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

Trials

Volumn 12, Issue , 2011, Pages

  Murdoch, Megan ^a   McColl, Elaine ^b   Howel, Denise ^b   Deverill, Mark ^b   Buckley, Brian S ^c   Lucas, Malcolm ^c   Chapple, Christopher R ^d   Tincello, Douglas G ^e   Armstrong, Natalie ^e   Brennand, Cath ^b   Shen, Jing ^b   Vale, Luke ^b   Hilton, Paul ^a  

^a ROYAL VICTORIA INFIRMARY   (United Kingdom)

^b NEWCASTLE UNIVERSITY   (United Kingdom)

^c MORRISTON HOSPITAL   (United Kingdom)

^d ROYAL HALLAMSHIRE HOSPITAL   (United Kingdom)

^e UNIVERSITY OF LEICESTER   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL PROTOCOL; CONTROLLED STUDY; FEASIBILITY STUDY; FEMALE; HUMAN; INTERVIEW; INVASIVE PROCEDURE; MAJOR CLINICAL STUDY; MEDICAL DECISION MAKING; MULTICENTER STUDY; OUTCOME ASSESSMENT; PILOT STUDY; PURPOSIVE SAMPLE; RANDOMIZED CONTROLLED TRIAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); URINE INCONTINENCE; URODYNAMICS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; HEALTH CARE SURVEY; HEALTH PERSONNEL ATTITUDE; METHODOLOGY; PATHOPHYSIOLOGY; PATIENT SELECTION; PREDICTIVE VALUE; QUALITATIVE RESEARCH; QUALITY ADJUSTED LIFE YEAR; TREATMENT OUTCOME; UNITED KINGDOM; UROLOGIC SURGERY;

ATTITUDE OF HEALTH PERSONNEL; FEASIBILITY STUDIES; FEMALE; GREAT BRITAIN; HEALTH CARE SURVEYS; HUMANS; PATIENT SELECTION; PILOT PROJECTS; PREDICTIVE VALUE OF TESTS; QUALITATIVE RESEARCH; QUALITY-ADJUSTED LIFE YEARS; RESEARCH DESIGN; TREATMENT OUTCOME; URINARY INCONTINENCE; URODYNAMICS; UROLOGIC SURGICAL PROCEDURES;

EID: 79959861471     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-12-169     Document Type: Article

References (41)

