AUA: Female SUI (2023)

See 2017 Original Guideline

See 2023 Updated Original Guideline

See Algorithm from Original Guideline

See Video Review of 2017 AUA Guidelines for the Treatment of Stress Urinary Incontinence

Definitions

• Stress Urinary Incontinence (SUI): symptom of urinary leakage due to increased abdominal pressure, which can be caused by activities such as sneezing, coughing, exercise, lifting, and position change.
• Intrinsic sphincter deficiency (ISD): often defined as an abdominal leak point pressure <60 cm H20 or a maximal urethral closure pressure <20 cm H20, often in the face of minimal urethral mobility
  • The utility of urethral function assessment remains controversial
• Urgency urinary incontinence (UUI): symptom of urinary leakage that occurs in conjunction with the feeling of urgency and a sudden desire to urinate that cannot be deferred.
• Mixed urinary incontinence refers to a combination of SUI and UUI

Background

• Prevalence of female SUI: up to 49%
• The index patient for this guideline is an otherwise healthy female who is considering surgical therapy for the correction of pure stress and/or stress-predominant mixed urinary incontinence (MUI) who has not undergone previous SUI surgery.
• Non-index patients include (9):
  1. Prior surgical interventions for SUI
  2. Neurogenic lower urinary tract dysfunction
  3. Females with SUI and high-grade pelvic organ prolapse (stage 3 or 4)
     • Patients with low-grade pelvic organ prolapse were also considered to be index patients.
  4. Advanced age (geriatric)
  5. High BMI
  6. MUI (non-stress-predominant)
  7. Incomplete emptying/elevated post-void residual (PVR) and/or other voiding dysfunction
  8. Recurrent or persistent SUI
  9. Mesh complications

Differential Diagnosis of SUI

• Options (7)
  1. Overflow incontinence
  2. Detrusor overactivity incontinence
  3. Low bladder compliance
  4. Stress-induced detrusor overactivity
  5. Diverticulum
  6. Urinary fistula
  7. Ectopic ureter

Diagnosis and Evaluation of Patients Wanting Surgery for SUI

Recommended Investigations

Mandatory (4):

1. History (including assessment of bother) and Physical Exam
2. Objective demonstration of stress urinary incontinence
3. Urinalysis
4. PVR

History and Physical Exam

History

• Characterize incontinence (stress, urgency, mixed, continuous, without sensory awareness).
  • Presence of coughing, sneezing, lifting, walking, or running as initiators of incontinence increases the likelihood of SUI as the cause of urinary leakage
  • Chronicity of symptoms
  • Frequency, bother, and severity of incontinence episodes. Pad or protection use.
    • An assessment of bother is paramount to the decision to operate in the index patient.
• Associated
  • Urinary tract symptoms (e.g., urgency, frequency, nocturia, dysuria, hematuria, slow flow, hesitancy, incomplete emptying)
  • Pelvic symptoms (e.g., pelvic pain, pressure, bulging, dyspareunia)
  • GI symptoms (e.g., constipation, diarrhea, splinting to defecate)
• Menopausal status
• Obstetric history (e.g., gravity, parity, method of delivery)
• Previous pelvic surgeries
• Past medical history (e.g., hypertension, diabetes, history of pelvic radiation)
• Current and past medications
• Fluid, alcohol, and caffeine intake
• Previous treatments for incontinence (e.g., behavioral therapy, Kegel exercises/pelvic floor muscle training, pharmacotherapy, surgery)
• Patient’s expectations of treatment (patient-centered goals)
• History alone, while helpful, does not definitively diagnose SUI in women

Physical exam (6):

1. Stress test (supine and/or standing) with comfortably full bladder
2. Focused abdominal examination
3. Urethral mobility (Q-tip test or other method)
4. Pelvic prolapse (any method)
5. Vaginal atrophy/estrogenization status
6. Focused neurologic examination

Objective demonstration of SUI

• Stress test (supine and/or standing) with comfortably full bladder
  • Considered positive if involuntary urine loss from the urethral meatus is witnessed coincident with increased abdominal pressure
    • A positive stress test had a high sensitivity and specificity for detecting SUI
  • If leakage is not witnessed in the supine position, the test may be repeated in the standing position to facilitate the diagnosis

