Tags

Type your tag names separated by a space and hit enter

Comparison of the efficacy of tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of female stress urinary incontinence: a 1-year follow-up randomized trial.
Int Urogynecol J. 2016 Oct; 27(10):1497-505.IU

Abstract

INTRODUCTION AND HYPOTHESIS

The aim of this study was to compare the efficacy of the tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of stress urinary incontinence in a randomized two-arm study with a 1-year follow-up.

METHODS

This single-centre randomized trial compared the objective and subjective cure rates of TVT-O and Ajust using objective criteria (cough test) and subjective criteria (International Consultation on Incontinence Questionnaire short form, ICIQ-UI SF). The objective cure rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined as no stress leakage of urine after surgery based on the ICIQ-UI SF. The primary outcome was to establish differences in objective and subjective cure rates between the TVT-O and Ajust groups. We also compared postoperative pain profiles using a visual analogue scale (VAS), improvement in quality of life using the ICIQ- UI SF and the Incontinence Quality of Life questionnaire, and overall satisfaction with the surgical procedure using a VAS and a five-item Likert scale. Inclusion criteria were age over 18 years, signed informed consent, and urodynamic stress urinary incontinence. Following a power calculation, 50 patients were enrolled into each group (Ajust and TVT-O).

RESULTS

The mean follow-up after surgery was 445 days (SD 157.6 days) in the TVT-O group and 451.8 days (SD 127.6 days) in the Ajust group (p = 76.6 %). At 1 year, 47 patients were evaluated in the TVT-O group and 49 in the Ajust group. No differences in subjective cure rates or objective cure rates were observed. In the Ajust and TVT-O groups, the rates for no subjective stress leakage were 89.8 % and 91.5 %, respectively (p = 1.0, OR 1.22, 95 % CI 0.24 - 6.58), and the rates for a negative stress test were 89.8 % and 87.2 %, respectively (p = 0.76, OR 0.77, 95 % CI 0.17 - 3.32). In the Ajust group two patients reported de novo pain during sexual intercourse.

CONCLUSIONS

After a 1-year-follow-up, no significant differences were found with regard to subjective and objective outcomes between the single-incision tape Ajust and TVT-O.

Authors+Show Affiliations

Department of Obstetrics and Gynaecology, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic.Department of Obstetrics and Gynaecology, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic. kamil@svabik.cz.Faculty of Sciences, Charles University Prague, Prague, Czech Republic.Department of Obstetrics and Gynaecology, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic.1st Faculty of Medicine, Charles University Prague, Prague, Czech Republic.Department of Obstetrics and Gynaecology, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27037563

Citation

Masata, Jaromir, et al. "Comparison of the Efficacy of Tension-free Vaginal Tape Obturator (TVT-O) and Single-incision Tension-free Vaginal Tape (Ajust™) in the Treatment of Female Stress Urinary Incontinence: a 1-year Follow-up Randomized Trial." International Urogynecology Journal, vol. 27, no. 10, 2016, pp. 1497-505.
Masata J, Svabik K, Zvara K, et al. Comparison of the efficacy of tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of female stress urinary incontinence: a 1-year follow-up randomized trial. Int Urogynecol J. 2016;27(10):1497-505.
Masata, J., Svabik, K., Zvara, K., Hubka, P., Toman, A., & Martan, A. (2016). Comparison of the efficacy of tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of female stress urinary incontinence: a 1-year follow-up randomized trial. International Urogynecology Journal, 27(10), 1497-505. https://doi.org/10.1007/s00192-016-3012-x
Masata J, et al. Comparison of the Efficacy of Tension-free Vaginal Tape Obturator (TVT-O) and Single-incision Tension-free Vaginal Tape (Ajust™) in the Treatment of Female Stress Urinary Incontinence: a 1-year Follow-up Randomized Trial. Int Urogynecol J. 2016;27(10):1497-505. PubMed PMID: 27037563.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of the efficacy of tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of female stress urinary incontinence: a 1-year follow-up randomized trial. AU - Masata,Jaromir, AU - Svabik,Kamil, AU - Zvara,Karel, AU - Hubka,Petr, AU - Toman,Ales, AU - Martan,Alois, Y1 - 2016/04/01/ PY - 2015/12/02/received PY - 2016/03/14/accepted PY - 2016/4/3/entrez PY - 2016/4/3/pubmed PY - 2017/8/9/medline KW - Ajust™ KW - Single incision midurethral sling KW - Stress urinary incontinence KW - Surgical treatment KW - TVT-O SP - 1497 EP - 505 JF - International urogynecology journal JO - Int Urogynecol J VL - 27 IS - 10 N2 - INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the efficacy of the tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of stress urinary incontinence in a randomized two-arm study with a 1-year follow-up. METHODS: This single-centre randomized trial compared the objective and subjective cure rates of TVT-O and Ajust using objective criteria (cough test) and subjective criteria (International Consultation on Incontinence Questionnaire short form, ICIQ-UI SF). The objective cure rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined as no stress leakage of urine after surgery based on the ICIQ-UI SF. The primary outcome was to establish differences in objective and subjective cure rates between the TVT-O and Ajust groups. We also compared postoperative pain profiles using a visual analogue scale (VAS), improvement in quality of life using the ICIQ- UI SF and the Incontinence Quality of Life questionnaire, and overall satisfaction with the surgical procedure using a VAS and a five-item Likert scale. Inclusion criteria were age over 18 years, signed informed consent, and urodynamic stress urinary incontinence. Following a power calculation, 50 patients were enrolled into each group (Ajust and TVT-O). RESULTS: The mean follow-up after surgery was 445 days (SD 157.6 days) in the TVT-O group and 451.8 days (SD 127.6 days) in the Ajust group (p = 76.6 %). At 1 year, 47 patients were evaluated in the TVT-O group and 49 in the Ajust group. No differences in subjective cure rates or objective cure rates were observed. In the Ajust and TVT-O groups, the rates for no subjective stress leakage were 89.8 % and 91.5 %, respectively (p = 1.0, OR 1.22, 95 % CI 0.24 - 6.58), and the rates for a negative stress test were 89.8 % and 87.2 %, respectively (p = 0.76, OR 0.77, 95 % CI 0.17 - 3.32). In the Ajust group two patients reported de novo pain during sexual intercourse. CONCLUSIONS: After a 1-year-follow-up, no significant differences were found with regard to subjective and objective outcomes between the single-incision tape Ajust and TVT-O. SN - 1433-3023 UR - https://www.unboundmedicine.com/medline/citation/27037563/Comparison_of_the_efficacy_of_tension_free_vaginal_tape_obturator__TVT_O__and_single_incision_tension_free_vaginal_tape__Ajust™__in_the_treatment_of_female_stress_urinary_incontinence:_a_1_year_follow_up_randomized_trial_ L2 - https://dx.doi.org/10.1007/s00192-016-3012-x DB - PRIME DP - Unbound Medicine ER -