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Five-year results of a randomized trial comparing retropubic and transobturator midurethral slings for stress incontinence.
Eur Urol. 2014 Jun; 65(6):1109-14.EU

Abstract

BACKGROUND

Midurethral slings have become the most preferred surgical treatment for female urinary incontinence.

OBJECTIVE

To compare the efficacy and safety of two midurethral sling procedures with a different technique of sling insertion 5 yr after intervention.

DESIGN, SETTING, AND PARTICIPANTS

Multicenter randomized clinical trial conducted in seven public hospitals in Finland including primary cases of stress urinary incontinence.

INTERVENTION

Surgical treatment with the retropubic tension-free vaginal tape (TVT) procedure or the transobturator tension-free vaginal tape (TVT-O) procedure.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Objective treatment success criteria were a negative stress test, a negative 24-h pad test, and no retreatment for stress incontinence. Patient satisfaction was assessed by condition-specific quality-of-life questionnaires.

RESULTS AND LIMITATIONS

A total of 95% of the included women could be assessed according to the protocol 5 yr after surgery. The objective cure rate was 84.7% in the TVT group and 86.2% in the TVT-O group, with no statistical difference between the groups. Subjective treatment satisfaction was 94.2% in the TVT group and 91.7% in the TVT-O group, with no difference between groups. Complication rates were low, with no difference between groups.

CONCLUSIONS

Both objective and subjective cure rates were >80% in both groups even when women lost to follow-up were included as failures. The complication rates were low, with no difference between the groups. No late-onset adverse effects of the tape material were seen.

PATIENT SUMMARY

Female urinary stress incontinence can be treated surgically with minimally invasive midurethral sling procedures. Two main approaches of sling placement have been developed: the retropubic and the transobturatory. We compared both approaches and followed the patients for 5 yr. We found no difference in cure rate between the procedures, and patient satisfaction was high.

TRIAL REGISTRATION

ClinicalTrials.gov identifier NCT00379314.

Authors+Show Affiliations

Turku University Hospital, Turku, Finland.South Carelia Central Hospital, Lappeenranta, Finland.Central Finland Central Hospital, Jyväskylä, Finland.Oulu University Hospital, Oulu, Finland.Kuopio University Hospital, Kuopio, Finland.Päijät-Häme Central Hospital, Lahti, Finland.Helsinki University Central Hospital, Helsinki, Finland. Electronic address: carl.nilsson@hus.fi.

Pub Type(s)

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

Language

eng

PubMed ID

24508070

Citation

Laurikainen, Eija, et al. "Five-year Results of a Randomized Trial Comparing Retropubic and Transobturator Midurethral Slings for Stress Incontinence." European Urology, vol. 65, no. 6, 2014, pp. 1109-14.
Laurikainen E, Valpas A, Aukee P, et al. Five-year results of a randomized trial comparing retropubic and transobturator midurethral slings for stress incontinence. Eur Urol. 2014;65(6):1109-14.
Laurikainen, E., Valpas, A., Aukee, P., Kivelä, A., Rinne, K., Takala, T., & Nilsson, C. G. (2014). Five-year results of a randomized trial comparing retropubic and transobturator midurethral slings for stress incontinence. European Urology, 65(6), 1109-14. https://doi.org/10.1016/j.eururo.2014.01.031
Laurikainen E, et al. Five-year Results of a Randomized Trial Comparing Retropubic and Transobturator Midurethral Slings for Stress Incontinence. Eur Urol. 2014;65(6):1109-14. PubMed PMID: 24508070.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Five-year results of a randomized trial comparing retropubic and transobturator midurethral slings for stress incontinence. AU - Laurikainen,Eija, AU - Valpas,Antti, AU - Aukee,Pauliina, AU - Kivelä,Aarre, AU - Rinne,Kirsi, AU - Takala,Teuvo, AU - Nilsson,Carl Gustav, Y1 - 2014/01/31/ PY - 2013/12/02/received PY - 2014/01/21/accepted PY - 2014/2/11/entrez PY - 2014/2/11/pubmed PY - 2015/2/24/medline KW - Midurethral slings KW - Randomized multicenter trial KW - Retropubic and transobturator procedures SP - 1109 EP - 14 JF - European urology JO - Eur. Urol. VL - 65 IS - 6 N2 - BACKGROUND: Midurethral slings have become the most preferred surgical treatment for female urinary incontinence. OBJECTIVE: To compare the efficacy and safety of two midurethral sling procedures with a different technique of sling insertion 5 yr after intervention. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized clinical trial conducted in seven public hospitals in Finland including primary cases of stress urinary incontinence. INTERVENTION: Surgical treatment with the retropubic tension-free vaginal tape (TVT) procedure or the transobturator tension-free vaginal tape (TVT-O) procedure. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Objective treatment success criteria were a negative stress test, a negative 24-h pad test, and no retreatment for stress incontinence. Patient satisfaction was assessed by condition-specific quality-of-life questionnaires. RESULTS AND LIMITATIONS: A total of 95% of the included women could be assessed according to the protocol 5 yr after surgery. The objective cure rate was 84.7% in the TVT group and 86.2% in the TVT-O group, with no statistical difference between the groups. Subjective treatment satisfaction was 94.2% in the TVT group and 91.7% in the TVT-O group, with no difference between groups. Complication rates were low, with no difference between groups. CONCLUSIONS: Both objective and subjective cure rates were >80% in both groups even when women lost to follow-up were included as failures. The complication rates were low, with no difference between the groups. No late-onset adverse effects of the tape material were seen. PATIENT SUMMARY: Female urinary stress incontinence can be treated surgically with minimally invasive midurethral sling procedures. Two main approaches of sling placement have been developed: the retropubic and the transobturatory. We compared both approaches and followed the patients for 5 yr. We found no difference in cure rate between the procedures, and patient satisfaction was high. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00379314. SN - 1873-7560 UR - https://www.unboundmedicine.com/medline/citation/24508070/Five_year_results_of_a_randomized_trial_comparing_retropubic_and_transobturator_midurethral_slings_for_stress_incontinence_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0302-2838(14)00100-6 DB - PRIME DP - Unbound Medicine ER -