Urinalysis

• Screen for abnormalities (microscopic hematuria, pyuria, etc.), which may prompt further investigations and reveal underlying cause (bladder tumour, for example) of incontinence

Post-void Residual (PVR)

• May prompt further investigations and reveal underlying cause (overflow, for example) of incontinence

Other Tests

Questionnaires

• Overall, low strength of evidence due to limited number of studies for each questionnaire

Q-tip test

• Positive test is unlikely to aid in the diagnosis of SUI; SUI may exist without urethral hypermobility and vice versa.
• Can provide potentially useful information regarding the degree of urethral mobility

Pad test

• May confirm the presence of incontinence but does not distinguish the specific type

Additional Evaluations

• Should be considered for patients with the following conditions (8):
  1. Neurogenic lower urinary tract dysfunction (known or suspected)
  2. Inability to demonstrate stress urinary incontinence
  3. Inability to make definitive diagnosis based on symptoms and initial evaluation
  4. Elevated post-void residual per clinician judgment
  5. Evidence of significant voiding dysfunction
  6. Urgency-predominant mixed urinary incontinence
  7. Abnormal urinalysis, such as unexplained hematuria or pyuria
  8. High grade pelvic organ prolapse (POP-Q stage 3 or higher) if SUI not demonstrated by pelvic organ prolapse reduction
• May be performed in patients with:
  • Concomitant overactive bladder symptoms
  • Failure of prior anti-incontinence surgery
  • Prior pelvic prolapse surgery

Cystoscopy

• Should not be performed in index patients for the evaluation of SUI
• Indications (3):
  1. Suspected bladder pathology based on history or concerning findings on physical exam or urinalysis (e.g. microhematuria)
  2. Structural lower urinary tract abnormality
  3. Patients undergoing certain surgical procedures (e.g., midurethral (MUS) or pubovaginal fascial (PVS) slings) to confirm the integrity of the lower urinary tract and the absence of foreign body
  4. History of prior anti-incontinence surgery or pelvic floor reconstruction, particularly if mesh or suture perforation is suspected
     • Perforation should be suspected with new onset of lower urinary tract symptoms, hematuria, or recurrent UTI

UDS

• May be omitted for the index patient desiring treatment when SUI is clearly demonstrated
  • VALUE (NEJM 2012)
    • Population: 630 females with uncomplicated SUI
    • Randomized to preoperative office evaluation and urodynamic tests vs. evaluation only
    • Primary outcome: Treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of “much better” or “very much better” on the Patient Global Impression of Improvement
    • Results: preoperative office evaluation alone was not inferior to evaluation with urodynamic testing
    • Nager, Charles W., et al. "A randomized trial of urodynamic testing before stress-incontinence surgery." New England Journal of Medicine 366.21 (2012): 1987-1997.
• May be performed at the urologist’s discretion in certain non-index patients, including but not limited to (8):
  1. Neurogenic lower urinary tract dysfunction
  2. Unconfirmed SUI
  3. Mismatch between subjective and objective measures
  4. Elevated PVR per clinician judgment
  5. Significant voiding dysfunction
  6. Significant urgency, UUI, overactive bladder (OAB)
  7. History of prior pelvic organ prolapse surgery
  8. History of prior anti-incontinence surgery

Management

Options

• Observation
• Non-surgical interventions (3):
  1. Urethral plugs
  2. Continence pessary
  3. Vaginal inserts
  4. Pelvic floor muscle training (± biofeedback)
• Surgical intervention
  • Options (4):
    1. Bulking agents
    2. Midurethral sling (MUS)
    3. Autologous pubovaginal sling (PVS)
    4. Burch culposuspension
• Physicians should not offer stem cell therapy for SUI outside of investigative protocols

Observation

Indications (2)

1. Patient expresses minimal subjective bother due to the SUI
   • The degree of bother should be considered when considering treatment
2. Not candidate for other forms of therapy

Non-surgical interventions (3):

Options (3):

1. Urethral plugs
2. Continence pessary
3. Vaginal inserts
4. Pelvic floor muscle training (± biofeedback)

Pelvic floor physical therapy

• Patient must be willing and able to commit to regularly and consistently performing pelvic floor training for this to be successful.

