Factors Influencing the Rate of Lost to Followup after Suburethral Synthetic Sling Removal

Author's Accepted Manuscript Factors influencing the rate of Lost to Follow-Up after sub-urethral synthetic sling removal Jeannine Foster, Alana Christie, Philippe Zimmern

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S2352-0779(17)30039-0 10.1016/j.urpr.2017.02.008 URPR 273

To appear in: Urology Practice Accepted Date: 9 February 2017 Please cite this article as: Foster J, Christie A, Zimmern P, Factors influencing the rate of Lost to FollowUp after sub-urethral synthetic sling removal, Urology Practice (2017), doi: 10.1016/j.urpr.2017.02.008. DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to The Journal pertain. All press releases and the articles they feature are under strict embargo until uncorrected proof of the article becomes available online. We will provide journalists and editors with full-text copies of the articles in question prior to the embargo date so that stories can be adequately researched and written. The standard embargo time is 12:01 AM ET on that date.

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Factors influencing the rate of Lost to Follow-Up after sub-urethral synthetic sling removal Jeannine Foster, Alana Christie, Philippe Zimmern

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UT Southwestern Medical Center, Dallas, Texas

Abstract count: 230

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Word count: 2002 Figure: 2 Table: 3 Appendix: 1

Philippe E. Zimmern, MD UT Southwestern Medical Center 5323 Harry Hines Blvd. Dallas, TX 75390-9110 Telephone: 214-648-9397 Fax: 214-648-8786 [email protected]

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Corresponding author:

Conflicts of Interest: None

Foster: Project development, manuscript writing Christie: Data collection and analysis Zimmern: Manuscript writing, supervision

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Author contribution:

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ABSTRACT Introduction and hypothesis: To report on variables associated with lost to follow-up (LTF) in

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women undergoing sub-urethral synthetic sling removal (SSR) for complications of mid-urethral slings (MUS).

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Methods: Following Institutional Review Board Approval, a prospectively maintained database of consecutive non-neurogenic women who underwent one SSR only were reviewed. Data

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reviewed by a third party investigator included distance traveled for appointment, marital status, employment status, if the patient received primary care from institution, if patient’s last follow-up visit was routine or for ongoing urologic treatment, type of insurance coverage, and UDI-6 questionnaire scores. Patients who did not reach a minimum follow-up length of 6

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months were contacted via phone and interviewed using a standardized script.

Results: From 2005-2015, 129 patients had a mean follow-up of 25 months (6-114). Among the

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38 women LTF, 19 could not be reached, and there was one non-recoverable loss due to death. There was a significant increase in patients returning for follow-up if they had on-going

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treatment (p=.0035) (Table 1). The most commonly reported reasons for LTF were distance to the care center and the patient being content with their post-operative outcome (Figure 1). UDI-6 total score significantly decreased after SSR in the LTF population by an average of 4.2 points (p = 0.0337).

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Conclusion: Geographical factors and ongoing treatment may explain the LTF in women

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referred for complications of MUS to a tertiary care center.

INTRODUCTION

Stress urinary incontinence (SUI) is a common problem affecting 25%- 45% of the female

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population, and midurethral sling placement has become the leading treatment procedure [13]. The range of complications resulting from sling placement are well documented and include

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extrusion, voiding dysfunction, persistent or worsening incontinence, dyspareunia, chronic vaginal pain, urethral erosion, and/or urethrovaginal fistulas [4-6]. In efforts to relieve these symptoms, many women elect to undergo synthetic suburethral sling removal (SSR). The longterm effectiveness of SSR remains uncertain as few series have been able to report sufficient

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follow-up [7-11].

In some contemporary series on outcomes after sling and mesh revision, the issue of LTF patients was prevalent.

In Rogo-Gupta et al. series, of 306 patients that underwent

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incontinence and prolapse graft removal, 179 completed follow-up evaluation, with a mean

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time to follow-up of 24 months [12]. In Crescenze et al. series, only 3 of 110 patients were excluded due to follow-up less than one month. However, follow-up was based on a last visit note, mailed questionnaire, or telephone interview and the mean follow-up was 29 months [13].

