Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02705495 |
| Other study ID # |
SARUTI V1.6 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2015 |
| Est. completion date |
June 2022 |
Study information
| Verified date |
August 2022 |
| Source |
Medical University of Graz |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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).
