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Protocol for Physiotherapy Or TVT Randomised Efficacy Trial (PORTRET): a multicentre randomised controlled trial to assess the cost-effectiveness of the tension free vaginal tape versus pelvic floor muscle training in women with symptomatic moderate to severe stress urinary incontinence.
BMC Womens Health. 2009 Sep 01; 9:24.BW

Abstract

BACKGROUND

Stress urinary incontinence is a common condition affecting approximately 20% of adult women causing substantial individual (quality of life) and economic (119 million Euro/year spent on incontinence pads in the Netherlands) burden. Pelvic floor muscle training (PFMT) is regarded as first line treatment, but only 15-25% of women will be completely cured. Approximately 65% will report that their condition improved, but long term adherence to treatment is problematic. In addition, at longer term (2-15 years) follow-up 30-50% of patients will end up having surgery. From 1996 a minimal invasive surgical procedure, the Tension-free Vaginal Tape (TVT) has rapidly become the gold standard in surgical treatment of stress urinary incontinence. With TVT 65-95% of women are cured. However, approximately 3-6% of women will develop symptoms of an overactive bladder, resulting in reduced quality of life. Because of its efficacy the TVT appears to be preferable over PFMT but both treatments and their costs have not been compared head-to-head in a randomised clinical trial.

METHODS/DESIGN

A multi-centre randomised controlled trial will be performed for women between 35-80 years old with moderate to severe, predominantly stress, urinary incontinence, who have not received specialised PFMT or previous anti-incontinence surgery. 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. The main endpoint of the study is the subjective improvement of urinary incontinence. As secondary outcome the objective cure will be assessed from history and clinical parameters. Subjective improvement in quality of life will be measured by generic (EQ-5D) and disease-specific (Urinary Distress Inventory and Incontinence Impact Questionnaire) quality of life instruments. The economical endpoint is short term (1 year) incremental cost-effectiveness in terms of costs per additional year free of urinary incontinence and costs per Quality Adjusted Life Years (QALY) gained. Finally, treatment strategy and patient characteristics will be combined in a prediction model, to allow for individual treatment decisions in future patients. Four hundred female patients will be recruited from over 30 hospitals in the Netherlands.

TRIAL REGISTRATION

Nederlands trial register: NTR 1248.

Authors+Show Affiliations

Department of Obstetrics and Gynaecology, University Medical Centre Utrecht, The Netherlands. j.labrie@umcutrecht.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19723313

Citation

Labrie, Julien, et al. "Protocol for Physiotherapy or TVT Randomised Efficacy Trial (PORTRET): a Multicentre Randomised Controlled Trial to Assess the Cost-effectiveness of the Tension Free Vaginal Tape Versus Pelvic Floor Muscle Training in Women With Symptomatic Moderate to Severe Stress Urinary Incontinence." BMC Women's Health, vol. 9, 2009, p. 24.
Labrie J, van der Graaf Y, Buskens E, et al. Protocol for Physiotherapy Or TVT Randomised Efficacy Trial (PORTRET): a multicentre randomised controlled trial to assess the cost-effectiveness of the tension free vaginal tape versus pelvic floor muscle training in women with symptomatic moderate to severe stress urinary incontinence. BMC Womens Health. 2009;9:24.
Labrie, J., van der Graaf, Y., Buskens, E., Tiersma, S. E., & van der Vaart, H. C. (2009). Protocol for Physiotherapy Or TVT Randomised Efficacy Trial (PORTRET): a multicentre randomised controlled trial to assess the cost-effectiveness of the tension free vaginal tape versus pelvic floor muscle training in women with symptomatic moderate to severe stress urinary incontinence. BMC Women's Health, 9, 24. https://doi.org/10.1186/1472-6874-9-24
Labrie J, et al. Protocol for Physiotherapy or TVT Randomised Efficacy Trial (PORTRET): a Multicentre Randomised Controlled Trial to Assess the Cost-effectiveness of the Tension Free Vaginal Tape Versus Pelvic Floor Muscle Training in Women With Symptomatic Moderate to Severe Stress Urinary Incontinence. BMC Womens Health. 2009 Sep 1;9:24. PubMed PMID: 19723313.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Protocol for Physiotherapy Or TVT Randomised Efficacy Trial (PORTRET): a multicentre randomised controlled trial to assess the cost-effectiveness of the tension free vaginal tape versus pelvic floor muscle training in women with symptomatic moderate to severe stress urinary incontinence. AU - Labrie,Julien, AU - van der Graaf,Yolanda, AU - Buskens,Eric, AU - Tiersma,Stella E S M, AU - van der Vaart,Huub C H, Y1 - 2009/09/01/ PY - 2009/06/29/received PY - 2009/09/01/accepted PY - 2009/9/3/entrez PY - 2009/9/3/pubmed PY - 2009/10/30/medline SP - 24 EP - 24 JF - BMC women's health JO - BMC Womens Health VL - 9 N2 - BACKGROUND: Stress urinary incontinence is a common condition affecting approximately 20% of adult women causing substantial individual (quality of life) and economic (119 million Euro/year spent on incontinence pads in the Netherlands) burden. Pelvic floor muscle training (PFMT) is regarded as first line treatment, but only 15-25% of women will be completely cured. Approximately 65% will report that their condition improved, but long term adherence to treatment is problematic. In addition, at longer term (2-15 years) follow-up 30-50% of patients will end up having surgery. From 1996 a minimal invasive surgical procedure, the Tension-free Vaginal Tape (TVT) has rapidly become the gold standard in surgical treatment of stress urinary incontinence. With TVT 65-95% of women are cured. However, approximately 3-6% of women will develop symptoms of an overactive bladder, resulting in reduced quality of life. Because of its efficacy the TVT appears to be preferable over PFMT but both treatments and their costs have not been compared head-to-head in a randomised clinical trial. METHODS/DESIGN: A multi-centre randomised controlled trial will be performed for women between 35-80 years old with moderate to severe, predominantly stress, urinary incontinence, who have not received specialised PFMT or previous anti-incontinence surgery. 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. The main endpoint of the study is the subjective improvement of urinary incontinence. As secondary outcome the objective cure will be assessed from history and clinical parameters. Subjective improvement in quality of life will be measured by generic (EQ-5D) and disease-specific (Urinary Distress Inventory and Incontinence Impact Questionnaire) quality of life instruments. The economical endpoint is short term (1 year) incremental cost-effectiveness in terms of costs per additional year free of urinary incontinence and costs per Quality Adjusted Life Years (QALY) gained. Finally, treatment strategy and patient characteristics will be combined in a prediction model, to allow for individual treatment decisions in future patients. Four hundred female patients will be recruited from over 30 hospitals in the Netherlands. TRIAL REGISTRATION: Nederlands trial register: NTR 1248. SN - 1472-6874 UR - https://www.unboundmedicine.com/medline/citation/19723313/Protocol_for_Physiotherapy_Or_TVT_Randomised_Efficacy_Trial__PORTRET_:_a_multicentre_randomised_controlled_trial_to_assess_the_cost_effectiveness_of_the_tension_free_vaginal_tape_versus_pelvic_floor_muscle_training_in_women_with_symptomatic_moderate_to_severe_stress_urinary_incontinence_ L2 - https://bmcwomenshealth.biomedcentral.com/articles/10.1186/1472-6874-9-24 DB - PRIME DP - Unbound Medicine ER -