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CompletedNCT01782404Updated Aug 13, 2015

Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine

An interventional study of Chlorhexidine in Bacteriuria, Intermittent Catheterization, sponsored by Wellspect HealthCare. Completed at 4 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-13.

Sponsored by Wellspect HealthCare (part of Dentsply Sirona) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This a prospective, non-controlled, open, multi-center study evaluating the reduction of bacteriuria after bladder irrigation with chlorhexidine in spinal cord injured patients with chronic bacteriuria practicing intermittent catheterisation (IC). Patients will be treated with chlorhexidine for bladder irrigation twice daily for a maximum of 7 days.

The study hypothesis is that bladder irrigation with chlorhexidine is efficient for a short term reduction of bacteriuria in patients performing intermittent catheterization (IC).

02

Conditions studied

  • Bacteriuria, Intermittent Catheterization

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03

In context

Bacteriuria

51 studies on the registry are indexed under Bacteriuria; 3 are open to participants now.

This study's enrollment of 50 is below the median of 100 across 37 interventional studies indexed under Bacteriuria.

Browse Bacteriuria studies →

Lead sponsor

Wellspect HealthCare is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

First submitted after Wellspect HealthCare became part of Dentsply Sirona.

Browse Wellspect HealthCare studies →All Dentsply Sirona studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Provision of
  2. Female or male spinal cord injured subject aged 18 years and over
  3. Bacteriuria of >10\^5 CFU/mL of >1 bacterial species verified during screening visit
  4. Regular users of intermittent catheterisation as primary method for bladder management (defined as a normal catheterisation frequency of at least 3 times daily for at least 1 month)
  5. Ability to retain fluid in the bladder (approx. 120 ml) for at least 10 minutes, as judged by the investigator

Exclusion criteria

Exclusion Criteria

  1. Signs or symptoms of symptomatic UTI that requires treatment, as judged by the investigator.
  2. Ongoing antibiotic treatment
  3. Known anatomical pathology of the urinary tract that could compromise results, as judged by investigator
  4. Subject with severe catheterisation difficulties, as judged by investigator
  5. Known to chlorhexidine
  6. Use of other instillation products
  7. Pregnancy
  8. Use of medications that may affect the bacterial culture in the urine and bladder (e.g. methenamine hippurate)
  9. Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
  10. Previous enrolment or allocation of treatment in the present study.
  11. Simultaneous participation in another clinical study that may interfere with the present study.
  12. Severe non-compliance to protocol as judged by the investigator and/or Wellspect HealthCare
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Chlorhexidine

    Device: Chlorhexidine

Interventions

  • DeviceChlorhexidine

    Bladder irrigation with chlorhexidine 0.2 mg/ml twice daily

06

What researchers measure

Primary outcomes

  1. Proportion of patients with bacteriuria <10^3 CFU/ml

    Bacteriuria will be followed by daily urinary cultures, 3 hours after morning irrigation. The proportion of patients with at least one sample \<10\^3 CFU/ml within the 7 day treatment period will be evaluated.

    Time frame: 7 days

Secondary outcomes

  1. Time (number of days) to reduction of bacteriuria (<10^3 CFU/ml)

    Bacteriuria will be followed by daily urinary cultures, 3 hours after morning irrigation. The number of days until reduction of bacteriuria (\<10\^3 CFU/ml) will be evaluated. Maximum treatment period is 7 days.

    Time frame: 7 days

07

Study locations

4 sites
  • Spinal Cord Injury Unit, Sahlgrenska University Hospital
    Göteborg, 413 45, Sweden
  • Spinal Cord Injury Unit, Skåne University Hospital
    Höör, Sweden
  • Spinal Cord Injury Unit, Linköping University Hospital
    Linköping, Sweden
  • Neurocentrum, Neurorehab, Norrlands Universitetssjukhus
    Umeå, 90185, Sweden
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2013, a primary completion of Jun 2014 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2013
First posted
Feb 1, 2013
Start
Jan 2013
Primary completionActual
Jun 2014
CompletionActual
Jun 2014
Last update
Aug 13, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01782404
Lead sponsor
Wellspect HealthCare
Responsible party
Sponsor
First posted
Feb 1, 2013
Start date
Jan 2013
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Aug 13, 2015

Study contacts

Lena Rutberg, MD
principal investigator · Sahlgrenska University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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