Following patients after surgical procedures remains a challenge for physicians, and those lost to follow-up (LTF) have the potential to play major roles in the long-term assessment

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of safety and efficacy of SSR. Although there are reports on rates of LTF, to date no series has examined the reasons why LTF patients fail to return to providers for care [14-16]. Therefore,

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our goal was to report on the variables that could influence the rate of lost to follow-up (LTF) in women undergoing sub-urethral synthetic sling removal (SSR) for complications of mid-urethral

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slings (MUS).

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METHODS

Following Institutional Review Board Approval, a prospectively maintained database of consecutive non-neurogenic women who underwent one SSR only were reviewed. Women who underwent both vaginal mesh kits for prolapse repair and SSR, SSR and any concomitant

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procedure, had a non-synthetic sling removal, had a past vaginal mesh in place even if currently asymptomatic, or had more than one sling mesh in place were excluded from this review. The standardized technique for SSR has been previously reported and remained

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unchanged throughout the study (Figure 1) [17]. In brief, following urethrocystoscopy to locate

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the course of the tape, which frequently indents the floor of the midurethra, an inverted Ushape vaginal incision is made over the course of the tape. To reduce the risk of urethral injury, we locate the tape lateral to the urethra (Figure 1a) and divide it there. Then the tape is carefully lifted off from the under surface of the urethra (Figure 1b). We make no attempt at removing the extensions of the MUS in the retropubic space (TVT) or towards the obturator foramen (TOT). Following the suburethral sling removal, cystoscopy is repeated to ensure urethral integrity.

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Data reviewed by a third party investigator not involved in the care of these patients from an electronic medical record (EPIC) included distance traveled for appointment, marital

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status, mode of transportation taken, employment status, whether the patient received primary care from the institution, whether the patient’s last follow-up visit was routine or for ongoing treatment, and type of insurance coverage. Urogenital Distress Inventory Short Form

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(UDI-6) questionnaire scores and Quality of Life (QoL) scores were also examined to evaluate for residual symptomatology [18].

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In our practice, patients are followed at 6 weeks, 6 months, 1 year and yearly thereafter. This decision is not based on insurance coverage (up to 90 days) but on the desire to determine if critical post-operative domains such as dyspareunia, pelvic pain, urinary incontinence, voiding dysfunction, and/or urinary tract infection have durably resolved or not [19].

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Patients who did not reach a minimum follow-up length of 6 months were contacted via phone and interviewed using a standardized script (see Appendix 1). A patient was defined as lost to follow-up when she did not return for follow-up examination after 6 months. Therefore

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these LTF patients included two groups: 1. Women never seen again (completely lost) 2. Women who responded to our standardized interview by phone but were not seen back in

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clinics for examination/questionnaire (partially lost). Information collected included reasons for loss of follow-up, as well as Urogenital Distress Inventory Short Form (UDI-6) questionnaire and Quality of Life (QoL) scores.

Using SPSS (Chicago, IL), statistical analysis was conducted and included Chi square and paired T- tests as well as Wilcoxon matched pairs test with p< 0.05 considered significant.

RESULTS

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From December 2005 to April 2015, 150 women underwent one synthetic SSR only. Out of the 150, 112 women had a length of follow-up greater than 6 months. Therefore, 38 women

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in this population were considered LTF.

Of these 38 women, 8 did not return for any appointments post-operatively, 14 had a follow-up of 1 month, 2 at 2 months, 2 at 3 months, 8 at 4 months and 4 at 5 months.

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Demographic data are reported in Table 1. When comparing each of these factors, there

the Medical Center (p=0.0035) (Table 1).

