Long-term efficacy and complications of a multicentre randomised controlled trial comparing retropubic and transobturator mid-urethral slings: a prospective observational study.


Journal

BJOG : an international journal of obstetrics and gynaecology
ISSN: 1471-0528
Titre abrégé: BJOG
Pays: England
ID NLM: 100935741

Informations de publication

Date de publication:
12 2021
Historique:
accepted: 02 03 2021
pubmed: 4 9 2021
medline: 17 12 2021
entrez: 3 9 2021
Statut: ppublish

Résumé

There are concerns regarding the risks of mid-urethral slings (MUS) for stress urinary incontinence (SUI), particularly because of the lack of long-term data. We compare patient-reported outcomes of a multicentre randomised controlled trial of retropubic (TVT, GYNECARE™) versus transobturator (TOT, MONARC™) tape surgery at 12 years. A multicentre study was performed in 11 tertiary referral centres. A cohort of 180 participants from the original trial, the majority of whom had mixed urinary incontinence. Postal questionnaire survey of patient-reported outcome measures using the International Consultation on Incontinence Questionnaire, Patient Global Impression of Improvement questionnaire (PGI-I) and a numeric rating scale pain questionnaire. Comparison of the efficacy and complications between the TVT and TOT procedures in the long term. A total of 110/180 responses were received: 55 for TVT and 55 for TOT. The mean follow-up was 12.8 ± 0.29 years (SD). TVT was significantly superior to TOT: 41.8% TVT with no SUI, versus 21.8% TOT (P = 0.04). Urgency urinary incontinence (UUI) was the most bothersome urinary symptom: 14.5% of respondents reported UUI after TVT and TOT. This was an improvement from the baseline levels: 61.8% TVT and 76.4% TOT. Seventeen patients (9 TVT and 8 TOT) out of 121 reported moderate or severe pain with severe pain in 3 with TVT and 2 with TOT. Overall, 80% TVT and 77% TOT participants reported their symptoms as improved on the PGI-I. TVT is superior to TOT for SUI cure. Efficacy is reduced by 12 years. There is low incidence of severe vaginal or groin pain. Careful patient counselling on long-term outcomes is required. The Retropubic tape appears to be an effective treatment for the majority of women with SUI. Retropubic tape has superior efficacy to transobturator tape. Complications are comparable with low rates.

Identifiants

pubmed: 34478604
doi: 10.1111/1471-0528.16899
doi:

Types de publication

Journal Article Multicenter Study Observational Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

2191-2199

Subventions

Organisme : United Kingdom Continence Society

Investigateurs

I Offiah (I)
R Freeman (R)
M Waterfield (M)
K Lochhead (K)
T Hillard (T)
C Madhu (C)
A Sultan (A)
M James (M)
S Foley (S)
S Buckley (S)
M Speaksman (M)
F Reid (F)
P Abrams (P)

Commentaires et corrections

Type : CommentIn
Type : CommentIn

Informations de copyright

© 2021 John Wiley & Sons Ltd.

Références

https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf
NICE. Final Appraisal Determination Tension-free Vaginal Tape (Gynecare TVT) for Stress Incontinence. London, UK: National Institute for Health and Clinical Excellence; 2003.
Smith A, Bevan D, Douglas HR, James D. Management of urinary incontinence in women: summary of updated NICE guidance. BMJ 2013;347:f5170.
The Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women. Interim Report. October 2015.
SCENIHR Opinion on the safety of surgical meshes used in urogynecological surgery. December 2015.
Ford AA, Rogerson L, Cody JD, Aluko P, Ogah JA. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev 2017:CD006375. https://doi.org/10.1002/14651858.CD006375.pub4
Freeman R, Holmes D, Hillard T, Smith P, James M, Sultan A, et al. What patients think: patient reported outcomes of retropubic versus trans-obturator mid-urethral slings for urodynamic stress incontinence. A multicentre randomised controlled trial. Int Urogynecol J 2011;23:279-86.
Yalcin I, Bump RC. Validation of two Global Impression questionnaires for incontinence. Am J Obstet Gynecol 2003;189:98-101.
Homma Y, Yoshida M, Yamanishi T, Gotoh M. Core Lower Urinary Tract Symptom Score (CLSS) questionnaire: a reliable tool in the overall assessment of lower urinary tract symptoms. Int J Urol 2008;15:816-20.
Abrams P, Andersson KE, Apostolidis A, Birder L, Bliss D, Brubaker L, et al. 6th International consultation on Incontinence. Recommendations of the International Scientific Committee: evaluation and treatments of urinary incontinence, pelvic organ prolapse and faecal incontinence. Neurourol Urodyn 2018;2:2271-2.
Maggiore ULR, Agri EF, Soligo M, Marzi VL, Digesu A, Serati M. Long-term outcomes of TOT and TVT procedures for the treatment of female stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J 2017;28:1119-30.
Nilsson CG, Palva K, Aarnio R, Morcos E, Falconer C. Seventeen years' follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence. Int Urogynecol J 2013;24:1265-9.
Bakas P, Papadakis E, Karachalios C, Liapis I, Panagopoulos N, Liapis A. Assessment of the long-term outcomes of TVT procedure for stress urinary incontinence in a female population: results at 17 years follow-up. Int Urogynecol J 2019;30:265-9.
Bakas P, Papadakis E, Karachalios C, Beta A, Liapis A. Long-term efficacy follow-up of tension free vaginal tape obturator in patients with stress urinary incontinence with or without cystocoele. Int J Gynecol Obstet 2018;143:339-43.
Serati M, Braga A, Athanasiou S, Tommaselli GA, Caccia G, Torella M, et al. Tension-free vaginal tape-obturator for treatment of pure urodynamic stress urinary incontinence: efficacy and adverse effects at 10-year follow-up. Eur Urol 2017;71:674-9. https://doi.org/10.1016/j.eururo.2016.08.054
Abdel-Fattah M, Cao G, Mostafa A. Long-term outcomes for transobturator tension-free vaginal tapes in women with urodynamic mixed urinary incontinence. Neurourol Urodyn 2017;36:902-8.
Karmakar D, Hayward L. What can we learn from the vaginal mesh story? Climacteric 2019;22:277-82.
Offiah I, Rachaneni S, Dua A. Management of mid-urethral tape complications: a retrospective study. J Obstet Gynecol India 2019;70:152-7. https://doi.org/10.1007/s13224-019-01269-5
Toozs-Hobson P, Cardozo L, Hillard T. Managing pain after mesh implants in pelvic surgery. Eur J Obs Gyn Rep Biol 2019;234:49-52.
Ranson RN, Saffery MJ. Neurogenic mechanisms in bladder and bowel ageing. Biogerontology 2015;16:265-84.

Auteurs

I Offiah (I)

University of Plymouth, Plymouth, UK.
University Hospital Plymouth NHS Trust, Plymouth, UK.

R Freeman (R)

University Hospital Plymouth NHS Trust, Plymouth, UK.

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