Een onderzoek naar de kosten en effectiviteit van de mid-urethrale slingoperatie in vergelijking met bulkinjecties bij vrouwen met stressincontinentie.

The primary outcome of this study is subjective improvement assessed by the 1-item questionnaire ‘Patient Global Impression of Improvement’ (PGI-I) (Appendix A). The PGI-I has a 7-point Likert scale with a response range from ‘very much worse’ to ‘very much better’. Improvement is considered to be clinically significant when answers to the PGI-I are either “much better” or “very much better”. Subjective improvement will be assessed at 4-6 weeks, 6 months and 12 months.

• Subjective cure defined as patients answering negative at the question: ‘Do you experience urine leakage related to physical activity, coughing or sneezing?’ This will be assessed at 4-6 weeks, 6 months and 12 months

• Patients Global impression of severity, which is a validated 1-item questionnaire (Appendix B). The Patient Global Impression of Severity (PGI-S) will be assessed prior to the intervention, at 4-6 weeks, 6 months and 12 months. The PGI-S has a 4-point Likert scale. The response on the question: “Check the number that best describes best what your urinary tract condition is at this point” ranges from ‘normal’ to ‘severe’. The PGI-S will be assessed prior to the intervention at 4-6 weeks, 6 months and 12 months.

• Objective cure by means of the cough stress test in lithotomy or supine position. The CST will be assessed prior to the intervention, at 4-6 weeks and at 12 months.

• Morbidity which is reported per- and post procedurally using the Clavien Dindo classification. Pain and procedure related discomfort will be assessed by a patient diary. This diary includes a visual analogue scale which measures pain, and consists of two questionnaires:

o 1. The validated AMC disability scale: item bank that assesses patients’ functional disability concerning activities of daily life (ADL) (getting in and out of bed, dressing and undressing, picking an object from the floor, walking) at interval level.

o A self-developed questionnaire consisting of questions that evaluate the presence and experienced bother of pain, being impaired in self-care or having impaired mobility after surgery. Each of these questions consists of two parts. The first part asks whether or not a type of discomfort is present. The second part of the question asks about the degree of bother that is experienced from that symptom. This is recorded on a four-point Likert scale: not at all, slightly, moderately or very much. Patients are asked to fill out the diary prior to the intervention and at day 0,1,2,3,7,14 and 28.

• Disease specific quality of life is measured by the validated short version of the Dutch validated Urogenital Distress Inventory (UDI-6) (Appendix D), the short version of the Incontinence Impact Questionnaire (IIQ-7) and the Pelvic Organ Prolapse/Urinary Incontinence (Appendix E)

• Sexual Function Questionnaire (PISQ-IR) (Appendix F). Combined, this questionnaire consists of 26 questions. This questionnaire will be assessed at 4-6 weeks, 6 months and 12 months.

• Performed re-interventions: re-injections of Urolastic, PFMT and MUS are recorded in both groups.

• Economic evaluation: EQ5D (Appendix G) is used to establish health outcomes of the patient. Also, a diary evaluation costs (using IMCQ and IPCQ) needs to be filled in by patients prior tot the intervention, 4-6 weeks, 6 months and 12 months after intervention.