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was a significant increase in patients returning for follow-up if they had ongoing treatment, at

Among the 38 LTF women called for phone interview, 19 could not be reached, and there was one non-recoverable loss due to death. The 18 women contacted were asked for

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both “primary” and “secondary” reasons for loss of follow-up. For “primary” reasons, 4 (22%) stated distance to care facility, 4 (22%) that they were content with their post-SSR outcome, 3 (17%) family issues, 2 (11%) that they had moved, 1 (6%) stated that they were hesitant for

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another procedure, 1 (6%) was unhappy with care received, 1 had a lawsuit in progress (6%), 1

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(6%) lost their insurance. and 1 (6%) could not recall. Ten (56%) stated “secondary” reasons for loss of follow-up, including distance to care facility (3), content with their post-SSR outcome (4), family issues (1), and hesitant for another procedure (2).

Twelve patients who were contacted had both pre- and post-SSR UDI-6 questionnaires

(Table 2). The UDI-6 score of these patients significantly decreased after SSR by an average of 4.2 points (p=0.0337). Question 5 regarding emptying and question 6 regarding pain also

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decreased significantly, by an average of 1.2 (p=0.0271) and 1.6 points (p=0.0074) respectively.

Pre-operative UDI-6 scores were not available for 6 of the partially lost patients because

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their presenting symptoms were not related to LUTS. Their symptomatology pre- and post-SSR is presented in Table 3. Out of the 8 patients with dyspareunia before SSR, 6 (75%) still had dyspareunia after surgery, while none of the 10 patients without dyspareunia before SSR

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developed it afterwards (p = 0.0015). For the 10 patients with UTI pre-SSR, 7 (70%) still had UTI post-SSR, while none of the 8 patients without UTI pre-SSR developed any afterwards (p =

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0.0040) (Table 3). QoL scores decreased by 4.1 points following SSR.

A ROC curve of patient distances found a cut-off point at 62 miles from the medical center (Figure 2).

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DISCUSSION

To our knowledge this is the first review reporting on factors associated with LTF. The main

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difference in demographic factors between the LTF group and the followed group was whether or not the patient was receiving ongoing urological care. The two most common primary

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reasons for LTF were distance to the care facility and the patient being content with their postSSR outcome.

We examined factors such as marital and employment status and insurance coverage mainly because these were seen as potential barriers to care. It would seem plausible for a patient with a stable source of income or support system, such as a spouse an appropriate insurance coverage and a retired status to be more likely to return for follow-up visits. However, there

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was no significant difference noted between the LTF and followed groups for these domains. Only one patient interviewed stated loss of insurance as a reason for LTF.

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Although the discussions on reasons for LTF with patients were personal and varied, several common themes were found. Many patients, despite having some residual symptoms, considered themselves to be doing well post-SSR. Several individuals expressed that SSR had

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cured their most bothersome symptoms, such as pain or incomplete emptying. Though many

state prior to sling implantation.

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still had incontinence, this was an acceptable outcome because it returned them near their

One might expect that dissatisfied patients with a high Quality of Life score would return for follow-up, but this study identified additional factors possibly related to their LTF. Among them were distance, not having the time or means to travel, family members not being able to take

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them to appointments, and loss of insurance. Several patients asked for the contact information of the institution and seemed interested in making a follow-up appointment

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because, at the time of the phone interview, their situation had changed.

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One patient stated that although she was very unhappy with her present condition, she did not return to the institution at the advice of her lawyer, and was waiting to hear about the results of her lawsuit.

In the studies that have reported on rates of LTF, the rate of LTF for patients at 12 months or less for surgical treatment of SUI [14], surgical treatment of POP [15], the SISTEr trial and the TOMUS study [16] were 8.1%, 9.8%, 9.5%, and 8%, respectively. These rates are significantly

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lower than the LTF rate following SSR observed in our study, which was at 25%. This difference is most likely due to our retrospective study being conducted in a real life practice, as opposed

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to NIH sponsored trials. Without a study coordinator and frequent contact with patients, it is conceivably more difficult to maintain patient follow-up.

