THE RISK OF URINARY RETENTION AFTER NERVE-SPARING SURGERY FOR DEEP INFILTRATING ENDOMETRIOSIS: A SYSTEMATIC REVIEW AND META-ANALYSIS

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THE RISK OF URINARY RETENTION AFTER NERVE-SPARING SURGERY FOR DEEP INFILTRATING ENDOMETRIOSIS: A SYSTEMATIC REVIEW AND META-ANALYSIS JOSÉ ANACLETO

1 THE RISK OF URINARY RETENTION AFTER NERVE-SPARING SURGERY FOR DEEP INFILTRATING ENDOMETRIOSIS: A SYSTEMATIC REVIEW AND META-ANALYSIS JOSÉ ANACLETO RESENDE JR (Urology) LUCIANA CAVALINI (Epidemiology) CLAUDIO CRISPI (Gynecology) MARLON FONSECA (Anesthesiology) *Authors have no competing interests.

2 Background The radical surgical exeresis of the lesions can improve symptoms and quality of life (the mainstay of the treatment). Important urinary complications may occur due to iatrogenic injury of autonomic pelvic nerves.

3 Background Recently, nerve-sparing (NS) approaches have been performed in order to prevent urinary complications. What about the scientific evidences?

4 Objective To perform a systematic review and a metaanalysis to assess the risk of urinary retention (need of urinary catheterization) after a NS surgery for DIE when compared to classical (non-ns) techniques.

5 Methods The present review was conduced according to the MOOSE guidelines for systematic reviews of observational studies. [Stroup DF, et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA 2000; 283: ]

6 Methods Published research articles (up to Dec/2014) comparing NS technique to non-ns technique regarding urinary complications after surgery for DIE. Endpoint: relative risk for urinary retention.

7 Methods Inclusion criteria: randomized clinical trials, intervention and observational studies. Exclusion criteria: cancer surgery, bladder or ureteral resections. The same two authors evaluated all publications. There were no restrictions for language. No attempt was made to identify grey literature.

8 Combinations of medical subject heading terms (search strategy) (Endometriosis) AND (Surgery OR Resection OR Laparotomy OR Laparotomic OR Open OR Laparoscopy OR Laparoscopic OR Hand Assisted OR Video Assisted OR Robotic OR Robot OR Nerve sparing OR Colorectal OR Rectum OR Rectosigmoid OR Intestine OR Bowel OR Pelvic OR Pelvis OR Uterosacral OR Parametrial OR Parametrium OR Bladder OR Ureter) AND (Nerve OR Nervous OR Plexus) AND (Urinary OR Retention OR Urethral OR Catheterization OR Complication OR Voiding OR Disorders OR Dysfunction OR Urologic OR Urological OR Urology OR Bladder OR Neurogenic OR Incontinence OR Stress OR Overactive OR Urge OR Urgency OR Urination OR Urodynamics).

9 Combinations of medical subject heading terms (search strategy) (Endometriosis) AND (Surgery OR Resection OR Laparotomy OR Laparotomic OR Open OR Laparoscopy OR Laparoscopic OR Hand Assisted OR Video Assisted OR Robotic OR Robot OR Nerve sparing OR Colorectal OR Rectum OR Rectosigmoid OR Intestine OR Bowel OR Pelvic OR Pelvis OR Uterosacral OR Parametrial OR Parametrium OR Bladder OR Ureter) AND (Nerve OR Nervous OR Plexus) AND (Urinary OR Retention OR Urethral OR Catheterization OR Complication OR Voiding OR Disorders OR Dysfunction OR Urologic OR Urological OR Urology OR Bladder OR Neurogenic OR Incontinence OR Stress OR Overactive OR Urge OR Urgency OR Urination OR Urodynamics).

10 Combinations of medical subject heading terms (search strategy) (Endometriosis) AND (Surgery OR Resection OR Laparotomy OR Laparotomic OR Open OR Laparoscopy OR Laparoscopic OR Hand Assisted OR Video Assisted OR Robotic OR Robot OR Nerve sparing OR Colorectal OR Rectum OR Rectosigmoid OR Intestine OR Bowel OR Pelvic OR Pelvis OR Uterosacral OR Parametrial OR Parametrium OR Bladder OR Ureter) AND (Nerve OR Nervous OR Plexus) AND (Urinary OR Retention OR Urethral OR Catheterization OR Complication OR Voiding OR Disorders OR Dysfunction OR Urologic OR Urological OR Urology OR Bladder OR Neurogenic OR Incontinence OR Stress OR Overactive OR Urge OR Urgency OR Urination OR Urodynamics).

