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A multicentre pilot study to assess the feasibility of a future randomised controlled trial to investigate whether carrying out invasive bladder function tests in women about to undergo operations for stress incontinence alters the outcome of their surgery.
ISRCTN ISRCTN71327395
DOI 10.1186/ISRCTN71327395
ClinicalTrials.gov identifier
EudraCT number
Public title A multicentre pilot study to assess the feasibility of a future randomised controlled trial to investigate whether carrying out invasive bladder function tests in women about to undergo operations for stress incontinence alters the outcome of their surgery.
Scientific title INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?: a pragmatic multicentre pilot study to assess the feasibility of a future randomised controlled trial
Acronym INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?)
Serial number at source N/A
Study hypothesis 1. A randomised controlled trial to investigate the clinical utility of invasive urodynamic investigation in women prior to surgical treatment of stress urinary incontinence is feasible.
2. Carrying out invasive urodynamic investigation prior to surgical treatment does not affect patient outcomes in women with stress or stress predominant mixed urinary incontinence.

Please note as of 11/02/2011 the anticipated start date was updated from 01/09/2010 to 04/01/2011 and anticipated end date extended from 31/08/2012 to 31/12/2012.
Lay summary Lay summary under review 3
Ethics approval Newcastle & North Tyneside 1 Research Ethics Committee. Ref: 10/H0906/76
Study design A mixed methods study to assess feasibility of a future RCT: (1) a pragmatic multicentre randomised pilot trial; (2) a survey of clinicians; (3) qualitative interviews with women and clinicians.
Countries of recruitment United Kingdom
Disease/condition/study domain Stress urinary incontinence in women
Participants - inclusion criteria Women with a clinical diagnosis of stress urinary incontinence or stress predominant mixed urinary incontinence, who have completed their family, and have undergone a course of pelvic floor muscle training (+/- other non-surgical treatments for their urge symptoms) with inadequate resolution of their symptoms, where both the woman and clinician agree that surgery would be an appropriate and acceptable next line of treatment.
Participants - exclusion criteria 1. Symptomatic utero-vaginal prolapse requiring treatment
2. Previous surgery for urinary incontinence or pelvic organ prolapse
3. Neurological disease causing urinary incontinence
4. Unable to give competent informed consent
Anticipated start date 04/01/2011
Anticipated end date 31/12/2012
Status of trial Completed
Patient information material Patient information can be found at http://www.investigate-trial.com/INVESTIGATE-trial/Patient_information.html
Target number of participants 60 responses per arm required; allowing for 50% losses at recruitment, randomisation and response stages up to 240 patients will be approached
Interventions Invasive urodynamic testing; dual-channel subtracted cystometry with simultaneous pressure/flow voiding studies is the most commonly applied technique in the evaluation of patients prior to surgery for stress urinary incontinence in most centres. The clinical utility of invasive tests will be judged against the comparator of basic clinical assessment supplemented by non-invasive tests including frequency/volume charting or bladder diary, mid-stream urine culture, cough stress test, urine flow rate and residual urine volume measurement. This study is NOT intended to examine the outcomes of specific surgical procedures.
Primary outcome measure(s) The aim of this feasibility study is to estimate (via the pilot trial) rates of patient recruitment, randomisation, retention and response, logistics of trial methodology, and resource utilisation, and (via the clinician survey & interviews) clinicians' willingness to randomise. Qualitative patient interviews will explore understandings and experiences of the study, including participation decisions. In addition, estimation of the parameters of the primary outcome (from the pilot trial) would allow the sample size of a definitive trial to be determined.
The proposed primary outcome of the future definitive trial is the International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS - combined score) at 6 months after treatment.
Secondary outcome measure(s) Secondary outcomes of the definitive trial will include:
1. SF-36 general health questionnaire
2. Quantification of urinary leakage by
2.1. Bladder diary
2.2. International Consultation on Incontinence Questionnaire - Urinary Incontinence, Short Form (ICIQ-UI SF)
3. Prevalence of symptomatic 'de novo' functional abnormalities including voiding dysfunction and detrusor overactivity (subscales of ICIQ-FLUTS, with cystometry in symptomatic patients)
4. Impact of urinary symptoms on quality of life (ICIQ-LUTSqol)
5. Utility values computed from EQ-5D & SF-6D
6. Costs
These will all be rehearsed within the pilot study with a view to refining the choice of secondary outcomes for the main trial, based on data yield and quality. Longer term follow-up may also be considered as a secondary outcome in the definitive trial.
Sources of funding NETSCC Health Technology Assessment Programme. Project no. is 09/22/136
Trial website http://www.investigate-trial.com
Publications 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21733166
Contact name Mr  Paul  Hilton
  Address Directorate of Women's Services
Level 5, Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
  City/town Newcastle upon Tyne
  Zip/Postcode NE1 4LP
  Country United Kingdom
  Tel +44 (0)191 28 25853
  Fax +44 (0)191 28 25873
  Email paul.hilton@ncl.ac.uk
Sponsor Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
  Address Prof GA Ford
Clinical Director for R&D
Royal Victoria Infirmary
  City/town Newcastle upon Tyne
  Zip/Postcode NE1 4LP
  Country United Kingdom
Date applied 04/06/2010
Last edited 02/08/2012
Date ISRCTN assigned 07/06/2010
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