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Research Article: Systematic Review and Meta-Analysis

Focusing on long-term complications of mid-urethral slings among women with stress urinary incontinence as a patient safety improvement measure

A protocol for systematic review and meta-analysis

Lin, Yi-Hao MDa,b; Lee, Cheng-Kai MDc; Chang, Shuenn-Dyh MDa,b; Chien, Pei-Chun NPc; Hsu, Yu-Ying NPc; Tseng, Ling-Hong MDc,∗

Editor(s): Bayraktar., Burak

Author Information
doi: 10.1097/MD.0000000000026257
  • Open


1 Introduction

Stress urinary incontinence (SUI) is urinary incontinence caused by increasing intra-abdominal pressure increases, such as on effort or exertion, such as cough or sneezing.[1] SUI affects many women, especially the aged and although it is not life-threatening, SUI can compromise social, economic functions and psychology of affected individuals.[2] Treatment for SUI can begin with conservative means including lifestyle modification, physiotherapy (pelvic floor muscle training or using incontinence pessary), or injection of periurethral materials, whereas surgical treatment may be considered should conservative management fail.

Among all kinds of surgeries for SUI, open abdominal retropubic suspension, laparoscopic retropubic suspension, anterior vaginal repair, needle suspensions, and traditional suburethral sling were once preferred surgical interventions yet become less in use because of lower effectiveness and higher risk of postoperative complications.[3] With the evolution of surgical methods, mid-urethral sling (MUS) is the current mainstay surgical treatment of SUI. There are 3 different types of MUS, retropubic (RP), transobturator (TO), and single incision (SI). The RP-MUS has incisions on the abdominal wall and the vagina, and the tape is passed through the retropubic space. The tape can be inserted from vagina to abdominal wall (bottom-to-top, eg, tension-free vaginal tape [TVT] [Ethicon Inc., Somerville, NJ])[4] or from abdominal wall to vagina (top-to-bottom, eg, suprapubic arc [American Medical Systems, Minnetonka, MN]).[5] For the TO-MUS, the tape is inserted through the 2 obturator foramen, either from the vagina to the skin of groin area (inside-out, eg, TVT-O [Gynecare TVT-Obturator System, Ethicon, Inc., Somerville, NJ])[6] or from the skin of groin area to vagina (outside-in, eg, TOT/MONARC [American Medical Systems, Minnetonka, MN]).[7] The SI-MUS (eg, Needleless [Mayumana Healthcare, Lisse, The Netherlands][8]; Adjust [CR Bard Inc., Covington, GA])[9] is different from full-length RP and TO-MUS in 2 ways: they (the tapes per se) are shorter, approximately 8 cm rather than 40 cm, and they require only a vaginal incision, and not an abdominal incision.

Initiating patient safety awareness is an attribute of health care systems in hopes to minimize the incidence and impact of, and maximize recovery from, adverse events. Thus, it is clinically relevant is to investigate postoperative complications and consequently figure out how to manage those conditions to bring benefits to patients. The objective of this article was to update the available data pertaining to operative complications of MUS procedures. We have used the optimized literature search algorithm to identify appropriate literatures on the subject of MUS procedures for women with SUI from the MEDLINE.[10]

2 Materials and methods

2.1 Literature search

In September 2020, we applied the optimized literature search algorithm Etblast ( to retrieve relevant studies on the topic of MUS procedures for women with SUI from the MEDLINE. We utilized both “MeSH" and “free text" protocols as complex search strategy. Specifically, we used the MeSH terms “urinary incontinence,” “midurethral slings,” and “complications” in combination. Multiple “free text" searches were performed by using the following terms singly and in combination: midurethral sling, retropubic, TVT, tension free tape, transobturator, transobturator tape, transobturator tape using the out–in technique (TOT), TVT-O, Monarc, suprapubic arc, and single incision sling, Needleless and Adjust. Additionally, references from retrieved publications were checked to find extra articles on the topic. Published articles from 2009 to September 2020 were selected for analysis.

2.2 Selection criteria

The collected searches were subject to the following limits: full text available, meta-analysis, randomized controlled trial (RCT), systematic review, review; female participants >18 years diagnosed with SUI; the outcomes should include postoperative complications of MUS and patients’ subjective cure rate and objective cure rate; 10 years, species (humans), sex (female), language (English). The “Find Expert” and “Find Journal” functions of the eTBLAST suggested published relevant studies to the query. References and reports cited in identified research articles were also examined.

2.3 Data extraction and quality assessment

Two authors (LYH and LCK) assessed the abstracts and full texts to select the articles relevant to the review topic by the following criteria (Fig. 1): they were studies (eg, meta-analysis, RCT, systematic review, review) of MUS for SUI; complications measures were clearly defined. All follow-up periods were available. Subsequently, we evaluated those articles and abstracted the following information: study design, type of intervention, number of patients, follow-up in months, perioperative complications (defined as vascular or bladder/vaginal injury, hematoma, infection), postoperative lower urinary tract symptoms (including storage and voiding), postoperative pain, dyspareunia, sexual dysfunction, and late complications such as tape erosion and/or extrusion. The study did not take in the TVT-Secur (ETHICON) and the MiniArc (ASTORA) which were withdrawn or recalled from the market. Since this study was a systematic review, it was exempted from human research review committee approval.

