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

Conditions

Stress urinary incontinence in women Urological and Genital Diseases Other disorders of urinary system

Homer T, Shen J, Vale L, McColl E, Tincello DG, Hilton P, INVESTIGATE-I studies group.

2018-03-236 citations

Understanding variations in patient screening and recruitment in a multicentre pilot randomised controlled trial: a vignette-based study

Paul Hilton, Brian S Buckley, Elaine McColl, Denise Howel, Douglas G. Tincello et al. (7 authors)

Trials2016-10-2510 citations

10.1186/s13063-016-1652-2

INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): a mixed-methods study to assess the feasibility of a future randomised controlled trial of invasive urodynamic testing prior to surgery for stress urinary incontinence in women.

Hilton P, Armstrong N, Brennand C, Howel D, Shen J, Bryant A, Tincello DG, Lucas MG, Buckley BS, Chapple CR, Homer T, Vale L, McColl E, INVESTIGATE studies group.

2015-02-0110 citations

10.3310/hta19150

INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): study protocol for a mixed methods study to assess the feasibility of a future randomised controlled trial of the clinical utility of invasive urodynamic testing.

Murdoch M, McColl E, Howel D, Deverill M, Buckley BS, Lucas M, Chapple CR, Tincello DG, Armstrong N, Brennand C, Shen J, Vale L, Hilton P.

2011-07-0612 citations

10.1186/1745-6215-12-169

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

Eligibility

Sex/Gender

Female

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed