Recurrent urinary tract infections MedDRA version: 17.0 Level: HLT Classification code 10046577 Term: Urinary tract infections System Organ Class: 100000004862
Conditions
Interventions
Product Name: Preventative Herbal Formula
Product Code: RUTI-p
Pharmaceutical Form: Capsule
INN or Proposed INN: Astragalus membranaceus Moench
Sponsors
Southampton University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women will be eligible for the trial if they are aged over 18 and under 65 years of age and have reported 3 or more uncomplicated recurrent lower UTIs in the previous 12 months where at least one episode has been documented as bacterial UTI. The reason for the upper age limit of 65 years is that Chinese medicine differentiates several different diagnostic patterns relating to RUTIs. The herbal formulae used for this trial have been designed for a pattern more common in women aged under 65 years. Women over the age of 65 will tend to present with a different pattern to a younger age group and therefore the standardised formula may not be appropriate for them. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Women will be excluded from the trial if they have symptoms of complicated UTI’s such as acute pyelonephritis; have known hepatic or renal disease; are pregnant or breast feeding; have diabetes; have commenced a new treatment for RUTIs in the previous 6 months; are taking drugs which may interact with Chinese herbal medicine: cardiac glycosides (Digoxin), warfarin and lithium; have psychosis, dementia or terminal illness that may prevent completion of symptom diaries. During the trial women will be excluded if they develop significantly raised liver (ALT > 90 U/l) or renal function tests (GFR < 90 mL/mm/1.73m2). Any women who also become pregnant during the trial will also be advised to stop taking the CHM and to inform a member of the study team for further advice. If pregnancy is confirmed, the participant will be asked to withdraw from the intervention in the study and asked for their consent to remain for safety monitoring purposes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare outcomes observed during and after the 16-week trial from participants in each of the 4 arms of the trial. In particular the: • duration and severity of acute urinary tract infections • rates of re-infection within the 4 month treatment period • quality of life measured by a validated questionnaire (MYMOP) and in depth qualitative research • rates of acute and prophylactic antibiotic use • adverse effects experienced during treatment • To assess the safety of CHM • long term changes (6 months after stopping the trial) from each intervention ;Primary end point(s): The primary outcomes will be the number episodes of recurrent UTIs during the trial period and after 6 months follow up and the number of days of symptoms rated moderately bad or worse based on patient diaries. ;Timepoint(s) of evaluation of this end point: All participants will receive treatment lasting 16 weeks. Subsequent to this there will be a 6 month follow up period to assess any lasting benefits from the intervention.; Secondary Objective: • To explore the feasibility of developing, implementing and evaluating a CHM intervention within the primary care networks with particular regard to recruitment, referral patterns, patient compliance, the use of a plausible herbal placebo, and drop out rates. • To evaluate the acceptability and sensitivity to change of different outcomes measures and to provide a provisional estimation of any effect size relating to CHM treatment that could inform a more definitive future study. • To use nested qualitative research and quantitative quality of life outcome measures to explore the experience of women taking CHM and to investigate any perceived differences between the delivery of standardised remedies via GPs and individualised remedies via CHM practit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): After 6 months treatment we will be evaluating: • Symptom diaries indicating the severity of acute and recurrent UTI symptoms (reporting dysuria, haematuria, frequency during day and night, “smelly urine,” “tummy pain,” generally feeling unwell, and restriction of daily activities). Use of these diaries in this format for acute respiratory infections has been validated and shown to be sensitive to change (Watson et al 2001) and now have been shown to be sensitive to change, reliable, and having construct validity in UTIs (Little et al 2010a,b). • Rate of UTI recurrence-as reported in the symptom diaries completed for each acute UTI episode during the active phase of the trial. • In addition to the diary for acute UTIs participants will be asked to complete a monthly end of month diary in which they record number of days with symptoms, time lost from work etc. These diaries would provide information on the rate and severity of acute infection but also on the impact of low grade, chronic infection on the lives of women. Participants will be asked to complete both an acute and a monthly diary for the 6 month follow up of the trial to enable the evaluation of any longer term changes in infection rates. • Use of antibiotics for acute UTIs-elicited from symptom diaries and cross-referenced with GP notes. • The Borkevic and Devilly questionnaire will be used to assess participants’ attitudes relating to the effectiveness of CHM prior to and on completion of the trial (Devilly & Borkevic 2000). • MYMOP a validated patient centred QoL outcome completed every 4 weeks (Patterson 1996) • Economic assessment (EQ5D) to be completed prior to and on completion of the trial (also reduction in GP appointments gathered from a review of GP patient notes/ days lost to work). We will also estimate the quality of life during acute UTI episodes by | — |
Countries
United Kingdom
Contacts
Public ContactBarbara Halliday
Southampton University
Outcome results
None listed