NCT02705495

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

6.6 years

First QC Date

February 1, 2016

Last Update Submit

August 4, 2022

Conditions

Recurrent Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

  • Urinary tract infection (UTI)

    Number of women with no acute UTI at 6 months

    6 months

Secondary Outcomes (3)

  • Urinary symptoms

    6 months

  • Study diary

    6 months

  • Health related quality of life

    6 months

Study Arms (2)

acupuncture

ACTIVE COMPARATOR

12 acupuncture treatments according to a standardized protocol, plus recommendation for use of cranberry products

Other: acupunctureDrug: Cranberry products

Control

OTHER

Recommendation for use of cranberry products only

Drug: Cranberry products

Interventions

acupunctureOTHER

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.

acupuncture
Cranberry productsDRUG

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

Also known as: Cranberry tablets and juice
Controlacupuncture

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Women, Age 18 - 90 years
  • Informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gynecology/ Medical University of Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Gerda Trutnovsky

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2016

First Posted

March 10, 2016

Study Start

May 1, 2015

Primary Completion

December 1, 2021

Study Completion

June 1, 2022

Last Updated

August 5, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)