Surgical intervention

Options (4):

1. Bulking agents
2. Synthetic midurethral slings (MUS)
3. Autologous pubovaginal sling (PVS)
4. Burch culposuspension

Bulking agents

• Trade name: Bulkamid
  • FDA approved in 2020§
• Little long-term data
• Indications (2):
  1. Patients who wish to avoid more invasive surgical management or are concerned with the lengthier recovery time after surgery
  2. Patients who experience insufficient improvement following a previous anti-incontinence procedure.
• Disadvantage (1)
  1. Patients should be counseled on the expected need for repeat injections
• Adverse events§
  • Pain at implantation (13%)
  • Acute urinary retention (6%)
  • Urinary tract infection (4%)
  • Blood in urine (2%)

Synthetic Midurethral Sling (MUS)

• Most studied surgical treatment for female SUI
• Other than bulking agents, MUS is also the least invasive surgical options to treat SUI
• Classification (3):
  1. Retropubic MUS (RMUS, e.g. TVT-R); top-down or bottom-up
  2. Transobturator MUS (TMUS e.g. TVT-O); inside-out or outside-in
     • TVT without specification refers to TVT-R
  3. Single incision sling (SIS)/adjustable sling types
• Retropubic vs. Trans-obturator synthetic midurethral sling
  • Efficacy
    • Short-term analyses found them to be equivalent
    • Long-term comparisons are relatively lacking, however, data from increasing follow up appear to be demonstrating a lack of durability of Transobturator MUS, compared to Retropubic MUS
  • Adverse events:
    • Significant differences:
      • Retropubic MUS more likely to have (4):
        1. Major vascular or visceral injuries
        2. Bladder or urethral perforations
        3. Voiding dysfunction
        4. Suprapubic pain
      • Transobturator MUS more likely to have (3):
        1. Groin pain
        2. Repeat incontinence surgery between 1-5 years
        3. Repeat incontinence surgery after >5 years
      • Briefly, Retropubic MUS riskier but lasts longer
        • TOMUS (Trial of Mid-Urethral Slings) (NEJM 2010)
          • Population: 597 women with SUI
          • Randomized to retropubic vs. transobturator midurethral sling
          • Primary outcome: treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment)
          • Results:
            • At 12 months, retropubic slings equivalent efficacy and greater risk of post-operative voiding dysfunction compared to transobturator slings
          • Richter, Holly E., et al. "Retropubic versus transobturator midurethral slings for stress incontinence." New England Journal of Medicine 362.22 (2010): 2066-2076.
• Single incision sling
  • Introduced as a less invasive, lower morbidity surgery with the potential to maintain the efficacy of the existing MUS techniques
• Single incision sling vs. Retropubic MUS vs. Trans-obturator MUS MUS
  • SIS demonstrates similar efficacy to TMUS; however, there is limited comparative data to RMUS.
• Guideline Recommendations on choice of MUS
  • Both Retropubic MUS (either the bottom-up or the top-down) and Transobturator MUS (either the in-to-out) or out-to-in can be offered for MUS.
  • SIS can be offered with patient understanding that long-term data on safety and efficacy is lacking
• Patient counselling
  • Must discuss the specific risks and benefits of mesh as well as the alternatives to a mesh sling.
  • Patients considering MUS should be made aware of the prior FDA public health notifications regarding the use of transvaginal mesh to treat SUI or pelvic organ prolapse and be advised of possible mesh-related risks, such as vaginal exposure (which can also be associated with dyspareunia) and perforation into the lower urinary tract or other neurovascular or visceral symptoms either of which could require additional procedures for surgical removal of the involved mesh and, if necessary, repair of the lower urinary tract.
    • Risk factors for mesh erosion (5):
      1. Diabetes
      2. History of smoking
      3. Older age
      4. >2 cm vaginal incision length
      5. Previous vaginal surgery
  • Abdominal, pelvic, vaginal, groin, and thigh pain can be seen after sling placement
  • The literature does not definitively suggest that MUS is more or less effective to alternative interventions, such as PVS or colposuspension
• Technique
  • Do not place a mesh sling if the urethra is inadvertently injured at the time of planned MUS procedure
    • If the surgeon feels it is appropriate to proceed with sling placement in the face of an inadvertent entry into the urethra, then a non-synthetic sling should be utilized
• Contraindications
  • Should not utilize a synthetic MUS in patients undergoing concomitant (3):
    1. Urethral diverticulectomy
    2. Repair of urethrovaginal fistula
    3. Urethral mesh excision
    • Mesh placed in close proximity to a concurrent urethral incision can theoretically affect wound healing, potentially resulting in mesh perforation.
    • Instead, an anti-incontinence procedure that does not involve placement of synthetic material suburethrally, or use of a biologic material, preferably autologous fascia, should be considered.
  • Consider avoiding the use of mesh in patients undergoing SUI surgery who are at risk for poor wound healing, including
    1. Following radiation therapy
    2. Presence of significant scarring
    3. Poor tissue quality
    4. Long-term steroid use
    5. Impaired collagen associated with systemic autoimmune disorders, such as visceral Sjogren’s disease or systemic lupus erythematosus
    6. Immune suppression