In the series reporting on rate of LTF in the SISTEr study and TOMUS study, it was found that

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a higher proportion of younger patients had missing data and that the number of patients LTF increased with time17. In our study, the 38 patients LTF had the same mean age as those with a

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follow-up of >6 months. In addition, the majority of patients became LTF at 1 month postoperatively.

By incorporating factors such as patient distance from facility and care at the same institution into study design, it may be possible for future studies to gather a more complete picture of

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patient status post-operatively. In addition, phone interviews to reach LTF patients have the potential to fill in missing data in this important population.

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The strengths of this study include a focused group of patients with one SSR only (no

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additional mesh removal and only one prior MUS placed). In addition, these patients underwent the same procedure (SSR) by the same surgeon at one institution using a published surgical technique [17]. Nearly half of the LTF population was reached by the same interviewer using a standardized script, including validated questionnaires (see Appendix 1).

The limitations include that the UDI-6 questionnaire does not cover all aspects of outcomes of sling removal, such as dyspareunia, exposure and/or recurrent urinary tract infections. This

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explains why UDI-6 data was only available for a small number of patients and why the deltas did not meet the MID for the UDI-6 both with respect to total or subscale scores. Another

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limitation is that only external influences such as geographic distance from the treating center, insurance coverage, marital status, work situation were examined as critical decisional factors for LTF. Clearly the impact of SSR outcome on patient decision to return for follow-up is

require more elaborate assessment tools in future studies.

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CONCLUSION

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complex and was only captured by means of a global quality of life score. This domain will

In this series examining factors associated with lost to follow-up in women after SSR, geographical factors, care at the same institution or not, and satisfaction with current outcome may explain LTF in women referred for complications of MUS to a tertiary care center.

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However, other factors such as marital and employment status and insurance coverage did not

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seem to influence patient’s compliance with follow-up visits.

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16. Brubaker L, Litman HJ, Kim HY, Zimmern P, Dyer K, Kusek JW, Richter HE, Stoddard A, Urinary Incontinence Treatment N (2015) Missing data frequency and correlates in two randomized surgical trials for urinary incontinence in women. Int Urogynecol J 26 (8):1155-

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suburethral tape placement. Can Journ Urol 2012;19(5):6424-6430.

18. Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl AJ. Short forms to assess life quality and symptom distress for urinary incontinence in women: the incontinence impact questionnaire and the urogenital distress inventory. Neurourol and Urodynam. 14:131-139,

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Table 1. Patient demographics by follow-up status Currently Lost to followed follow-up p (n = 112) (n = 38) Median age (range) 54.5 (28-88) 53.5 (34-86) 1.00 Race White 150 (94%) 33 (87%) 0.18 Other 7 (6%) 5 (13%) Median BMI (IQR) 26.3 (22.8-30.0) 30.1 (25.0-36.0) 0.0027 Median parity (range) 2 (0-6) 2 (0-5) 0.82 Median distance from UTSW (IQR) 36.0 (19.3-136.7) 84.4 (17.8-278.5) 0.13 Lives <60 miles from UTSW 64 (57%) 16 (42%) 0.13 UTSW Primary Care 33 (29%) 5 (13%) 0.0530 Ongoing treatment 78 (70%) 16 (42%) 0.0035 Married 79 (71%) 27 (71%) 1.00 Employed 62 (55%) 22 (58%) 0.85 Insurance Type Medicare 30 (27%) 10 (26%) 0.43 BCBS 37 (33%) 15 (39%) Other 43 (38%) 11 (29%) Uninsured 2 (2%) 2 (5%) (n = 30) (n = 10) Median UDI-6 Total (0-18; IQR) 11 (7-14) 14 (9-18) 0.14

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-4.1 (-8.3, 0.1)

0.0542

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Quality of Life (0-10)

