A Prospective Multicentre Study of Adjustable Single-Incision Mini-Sling (Ajust®) in Management of Stress Urinary Incontinence in Women: 1-Year Follow-Up Study.

Mohamed Abdel-Fattah, Wael Agur, Mohamed Abdel-All, Karen Guerrero, Mohamed Allam, Alison Mackintosh, Alyaa Mostafa, Mohamed Yousef

Research output: Contribution to journalArticle

53 Citations (Scopus)

Abstract

Study Type – Therapy (individual cohort)

Level of Evidence 2b

What's known on the subject? and What does the study add?

A number of SIMS have been introduced into clinical practice in 2006 and has been so far shown to be inferior to standard mid urethral‐slings. Adjustable SIMS (Ajust) have been recently introduced into clinical practice however with little evidence on its safety and efficacy in surgical treatment of female SUI.

SIMS‐Ajust® is associated with low rates of postoperative pain and peri‐operative morbidity and is both feasible and acceptable under local anaesthesia. The patient reported success rate at 1‐year is 80%.

OBJECTIVES

•To determine whether an adjustable single‐incision mini‐sling (SIMS, Ajust®) is safe and effective in the management of female stress urinary incontinence (SUI) at 12 months follow‐up.

•To determine whether it is feasible to be performed under local anesthesia (LA).

MATERIALS AND METHODS

• The present study is a multicentre prospective cohort study in which 90 female patients underwent SIMS‐Ajust® using a standardized insertion technique.

• The last 45 women were offered the procedure under LA.

•All patients completed their 12‐month follow‐up.

RESULTS

• The patient‐reported success rate, using Patient Global Impression of Improvement (PGI‐I), was 80% at 12 months follow‐up and a further 6% (n= 5) reported themselves to be ‘improved’.

• In all, 32/45 (71%) patients agreed to undergo the procedure under LA while one patient required conversion to general anaesthetic. 
• There was no organ damage or requirement for blood transfusion. 
• Significantly lower rates of blood loss (P= 0.025) and postoperative voiding difficulties (P= 0.026) were seen in the LA group.
• The re‐operation rate for SUI was 6% at 12 months.

CONCLUSIONS

• SIMS (Ajust) appears to be a safe procedure, which is feasible under LA.

• SIMS (Ajust) have an 80% patient‐reported success rate at 12 months follow‐up.
Original languageEnglish
Pages (from-to)880-886
Number of pages7
JournalBJU International
Volume109
Issue number6
Early online date26 Aug 2011
DOIs
Publication statusPublished - Mar 2012

    Fingerprint

Cite this