Autologous Fascia Pubovaginal Sling

• Involves the placement of autologous fascia lata or rectus fascia beneath the urethra to provide support
  • Procedure more morbid than MUS
  • Efforts to use other materials, such as porcine dermis and cadaveric fascia, as substitution for the autologous fascia have shown inferior results.
• Adverse events:
  1. Wound infection
  2. Seroma formation
  3. Ventral incisional or leg hernia depending on the fascial harvest site
• SISTEr (NEJM 2007)
  • Population: 655 women with SUI
  • Randomized to autologous rectus fascia PVS vs. Burch colposuspension
  • Results
    • Success rates higher for PVS
    • Voiding dysfunction (63% vs. 47%, P < .001), UTI, difficulty voiding, and postoperative urgency incontinence higher for PVS
  • Albo, Michael E., et al. "Burch colposuspension versus fascial sling to reduce urinary stress incontinence." New England Journal of Medicine 356.21 (2007): 2143-2155.

Burch colposuspension

• Largely replaced by MUS
  • Several RCTs showed essentially equivalent outcomes with the Burch colposuspension vs. TVT
• Likely inferior to pubovaginal fascial sling
• Indications (2):
  1. Patient preference to avoid mesh and avoid the morbidity of fascial harvest
  2. Undergoing a simultaneous abdominal procedure, such as open or minimally invasive hysterectomy

Risks of surgical intervention

• Intra-operative risks: risks of anesthesia, bleeding, UTI, bladder injury, and urethral injury, and procedure-specific risks (see below)
• Post-operative (4):
  1. Voiding dysfunction
     • May involve both storage and emptying symptoms
     • Risk of de novo or worsening of baseline storage symptoms for patients with MUI or SUI with urinary urgency.
     • Management
       • Appropriate and effective to initially treat persistent voiding dysfunction conservatively. This includes temporary catheter drainage, CIC, timed voiding, double voiding, biofeedback, pelvic floor muscle training, and anticholinergic therapy.
  2. Obstruction resulting in urinary retention
     • Management
       • Would require intermittent catheterization, indwelling Foley catheter drainage, and possible sling incision, sling loosening, or urethrolysis if this does not resolve spontaneously
       • Midurethral slings
         • Urinary obstruction after MUS surgery is usually transient and can be managed with short-term intermittent catheterization, although occasionally symptoms mandate sling release.
         • If persistently elevated residual urine and bothersome symptoms refractory to conservative management, transvaginal sling release can be attempted
           • Transvaginal sling release procedures consistently provide resolution of symptoms with maintenance of continence in the majority of patients.
           • A waiting period of at least 2 to 4 weeks is recommended before sling release.
       • Pubovaginal slings
         • Transient urinary retention is common, usually improves or resolves with time
           • Most patients return to spontaneous voiding within the first 10 days
         • If persistently elevated residual urine and bothersome symptoms refractory to conservative management and within first 6 weeks after autologous PVS surgery, sling loosening in the operating room can be attempted.
           • This is done by first inserting a cystoscope into the bladder (using spinal or general anesthesia) and then gently applying caudal pressure to the urethra.
           • This procedure is not advised with synthetic slings
         • After 6 weeks or when conservative measures fail, a formal urethrolysis or sling incision is indicated.
  3. Pain with sexual activity
  4. Persistent SUI immediately after the procedure or recurrent SUI at a later time that may require further intervention