11 Combinations of medical subject heading terms (search strategy) (Endometriosis) AND (Surgery OR Resection OR Laparotomy OR Laparotomic OR Open OR Laparoscopy OR Laparoscopic OR Hand Assisted OR Video Assisted OR Robotic OR Robot OR Nerve sparing OR Colorectal OR Rectum OR Rectosigmoid OR Intestine OR Bowel OR Pelvic OR Pelvis OR Uterosacral OR Parametrial OR Parametrium OR Bladder OR Ureter) AND (Nerve OR Nervous OR Plexus) AND (Urinary OR Retention OR Urethral OR Catheterization OR Complication OR Voiding OR Disorders OR Dysfunction OR Urologic OR Urological OR Urology OR Bladder OR Neurogenic OR Incontinence OR Stress OR Overactive OR Urge OR Urgency OR Urination OR Urodynamics).

12 Combinations of medical subject heading terms (search strategy) (Endometriosis) AND (Surgery OR Resection OR Laparotomy OR Laparotomic OR Open OR Laparoscopy OR Laparoscopic OR Hand Assisted OR Video Assisted OR Robotic OR Robot OR Nerve sparing OR Colorectal OR Rectum OR Rectosigmoid OR Intestine OR Bowel OR Pelvic OR Pelvis OR Uterosacral OR Parametrial OR Parametrium OR Bladder OR Ureter) AND (Nerve OR Nervous OR Plexus) AND (Urinary OR Retention OR Urethral OR Catheterization OR Complication OR Voiding OR Disorders OR Dysfunction OR Urologic OR Urological OR Urology OR Bladder OR Neurogenic OR Incontinence OR Stress OR Overactive OR Urge OR Urgency OR Urination OR Urodynamics).

Combinations of medical subject heading terms (search strategy) (Endometriosis) AND (Surgery OR Resection OR Laparotomy OR Laparotomic OR Open OR Laparoscopy OR Laparoscopic OR Hand Assisted OR Video

13 Combinations of medical subject heading terms (search strategy) (Endometriosis) AND (Surgery OR Resection OR Laparotomy OR Laparotomic OR Open OR Laparoscopy OR Laparoscopic OR Hand Assisted OR Video Assisted OR Robotic OR Robot OR Nerve sparing OR Colorectal OR Rectum OR Rectosigmoid OR Intestine OR Bowel OR Pelvic OR Pelvis OR Uterosacral OR Parametrial OR Parametrium OR Bladder OR Ureter) AND (Nerve OR Nervous OR Plexus) AND (Urinary OR Retention OR Urethral OR Catheterization OR Complication OR Voiding OR Disorders OR Dysfunction OR Urologic OR Urological OR Urology OR Bladder OR Neurogenic OR Incontinence OR Stress OR Overactive OR Urge OR Urgency OR Urination OR Urodynamics).

14 1270 potentially relevant studies 1. Scin-finder 0 2. Scopus Web of Science Pubmed Cochrane 0 6. Lilacs Clinical Trials 0

15 1270 potentially relevant studies 1. Scin-finder 0 2. Scopus Web of Science Pubmed Cochrane 0 6. Lilacs Clinical Trials 0 5 publications were preliminarily selected because its focus on complications after NS surgery for complete excision of DIE. 1 study was excluded due to lacks regarding follow-up information. Total = 4 publications

16 Methodological aspects of the four non-randomized observational studies included in the meta-analysis. Publication Design and main endpoints Sample characteristics Volpi et al., 2004 (Torino, Italy) Retrospective study assessing urinary retention with focus on preservation or not of the hypogastric plexus based on videotape recordings. Median age: 31.5 [Range 23-42] Median BMI: 21.5 [Range: ] Kavallaris et al., 2011 (Luebeck, Germany) Retrospective study comparing laparoscopic NS to non-ns with respect to pain and bladder function. Median age: 32 [Range 24-42] Median BMI: 23.5 [Range: ] Ceccaroni et al., 2012 (Verona, Italy) Prospective study comparing NS to non-ns laparoscopy in terms of bowel, bladder and sexual function. Median age: 31 [Range: 24-43] Mean BMI: 22.2 [SD: 3.0] Che et al., 2014 (Zhejiang, China) Prospective study investigating the efficacy and the bladder and sexual dysfunction that follow NS (open and laparoscopic) and non-ns. Mean age: 33 [Range: 26-46]# Mean BMI: 20 [Range: 16-25]# #Calculated. Age in years. NS: nerve-sparing technique. SD: standard deviation. BMI (body mass index) in Kg.m -2. Patients undergone bladder or ureteral resections were not included.

Methodological aspects of the four non-randomized observational studies included in the meta-analysis. Publication Design and main endpoints Sample characteristics Volpi et al.

5 [Range 23-42] Temporal evolution Median BMI: 21.5 [Range: 17.3-28.0] Kavallaris et al.

