Should SUI Surgery be Combined with Pelvic Organ Prolapse Surgery?

Transcription

1 Should SUI Surgery be Combined with Pelvic Organ Prolapse Surgery? Geoffrey W. Cundiff, M.D. 36 th National Congress of the South African Society of Obstetricians and Gynaecologists SASOG 2014

2 Learning Objectives: At the conclusion the physician should be able to: Describe the benefit of concurrent incontinence surgery with POP surgery Define reduced urodynamic stress incontinence Discuss the role of pre-operative urodynamics in advanced pelvic organ prolapse

3 Potential Conflict of Interest: Corporate Grants None Speaker Bureau None Consultant None Investments None

4 Cumulative Incidence of Surgery for Urinary Incontinence or Pelvic Organ Prolapse 11 % lifetime risk of surgery for pelvic organ prolapse of urinary incontinence Olsen A, et al. Obstet Gynecol. 1997, 89:501-6.

5 Commonly Performed Procedures Vaginal Apical Suspension Sacral Colpopexy

6 UROGYNECOLOGY QUÉBEC 2007

7 Prolapse without SUI Symptoms Most surgeons treat women with prolapse and concurrent SUI the same as women with SUI, recommending concurrent SUI surgery

8 Burch Retropubic Urethropexy

9 Mid-Urethral Sling

10 Prolapse without SUI Symptoms Most surgeons treat women with occult SUI the same as women with SUI, recommending concurrent SUI surgery The approach to women with symptomatic prolapse and no SUI on reduction testing is more controversial

11 What does stage 3-4 Prolapse do to urethral function? UROGYNECOLOGY QUÉBEC 2007

12 Treatment Dilemma Do continent women undergoing surgery for prolapse need a procedure for stress incontinence too? Stress continent women with advanced prolapse may develop stress incontinence after prolapse repair How to identify the subset that needs incontinence surgery with POP repair? Can urodynamics help guide decision making? What is the role of prolapse reduction? Is there an ideal method of prolapse reduction?

13 Treatment Options Repair POP only (leaving a risk of de novo stress incontinence that may require further treatment, and possibly a second surgery) Repair POP and include a continence procedure (may be unnecessary for a subset of women) Perform testing to predict the benefit of a concurrent continence procedure (stress test, urodynamics)

14 Continent Prolapse Patients Potential or Occult Stress Incontinence Stress incontinence that occurs following reduction of prolapse Variety of methods Prevalence of 6 90% Reduced Urodynamic Stress Incontinence New nomenclature Urodynamic diagnosis

15 Diagnosis of Reduced SUI Medical History Stress test of urodynamics with prolapse reduction Pessary Hand Swabs Forceps Speculum blade

16 Risk of Developing Postoperative SUI Following POP Surgery Planned Surgery for POP No symptoms of SUI + symptoms of SUI Up-To-Date 2011

17 Risk of Developing Postoperative SUI Following POP Surgery Planned Surgery for POP No symptoms of SUI + symptoms of SUI No Surgery for SUI Surgery for SUI Borstad(06) 65/90 (72%) Colombo(00) 19/33 (58%) De Tayrac(04) 5/14 (36%) Total: 89/137 (65%) Colombo(97) SUP 6/15 (40%) NS 6/21 (29%) RPU 5/35 (14%) De Tayrac(04) TVT 1/15 (7%) Partoll (06) TVT2/37 (5%) Wille(06) RPU0/14 (0%) Total: 20/137 (15%) Up-To-Date 2011

18 Risk of Developing Postoperative SUI Following POP Surgery Planned Surgery for POP No symptoms of SUI + symptoms of SUI - Reduced SUI + Reduced SUI No Surgery for SUI Surgery for SUI Bergman(98) 0/43 (0%) Chalkin(00) 0/10 (0%) Colombo(90) 4/62 (8%) Klutke (00) 0/20 (0%) Liang(04) 0/30 (0%) Reena(07) 0/25 (0%) Visco(08) 41/109 (38%) Total: 45/399 (12%) Bump(96) SUP 0/5 (0%) NS 0/4 (0%) Colombo(96) SUP 4/50 (8%) Visco(08) RPU 22/106 (22%) Wille(06) RPU0/14 (0%) Total: 26/179 (15%) Up-To-Date 2011

19 Risk of Developing Postoperative SUI Following POP Surgery Planned Surgery for POP No symptoms of SUI + symptoms of SUI - Reduced SUI + Reduced SUI No Surgery for SUI Surgery for SUI No Surgery for SUI Surgery for SUI Bergman(98) 0/43 (0%) Chalkin(00) 0/10 (0%) Colombo(90) 4/62 (8%) Klutke (00) 0/20 (0%) Liang(04) 0/30 (0%) Reena(07) 0/25 (0%) Visco(08) 41/109 (38%) Bump(96) SUP 0/5 (0%) NS 0/4 (0%) Colombo(96) SUP 4/50 (8%) Visco(08) RPU 22/106 (22%) Wille(06) RPU0/14 (0%) Total: 26/179 (15%) DeTayrac(04) 1/6 (13%) Liang(04) 11/17 (65%) Reener(06) 34/53 (64%) Visco(08) 23/40 (50%) Total: 69/126 (55%) 17 Studies Total: 76/502 (15%) Total: 45/399 (12%) Up-To-Date 2011