Figure 1:
Flowchart of study selection in the systemic review.

3 Results

Our search identified 378 published articles, of which 323 were excluded on the basis of title or abstract due to procedures other than MUS in retropubic, transobturator or single incision route, or lack of discussions about complications. Among the remaining 55 articles, 35 were RCTs, 12 were systematic review and meta-analysis, and 8 were reviews. Since no reported RCT focused on complications of MUS, effect estimate statistics are not suitable for meta-analysis so a meta-analysis cannot proceed.

The 55 articles were summarized chronologically in Table 1 with detailed information on study design, intervention and comparator, measurements of reported complications and follow-up duration that were listed by the following order: RCT, systematic review/meta-analysis and review.[11–65]

Table 1 - Summary of chronological reported studies.
Study Design Intervention Comparison Follow-up duration Complications
Palos et al,[11] 2018 RCT TOT 47 RP-MUS 45 12 mo Bladder perforation RP 2.5%, TO 2.4%
Urinary infection RP 29.3%, TO 30%
Deep vein thrombosis RP 2.5%, TO 0%
Tape extrusion RP 0%, TO 2.4%
Urinary retention RP 7.5%, TO 2.4%
De novo urgency RP 0%, TO 2.4%
Dyspareunia RP 2.5%, TO 0%
Tammaa et al,[12] 2018 RCT TVT-O 170 TVT 161 60 mo Tape erosions TVT 3%, TVT-O 3%
UTI TVT 21.2%, TVT-O 18.2%
LUTS TVT 2.8%, TVT-O 7.9%
Tape-related pain TVT 1.4%, TVT-O 2.7%
Detrusor overactivity TVT 6.4%, TVT-O 6.4%
Dogan et al,[13] 2018 RCT SI-MUS 84 TVT-O 41 18 mo Palpable mesh fiber on anterior vaginal wall in SI group (2.4%), else not mentioned
Pascom et al,[14] 2018 RCT SI-MUS 69 TOT 61 36 mo Further SUI surgery SI 17%, TOT 4.9%
Tape exposure SI 4.9%, TOT 4.9%
De novo urgency SI 12.2%, TOT 4.9%
Schellart et al,[15] 2018 RCT TOT 75 36 mo Reintervention 5.2%
Unintentional perforation 5.2%
Post voiding residual 1%
Dyspareunia 0%
Tieu et al,[16] 2017 RCT TOT 42 12 mo De novo urgency 0.7%
Repeat SUI surgery 12%
Vaginal mesh exposure 6.1%
Fernandez et al,[17] 2017 RCT SI-MUS 87 TOT 96 12 mo De novo urgency SI 10.1%, TOT 12.5%
Persistent urgency SI 20.2%, TOT 11.5%
Difficulty urinating SI 0%, TOT 2%
Mesh extrusion SI 4.5%, TOT 7.3%
UTI SI 2.2%, TOT 1%
Zhang et al,[18] 2016 RCT TVT 58 TVT-O 62 95 mo Postoperative urinary difficulty TVT 10%, TVT-O 2.9%
De novo voiding symptoms TVT 20.7%, TVT-O 11.3%
De novo storage symptoms TVT 12.1%, TVT-O 9.7%
Recurrent UTI TVT 8.6%, TVT-O 4.8%
De novo dyspareunia TVT 5.2%, TVT-O 8.1%
Tape exposure TVT 3.5%, TVT-O 8.1%
Costantini et al,[19] 2016 RCT TVT 40 TOT 47 100 mo De novo storage symptoms TVT 5%, TOT 14.9%
De novo voiding symptoms TVT 12.5%, TOT 14.9%
Mesh complication TVT 5%, TOT 14.9%
Ross et al,[20] 2016 RCT TVT 93 TOT 83 60 mo Vaginal mesh exposure TVT 2%, TOT 7%
Urine retention requiring intervention TVT 6%, TOT 4%
Substantial pain TVT 21%, TOT 10%
Schellart et al,[21] 2016 RCT TOT 72 24 mo Haemorrhage right groin 2%
Exposure requiring re-operation 4%
Failure needing re-operation 4%
UTI 33%
Overactive bladder symptoms 13%
Pain limiting normal mobility 17%
Masata et al,[22] 2016 RCT SI-MUS 49 TVT-O 47 12 mo De novo urgency TVT-O 8.5%, SI 10.2%
De novo dyspareunia TVT-O 0%, SI 6.3%
Reoperation for SUI TVT-O 1%, SI 0%
Tape erosion TVT-O 0%, SI 0%
Jurakova et al,[23] 2016 RCT SI-MUS 44 TVT-O 46 12 mo Major postoperative complications TVT-O 0%, SI 0%
Vaginal tape erosion TVT-O 0%, SI 0%
Gaber et al,[24] 2016 RCT SI-MUS 69/70 TVT-O 70 12 mo De novo urge incontinence at 1 mo SI 7.1%–11.6%, TVT-O 5.7%
De novo voiding difficulty at 1 month SI 4.3%–8.7%, TVT-O 2.9%
Martinez et al,[25] 2015 RCT SI-MUS 131 TVT-O 108 54 mo De novo urgency SI 8.4%, TVT-O 12.9%
Difficulty urinating SI 0.7%, TVT-O 0.9%
Mesh extrusion SI 2.3%, TVT-O 1.9%
Recurrent UTI SI 0.7%, TVT-O 0.9%
Lee et al,[26] 2015 RCT TOT 103 12 mo Repeat surgery 1.8%
Groin pain 6.2%
Tommaselli et al,[27] 2015 RCT TVT-O 62 60 mo UTI 19.6%
De novo urgency 4.3%
Repeated anti-incontinence surgery 19.6%
Laurikainen et al,[28] 2014 RCT TVT 131 TVT-O 123 60 mo De novo urgency incontinence TVT 3.1%, TVT-O 2.4%
UTI TVT 20.6%, TVT-O 22.1%
No woman had any sign of tissue reaction, erosion, or tape protrusion.
Nyyssönen et al,[29] 2014 RCT TVT 50 TOT 50 46 mo De novo urgency TVT 3%–25%%, TOT 6%–25%
Scheiner et al,[30] 2014 RCT TVT 50 TOT 28/TVT-O 34 12 mo Bladder perforation TOT/TVT-O 0%, TVT 3.7%
Vaginal perforation TOT/TVT-O 1.3%–15%, TVT 10%
Voiding obstructions TOT/TVT-O 2.5%, TVT 2.5%
Vaginal tape exposure TOT/TVT-O 1.5%–10%, TVT 0%
Thigh or groin pain TOT/TVT-O 1.5%–8.3%, TVT 2.7%
Sexual dysfunction TOT/TVT-O 1.9%–17.2%, TVT 0%
Abdel et al,[31] 2014 RCT TOT 112 TVT-O 126 36 mo None of the women reported thigh pain
Late vaginal erosion TOT 1.8%
Recurrent UTI 1.7%
Repeat continence surgery 6%
Bianchi et al,[32] 2014 RCT TVT-O 54 24 mo Urinary retention 3.5%
UTI 7.1%
Thigh pain 26.7%
Tape exposure 5.3%
De novo urgency 3.5%
SUI surgical revision 3.5%
Ross et al,[33] 2014 RCT TVT 30 12 mo Bladder perforation 2.9%
Djehdian et al,[34] 2014 RCT SI-MUS 64 TOT 56 12 mo Tape exposure SI 9.4%, TOT 8.9%
De novo urgency SI 6.3%, TOT 7.1%
UTI SI 28.1%, TOT 21.4%
Thigh pain SI 0%, TOT 7.1%
Ecchymosis SI 0%, TOT 5.4%
Schellart et al,[35] 2014 RCT TOT 87 12 mo UTI 4.2%
Reoperation 3.1%
Bladder retention 1%
Wadie et al,[36] 2013 RCT TVT 36 TOT 35 24 mo Bladder injury TVT 6.7%, TOT 2.4%
Thigh pain TOT 9.5%
De novo urge TOT 7.1%
Vaginal extrusion TOT 2.4%
Prolonged retention TVT 2.2%, TOT 2.4%
Injury of inferior epigastric vessels TVT 2.2%
Basu et al,[37] 2013 RCT TVT 33 36 mo Repeat continence procedure 0%
SUI symptoms 9%
Mostafa et al,[38] 2013 RCT SI-MUS 69 TVT-O 62 12 mo Voiding dysfunction SI 1.4%, TVT-O 2.9%
Vaginal erosion SI 1.4%, TVT-O 2.9%
Grigoriadis et al,[39] 2013 RCT SI-MUS 85 TVT-O 86 22.3 mo Postoperative groin pain TVT-O 5.8%
Dull pain deep inside the vagina SI 3.5%
No postoperative urinary retention
Schierlitz et al,[40] 2012 RCT TVT 72 TOT 75 36 mo SUI at 6 or 12 mo TOT 28%, TVT 16.3%
Repeat sling procedure at 36 mo TOT 18.3%, TVT 1.2%
Barber et al,[41] 2012 RCT TVT 127 12 mo Stress incontinence 14%
Urge incontinence 29%
Bladder perforation 4.8%
Voiding dysfunction 2.4%
Masata et al,[42] 2012 RCT TVT-O 68 24 mo De novo urgency 19.1%
Tape cut 2.9%
Tape erosion 1.5%
UTI 2.9%
Teo et al,[43] 2011 RCT TVT 66 TVT-O 61 12 mo Hemorrhage TVT-O 1.5%, TVT 1.6%
Intermittent self-catheterization TVT-O 1.6%, TVT 4.5%
Vaginal injury TVT-O 4.9%, TVT 0%
Leg pain TVT-O 26.4%, TVT 1.7%
De novo/worsening overactive bladder TVT-O 11.3%, TVT 5.1%
Vaginal tape erosion TVT-O 2%, TVT 5.3%
Angioli et al,[44] 2010 RCT TVT 35 TVT-O 37 60 mo De novo urgency TVT 5.7%, TVT-O 2.7%
Urinary retention TVT 0%, TVT-O 0%
Chronic pelvic pain TVT 0%, TVT-O 2.7%
Pain during intercourse TVT 2.9%, TVT-O2.7%
Incontinence during intercourse TVT 5.7%, TVT-O 5.4%
Vaginal erosions TVT 5.7%, TVT-O 2.7%
Deffieux et al,[45] 2010 RCT TVT 75 TVT-O 74 24 mo Bladder injury TVT 5%, TVT-O 2%
Urethral injury TVT 1%
Vaginal extrusion TVT-O 1%
Repeat surgery (reintervention) TVT 2.7%, TVT-O 1.4%
Bladder outlet obstruction symptoms TVT10%, TVT-O 5%
Kim et al[46] Meta-analysis Oct. 2017 29 included RCTs Standard midurethral slings (SMUS) vs SI-MUS
Sexual function: No significant difference
Postoperative pain scores: No significant difference
Bladder injury, UTI, urinary retention, de novo urgency, mesh extrusion, groin pain,vaginal erosion, tape release, urgency, and re-operation: No significant difference
Voiding dysfunction was less observed in SI-MUS
Bai et al[47] Meta-analysis Dec. 2016 8 studies Adjustable SI-MUS (Ajust) vs other slings (TOT, TVT-O)
Groin pain SI 2%, TOT/TVT-O 5.8%
Repeated continence surgery SI 2.1%–7.2% TOT/TVT-O 1.9%–4.4%
Postoperative voiding difficulties SI 2.2%–4.3% TOT/TVT-O 2%–11.7%
Vaginal tape erosion SI 1.5%–4.3% TOT/TVT-O 1.6%–1.8%
De novo urgency and/or worsening of preexisting surgery SI 7%–25% TOT/TVT-O 8.7%–21.1%
Jiao et al[48] Meta-analysis Nov. 2017 12 studies Single-incision mini-slings (MiniArc) vs transobturator mid-urethral slings
Postoperative groin pain TO 3.6%–57.6%
Urinary retention TO 1.9%–51%
Repeat stress incontinence surgery TO 1%–6.7%
Bladder perforation. TO 1.8%–5.2%
De novo urgency TO 4.4%–19.5%
UTI TO 4.4%–19.5%
Vaginal mesh erosion TO 1.4%–1.8%
Sexual function TO 0%
Fusco et al[49] Meta-analysis Nov. 2016 28 studies The comparative data on colposuspensions, pubovaginal slings, and midurethral tapes
Bladder/vaginal perforation RP-TVT 0.8%–11.4%, TVT-O 0.8%–10%
Pelvic haematoma RP-TVT 0.7%–5.5%, TVT-O 1.4%–2.4%
Vaginal erosions RP-TVT 1.2%–5.9%, TVT-O 0.8%–7%
UTI RP-TVT 3.5%–20.6%, TVT-O 0.7%–21.9%
Storage lower urinary tract symptoms RP-TVT 2.2%–35.3%, TVT-O 1.2%–28.6%
Voiding lower urinary tract symptoms RP-TVT 2.6%–21.4%, TVT-O 0.8%–15.7%
CIC RP-TVT 0.7%–13.9%, TVT-O 1.5%–17%
Reoperation rate RP-TVT 1.5%–17.6%, TVT-O 0.4%–17%
Ford et al[50] Meta-analysis Jun. 2014 81 studies Mid-urethral sling
Bladder or urethral perforation RP 4.9%, TO 0.6%
Voiding dysfunction RP 7.2%, TO 3.8%
De novo urgency or urgency incontinence RP 8.2%, TO 8%
Groin pain RP 1.4%, TO 6.6%
Suprapubic pain RP 2.9%, TO 0.8%
Vaginal tape erosion RP 2%, TO 2.2%
Repeat incontinence surgery RP 1.1%, TO 10%
Nambiar et al[51] Meta-analysis Feb. 2013 31 studies Single-incision sling
Major vascular or visceral injury SI 1.6%
Vaginal wall perforation SI 1.6%, RP 1.6%
Bladder or urethral perforation SI 0.7%–2.9%, RP 2.9%–4.7%
Urinary retention SI 1.5%–10%, RP 2.4%–9.3%
Infection SI 10%, RP 5%
Vaginal mesh exposure SI 5.4%, RP 0.7%
Mesh extrusion into the bladder or urethra SI 3.3%, RP 6.9%
Dyspareunia SI 10%, RP 3.4%
De novo urgency SI 13.3%–35.3%, RP 6.5%–15.6%
New-onset detrusor overactivity SI 5.4%, RP 6%
Repeat stress incontinence surgery SI 1.5%–24.3%, RP 3.1%
Pergialiotis et al[52] Meta-analysis 2016 32 studies De novo overactive bladder following midurethral sling procedures
De novo OAB SI 7.4%–10.2%, TO 2.4%–8.5%, RP 3%
Leone et al[53] Meta-analysis Oct. 2016 16 studies Long-term outcomes of TOT and TVT procedures
De novo OAB TOT 3.9%–9.7%, TVT 1.4%–10.1%
Voiding dysfunction TOT 0.8%–11.3%, TVT 0.6%–20.6%
Vaginal tape erosion TOT 0.8%–14.9% TVT 1.6%–6.4%
Bladder tape erosion TOT 2.6%, TVT 0.6%
Groin pain TOT 3.9%–33.9%, TVT 1.7%–6.7%
Recurrent UTI TOT 4.3%–4.8%, TVT 7.5%–8.6%
Tommaselli et al[54] Meta-analysis Jun. 2014 11 studies Midurethral slings
Pain RP 1.8%, TO 5.7%
Urinary retention RP 5.4%, TO 4%
Infection RP 2.7%, TO 3.8%
Hematoma/bleeding RP 3.7%, TO 3.9%
Vaginal injury RP 0.4%, TO 3.3%
Bladder/urethral injury RP 2.5%, TO 0.4%
UTI RP 9.3%, TO 3%
De novo urgency RP 10%, TO 10.2%
Tape erosion RP 2.1%, TO 2.7%
Sun et al[55] Meta-analysis 2011 18 studies Comparison between the retropubic and transobturator approaches
Bladder perforation TO 0.2%–0.7%, RP 0.3%–0.5%
Hematoma TO 1.4%, RP 1.9–2.9%
Thigh/groin pain TO 8%–8.4%, RP 2.9%–4.6%
Voiding dysfunction TO 0.5%–2.4%, RP 3.3%–4.4%
De novo urgency TO 5.9%–8.5%, RP 5.6%–8.6%
Tape erosion TO 1.5%–1.9%, RP 0.7%–1.6%
Seklehner et al[56] Meta-analysis Jan. 2014 21 studies The performance of retropubic mid urethral slings vs transobturator mid urethral slings
Mesh erosion/exposure TO 0.8%–5.4%, RP 0.9%–5.7%
Urinary retention TO 0.6%–17%, RP 2.7%–15.8%
LUTS TO 0.6%–17%, RP 2.7%–15.8%
Perforation bladder TO 1.4%–4.8%, RP 0.7%–8%
Perforation vagina TO 4.2%–12.5%, RP 1.1%–2%
Infection TO 0.7%–29.3%, RP 3.4%–26.1%
Neurologic symptoms TO 2.7%–23%, RP 1.3%–8.2%
Jha et al[57] Meta-analysis 2009 21 studies Impact of incontinence surgery on sexual function
A significant reduction in coital incontinence (OR 0.11; 95% CI 0.07–0.17)
Linder et al[58] Review 2019 Synthetic midurethral slings
Bladder perforation 1%–34%; More common with RP passage
Vascular injury RP 0.7%–8%, TO 0–2%
Bowel injury RP 0.03%–0.07%
Postoperative pain. groin pain TO > RP
1.3% persistent urinary urgency (which was present preoperatively)
De novo urinary urgency, and/or bladder outlet obstruction RP 3% TO 0%
Urinary retention 21.8%
Vaginal mesh exposure 1.5% to 2%
Gomes et al[59] Review 2017 Update on complications of synthetic suburethral slings
Bleeding RP 0.7%–8%, TO 0–2%
Bladder injury RP 0.7%–24%, TO 0–15%
Urethral injury RP 0.1%–0.2%, TO 0.1%–2.5%
Urethral erosion RP 0.03%–0.8%, TO 0.03%–0.8%
Intestinal injury RP 0.03%–0.7%, TO 0%
Vaginal erosion RP 0–1.5%, TO 0%–10.9%
UTI RP 7.4%–13%, TO 7.4%–13%
Pain RP 4%, TO 9.4%
Urgency “de novo" RP 0.2%–25%, TO 0–15.6%
Bladder outlet obstruction RP 6%–18.3%, TO 3.0%–11%
Urinary retention RP 4.1%–19.5%, TO 2.7%–11%
Alwaal et al[60] Review 2016 Female sexual function following mid-urethral slings
PISQ-12 Improvements
Pastore et al[61] Review 2016 Sexual Function and Quality of Life: TOT vs SI-MUS
Improved in all the six Female Sexual Function Index domains
Blaivas et al[62] Review 2015 Safety considerations for synthetic sling surgery
Urethral obstruction/voiding dysfunction 5.5%
Urethral obstruction requiring surgery 3.2%
Urinary infections 4.5%
De novo OAB 10.2%
Pelvic organ perforation 3.3%
Mesh exposure/erosion/extrusion 2.7%
Refractory pain 3.5%
Neurologic symptoms 2.0%
Fistulas 0.3%
Kirby et al[63] Review 2013 Indications, contraindications, and complications of mesh in the surgical treatment of urinary incontinence
Failure to correct incontinence 27%–18%
Voiding dysfunction RP 2.7%, TO 2.7%
Postoperative urge symptoms RP 6%–25%, TO 6%
De novo urgency incontinence RP 0%, TO 0.3%
Persistent postoperative urgency incontinence RP 12%, TO 10%
UTI RP 12.8%, TO 17.7%
Bladder and urethral perforation RP 3.5%, TO 6.6%
Vaginal perforation RP 2%, TO 4%
Pelvic hematomas 1.4%
Vaginal mesh exposure RP 4.4%, TO 2.7%
Cerruto et al[64] Review 2011 Transobturator versus retropubic synthetic slings
Postoperative pain RP 1.7%, TO 12%
Voiding dysfunction RP 7%, TO 4%
Bladder perforations RP 5.5%, TO 0.3%
Brubaker et al[65] Review 2011 Adverse events over 2 y after retropubic or transobturator midurethral sling surgery
Bladder perforation RP 4.4%, TO 0%
Urethral perforation RP 0.4%, TO 0%
Mesh erosion RP 0.4%, TO 0.5%
Mesh exposure RP 4%, TO 2.3%
Recurrent UTI RP 21%, TO 13%
Surgical site infection RP 0.9%, TO 0%
Neurologic symptoms RP 5.8%, TO 8.1%
Voiding dysfunction RP 1.8%, TO 2.7%
De novo urge incontinence RP 0%, TO 0.5%
Persistent urge incontinence RP 15%, TO 14.9%
LUTS = lower urinary tract symptoms, MUS = midurethral sling, OAB = overactive bladder, PISQ = Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, RCT = randomized controlled trial, RP = = retropubic approach, SI = single incision, SUI = stress urinary incontinence, TO = transobturator approach, TOT = transobturator tape using the out–in technique, TVT = = tension-free vaginal tape using the retropubic technique, TVT-O = transobturator tape using the in–out technique, UTI = Urinary tract infection.

Perioperative complications were summarized in Table 2 for comprehensive comparing in percentages between the groups. All collected studies were listed in the reference section.

Table 2 - Perioperative complications between the groups.
Complications RP-MUS TO-MUS SI-MUS
Bladder perforation 0.8%–11.4% 0.8%–10% 0.7%–2.9%
Vaginal injury 0.8%–11.4% 0.8%–15% 1.6%
Hemorrhage 1.6% 1.5%
Hematoma 0.7%–5.5% 1.4%–2.4%
UTI 0.9%–29.3% 4.8%–33% 0.7%–28.1%
LUTS 0%–15% 2.4%–29% 4.3%–10.2%
Urine retention 0.8%–11.4% 0.8%–10% 0.7%–2.9%
De novo urgency 0%–29% 0.7%–25% 4.3%–12.2%
Post-op pain 1.4%–2.1% 1.5%–26.7% 0%–3.5%
Tape erosion/extrusion 0%–5.7% 1.9%–10% 1.4%–4.5%
Further SUI surgery 0%–2.7% 1.4%–19.6% 0%–17%
Deep vein thrombosis 2.5% 0%
Injury of inferior epigastric vessels 2.2%
Sexual dysfunction 0%–5.2% TOT 1.9%; TVT-O 0%–17.2% 6.3%
LUTS = lower urinary tract symptoms, MUS = midurethral sling, RP = retropubic approach, SI = single incision, SUI = Stress urinary incontinence, TO = transobturator approach, TOT = transobturator tape using the out–in technique, TVT-O = transobturator tape using the in–out technique, UTI = urinary tract infection.

4 Discussion

The present study used the data of 55 studies which composed of 4188 participants to evaluate the complications of MUS for women with SUI.

Presently, the most popular surgical methods for SUI are minimally invasive techniques using retropubic, transobturator, and single incision approaches, their names indicating their distinct variation. The advantages of these techniques include short operation time, less hospital stay, and thus rapid recuperation, allowing patients earlier returning to their daily work activities. However, complication of these procedures is one of the most important factors affecting patients’ safety, which is less addressed or under reported.[66,67]

In our review, the RP-MUS was associated with a high incidence of perioperative complications; among them, bladder perforation (0.8%–11.4%), hemorrhage (1.6%), hematoma (0.7%–5.5%), urine retention (0.8%–11.4%), and de novo urgency (0%–29%), whereas deep vein thrombosis (2.5%) and injury of inferior epigastric vessels (2.2%) were rarely reported. Bladder perforation was a common complication observed during the MUS procedures where the blind retropubic passage of trocars between the vagina and the abdomen is responsible for a high bladder perforation rate and sometimes bowel and major vascular injuries. In contrast, the TO and SI-MUS avoided the retropubic passage, thereby reducing the risk of bladder and bowel injury. Once bladder perforation was recognized, the trocar should be removed and replaced immediately. According to the size of the injury, one might consider draining the bladder for 24 to 48 hours with an indwelling catheter. Hematoma was caused by extravascular pooling of blood within tissue due to vascular injury and with the same reason for bladder perforation, the blind retropubic passage caused a higher incidence of vessel injury. In our department, we routinely performed suprapubic ultrasonography after continence taping procedures (the RP-MUS) (Fig. 2) for detecting any concealed hematoma. It is a procedure noninvasive, without any radiation hazard, and easy to apply. It is of paramount importance to detect subcutaneous or retropubic hematoma left unrecognized by the surgeon.[68] Nevertheless, in spite of circumscribing the space of Retzius and thus reducing the risk of bladder injury, the TO and SI-MUS might potentially cause obturator neurovascular bundle injury and high hematoma. Luckily, conservative management would be sufficient in most cases.

Figure 2:
A retropubic hematoma following the TVT procedure detecting by suprapubic ultrasonography.

Voiding dysfunction, which results in urinary retention and increased postvoid residual volume, might compromise a patient life quality. The incidence of voiding dysfunction was higher in the RP-MUS as a sling inserted in this manner has a propensity to cause more obstruction owing to a roughly vertical sling axis in relation to the urethral axis.[69] In contrast, the TO and SI-MUS create a more horizontal sling axis. Consequently, TO and SI-MUS cause less circumferential compression of the urethra, which is consistent with a sling that is less obstructive[66] and is a distinct advantage. Overall, overactive bladder (OAB) and obstruction make up the most complications and this information should be explained to patients, so they can pay attention to the need for a long-term follow-up.

Among MUS, TO-MUS was associated with the highest incidence in peri/post-operative complications, including vaginal injury (0.8%–15%), urinary tract infection (UTI) (1%–33%), lower urinary tract symptoms (LUTS) (1%–33%), post-op pain (1.5%–26.7%), tape erosion/ extrusion (1.9%–10%), and further SUI surgery (1.4%–19.6%). Vaginal injury (including bleeding and laceration) and post-op pain were encountered more often in the TO-MUS because the tape is passed beneath the pubic bone through the groin. During passage of trocars through the TO route, it may cause mechanical injury to tissues (muscles, tendons, and nerves) and results in adductor muscle injury, osteitis pubis, obturator/groin abscess, inflammation and edema or nerve entrapment of the anterior branch of the obturator nerve, and structural adhesions.[70] Regarding the persistent groin or thigh pain, we had some experiences in handling this kind of complications; if conservative treatments failed, we would usually perform a urethrolysis procedure or add a Martius flap interposition for relief of the tension.

UTI, in this review, included culture proven, empiric infection, and recurrent infection. Recurrent UTI was defined as at least 2 documented urinary tract infections in the first 3 months postoperatively.[71] Treatment of acute UTI is highly effective and the occurrence of acute cystitis was considered a minor postoperative complication. But management of recurrent episodes of UTI is, however, difficult and may require long-term antibiotics coverage or even reoperation.[72] Late complications such as tape extrusion and erosion, in our review, were more frequent in the TO-MUS. Extrusion may be associated with symptoms affecting daily life: discharge, discomfort, pain, or dyspareunia. Management of extrusion can range from observation to more aggressive surgical intervention. As to tape erosion into the urethra and even the bladder, open excision may be a preferred choice.

Postoperative LUTS are the common most among all the complications of MUS. LUTS include de novo overactive bladder and de novo urgency with/ without incontinence. The development of OAB symptoms after anti-incontinence surgery[71] has a severe impact on the quality of life (QOL).[73] It is also known that urgency and urgency urinary incontinence worsen quality of life more than SUI.[69] Women who develop post-surgical OAB and feel worse than their pre surgical status should be carefully evaluated.

As mentioned before, only 6 of 35 (17.1%) RCTs in our review took into account sexual dysfunction. Palos et al[11] reported a total of 92 complications from patients of MUS and they found the RP-MUS had a proportionately higher number of dyspareunia (2.5% vs 0%) compared to the TO-MUS. Schellart et al[15] reported a total of 75 patients with complications of TOT and they found none of them complaining of dyspareunia. Zhang et al[18] discovered a total of 110 patients with complications of MUS and they found the TVT-O group had more cases of dyspareunia (8.1% vs 5.2%) compared to the TVT group. Masata et al[22] reported a total of 96 patients with complications of MUS where the SI-MUS had more de novo dyspareunia (6.3% vs 0%) in comparison with the TVT-O group. Scheiner et al[30] reported a total of 112 patients with complications and among them the TVT-O group had a higher number of patients with sexual dysfunction (17.2%, 1.9%, 0%) than the TVT/TOT group. In addition, Angioli et al[44] found a total of 72 patients with complications of MUS with the TVT group showing slightly more patients with pain during intercourse (2.9% vs 2.7%) than the TVT-O group. We thought the reasons might be related to the formation of paraurethral bands (anterior vaginal wall banding in the paraurethral folds immediately adjacent to the midurethral placement of the sling) or the localization of the MUS resulting in vaginal narrowing due to more vaginal tissue (perineal membrane) incorporated. Sexual dysfunction has a severe impact on patients’ postoperative life, both physically and mentally; it should be clearly documented as a patient safety issue.

We also included systematic review/meta-analysis and review in our studies in order to find out any other situations that might not appear in RCTs.[46–65] In Kim et al's study[46] which included 29 RCTs, they found there were no significant differences in sexual function, postoperative pain scores and other domains (bladder injury, UTI, urinary retention, de novo urgency, mesh extrusion, groin pain, vaginal erosion, tape release, urgency, and re-operation rate) among women undergoing MUS or SI-MUS. They did find voiding dysfunction was less frequently observed in SI-MUS group. Nambiar et al[51] reported a total of 31 studies regarding SI-MUS procedures indicating that a major vascular or visceral injury was 1.6%. Pergialiotis et al[52] reported a total of 32 studies specifically focusing on de novo OAB following MUS procedures and they found the SI-MUS was associated with a more elevated rate of OAB than the TO and RP-MUS (7.4%–10.2%, 2.4%–8.8%, 3%). In Seklehner et al's study[56] collecting 21 researches, they discovered patients in TO-MUS group had a higher incidence of neurologic symptoms than the RP-MUS group (2.7%–23% vs 1.3%–8.2%). In Blaivas et al's review[62] on the safety considerations for synthetic sling surgery, he pointed out some crucial points: at least 15% of women with MUS experienced a serious adverse outcome and/or recurrent sphincteric incontinence; A subset of women sustain refractory, lifestyle-altering complications that are unique to women with a MUS; MUS-associated complications are under-reported.

From our review, we can see that most studies did not discuss complications or report clearly defined complication measures. Patient safety should be the first priority to keep in mind all the time by surgeon throughout the pre and post-operative period. Besides, the World Health Organization also calls patient safety an endemic concern.[74] Patient safety is a discipline that emphasizes safety in health care through prevention, reduction, reporting, and analysis of medical error that often leads to adverse events.

Despite that many series have documented complications with synthetic MUS, there is compelling evidence showing that these complications remain under-reported in the literature. Deng et al[75] reviewed the MAUDE (Manufacturer and User Facility Device Experience) database[76] and identified 161 major complications included 39 vascular injuries, 38 bowel injuries, and 10 deaths due to surgical complications of synthetic sling placement. They think the under-reporting of major complications of sling procedures is likely due to surgeon awareness, referral patterns and failure to diagnose. In the same study, the ratio of major to total complications in the MAUDE database as compared to literature review suggested significant under-reporting of major complications resulting from synthetic sling placement. They also indicate that surgeons need to proceed with caution as serious complications do occur and be aware of the nature and symptoms of tape related complications for prompt diagnosis and appropriate postoperative management.

5 Conclusions

In summary, any common surgery might carry potential risk and result in long term complications. Physician should always keep in mind that patient safety is the first major concern instead of merely concentrating on the successful rate or efficacy of the surgery. It is indispensable for physician to counsel patient with regard to long-term complications of MUS before surgery, offer all relevant information possible, and have what is in the best interest of patients in mind.

Author contributions

Ling-Hong Tseng and Cheng-Kai Lee wrote the article; Shuenn-Dyh Chang developed analytical tools and analyzed data; Pei-Chun Chien and Yu-Ying Hsu validated the results; Ling-Hong Tseng supervised the project.

Data curation: Ling-Hong Tseng, Yi-Hao Lin, Cheng-Kai Lee, Shuenn-Dyh Chang, Pei-Chun Chien, Yu-Ying Hsu.

Formal analysis: Cheng-Kai Lee, Shuenn-Dyh Chang, Pei-Chun Chien, Yu-Ying Hsu.

Investigation: Ling-Hong Tseng, Yi-Hao Lin.

Methodology: Ling-Hong Tseng, Cheng-Kai Lee, Shuenn-Dyh Chang.

Project administration: Ling-Hong Tseng.

Software: Yu-Ying Hsu.

Supervision: Ling-Hong Tseng.

Validation: Yi-Hao Lin, Cheng-Kai Lee, Shuenn-Dyh Chang, Pei-Chun Chien, Yu-Ying Hsu.

Writing – original draft: Yi-Hao Lin, Cheng-Kai Lee, Pei-Chun Chien.

Writing – review & editing: Shuenn-Dyh Chang.


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[76]. Available at:

complications; female; mesh; midurethral sling; slings; urinary incontinence

Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.