Comparatve study between self catheterisation with a silicone catheter and a stainless steel catheter assessing bladder infection rate in female patients who are self catheterising.
Phase 3
- Conditions
- eurogenic bladder with post void residual volumes of greater than 100mlsNeurogenic bladder with post void residual volumes of greater than 100mlsRenal and Urogenital - Other renal and urogenital disorders
- Registration Number
- ACTRN12611000344998
- Lead Sponsor
- Dr LJ (Vic) du Plessis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
(1) Female patients aged 16 - 75.
(2) The patient must have a neurogenic bladder and a post void residual volume > 100mls.
(3) The patient must be able to self-catheterise without assistance from a carer.
(4) There must be a history of recurrent urinary tract infections associated with self-catheterisation.
Exclusion Criteria
(1) History of urethral trauma/stricture.
(2) Inadequate upper limb dexterity to be able to self-catheterise.
(3) No history of infections in the preceding 14 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of urinary tract infection. Any patient developing symptoms during the trial period will be investigated for urinary tract infection with microscopy and culture to confirm infection and treated accordingly[At any time during the 6 months study period if the patient is symptomatic]
- Secondary Outcome Measures
Name Time Method Comparing Ease of use using a questionnaire[End of study period];Assessing continence specific quality of life changes usng a questionnaire[End of study period];Evaluate effectiveness simplified cleaning techniques compared to costly replacement of silicone catheters using a questionnaire and performing urinalysis if symptomatic with UTI[End of study period]