20 Risk of Developing Postoperative SUI Following POP Surgery Planned Surgery for POP No symptoms of SUI + symptoms of SUI No Surgery for SUI Surgery for SUI Total: (65%) Total: (15%) - Reduced SUI + Reduced SUI No Surgery for SUI Surgery for SUI No Surgery for SUI Surgery for SUI Total: (12%) Total: (15%) Total: (55%) Total: (15%)

21 CARE: Colpopexy and Urinary Reduction Efforts Primary Aim Evaluate whether a Burch added to sacrocolpopexy: Improves rate of urinary stress continence Effect on other aspects of urinary function urgency urge incontinence voiding dysfunction Study Aims Secondary Aims Compare immediate and short-term complications w/ without Burch Assess value of preoperative UDS with POP reduction w/ without Burch

22 CARE Study Design Population: Women planning a sacrocolpopexy who had no stress incontinence symptoms (MESA) Able to undergo Burch RCT with 1:1 assignment Burch No Burch Primary outcome at three months following surgery Methods published in Controlled Clinical Trials 24 (2003)

23 UROGYNECOLOGY QUÉBEC 2007

24 Endpoints: Measured 3 Months Post-Op SUI Endpoint : Symptoms (validated, standardized questionnaire) OR Positive standardized stress test OR Treatment for Stress Incontinence Urge Endpoint: Bothersome symptoms of urge incontinence or enuresis (PFDI 19, 28), OR Bothersome symptoms of frequency, urgency or nocturia (PFDI 17, 18, 27)

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28 Primary Outcome: Stress

29 Urge Outcomes Baseline: p= Mos: p=.039 Burch No Burch

30 Three Month Outcomes: Group Differences Stress: p=.0019 Urge: p=.26 SAE: p=.17 Burch No Burch

31 Primary Outcome: Summary 3 month difference of 19.5% in the stress incontinence endpoint Burch Group (22.6%) No Burch Group (42.1%) Exceeded the difference set in planning the original protocol (difference of 10%).

32 Clinical Implications A stress continent woman planning sacral colpopexy can be counseled that: She has a 30-45% chance of post-operative bothersome urinary symptoms without concomitant Burch. The addition of a Burch reduces bothersome urinary symptoms in 20% of such women. The addition of the Burch retropubic urethropexy reduces bothersome urinary symptoms in approximately 50% of the women who would have had such symptoms if the Burch is not performed.

33 Unanswered questions For a woman planning a vaginal repair, what is the value of. Concurrent Burch? Mid-urethral sling? Retropubic? Trans-obturator?

34 OPUS Trial Aim: Determine the value of concurrent midurethral sling during vaginal POP surgery for women without SUI Design: Multi-centered RCT (PFDN) Randomized to TVT vs. Sham Sample: 337 women undergoing vaginal POP surgery at 7 centers Outcomes: Primary: SUI at 12 months postoperatively Secondary: surgical complications Wei JT, et al. N Engl J Med 2012: 366:

35 OPUS Trial Rate of SUI at 12 mos Sham 43% TVT 27.6% 6.3 Slings placed to prevent 1 case of SUI Complications higher with TVT UTIs Bleeding(3.1%) Voiding dysfunction (3.7%) Wei JT, et al. N Engl J Med 2012: 366:

36 Unanswered questions For a woman planning a vaginal repair, what is the value of. Concurrent Burch? Mid-urethral sling? Retropubic? Trans-obturator? For a woman planning a sacral colpopexy, what is the value of. Urodynamics and RST to diagnose reduced SUI?

37 CARE Baseline Urodynamic Evaluation Voiding studies Uroflowmetry Pressure Flow Study Bladder filling Multi-channel cystometrogram Compliance Urethral function Non-reduced stress testing Reduced stress testing 300 ml. and MCC VLLP and CLPP Reduction methods (2) Ring pessary Hand Swab Forceps Speculum Surgeons blinded to urodynamic findings.

38 Postoperative Stress Incontinence No Burch Burch Reduction Test - Reduction Test

39 Variation in Preoperative Stress Testing by Technique Pessary Hand Swab Forceps Speculum 5 0 Percent Incontinent *The order of tests did not effect results

40 T H E U N I V E R S I T Y O F B R I T I S H C O L U M B I A Test Characteristics: Predictive Value for Postop Incontinence UDS-/No Burch Dry UDS+/Burch Dry UDS-/No Burch Wet UDS+/Burch Wet Pessary Hand Swab Forceps Speculum

41 Secondary Aim: Summary A significant percentage of women who did not leak with prolapse reduction leaked postop Pessary was least predictive of postop SUI Swab was most predictive of postop SUI Leakage with prolapse reduction: is associated with an increased risk of leakage postop even in those that received a Burch (with sacrocolpopexy)

42 Using Reduction Stress Testing to plan MUS for POP Surgery Planned Surgery for POP No symptoms of SUI - Reduced SUI + Reduced SUI Laparoscopic Sacral Colpopexy Laparoscopic Sacral Colpopexy + TVT 18.6% underwent later MUS 7.3% required MUS revision for Voiding Dysfunction 88% of patients did not need a second surgery Park J, et al. Int Urogynecol J 2012; 23:

43 Summary Women with POP who are incontinent Patient planning Evidence Unreasonable Practice Sacral colpopexy Concurrent RPU Base choice on RST Vaginal POP repair Concurrent MUS Base choice on RST Women with POP who are not incontinent Patient planning Evidence Reasonable Practice Sacral colpopexy Concurrent RPU Replace RPU with MUS Base choice on RST Vaginal POP repair Council patient on MUS Base choice on RST