Special cases

• Fixed, immobile urethra (often referred to as ‘intrinsic sphincter deficiency’)
  • Autologous PVS is the preferred surgical approach
  • RMUS or urethral bulking agents can be offered as alternatives
• Concomitant surgery for pelvic prolapse repair and SUI
  • SUI may coexist with pelvic organ prolapse in a significant number of patients.
  • Women with preexisting SUI may have worsening of urinary incontinence, and some without any symptoms of SUI may develop de novo stress leakage following reduction of the prolapse.
  • Any of the incontinence procedures (e.g., midurethral sling, PVS, Burch colposuspension) may be performed
    • Must balance the benefits with the potential for an unnecessary surgery and possible additional morbidity
    • A nomogram has been developed that can help estimate the risk of developing SUI after vaginal prolapse surgery and can aid in the decision regarding whether or not to perform a concomitant anti-incontinence procedure.
• Concomitant neurologic disease affecting lower urinary tract function (neurogenic bladder)
  • Patients with neurogenic lower urinary tract dysfunction do not fall into the category of the index patient, and a detailed evaluation should be performed.
    • Issues, such as incomplete emptying, detrusor overactivity, and impaired compliance, should be identified and in many cases treated prior to surgical intervention for SUI.
  • Surgical treatment of SUI may be offered after appropriate evaluation and counseling have been performed.
    • In a patient who requires intermittent catheterization, one must be cognizant of possible complications with the use of a bulking agent (bulking effect may be attenuated by frequent catheter passage) or a synthetic sling (potential catheter trauma in the area of the sling could place the patient at risk for mesh erosion into the urethra).
    • Patients with neurogenic lower urinary tract dysfunction who undergo sling procedures in particular should be followed long-term for changes in lower urinary tract function that could be either induced over time by the neurologic condition itself, or potentially by the sling procedure.
      • New onset hydroureteronephrosis found after sphincter/sling placement in patients with a neurogenic bladder may be caused by bladder decompensation (detrusor noncompliance) that was not identified on pre-operative urodynamic studies
• Synthetic MUS, in addition to other sling types, may be offered to the following patient populations after appropriate evaluation and counseling have been performed:
  1. Patients planning to bear children
     • Placement of a sling should be postponed until child bearing is complete; among women with prior MUS, there is a high rate of SUI recurrence following delivery, independent of mode of delivery
  2. Diabetes
     • Higher risk for mesh erosion and reduced effectiveness compared with their non-diabetic counterparts.
  3. Obesity
     • Worse clinical effectiveness of slings in obese patients compared with those with lower BMI.
  4. Geriatric (age >65)
     • Lower likelihood of successful clinical outcomes compared with younger patients
• Severe outlet dysfunction or recurrent or persistent SUI after surgical intervention (e.g., surgical failure)
  • Patients who have an exceedingly compromised bladder outlet due to functional or anatomic issues such as neurogenic bladder, failed surgery for treatment of stress incontinence, or severe ISD may require more drastic measures to achieve relief from their SUI.
  • Obstructing pubovaginal sling or bladder neck closure with urinary drainage (catheterizable stoma, an AUS, or total urinary diversion via ileal conduit or continent diversion) may be offered after counseling regarding the risks, benefits, and alternatives.

