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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20079

Enrollment

400

Registered

2008-03-13

Start date

2008-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stress urinary incontinence, SUI, TVT, TVT-O, PFMT

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.

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Complete cure on objective and subjective parameters	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactJ. Labrie

Universitair Medisch Centrum Utrecht, secr. gyn. Kamer F 05.126

j.labrie@umcutrecht.nl+31 (887) 555555

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)