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Table 2. Pre- and post-SSR for patients lost to follow-up with phone interview Mean change from pren p to post-SSR (95% CI) UDI6 Questionnaire 12 UDI6 Total (0-18) -4.2 (-7.9, -0.4) 0.0337 Q1 – Frequency (0-3) -0.4 (-1.4, 0.6) 0.39 Q2 – UUI (0-3) -0.6 (-1.4, 0.2) 0.15 Q3 – SUI (0-3) 0.3 (-0.6, 1.2) 0.44 Q4 – Drops (0-3) -0.8 (-1.7, 0.2) 0.12 Q5 – Empty (0-3) -1.2 (-2.2, -0.2) 0.0271 Q6 – Pain (0-3) -1.6 (-2.6, -0.5) 0.0074

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Quality of Life (0-10)

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Table 3. Post-SSR for LTF patients with phone interview Post-SSR Score n ± Std. Dev. UDI6 Questionnaire 18 UDI6 Total (0-18) 7.0±4.8 Q1 – Frequency (0-3) 1.6±1.1 Q2 – UUI (0-3) 1.2±1.1 Q3 – SUI (0-3) 1.9±1.3 Q4 – Drops (0-3) 1.1±1.2 Q5 – Empty (0-3) 0.6±0.9 Q6 – Pain (0-3) 0.6±1.0

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LTF – Lost to follow-up SSR - Synthetic sling removal MUS – Mid-urethral slings SUI – Stress urinary incontinence QoL – Quality of Life

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Phone Interview Script Hello, may I please speak with _________?

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My name is ………….. I am a physician working with Dr. -------- in the Urology Department at ------ in ---------. I noticed you had an operation for sling removal in (surgery date) by Dr. ---------. In our notes, you last saw him in (last appointment year). Do you recall this?

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We’d like to update our files on how you’ve been doing since your last visit. This will just be a few questions so I do not take too much of your time. Since (last appointment date) when you saw Dr. ------- in ------, have you needed any additional urologic care? Yes No

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If yes, have you seen someone for this problem? What has been done?

If yes, have you had any other surgical procedures or other treatments for urinary symptoms: ……………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………… …………………………………………………………………………….. No

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Have you had any return of the original symptoms before you saw Dr. -----? Yes

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IF yes, what symptoms have you been experiencing? ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………………………..

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When did they return?................................................................................................................... How many pads/day do you currently use if any? Have you had any UTIs in the last year? None One Two More If any, how were you treated……………………… and how did you respond to the treatment?:……………………………………………………………………………….. Now, I’m going to run through a quick questionnaire of six short questions about your urination symptoms. For the following questions, the answer choices are: not at all, slightly, moderately, or greatly. In the past month, how much have you been bothered by:

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Frequent urination? Urine leakage related to the feeling of urgency? Urine leakage related to physical activity, coughing, or sneezing? Small amounts of urine leakage (drops)? Difficulty emptying your bladder? Pain or discomfort in the lower abdominal or genital area?

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1. 2. 3. 4. 5. 6.

***(If patient complains of leakage above) With the same answer choices of not at all, slightly, moderately, or greatly, how has urine leakage affected your:

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Ability to do household chores (cooking, housecleaning, laundry)? Physical recreation such as walking, swimming, or other exercise? Entertainment activities (movies, concerts, etc.) Ability to travel by car or bus more than 30 minutes from home? Participation in social activities outside your home? Emotional health (nervousness, depression, etc.)? Feeling frustrated?

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1. 2. 3. 4. 5. 6. 7.

With regards to the impact your bladder condition has on your life, how would you describe your current quality of life with your urinary condition just the way it is now, on a scale from 0 to 10 with 0 being pleased and 10 being terrible?........... no …if no, why? Dyspareunia, no partner or partner with ED,

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Are you sexually active? Yes other.

Question on lost to follow-up: Usually Dr. -------- likes to see his patients for follow up and he didn’t see you after six months, we just wanted to know what was the reason (list):

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Any message for Dr. ---------?

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If you wish to make an appointment to see him back or to see one of his Physician assistants, please call his office number. Thank you so much for your time.