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A three year follow-up of a prospective open randomized trial to compare tension-free vaginal tape with Burch colposuspension for treatment of female stress urinary incontinence.
Actas Urol Esp. 2009 Nov; 33(10):1088-96.AU

Abstract

BACKGROUND

Evidence comparing the effectiveness of tension-free vaginal tape (TVT) with Burch colposuspension (CS) over a long-term follow-up is scarce.

PURPOSE

To compare TVT with CS as primary treatment for female stress urinary incontinence (SUI).

DESIGN

Open randomised clinical trial with a three-year follow-up period.

PARTICIPANTS

49 consecutive women aged 35 to 70 with SUI demonstrated by a urodynamic study.

SETTING

Urology department of Severo Ochoa general hospital in Leganes, Madrid, Spain.

INTERVENTION

24 random patients treated with TVT and 25 with CS.

MEASUREMENTS

Main variable: assessment before treatment and at six months, one year and three years after the operation using the incontinence severity index (ISI) and the incontinence impact questionnaire (IIQ). Secondary variable: three groups for assessing cure, improvement and failure rates.

RESULTS

Time in surgery, consumption of postoperative analgesics and length of the postoperative hospital stay were lower in the TVT group (41.1 +/- 10.9 minutes; 6 [2.8-10.5] capsules and 1 [1-2] days vs. 57.1 +/- 18.3 minutes, 23.5 [18.0-31.5] capsules and 3 [3-3] days [p < 0.0001]). There was a significant reduction in ISI and IIQ scores in both groups and no differences in surgical complications, urgency, obstruction, one-hour pad test, urine culture, flowmetry, costs and cure rates at any moment during follow-up (cured/improved 76.2%, 78.3% and 77.3% at six months, one year and three years for TVT vs. 87.5%, 87.5% and 91.3% for CS; p = 0.32, p = 0.4 and p = 0.19).

LIMITATIONS

The trial is open, which can create observer bias. A study with a higher number of patients or a longer follow-up time could show differences between the procedures that we were unable to observe in this study, due to our budget and time limits.

DISCUSSION

Based on both short-term and long-term results, TVT is as effective as CS for the treatment of SUI, and has similar subjective cure and surgical complication rates. Time in surgery, consumption of analgesics and length of postoperative hospital stay are all lower in the TVT group. In our clinical setting, with a one-day postoperative stay for TVT, the two procedures have similar costs.

Authors+Show Affiliations

Urology Department, Severo Ochoa Hospital, Leganés, Madrid, Spain. migueltellez@hotmail.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng spa

PubMed ID

20096179

Citation

Téllez Martínez-Fornés, Miguel, et al. "A Three Year Follow-up of a Prospective Open Randomized Trial to Compare Tension-free Vaginal Tape With Burch Colposuspension for Treatment of Female Stress Urinary Incontinence." Actas Urologicas Espanolas, vol. 33, no. 10, 2009, pp. 1088-96.
Téllez Martínez-Fornés M, Fernández Pérez C, Fouz López C, et al. A three year follow-up of a prospective open randomized trial to compare tension-free vaginal tape with Burch colposuspension for treatment of female stress urinary incontinence. Actas Urol Esp. 2009;33(10):1088-96.
Téllez Martínez-Fornés, M., Fernández Pérez, C., Fouz López, C., Fernández Lucas, C., & Borrego Hernando, J. (2009). A three year follow-up of a prospective open randomized trial to compare tension-free vaginal tape with Burch colposuspension for treatment of female stress urinary incontinence. Actas Urologicas Espanolas, 33(10), 1088-96.
Téllez Martínez-Fornés M, et al. A Three Year Follow-up of a Prospective Open Randomized Trial to Compare Tension-free Vaginal Tape With Burch Colposuspension for Treatment of Female Stress Urinary Incontinence. Actas Urol Esp. 2009;33(10):1088-96. PubMed PMID: 20096179.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A three year follow-up of a prospective open randomized trial to compare tension-free vaginal tape with Burch colposuspension for treatment of female stress urinary incontinence. AU - Téllez Martínez-Fornés,Miguel, AU - Fernández Pérez,Cristina, AU - Fouz López,Concepción, AU - Fernández Lucas,Cristina, AU - Borrego Hernando,Jaime, PY - 2010/1/26/entrez PY - 2010/1/26/pubmed PY - 2010/8/25/medline SP - 1088 EP - 96 JF - Actas urologicas espanolas JO - Actas Urol Esp VL - 33 IS - 10 N2 - BACKGROUND: Evidence comparing the effectiveness of tension-free vaginal tape (TVT) with Burch colposuspension (CS) over a long-term follow-up is scarce. PURPOSE: To compare TVT with CS as primary treatment for female stress urinary incontinence (SUI). DESIGN: Open randomised clinical trial with a three-year follow-up period. PARTICIPANTS: 49 consecutive women aged 35 to 70 with SUI demonstrated by a urodynamic study. SETTING: Urology department of Severo Ochoa general hospital in Leganes, Madrid, Spain. INTERVENTION: 24 random patients treated with TVT and 25 with CS. MEASUREMENTS: Main variable: assessment before treatment and at six months, one year and three years after the operation using the incontinence severity index (ISI) and the incontinence impact questionnaire (IIQ). Secondary variable: three groups for assessing cure, improvement and failure rates. RESULTS: Time in surgery, consumption of postoperative analgesics and length of the postoperative hospital stay were lower in the TVT group (41.1 +/- 10.9 minutes; 6 [2.8-10.5] capsules and 1 [1-2] days vs. 57.1 +/- 18.3 minutes, 23.5 [18.0-31.5] capsules and 3 [3-3] days [p < 0.0001]). There was a significant reduction in ISI and IIQ scores in both groups and no differences in surgical complications, urgency, obstruction, one-hour pad test, urine culture, flowmetry, costs and cure rates at any moment during follow-up (cured/improved 76.2%, 78.3% and 77.3% at six months, one year and three years for TVT vs. 87.5%, 87.5% and 91.3% for CS; p = 0.32, p = 0.4 and p = 0.19). LIMITATIONS: The trial is open, which can create observer bias. A study with a higher number of patients or a longer follow-up time could show differences between the procedures that we were unable to observe in this study, due to our budget and time limits. DISCUSSION: Based on both short-term and long-term results, TVT is as effective as CS for the treatment of SUI, and has similar subjective cure and surgical complication rates. Time in surgery, consumption of analgesics and length of postoperative hospital stay are all lower in the TVT group. In our clinical setting, with a one-day postoperative stay for TVT, the two procedures have similar costs. SN - 1699-7980 UR - https://www.unboundmedicine.com/medline/citation/20096179/A_three_year_follow_up_of_a_prospective_open_randomized_trial_to_compare_tension_free_vaginal_tape_with_Burch_colposuspension_for_treatment_of_female_stress_urinary_incontinence_ L2 - https://linkinghub.elsevier.com/retrieve/pii/13146551 DB - PRIME DP - Unbound Medicine ER -