17 Methodological aspects of the four non-randomized observational studies included in the meta-analysis. Publication Design and main endpoints Sample characteristics Volpi et al., 2004 (Torino, Italy) Retrospective study assessing urinary retention with focus on preservation or not of the hypogastric plexus based on videotape recordings. Median age: 31.5 [Range 23-42] Temporal evolution Median BMI: 21.5 [Range: ] Kavallaris et al., 2011 (Luebeck, Germany) Retrospective study comparing laparoscopic NS to non-ns with respect to pain and bladder function. Median age: 32 [Range 24-42] Median BMI: 23.5 [Range: ] Ceccaroni et al., 2012 (Verona, Italy) Prospective study comparing NS to non-ns laparoscopy in terms of bowel, bladder and sexual function. Median age: 31 [Range: 24-43] Mean BMI: 22.2 [SD: 3.0] Che et al., 2014 (Zhejiang, China) Prospective study investigating the efficacy and the bladder and sexual dysfunction that follow NS (open and laparoscopic) and non-ns. Mean age: 33 [Range: 26-46]# Mean BMI: 20 [Range: 16-25]# #Calculated. Age in years. NS: nerve-sparing technique. SD: standard deviation. BMI (body mass index) in Kg.m -2. Patients undergone bladder or ureteral resections were not included.

18 What is nerve-sparing surgery..? Publication Description of nerve-sparing technique Urinary catheters after surgery Volpi et al., 2004 Objective; based on radical hysterectomy technique described by Trimbos et al. (2001). Removed on 2 nd day. Urinary retention was tested immediately after first voiding (method not described). Kavallaris et al., 2011 Comprehensive; representing a strategy to preserve nerves in DIE surgery. Removed on 1 st day. NS group: ISC if urinary residual urine volume >50 ml in two ultrasound measurements. Non-NS group: ISC if self-reported bladder dysfunction with incomplete emptying of the bladder (details not described). Ceccaroni et al., 2012 The most meticulous description; focused on DIE with segmental rectal and parametrial resection. Removed on 1 st day. ISC at discharge when voiding difficulty or urinary retention >100 ml on 3 consecutive catheterizations. Che et al., 2014 Reported as the same used by Volpi et al (2004). Some patients needed ISC (criteria/methods not described). NS: nerve-sparing technique. Patients undergone bladder or ureteral resections were not included. DIE: deep infiltrating endometriosis. SEUD Marlon Fonseca - Brazil

What about postoperative management of urinary tract Publication Description of nerve-sparing technique Urinary catheters after surgery Volpi et al.

19 What about postoperative management of urinary tract Publication Description of nerve-sparing technique Urinary catheters after surgery Volpi et al., 2004 Objective; based on radical hysterectomy technique described by Trimbos et al. (2001). Removed on 2 nd day. Urinary retention was tested immediately after first voiding (method not described). Kavallaris et al., 2011 Comprehensive; representing a strategy to preserve nerves in DIE surgery. Removed on 1 st day. NS group: ISC if urinary residual urine volume >50 ml in two ultrasound measurements. Non-NS group: ISC if self-reported bladder dysfunction with incomplete emptying of the bladder (details not described). Ceccaroni et al., 2012 The most meticulous description; focused on DIE with segmental rectal and parametrial resection. Removed on 1 st day. ISC at discharge when voiding difficulty or urinary retention >100 ml on 3 consecutive catheterizations. Che et al., 2014 Reported as the same used by Volpi et al (2004). Some patients needed ISC (criteria/methods not described). NS: nerve-sparing technique. Patients undergone bladder or ureteral resections were not included. DIE: deep infiltrating endometriosis. SEUD Marlon Fonseca - Brazil

20 RESULTS Frequency of urinary retention after nerve-sparing and nonnerve-sparing surgery for endometriosis (crosstabs). # Personal communication. NS: Nerve-sparing technique. ISC: intermittent self-catheterization.

21 RESULTS Frequency of urinary retention after nerve-sparing and nonnerve-sparing surgery for endometriosis (crosstabs). 4 2 # Personal communication. NS: Nerve-sparing technique. ISC: intermittent self-catheterization.

22 Heterogeneity among the 4 selected studies RR for urinary retention at discharge. I 2 = 50.2 % (P = 0.09) I 2 = total heterogeneity/total variability

23 Common RR for ISC at discharge in the NS group in relation to the classical technique was 0.19 [95%CI: ]

24 The common RR for need of ISC after 90 days was 0.16 [95%CI: ]

25 Discussion A significant advantage of NS with respect to the risk of persistent urinary retention (need of ISC for 3 months or more) No significant benefits of NS concerning the need of ISC immediately after surgery (?) The criteria for indicating ISC after surgery has been empirical (and not the same)

26 What about urinary function before surgery..?

27 CONCLUSION Considering the surgical treatment of DIE, a NS technique showed a significant lower risk of persistent urinary retention due to iatrogenic injury of autonomic pelvic nerves when compared to a classical (non-ns) technique.

28 Recommendations Clinical studies are required for evaluating concrete consequences of different persistent residual urinary volumes and the best individual postoperative urinary tract management. Unnecessary invasive emptying of the bladder must always be avoided, which is (at least) a risky, inconvenient and uncomfortable duty.

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