Outcomes assessment

• Patients should be evaluated within the early postoperative period to assess any significant voiding problems, pain, or other unanticipated events. If patients are experiencing any of these outcomes, they should be seen and examined.
  • If there is evidence a patient has symptoms of obstruction, early intervention may be necessary to reduce patient bother and to prevent development of bladder dysfunction in the long-term.
• Patients should be seen and examined within 6 months post-operatively.
  • Recommended evaluations
    1. Subjective outcome of surgery as perceived by the patient should be assessed and documented.
       • Patients should be asked about residual incontinence, ease of voiding/force of stream, recent UTI, pain, sexual function and new onset or worsened overactive bladder symptoms.
    2. Physical exam, including an examination of all surgical incision sites, should be performed
       • To evaluate healing, tenderness, mesh extrusion (in the case of synthetic slings), and any other potential abnormalities.
    3. Post-void residual should be obtained
  • Optional
    • Standardized questionnaire (e.g. PGI-I) may be considered
• Patients with unfavorable outcomes may require additional follow-up.

Questions

1. What is the differential diagnosis of a patient presenting with incontinence?
2. What is the recommended workup of a patient presenting with SUI?
3. Take a history of a patient presenting with SUI
4. Describe your physical exam.
5. When should UDS be considered in a patient presenting with SUI?
6. What are non-surgical/surgical treatment options for SUI?
7. What are the potential risks associated with surgical intervention for SUI?
8. What are the 3 surgical approaches to a MUS? Which approach to the MUS is more likely to be associated with bladder perforation?
9. In which patients should a synthetic MUS be avoided?
10. What is the preferred surgical treatment in a patient with SUI due to intrinsic sphincter deficiency?

Answers

1. What is the differential diagnosis of a patient presenting with incontinence?
   1. Overflow incontinence
   2. Detrusor overactivity incontinence
   3. Low bladder compliance
   4. Stress-induced detrusor overactivity
   5. Diverticulum
   6. Urinary fistula
   7. Ectopic ureter
2. What is the recommended workup of a patient presenting with SUI?
   1. History + physical exam
   2. Objective demonstration of SUI
   3. Urinalysis
   4. PVR
3. Take a history of a patient presenting with SUI
   1. Characterize LUTS
   2. Degree of bother
   3. Associated pelvic or GI symptoms
   4. Gyne/obstetric history, menopausal status
   5. Fluid intake
   6. PMHx, PSHx, Meds, allergies
   7. Previous treatments, treatment expectations
4. Describe your physical exam.
   1. Focused abdominal examination
   2. Evaluation of urethral mobility (any method)
   3. Supine and/or standing stress test with comfortably full bladder
   4. Assessment of pelvic prolapse (any method)
   5. Assessment of vaginal atrophy/estrogenization status
   6. Focused neurologic examination
5. When should UDS be considered in a patient presenting with SUI?
   1. History of prior anti-incontinence surgery
   2. History of prior pelvic organ prolapse surgery
   3. Mismatch between subjective and objective measures
   4. Significant voiding dysfunction
   5. Significant urgency, UUI, overactive bladder (OAB)
   6. Elevated PVR per clinician judgment
   7. Unconfirmed SUI
   8. Neurogenic lower urinary tract dysfunction
6. What are non-surgical/surgical treatment options for SUI?
   • Non-surgical:
     1. PFMT
     2. Biofeedback
     3. Pessary
     4. Vaginal inserts
   • Surgical:
     1. Bulking agents
     2. MUS
     3. PVS
     4. Burch-coloposuspension
7. What are the potential risks associated with surgical intervention for SUI?
   1. Voiding dysfunction (de novo or worsening of LUTS)
   2. Urinary retention
   3. Dyspareunia
   4. Persistent/recurrent SUI
8. What are the 3 surgical approaches to a MUS? Which approach to the MUS is more likely to be associated with bladder perforation?
   1. Retropubic, most likely to be associated with bladder perforation
   2. Transobturator
   3. Single-incision
9. In which patients should a synthetic MUS be avoided?
   • Patients undergoing concomitant
     1. Urethral diverticulectomy
     2. Repair urethrovaginal fistula
     3. Excision urethral mesh
10. What is the preferred surgical treatment in a patient with SUI due to intrinsic sphincter deficiency?
    • Autologous PVS

References

• Kobashi, Kathleen C., et al. "Surgical treatment of female stress urinary incontinence: AUA/SUFU guideline." The Journal of urology 198.4 (2017): 875-883.