1. Hunskaar S, Burgio K, Clark A, Lapitan M, Nelson R, Sillen U. Epidemiology of urinary and feacal incontinence and pelvic organ prolapse. ICUD-ICS-SIU 3rd International Consultation on Incontinence 2005, 255-312. Plymouth, UK: Health Publications, Abrams P, Khoury S, Cardozo L, Wein A, 3.
2. Hannestad YS, Rortveit G, Sandvik H, Hunskaar S. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. Journal of Clinical Epidemiology 2000, 53(11):1150-7. 10.1016/S0895-4356(00)00232-8, 11106889.
3. Turner DA, Shaw C, McGrother CW, Dallosso HM, Cooper NJ. The cost of clinically significant urinary storage symptoms for community dwelling adults in the UK. BJU Int 2004, 93(9):1246-52. 10.1111/j.1464-410x.2004.04806.x, 15180616.
4. Martin JL, Williams KS, Abrahams KR, Turner DA, Sutton A, Chapple C, Assessa R, Cheater F. Systematic review and evaluation of methods of assessing urinary incontinence. Health Technology Assessments 2006, Report No.: 6 Contract No.: 6.
5. Adekanmi OA, Edwards GJ, Barrington JW. The variation in urodynamic practice in the United Kingdom. J Obstet Gynecol 2002, 22(1):48-50.
6. Homma Y, Battista J, Bauer S, Griffiths D, Hilton P, Kramer G, Lose G, Rosier P. Urodynamics. ICUD-ICS-SIU 2nd International Consultation on Incontinence 2002, 317-72. Plymouth, UK: Health Publications Ltd, Abrams P, Cardozo L, Khoury S, A W, 2.
7. National Collaborating Centre for Women's & Children's Health Urinary Incontinence - the management of urinary incontinence in women. 2006, London: Commissioned by the National Institute for Health & Clinical Excellence, National Collaborating Centre for Women's & Children's Health.
8. Glazener CM, Lapitan MC. Urodynamic investigations for management of urinary incontinence in adults. Cochrane Database of Systematic Reviews 2002, 3:CD003195.
9. Griffiths D, Kondo A, Bauer S, Diamant N, Liao L, Schafer W, Yoshimura N. Dynamic testing. Incontinence; 3rd International Consultation on Incontinence 2005, 585-674. Plymouth: Health Publications Ltd, Abrams P, Cardozo L, Khoury S, Wein A.
10. Buckley BS, Grant AM, Tincello DG, Wagg AS, Firkins L. Prioritising reseach: patients, carers and clinicians working together to identify and prioritise clinical uncertainties in urinary incontinence. Neurourol Urodyn 2010, 29(5):708-14.
11. Hospital Episode Statistics [database on the Internet]. Department of Health 2010, [accessed 1st April 2011]., http://www.hesonline.nhs.uk
12. Fowler G, Richmond D. Urodynamics: a mandatory preoperative investigation?. The Obstetrician and Gynaecologist 2006, 8(2):86-90.
13. MacLean AB, Cardozo L. Recommendations arising from the 42nd Study Group. Incontinence in Women 2002, 433-41. London: RCOG Press, MacLean AB, Cardozo L.
14. Bakali E, Pitchforth E, Tincello D, Kenyon S, Slack MC, Toozs-Hobson P, Mayne CJ, Jones DR, Taylor DJ. Clinicians' Views on the feasibility of surgical Randomised Trials in Urogynecology: Results of a Quesionnaire Survey. Neurourol Urodyn 2011, 30(1):69-74. 10.1002/nau.20943, 20658541.
15. Kendrick D, Fielding K, Bentley E, Miller P, Kerslake R, Pringle M. The role of radiography in primary care patients with low back pain of at least 6 weeks duration: a randomised (unblinded) controlled trial. Health Technol Assess 2001, 5(30):1-69.
16. Kerry S, Hilton S, Patel S, Dundas D, Rink E, Lord J. Routine referral for radiography of patients presenting with low back pain: is patients' outcome influenced by GPs' referral for plain radiography?. Health Technol Assess 2000, 4(20):1-119.
17. O'Cathain A, Murphy E, Nicholl J. Why, and how, mixed methods research is undertaken in Health Services Research in England: a mixed methods study. BMC health services research 2007, 7:85. 10.1186/1472-6963-7-85, 1906856, 17570838.
18. Brookes ST, Donovan JL, Wright M, Jackson S, Abrams P. A scored form of the Bristol Female Lower Urinary Tract Symptoms questionnaire: data from a randomized controlled trial of surgery for women with stress incontinence. Am J Obstet Gynecol 2004, 191(1):73-82. 10.1016/j.ajog.2003.12.027, 15295345.
19. Staskin D, Kelleher C, Avery K, Bosch R, Cotterill N, Coyne K, Emmanuel A, Yoshida M. Patient reported outcomes assessment. WHO - ICS International Consultation on Incontinence 2009, 363-412. Plymouth: Health Publications Ltd, Abrams P, Cardozo L, Khoury S, Wein A, 4.
20. Brazier JE, Roberts JR. The estimation of a preference-based index from the SF-12. Medical Care 2004, 42(9):851-9. 10.1097/01.mlr.0000135827.18610.0d, 15319610.
21. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract 2004, 10(2):307-12. 10.1111/j..2002.384.doc.x, 15189396.
22. Ramsay IN, Ali HM, Hunter M, Stark D, Donaldson K. A randomized controlled trial of urodynamic investigations prior to conservative treatment of urinary incontinence in the female. Int Urogynecol J & Pelvic Floor Dysfunct 1995, 6(5):277-81. 10.1007/BF01901525, 21431391.
23. Allahdin S, Bain C, Glazener C. Feasibility study for a randomised controlled trial evaluating the use of absorbable mesh, polydioxanone and polyglactin sutures for anterior and posterior vaginal wall prolapse repairs. International Continence Society 2006, 412. Christchurch, New Zealand.
24. Kitchener HC, Dunn G, Lawton V, Reid F, Nelson L, Smith AR. Laparoscopic versus open colposuspension--results of a prospective randomised controlled trial. BJOG 2006, 113(9):1007-13. 10.1111/j.1471-0528.2006.01035.x, 16956332.
25. Ward K, Hilton P. Multicentre randomised trial of TVT and colposuspension: 5 year follow-up. BJOG 2008, 115(2):226-33.
26. Hagen S, Stark D, Glazener C, Sinclair L, Ramsay I. A randomized controlled trial of pelvic floor muscle training for stages I and II pelvic organ prolapse. Int Urogynecol J & Pelvic Floor Dysfunct 2009, 20(1):45-51. 10.1007/s00192-008-0726-4, 21431391.
27. Britten N. Qualitative interviews in medical research. BMJ [Review] 1995, 311(6999):251-3.
28. Green J, Thorogood N. Qualitative Methods for Health Research 2004, London: Sage.
29. Glaser BG, Strauss AL. The Discovery of Grounded Theory: Strategies for Qualitative Research 1967, Chicago: Aldine.
30. QSR International. Nvivo 9. 2011, http://www.qsrinternational.com/products_nvivo.aspx
31. Edwards P, Roberts I, Clarke M, DiGuiseppi C, Pratap S, Wentz R, Kwan I. Increasing response rates to postal questionnaires: systematic review. BMJ 2002, 324:1183-92. 10.1136/bmj.324.7347.1183, 111107, 12016181.
32. Edwards P, Roberts I, Clarke M, DiGuiseppi C, Pratap S, Wentz R, Kwan I, Cooper R. Methods to influence response to postal questionnaires (Cochrane Methodology Review). 2007, Oxford: Update Software.
33. Goyder J. The silent minority: Nonrespondents on sample surveys. 1987, Cambridge: Polity Press.
34. McColl E, Jacoby A, Thomas L, Soutter J, Bamford C, Steen N, Thomas R, Harvey E, Garratt A, Bond J. Design and use of questionnaires: a review of best practice applicable to surveys of health service staff and patients. Health Technology Assessment 2001, 5(31).
35. Medical Research Council MRC Guidelines for Good Clinal Practice in Clinial Trials. 1998, Medical Research Council., http://www.mrc.ac.uk/consumption/idcplg?IdcService=GET_FILE&dID=7525&dDocName=MRC002416&allowInterrupt=1
36. National Institute for Health Research NIHR Coordinated System for gaining NHS Permission. 2011, National Institute for Health Research., http://www.crncc.nihr.ac.uk/about_us/processes/csp
37. Department of Health The Caldicott Guardian Manual. 2010, Leeds: UK Council of Caldicott Guardians, Department of Health.
38. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomized controlled trials: a systematic review. Journal of Clinical Epidemiology 1999, 52:1143-56. 10.1016/S0895-4356(99)00141-9, 10580777.
39. Nager CW, Brubaker L, Daneshgari F, Litman HJ, Dandreo KJ, Sirls L, Lemack GE, Richter HE, Leng W, Norton P, Kraus SR, Chai TC, Chang D, Amundsen CL, Stoddard AM, Tennstedt SL. Design of the Value of Urodynamic Evaluation (ValUE) trial: A non-inferiority randomized trial of preoperative urodynamic investigations. Contemp Clin Trials 2009, 30(6):531-9. 10.1016/j.cct.2009.07.001, 3057197, 19635587., http://www.controlled-trials.com/mrct/trial/472073/urodynamic
40. van Leijsen SA, Kluivers KB, Mol BW, Broekhuis SR, Milani FL, van der Vaart CH, Roovers JP, Bongers MY, den Boon J, Spaans WA, de Leeuw JW, Dietz V, Kleinjan JH, Brolmann HA, Roos EJ, Schaafstra J, Heesakkers JP, Vierhout ME. Protocol for the value of urodynamics prior to stress incontinence surgery (VUSIS) study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered. BMC Women's Health 2009, 9:22. 10.1186/1472-6874-9-22, 21724748., http://www.controlled-trials.com/mrct/trial/474127/vierhout
41. Snapinn SM. Noninferiority trials. Current Controlled Trials in Cardiovascular Medicine 2000, 1(1):19-21. 10.1186/CVM-1-1-019, 59590, 11714400.