|- candidate number||3114|
|- NTR Number||NTR1248|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-mrt-2008|
|- Secondary IDs||80-82310-98-08203 ZonMw|
|- Public Title||A randomised controlled trial comparing the clinical and cost-effectiveness of pelvic floor muscle exercise versus TVT(O) procedure for female moderate to severe stress urinary incontinence|
|- Scientific Title||A randomised controlled trial comparing the clinical and cost-effectiveness of pelvic floor muscle exercise versus TVT(O) procedure for female moderate to severe stress urinary incontinence|
|- ACRONYM||PORTRET Trial|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Stress urinary incontinence, Tension-free vaginal tape (TVT), Tension free vaginal tape foramen obturatum (TVT-O), Pelvic floor muscle training (PFMT)|
|- Inclusion criteria||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.
|- Exclusion criteria||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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2008|
|- planned closingdate||31-dec-2010|
|- Target number of participants||400|
|- 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.|
|- Primary outcome||Complete cure on objective and subjective parameters|
|- Secondary outcome||1. The incremental cost-effectiveness of TVT as compared to PFMT, accounting for direct and indirect costs parameters.|
2.Subjective improvement in general and disease-specific quality of life.
3.Complications and de novo urogenital symptoms.
4.Development of a prediction model for successful treatment, with the therapy given (PFMT or TVT) as independent variable in the model.
|- Timepoints||0= randomisation|
|- Trial web site||www.urogynstudies.nl |
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. arts-onderzoeker J. Labrie|
|- CONTACT for SCIENTIFIC QUERIES||Dr. C.H. Vaart, van der|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||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.
|- Main changes (audit trail)|
|- RECORD||13-mrt-2008 - 27-mrt-2008|