To compare the clinical and cost-effectiveness of pelvic floor muscle training versus TVT/TVT-O surgery as primary treatment of moderate to severe female urinary incontinence.
ID
Bron
Verkorte titel
Aandoening
stress urinary incontinence, SUI, TVT, TVT-O, PFMT
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Complete cure on objective and subjective parameters
Achtergrond van het onderzoek
OBJECTIVE: To compare the clinical and cost-effectiveness of pelvic floor muscle training versus TVT-O)-surgery as primary treatment of moderate to severe female urinary incontinence.
STUDY DESIGN: Multi-centre randomised controlled trial.
STUDY POPULATION: Women with moderate to severe, predominantly stress, urinary incontinence,
who have not received specialised PFMT or previous anti-incontinence surgery.
INTERVENTIONS: Women will be assigned to either PFMT by a specialised physiotherapist for a standard of 9-18 session in a period of 6 months, or TVT(O)- surgery.
OUTCOME MEASURES: Objective cure will be assessed from history and clinical parameters. Subjective improvement will be measured by generic and disease-specific quality of life instruments. A prediction model for a successful outcome will be developed.
SAMPLE SIZE CALCULATION / DATA ANALYSIS: In order to observe a significant difference insubjective improvement, 65% in PFMT and 80% in TVT®, with a power of 0.9, a total of 200 women have to be assigned by randomisation to each group.
ECONOMIC EVELUATION: The short term (1 year) incremental cost-effectiveness in terms of costs per additional year free of urinary incontinence and costs per QALY gained will be estimated. As the vast
majority of relevant outcomes will have occurred by one year this period appears sufficient. Uncertainty will be evaluated using bootstrap techniques (1000 replicates) on the individual patient data. A CEA plane will be used to depict the dispersion of the estimates of incremental costs and effects of TVT(O) compared to PFMT, thus allowing a direct inference with regard to the certainty of one treatment having a more favourable balance between costs and effects over the other.
TIME SCEDULE: We estimate
that the inclusion will be finished within 18 months. PFMT may take up to 6 months to be regarded as optimal, leaving 12 months for follow-up after treatment ending.
Doel van het onderzoek
To compare the clinical and cost-effectiveness of pelvic floor muscle training versus TVT/TVT-O surgery as primary treatment of moderate to severe female urinary incontinence.
Onderzoeksopzet
0= randomisation
2 months
4 months
6 months
12 months
18/24 months
Onderzoeksproduct en/of interventie
Women will be assigned to either PFMT by a specialised physiotherapist for a standard of 9-18 session in a period of 6 months, or TVT(O) surgery.
Publiek
J. Labrie
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (887) 555555
j.labrie@umcutrecht.nl
Wetenschappelijk
J. Labrie
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (887) 555555
j.labrie@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. All women aged 35-80 years who present with symptoms of moderate to severe, predominant stress urinary incontinence.
2. Moderate to severe stress incontinence according to the Sandvik severity index. The index is calculated by multiplying the reported frequency (four levels, 1 to 4) by the amount of leakage (two levels, 1 and 2). The resulting index value (1-8) is further categorized into slight (1-2), moderate (3-4) and severe (5-8)
3. Objective confirmation of stress urinary incontinence by either examination, stress-test or urodynamics.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. A post voiding bladder volume of more than 100 ml.
2. History of anti-incontinence surgery.
3. PFMT exercises by a specialised physiotherapist for urinary incontinence in the previous 6 months.
4. Genital prolapse Stage 2 or more according to the POP-Q classification.
5. Probability of future pregnancy and childbirth present.
6. Co morbidity which is associated with increased surgical risks, for instance women with ASA 3 or 4 classification.
7. History of recurrent lower urinary tract infection (> 3 times/year).
8. Insufficient knowledge or understanding of the Dutch language.
9. Use of medication interacting in bladder function.
10. History of or current major psychiatric illness.
11. History of chronic neurological disease.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1203 |
| NTR-old | NTR1248 |
| Ander register | ZonMw : 80-82310-98-08203 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |