Int Urogynecol J DOI 10.1007/s00192-015-2862-y

REVIEW ARTICLE

Surgical management of urethral diverticula in women: a systematic review Barbara Bodner-Adler 1 & Ksenia Halpern 1 & Engelbert Hanzal 1

Received: 10 July 2015 / Accepted: 28 September 2015 # The International Urogynecological Association 2015

Abstract Urethral diverticula (UD) are pouch-like outgrowths of the urethral lumen and surgery is by far the most common approach in symptomatic patients. The aim of this systematic review was to evaluate surgical techniques and outcomes in adult women with urethral diverticula. Our secondary objective was to determine the types of study designs. A systematic review of the literature was conducted. Medline, Cinahl and Embase were used as data sources. One hundred and eight studies, including 1,947 patients, remained for final analysis. We summarised 40 single case reports and 68 case series. Overall, transvaginal resection of the UD ± reconstruction was performed in the majority of patients (84 %), followed by marsupialisation (3.8 %) and transurethral endoscopic unroofing (2.0 %). Various other surgical techniques were reported in 181 out of 1,858 cases (9.7 %). Nineteen studies, dealing with 584 patients in all, evaluated a combination of vaginal diverticulectomy with an additional surgical procedure. Fifty-six out of 108 studies (52 %) documented the resolution of symptoms, describing 717 out of 1,044 patients in all being completely symptom-free after surgery. Only 50 out of 108 studies (46.2 %) provided detailed information on the length of follow-up, but showed a poor reporting standard regarding prognosis. Complications were studied only selectively. Because of the inconsistency of these data, it was impossible to analyse them collectively. There were no comparative studies on the different types of surgery in women with urethral diverticula. Overall, the non-comparative nature of

* Barbara Bodner-Adler [email protected] 1

Department of General Gynaecology and Gynaecologic Oncology, Medical University of Vienna, Währinger Gürtel 18–20, 1090 Vienna, Austria

the current evidence on the surgical management of UD does not allow any accurate estimation of success and complication rates. Keywords Urethral diverticulum . Female patients . Surgery . Outcome

Introduction William Hey appears to have been the first to describe a diverticulum of the urethra in a female patient in 1805 [1]. Urethral diverticula (UD) are pouch-like outgrowths of the urethral lumen, most likely originating from periurethral glands, that can occur in varying sizes along the whole length of the female urethra [2]. Their clinical presentations range from asymptomatic women to those with painful vaginal tumours that can be associated with incontinence and obstruction. Even stones and malignancy have been described to be associated with UD. Post-micturition dribbling seems to be one of the more characteristic symptoms. Previous studies suggest that UD might be either congenital or acquired and the estimated prevalence of UD is reported to be between 0.6 and 4.7 % in the literature [3–5]. Conservative management is a reasonable option for women without bothersome symptoms and without signs suggestive of malignancy or a urethral calculus. However, an operation is by far the most common recommendation for affected women. Many different surgical techniques such as transvaginal diverticulectomy, marsupialisation, transurethral unroofing and many more have been described [6–9], but no studies have compared the surgical procedures and their outcomes for urethral diverticula. The most common postoperatively reported complications are urethrovaginal fistula, de

Int Urogynecol J

novo stress urinary incontinence (SUI), urethral strictures, recurrent UTIs and recurrence of the diverticulum [10]. However, the evidence concerning the surgical outcome with well-documented success and complication rates is lacking. Since surgical treatment is by far the most common recommendation for affected women, we sought to determine the techniques and effects of surgery in adult female patients with urethral diverticula. To our knowledge, this is the first systematic review investigating this topic. Our objective was to review and summarise the current body of literature regarding the surgical management of urethral diverticula. In detail we estimated the rates of patients with complete resolution of symptoms (CRS) and complication rates after surgery. A secondary objective was to determine the types of study designs used to evaluate the results of surgery.

Materials and methods This review was modelled on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement [11]. A systematic literature search was carried out using the following databases: Pubmed, Embase and Cinahl 1947– 2015 (January) in any language. Our keywords comprised Burethra* AND diverticul* AND (surg* OR operat* OR excis* OR marsup*)^ for PubMed, and Burethra* AND diverticul* AND disease management* or surgery* for Embase and Cinahl. Inclusion/exclusion criteria The limits for the literature search were adult women. We used no language restriction for screening. Three investigators independently reviewed random titles and abstracts to establish reliable, reproducible inclusion criteria. If original articles were not in the English language, a translator translated the paper into the English language to avoid degradation in quality of the paper. We excluded studies focusing on diagnosis or malignancy in UD from the screening process. Studies dealing with bladder diverticulum or review articles were also excluded. Reports including men, neonates or adolescents, despite the search limits, were not included. Each abstract and study was evaluated by three authors independently. All pertinent references from the manuscripts were obtained and reviewed. Data abstraction and study characteristics General characteristics were recorded from each study. The three authors independently abstracted study design, number of patients included and the type of surgery. The following outcome parameters were measured: complete and partial

resolution of symptoms, de novo stress incontinence, de novo irritative symptoms (defined as de novo urgency and/or de novo frequency), obstructed voiding (urethral stricture), urethrovaginal fistula, infection, new onset of pain and dyspareunia, and recurrent UD immediately or at any time postoperatively. Disagreements were resolved by discussion with a third person. The findings of all relevant studies were abstracted, categorised and summarised by study design and outcomes measured. All studies that consistently evaluated CRS after surgery are presented in Table 1.

Results We identified 532 studies published up to January 2015. The results of the search and screening procedure are presented as a PRISMA flow chart in Fig. 1. The final analysis included 108 papers involving 1,947 patients. There were no randomised controlled trials, no cohort studies and no case– control studies. The papers included consisted of 40 single case reports and 68 case series. Case series contained between 2 and 140 patients. The distribution of number of cases is shown in Table 2. Data synthesis Preoperative symptoms were described in most patients (1, 855 out of 1,947; 92 %). Only three studies reported that some patients were free from symptoms before the operation [48–50]. Seven out of 108 (6.4 %) studies did not make any comment regarding preoperative symptoms [51–57]. A total of 1,947 patients were planned for operation and included in this systematic review; in 1,858 cases a documented surgical procedure was reported. The preoperative classification system (LNSC3 system), proposed by Leach et al. in 1982 [58], was used and documented in only 8 out of 108 (7.4 %) studies. In 32 out of 108 studies (29.6 %), this classification system was not yet available, as they were published before 1982. Surgical procedures The major surgical procedure, described in literature, was a transvaginal diverticulectomy (complete excision of the UD − closure of the communication of the urethral lumen ± reconstruction) in 1,569 out of 1,858 (84.4 %) patients, followed by marsupialisation (70 out of 1,858; 3.8 %) and transurethral endoscopic unroofing (38 out of 1,858; 2.0 %). Sixty-nine studies, including 1,569 cases, evaluated transvaginal diverticulectomy as a single surgical procedure. Additionally, further various surgical techniques were reported in 181 out of 1,858 (9.7 %) cases, such as partial ablation,

Int Urogynecol J Table 1

Studies that reported a complete resolution of symptoms (CRS) after surgery

Study

Type of surgery

CRS

Other outcome

Juang et al. [12]

Diverticulectomy

2/2

No complications

Campuzano et al. [13]

Diverticulectomy

2/3

Complications not reported

Lopez et al. [14] Edwards and Beebe [15]

Diverticulectomy Diverticulectomy

3/4 5/5

Unsuccessful: 1 No complications

Fabregas et al. [16] Lanz et al. [17]

Diverticulectomy Diverticulectomy

4/5 8/10

Complications not reported Fistula: 1

Vistad et al. [52]

Diverticulectomy

6/11

Recurrence: 2; SUI: 1

Wright [18] Stewart et al. [19]

Diverticulectomy Diverticulectomy

11/11 10/14

No further details Poor outcome: 3

Benchekroum et al. [20] Jensen et al. [21]

Diverticulectomy Diverticulectomy

15/15 15/15

No complications occurred Stricture:1; SUI:2;

Khader et al. [22]

Diverticulectomy

12/15

Recurrence: 1; pain: 1

Faerber [23] Fortunato et al. [24]

Diverticulectomy Diverticulectomy

14/16 11/18

Recurrence: 2; urge: 2 SUI: 2

Amna et al. [48] Sallami et al. [25]

Diverticulectomy Diverticulectomy

18/21 18/21

Fistula: 3 Urge: 3; pain: 7

Rosmanich et al. [26]

Diverticulectomy

19/21

Complications not reported

Han et al. [27] Aguilera et al. [28] Ward et al. [88] Rozsahegyi et al. [53]

Diverticulectomy Diverticulectomy Diverticulectomy Diverticulectomy

23/30 31/31 17/33 48/50

Bladder injury: 2; SUI: 2 Fistula: 1; recurrence: 3 Fistula: 2; SUI: 2 Fistula: 1; urge: 1

Hoffman [29] Lee [85] Reeves et al. [66] Miskowiak and Honnens de Lichtenberg [80] Lapides [79]

Diverticulectomy Diverticulectomy Diverticulectomy/Martius plastic Unroofing Unroofing

55/60 70/85 NA 2/2 4/6

SUI: 3; fistula: 1 Late complications: 14; SUI:2 Early complications: 2; SUI: 25 Uneventful course All history of UD

Vergunst et al. [57] Ramirez Backhaus et al. [75] Roehrborn [78] Kochakarn et al. [77] Anidjar et al. [30]

Unroofing Diverticulectomy/marsupialisation Diverticulectomy/marsupialisation Diverticulectomy/marsupialisation Diverticulectomy/others

8/8 12/14 57/57 60/67 6/6

Uncomplicated course Infection: 3 SUI: 3; stricture: 1 Urge: 3; SUI: 1; pain: 3 No complications

Athanasopoulos and McGuire [68] Fujikawa et al. [31] Ganabathi et al. [59] Gillon et al. [60] Gousse et al. [32]

Diverticulectomy + TVT Others Diverticulectomy/others + TVT Others Diverticulectomy

0/1 1/1 48/56 6/8 1/1

Obstruction: 1 No complications Infection: 6 Lost to follow-up: 2 Complications not reported

Hansen et al. [33] Hatzinger et al. [34] Juang et al. [35] Leach [36] Lee et al. [37] Lichtman and Robertson [74] Mahdy et al. [69] Moran et al. [38] Muqim and Naz [39] Pauwels and Wyndaele [40] Spencer and Streem [81] Susco et al. [41] Tancer et al. [42]

Diverticulectomy Diverticulectomy Diverticulectomy Diverticulectomy/others Porcine xenograft Marsupialisation Diverticulectomy Diverticulectomy/others Diverticulectomy Diverticulectomy/others Unroofing Diverticulectomy Others

1/1 1/1 1/1 23/30 1/1 8/8 0/1 2/4 1/1 5/5 1/1 1/1 34/34

No complications Complications not reported No complications SUI: 6; urge: 1 Complications not reported Complications not reported SUI: 1 Pregnant; complications not reported No complications Dyspareunia: 1 No complications Complications not reported; stones No complications

Int Urogynecol J Table 1 (continued) Study

Type of surgery

CRS

Vakili et al. [43] Verebelyi et al. [44]

Diverticulectomy Not reported

1/1 9/9

Other outcome No complications No fistulas occurred

Wittich [49]

Diverticulectomy

1/1

Pregnant; complications not reported

Lee et al. [61] Reyes et al. [45]

Porcine xenograft Diverticulectomy

1/1 1/1

No complications No complications

Jadhav et al. [46]

Diverticulectomy

1/1

Complications not reported

Gunasekawan [47] Tolosa Eizaguirre et al. [67]

Diverticulectomy/others Collagen xenograft

1/1 1/1

No complications No complications

TVT transvaginal tape, NA not available, SUI stress urinary incontinence, UD urethral diverticula

Martius flap, transurethral division with marsupialisation, urethroplasty, incision, buccal plastic, removal of stones only, excision with porcine xenograft reinforcement and Ellik technique, transurethral electrocoagulation, imbrication, laparotomy, aspiration with secondary incision, bulbocavernosus fat pad interposition, transvaginal tape dissection with autologue pubovaginal sling procedures and bladder neck suspension. Nineteen studies, dealing with 584 patients in all, reported a combination of vaginal diverticulectomy with one of these various surgical techniques. In 2 studies (n=93 patients) the type of surgery was not mentioned. Resolution of symptoms after surgery

Surgical outcome Successful intraoperative or postoperative outcome was mentioned in detail in 28 out of 108 studies (26 %) dealing with 469 patients. Most of these studies defined a successful outcome as an uneventful intra-, or postoperative course and/or no immediate complications detected. Eleven studies mentioned a poor surgical outcome and in 30 patients this was described in detail: fistula (n=7), urinary tract infection (n= 6), wound gaping or graft infection (n=7), bleeding (n=3), bladder injury (n=3), residual urine (n=1), catheter stitched

Records idenfied through database searching n = 288 PUB MED n=229 EMBASE

Addional records idenfied through other sources (n = 4 References from other records)

n= 15 CINAHL TOTAL 532

Eligibility

Screening

Records aer duplicates removed (n = 320)

Included

Fig. 1 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow chart

Idenficaon

Fifty-six out of 108 studies (52 %) documented the resolution of symptoms after surgery, describing 717 out of 1,044 patients (68.8 %) being completely symptom-free and 36 out of

653 patients (5.5 %) showing partial resolution of symptoms after operation. The remaining 52 out of 108 (48 %) studies did not comment on recovery after surgery. All case reports and case series that consistently evaluated complete the resolution of symptoms after surgery are listed in Table 1.

Records screened (n = 333)

Full-text arcles assessed for eligibility (n = 166)

Studies included in analysis (n = 108)

Records excluded (n = 167)

Full-text arcles excluded, with reasons (n = 58)

Int Urogynecol J Table 2

Distribution of numbers of cases

Single

2–10

11–20

21–30

31–40

41–50

>50

40

24

15

7

5

5

12

to the urethra (n=1), non-identification of the diverticulum (n=1), extirpation of an insufflated catheter with the need for secondary revision and repair (n=1). Length of follow-up and rate of complications In a significant portion of studies, outcomes of interest, such as success rates and unwanted sequelae of surgery, were only reported selectively, rendering any attempt to estimate the likelihood of such events impossible. Only 50 out of 108 (46.2 %) studies provided detailed information for the length of follow-up. The remaining 58 studies did not mention the length of follow-up. The mean available follow-up time was 18.2 months. Complications were studied only selectively. The total number of studies mentioning complication outcome is shown in Table 3. In the mean follow-up time of 18.2 months, a total of 100 recurrent UD, 121 de novo stress incontinence, 71 urge symptoms, 38 fistulas, 6 strictures and 14 patients with obstructed voiding, 57 infections, 36 women with a new onset of pain, and 36 cases of dyspareunia were reported. Owing to the inconsistency of these data, it was impossible to analyse these data collectively.

incontinence, urge symptoms, obstructed voiding, urethrovaginal fistula, infection, new onset of pain and dyspareunia, and recurrent UD immediately or at any time postoperatively. Our secondary objective was to determine the types of study designs used to evaluate the results of surgery. The scientific literature regarding surgical management and urethral diverticula includes only case reports and case series and we could not find any comparative studies on surgical techniques. Under special circumstances, even small case series can be accepted as high-level evidence; these are called Ball or nothing^ case series. This applies when the sequelae of a given condition can be predicted very accurately and averted with a defined treatment (e.g. transplantation in end-stage organ failure). However, in the case of surgery for UD, this is clearly not the case. Surgical treatment Although an operation is by far the most common recommendation for affected women, evidence concerning surgical treatment is lacking. Multiple different surgical techniques such as transvaginal diverticulectomy, marsupialisation, transurethral unroofing have been described in the literature [6–9], but no studies have compared the surgical procedures for urethral diverticula. Surgical procedures Vaginal diverticulectomy

Discussion The aim of this systematic review was to evaluate the surgical effectiveness in adult women with urethral diverticula. We estimated in detail the rates of patients with resolution of symptoms, in addition to de novo symptoms such as stress Table 3

Number of studies mentioning complication outcome

Complication

Fistula Stricture Recurrence of UD Pain Obstructive voiding Dyspareunia De novo SUI De novo urge Urinary tract infection

Total number of studies mentioning this outcome, n (%) 45/1,928 (42 %) 21/495 (19 %) 59/829 (55 %) 34/829 (31 %) 38/800 (35 %) 28/597 (26 %) 55/1,361 (51 %) 38/729 (35 %) 38/923 (35 %)

Number of patients with this outcome, n

38 6 100 36 14 36 121 71 57

This systematic review confirmed that vaginal diverticulectomy was performed in most cases (84.4 %). In some patients, diverticulectomy was combined with another surgical procedure. For example, especially in cases with large UD, diverticulectomy was combined with graft interposition such as bulbocavernosus fat pad interposition, and the Martius fat flap technique [59–66]. One large investigation, published by Reeves et al. in 2014, investigated 89 patients who had undergone a diverticulectomy. In 31 cases, the defect was quite large and a Martius fat flap was indicated [66]. The results showed early complications due to graft infection in 2 patients; the remaining women had no undue postoperative events. Two case reports, published by Lee et al. and Tolosa Eizaguirre et al., used a modified technique with porcine xenograft and collagen xenograft interposition after diverticulectomy. Both reports showed CRS after surgery [61, 67]. Furthermore, some studies combined a diverticulectomy with a concomitant incontinence procedure such as bladder neck suspension, a retropubic midurethral sling or a pubovaginal sling procedure [58, 59, 66, 68–71]. The indications for these additional procedures were heterogeneous, as

Int Urogynecol J

prophylactic incontinence operations in addition to therapeutic procedures in patients with preoperative SUI were mixed. Because of this inconsistency, the results are not comparable and data do not allow any recommendations regarding diverticulectomy and a concomitant incontinence procedure. Although the literature is imprecise and inconsistent, we conclude that vaginal diverticulectomy is performed in most patients and therefore it is the surgical procedure with the highest level of experience reported in the literature.

Marsupialisation Marsupialisation was first described in 1976 by Spence and Duckett as a procedure for the management of distal urethral diverticula [7]. This technique results in a decreased urethral length and a more patulous meatus. Proper selection of patients with distal urethral diverticulum is important. The results of our systematic review identified only 3 studies evaluating this surgical technique. Downs published a case report with this technique, but the patient was then lost to follow-up [72]. Another case report was published by Woo et al. in 2014, reporting an uncomplicated course after marsupialisation [73]. Lichtman and Robertson documented the largest case series in 1976, including 8 patients with marsupialisation and CRS [74]. Additionally, 4 more studies investigated a mixed sample of patients, including cases involving marsupialisation alongside diverticulectomy [75–78]. Summarising these data, because of the small number (n=70 cases in all) and heterogeneity, no clear statement and recommendation can be made regarding the success and complication rates of this surgical technique.

Transurethral unroofing Endoscopic procedures such as transurethral unroofing have also been described rarely and our review included only 4 studies dealing with this technique [57, 79–81]. Lapides performed transurethral unroofing in 6 patients, all of them had a recurrent UD and CRS was reported in 4 cases after the second surgical intervention [79]. Miskowiak and Honnens de Lichtenberg reported two cases in 1989 in which the patients were treated with a transurethral incision, both of whom had a CRS [80]. Spencer and Streem treated one case endoscopically with a paediatric resectoscope and reported CRS [81]. One case series with 8 patients, published by Vergunst et al. in 1996, showed an uncomplicated course in all patients [57]. Two more additional studies also dealt with this technique [63, 82], but their results showed mixed surgical techniques. In conclusion, it seems that the correct patient selection is an important factor for the success rate of transurethral unroofing.

Specified long-term outcome and complication rates Observational studies have reported that transvaginal diverticulectomy is associated with the cure of diverticulumrelated symptoms in approximately 70–86 % of patients [83–85]. The reported cure rate of recurrent diverticula ranges from 1 to 25 % [10]. Our findings revealed that cure of diverticulum-related symptoms was mentioned in only 56 out of 108 studies (51.8 %) and most of the studies included were either case reports or small case series. Therefore, the authors focused on presenting these data as simple descriptive observations. Additionally, we found a poor reporting standard, not taking into account an adequate range of possible outcomes, in most of the studies. However, the current evidence does not allow an accurate estimation of success and complication rates. Postoperative complications appear to be common, likely because of the extensive dissection required to surgically excise the diverticulum. The most frequent postoperative complications reported in the literature are urethrovaginal fistula (1–8 %), de novo SUI (1–16 %), urethral strictures (0–5 %), recurrent UTIs (7–31 %) and the recurrence of diverticula [10, 86–88]. Analysing our data, we found that only 45 out of 108 (summarising 38 cases) studies actively reported the complication type as being fistula; in the remainder, the quality of reporting was too poor to safely assume that no fistulae occurred. Similarly, we summarised 55 out of 108 papers (including 121 cases) mentioning de novo SUI, but from the remaining studies, which did not mention de novo SUI, we can also not assume that this did not occur. As SUI appears to be more common after surgery for proximal and bladder neck diverticula, some authors have suggested the combination of diverticulectomy with a concomitant anti-incontinence procedure [10, 70]. Others disagree, as many patients are relatively young and will not develop urinary incontinence [86]. The data of our systematic review regarding concomitant antiincontinence procedures are insufficient and no safe conclusion can be drawn. Regarding the complication rate, we could demonstrate that most of the studies included did not even mention an adequate follow-up time and complications were described only selectively. Additionally, the types and rates of complication outcomes varied widely. Owing to the inconsistency of the data, it was impossible to analyse the data collectively and no accurate prediction of complication rates could be made. Quality and design of the studies included The scientific literature regarding the surgical management of urethral diverticula in female patients includes only case

Int Urogynecol J

reports and case series and a variety of surgical techniques. The poor quality of the studies included is a limitation of the paper. Overall, there were no randomised controlled trials or comparative studies and the reporting standards regarding the surgical outcome, follow-up time and complication rate were poor. For example, many studies did not comment on any adverse events, but we cannot assume that none occurred. In addition to differences in reporting, an adequate documented follow-up time was not mentioned in most cases, making it difficult to draw meaningful conclusions from these findings.

5.

6.

7.

8. 9. 10.

Conclusion 11.

Although the literature on the surgical management of UD is imprecise and inconsistent, the data of this systematic review show that vaginal diverticulectomy is performed in most female patients with UD. The quality and design of the studies reviewed were weak with poor reporting standards, limiting the conclusions that can be drawn. The authors focused on the experience contained in the case reports and case series, allowing them to draw conclusions relevant to clinicians, even in the absence of comparative studies. In summary, these data do not allow an accurate estimation of success and complication rates in female patients with urethral diverticula. From these findings, given the relatively low prevalence of the condition, registries of UD treatment outcomes with clearly defined diagnostic standards appear to be warranted. Ideally, randomised trials for different types of treatments would be needed to optimise the decision-making process in UD patients.

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16. 17.

18. Acknowledgements We express our sincere thanks to Gülen Yerlikaya, MD, for her support in data collection, and Oliver Kimberger, MD, Associate Professor, for his assistance with statistical analysis.

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Financial disclaimers/conflicts of interest None. Funding None.

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