ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000285752

Ethics application status

Approved

Date submitted

25/02/2013

Date registered

11/03/2013

Date last updated

14/11/2018

Date data sharing statement initially provided

14/11/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Refractory Urge Incontinence in Women: a randomized placebo controlled trial of antibiotic therapy for cystitis erradication

Scientific title

Refractory Urge Incontinence in Women: a randomized placebo controlled trial of antibiotic therapy for cystitis erradication

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

U1111-1139-8550

Trial acronym

To be determined

Linked study record

Health condition

Health condition(s) or problem(s) studied:

detrusor overactivity

urge incontinence

bacterial cystitis

Condition category

Condition code

Renal and Urogenital

Other renal and urogenital disorders

Infection

Studies of infection and infectious agents

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Antibiotic therapy will be as follows:
Amoxycillin 500mg and clavulanic acid 125mg twice daily for 2 weeks, oral capsule
then Norfloxacin 400mg twice daily for 2 weeks oral capsule
then Nitrofurantoin 100mg four times daily or 2 weeks, oral capsule

Intervention code [1]

Treatment: Other

Comparator / control treatment

Identical placebo tablets

Control group

Placebo

Outcomes

Primary outcome [1]

The primary outcome measure will be the relative change in urge incontinence, measured on 24 hour pad test. Cure will be defined as <8mL on a 24 hour pad test

Timepoint [1]

6 Months after randomization

Secondary outcome [1]

The secondary outcome measure will be frequency of micturition on 3 day Bladder diary. Cure on 3 day bladder diary is defined as < 8 voids per day.

Timepoint [1]

6 months after randomisation

Eligibility

Key inclusion criteria

Patients will be female, over 50 years of age who present with a main complaint of urge incontinence.
Urodynamic testing will show a primary diagnosis of detrusor overactivity (DO).
Patients will have failed to respond to bladder training with at least 2 anti-muscarinic therapeutic agents over 2 years.
Participants must leak urine at least 1 episode per 3 days on frequency volume chart.

Minimum age

50 Years

Maximum age

90 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

a. Neuropathic DO (such as multiple sclerosis, spinal cord injury, Parkinsonism) b. Voiding dysfunction, defined as urinary flow rate less than 15 ml per sec for volume greater than 200ml with residual volume greater than 100ml c. Insufficient English language skills, or dementia, ie unable to complete questionnaires unaided. d. elevated creatinine, renal failure, e. allergy to more than penicillin

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

All patients who meet inclusion and exclusion criteria, who give informed consent, will have a screening midstream urine culture and a 2 week wash out of previous anti-muscarinic drugs, then will be randomized to active treatment or placebo.

Allocation concealment procedure = Sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation will be dynamic (adaptive) random allocation methods. Patients will be randomised to the placebo or antibiotic group, using method minimisation stratified for severity of incontinence (based on 24 hour pad test, less than 75mL per 24 hours, equal to 75mL per 24 hours) and proven history of classical bacterial cystitis.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

None

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Previous studies suggest that approximately 20% of women would no longer suffer from severe urge incontinence (greater than 9 visits to the toilet per day) after 6 months of standard treatment. An increase of this rate to 35% with antibiotic treatment would provide sufficient activity. Based on the Simon’s 2 stage design, 80 patients receiving antibiotic treatment would have >80% power with 95% confidence to rule out an estimate of benefit of 20% in favour of a rate of 35%.

The primary outcome will be estimated as the proportion of patients experiencing a cure at 6 months post randomization together with 95% confidence intervals. Continuous variables will be described using mean and standard deviations; categorical variables will be summarized using percentages and time-to-event outcomes by the Kaplan-Meier method. Where exploratory analyses are performed these will be compared using t-tests or chi-squared tests as appropriate together with regression methods (logistic, proportional hazards) as required.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/06/2014

Actual

Date of last participant enrolment

Anticipated

1/02/2019

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

166

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

St George Hospital - Kogarah

Recruitment hospital [2]

Wollongong Hospital - Wollongong

Recruitment postcode(s) [1]

2217 - Kogarah

Recruitment postcode(s) [2]

2500 - Wollongong

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GPO Box 1421
Canberra ACT

Level 5, 20 Allara Street
Civic CANBERRA 2601

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Bupa Health Foundation

Address [2]

50 Bridge Street
Sydney, NSW, 2000

Country [2]

Australia

Primary sponsor type

University

Name

University of New South Wales

Address

University of New South Wales
Barker Street
Kensington New South Wales 2052

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Wollongong,
Illawarra Health and Medical Research Institute, NSW

Address [1]

University of Wollongong
Wollongong 2522

University of Wollongong
Northfileds Avenue
GWYNNEVILLE 2500

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Wollongong/ ISLHD Health and Medical HREC

Ethics committee address [1]

Ethics Unit, Research Services Office
University of Wollongong, NSW 2522, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/04/2013

Approval date [1]

20/05/2014

Ethics approval number [1]

CT13/003

Summary

Brief summary

Women with severe urgency of micturition and urge incontinence, who have not responded to treatment with bladder training and appropriate tablets for two years, will be invited to join a study whereby they will receive a highly effective tablet (darifenicin) as well as either 6 weeks of antibiotics, or 6 weeks of placebo. Followup of clinical outcome will occur over 6 months.

Trial website

nil

Trial related presentations / publications

Public notes

to be added

Contacts

Principal investigator

Name

Prof Kate H. Moore

Address

Level 1 Pitney Clinical Sciences Building
St George Hospital
Short Street
KOGARAH NSW 2217

Country

Australia

Phone

+61-2-91132054

Fax

+61-2-91133951

k.moore@unsw.edu.au

Contact person for public queries

Name

Wendy Allen

Address

Continence Research Nurse
Pelvic Floor Unit
St George Hospital
Cnr Belgrave & South Sts
KOGARAH NSW 2217

Country

Australia

Phone

+61-2-91132272

Fax

+61-2-91133546

wendy.allen@sesiahs.health.nsw.gov.au

Contact person for scientific queries

Name

Kate H. Moore

Address

Level 1 Pitney Clinical Sciences Building
St George Hospital
Short Street
KOGARAH NSW 2217

Country

Australia

Phone

+61-2-91132054

Fax

+61-2-91133951

k.moore@unsw.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Bacterial colonization of bladder urothelial cells in women with refractory Detrusor Overactivity: The effects of antibiotic therapy.	2021	https://dx.doi.org/10.1093/femspd/ftab031

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically