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

50 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

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Stress Urinary Incontinence
Local Anesthesia
Multicenter Studies
Prospective Studies
General Anesthetics
Postoperative Pain
Reoperation
Blood Transfusion
Cohort Studies
Morbidity
Safety
Therapeutics

Cite this

A Prospective Multicentre Study of Adjustable Single-Incision Mini-Sling (Ajust®) in Management of Stress Urinary Incontinence in Women : 1-Year Follow-Up Study. . / Abdel-Fattah, Mohamed; Agur, Wael; Abdel-All, Mohamed; Guerrero, Karen; Allam, Mohamed; Mackintosh, Alison; Mostafa, Alyaa; Yousef, Mohamed.

In: BJU International, Vol. 109, No. 6, 03.2012, p. 880-886.

Research output: Contribution to journalArticle

Abdel-Fattah, Mohamed ; Agur, Wael ; Abdel-All, Mohamed ; Guerrero, Karen ; Allam, Mohamed ; Mackintosh, Alison ; Mostafa, Alyaa ; Yousef, Mohamed. / A Prospective Multicentre Study of Adjustable Single-Incision Mini-Sling (Ajust®) in Management of Stress Urinary Incontinence in Women : 1-Year Follow-Up Study. . In: BJU International. 2012 ; Vol. 109, No. 6. pp. 880-886.
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abstract = "Study Type – Therapy (individual cohort)Level of Evidence 2bWhat'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{\circledR} 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{\circledR}) 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{\circledR} 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.",
author = "Mohamed Abdel-Fattah and Wael Agur and Mohamed Abdel-All and Karen Guerrero and Mohamed Allam and Alison Mackintosh and Alyaa Mostafa and Mohamed Yousef",
note = "ACKNOWLEDGEMENTS We would like to thank Dr. Amr Mandy (Consultant Anaesthetist – NHS Grampian) for his expert advice in developing the Local Anaesthesia Program. We also thank Dr. Mohamed Riad (clinical research fellow, Crosshouse Hospital Kilmarnock), Audrey Connolly and Carol Archibald (Urogynaecobgy sisters, Greater Glasgow and Clyde health Board) for their role in patients follow-up. We would like to thank all participants.",
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TY - JOUR

T1 - A Prospective Multicentre Study of Adjustable Single-Incision Mini-Sling (Ajust®) in Management of Stress Urinary Incontinence in Women

T2 - 1-Year Follow-Up Study.

AU - Abdel-Fattah, Mohamed

AU - Agur, Wael

AU - Abdel-All, Mohamed

AU - Guerrero, Karen

AU - Allam, Mohamed

AU - Mackintosh, Alison

AU - Mostafa, Alyaa

AU - Yousef, Mohamed

N1 - ACKNOWLEDGEMENTS We would like to thank Dr. Amr Mandy (Consultant Anaesthetist – NHS Grampian) for his expert advice in developing the Local Anaesthesia Program. We also thank Dr. Mohamed Riad (clinical research fellow, Crosshouse Hospital Kilmarnock), Audrey Connolly and Carol Archibald (Urogynaecobgy sisters, Greater Glasgow and Clyde health Board) for their role in patients follow-up. We would like to thank all participants.

PY - 2012/3

Y1 - 2012/3

N2 - Study Type – Therapy (individual cohort)Level of Evidence 2bWhat'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.

AB - Study Type – Therapy (individual cohort)Level of Evidence 2bWhat'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.

U2 - 10.1111/j.1464-410X.2011.10471.x

DO - 10.1111/j.1464-410X.2011.10471.x

M3 - Article

VL - 109

SP - 880

EP - 886

JO - BJU International

JF - BJU International

SN - 1464-4096

IS - 6

ER -