutnovsky Medical University of Graz

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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT02705495     History of Changes
Other Study ID Numbers: SARUTI V1.6
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases