Intrinsic Sphincter Deficiency & Slings Nader Gad MBChB, MChGO, FRCOG, FRANZCOG Consultant & Senior Lecturer in O&G Royal Darwin Hospital, Darwin, Australia

Definition of ISD SLPP less than 60 cmH2O MUCP less than 20 cmH2O Type III Stress Incontinence (Proximal urethra open at rest)

Classification of SUI Clinically & During UDA Bladder neck & proximal urethra During Rest Bladder Neck & Proximal urethra During Stress Cystocele Type 0 No SUI is seen Probably due to momentary voluntary contraction of External Urethral sphincter closed at rest At or above inferior Margin of SP Descend & open None Type I Closed at rest Above inferior Margin of SP Open Descend less than 2 cm None or Small Cystocele Type IIA Rotational descent characteristic of cysto-uretherocele Present Type IIB Closed At or below inferior Margin of SP May be further descent Type III Open at rest Proximal urethra no longer function as sphincter

Causes Of ISD Previous Pelvic Surgery Anti-incontinence surgery Urethral diverticulectomy Radical Hysterectomy Urethrotomy Resection or incision of vesical neck Aging & Hypo-oestrogenic States Pelvic Irradiation Neurologic Conditions Myelodysplasia Anterior spinal artery syndtome Lumbosacral neurologic conditions Shy-Drager syndrome

Treatment of ISD McGuire et al(1978 )were the first to note that ISD present in : 75% of women of patients who failed in multiple surgeries for SUI 13% with no previous anticontinence surgery Difficult to determine is it cause or effect?

Treatment of ISD Sand et al (1987): High failure rate of Burch colposuspension in women with low MUCP compared to those with MUCP more than 20cm H2O Failure rate of Burch at 3 months FU: Low MUCP: 54% Normal MUCP: 18%

Treatment of ISD Most data show simple elevation of the bladder neck is ineffective Recommend more obstructive procedure

Treatment of ISD Proximal Suburethral slings (Traditional) Mid-Urethral Tension-free Slings: TVT TOT 3. Artificial sphincter 4. Urethral Bulking Procedures

Proximal Suburethral Slings First introduced by Giordano in 1907 using Gracilis muscle flap Aldridge in 1942, developed the Fascial sling The principle: Create a hammock underneath bladder neck to prevent descent and provide a backboard at UVJ against which the urethra is compressed during increase of intra-abdominal pressure

Types of Proximal Slings Biologic Synthetic Fascia lata Mersilene Rectus fascia Nylon Gracilis muscle flap Marlex Pyramidalis muscle flap Gore-tex Round ligament Silastic Ox dura mater Polypropylene mesh Porcine small intestine submucosa Cadaver fascia

Patient most un-suitable History of irradiation Previous sling erosion Having surgery on the urethra at the same time (e.g., urethral diverticulectomy) Having POP surgery at the same time

Proximal Urethral slings Overall success for SUI + ISD at 5 years = 80 – 90% Summitt et al (1990) Sling procedure success rates were: 93% in ISD + HMBN 20% in ISD + no HMBN

Common Complications of Proximal Suburethral Slings Longer recovery Has the highest rate of retention: 2-37%

TVT & ISD Rezapour (2001) First report on 49 women: F-U for 3-5 years: 74% completely cured 12% improved 14% no improvement: Majority more than 70 years old & MUCP less than 10 cmH2O

TVT & ISD Overall Success rate: 55 – 74% (less than the 80-90% with PSUS) Some experts advise when TVT in ISD: tape is placed in immediate proximity with urethra (still without tension) instead of aiming for a ¼ inch gap

TVT Complications Voiding difficulties Recurrent UTI Bladder perforation (5-10%) Erosion (3 – 5 %) Vascular injury Bowel injury Haematoma Nerve injury Death (6 reported deaths by September of 2002)

TOT & Slings It leaves the sling in a more horizontal or hammock-like rather than U-orientation Less operative time Avoid risk of injury to bladder (only few reported cases) bowel & major vessels

TVT vs TOT (Monarc) Miller et al (2006) Retrospective study of 145 women Comparing TOT (Monarc) vs TVT under GA or Spinal anaesthesia : Monarc was nearly 6 times more likely to fail at 3 months after surgery in women with borderline MUCP (42 cm H2O or less) In this study women with MUCP 20cmH2O or less were exclusion criteria of TOT but not TVT

Failure Rate TVT vs TOT Miller et al 2006 Monarc (85) All (145) Objective Subjective 3% 14% 9% 16% MUCP 42 or less (81) Objective 13% 23% MUCP more than 42 (64) Objective 4% 2% 6%

TVT vs TOT vs Sling Jeon et al (2008) Retrospective study of 253 women with ISD defined as: LPP less than 60 cmH2O or MUCP less than 20 cmH2O - PVS: 87 TVT: 94 TOT: 72 TOT (polypropylene; Iris, Dowmedics Co, Korea, Outside – in ) Regional of General Anaesthesia

TVT vs TOT vs Sling Jeon et al (2008) Cure rates after 2 years: PVS: 87% TVT: 87% TOT: 35 % Cure rate after 7 years: PVS: 59% TVT: 55%

TVT vs TOT vs Sling Jeon et al (2008) Complications PVS (n=87) TVT (n=94) TOT (n=72) P value Bladder injury 1 (1.2%) 0.6 De novo urgency 14 (16%) 14 (15%) 13 (18%) 0.9 Voiding dysfunction (one month or longer) 18 (19%) 17 (18%) 8 (11%) 0.75 V.D. Requiring surgery 3 (3.1%) 1 (1.4%) 0.26 Recurrent UTI 2 (2.3%) 6 (6.4%) 0.06 Mesh Erosion - 1 (1.1%) 1

Darwin Experience Retrospective study of my First 25 cases of the TVT-O procedures (J&J) Procedure were completed in all women under sedation and local anaesthesia Outcome of the procedure: Complication: intra- & post-operative Success rate: Subjective & Cough test Any difference in outcome when ISD present?

Darwin Experience ISD was defined as valsalva or cough LPP = less than 60 cmH2O and/or MUCP = 20 cm H2O or less Women with ISD were given the option to chose between TVT vs TVT-O: TVT have a higher cure rate than TVT-O in women with ISD TVT has the potential risk of bowel or major blood vessels injury

Previous surgery for SUI Previous Hysterectomy Patients studied Public 7 28% Private 18 72% GP referral 20 80% Specialist Ref 5 20% Age 39 – 66 years Parity 1 – 6 Presence of SUI In All women 100% Urgency 9/25 36% Urge incontinence 5/25 Frequency 6/25 24% Nocturia Previous surgery for SUI 3/25 12% Previous Hysterectomy 10/25 40% Previous POP repair

UDA Findings Presence of POP 15/25 60% HMBN 21/25 84% ISD 10/25 40% 6/25 24% ISD alone 4/25 16% DI 2/25 8%

ISD Of the ten women with diagnosis of ISD: a. 5 women (50%) had MUCP < 20cm H2O 4 women had leakage on valsalva the remaining patient had leakage on Cough LPP of less than 60 cm H2O, this patient was the only patient lost to follow up.

Sedation Bolus of 1-2 mg midazolam Then propofol 1% infusion at a rate of 20-40mls/hour titrated to effect A small bolus of propofol (10-30mg) and/or alfentanil (100 – 200mcg) may be used when required in some patients during penetration of Obturator membranes.

Local Anaesthesia The local anaesthetic agent used was a total of 80 – 100 ml of 0.25% prilocaine with adrenaline (1:200,000)

Local Anaesthesia Administration of local anaesthesia to: the area of the suburethral vaginal incision paraurethral lateral dissection expected tape passage through the Obturator foramen and muscles and the exit on the skin of the inner upper part of the thigh on both sides.

Cough Test Once tape is inserted, cessation of all sedation Bladder is filled to a volume similar to that when SUI was demonstrated during UDA Cystoscopy performed When patient is awake enough, operative table is tilted head up about 30 degrees patient is instructed to cough strongly and the tape is very slowly adjusted to the point when urinary leakage just stops

Operative & Short-term Complications Intra-operative complications 0% Short term Urinary retention Short Term DI 1/25 4% One woman had 2 episode of nocturnal enuresis on the 2nd and 7th postoperative and day that resolved by the time she was reviewed 5 weeks later Short term postoperative complications 2/25 8% 2 patients (8%) developed significant pain in the upper thigh that resolved by 6 weeks post surgery

Hospital Stay AM list 7 28% 6/7 86% PM List 18 72% 2/18 11% 14/18 78% Discharge of AM list on same day 6/7 86% PM List 18 72% Discharged on the same day 2/18 11% Discharged next morning 14/18 78% Discharged within 48 hours

Follow-up Duration of FU Duration to Audit Mean = 4 – 52 weeks Average = 13.3 weeks Duration to Audit Mean = 7 – 156 weeks Average = 53 weeks

Long Term Outcome Urinary retention 0% Urgency 2 8% 0% Urgency 2 8% Two woman developed mild urgency Other complications 1 4% Pain in the vagina required excision of part of the tape No further SUI 24/24 100%

August 2008 Anast et al from Missouri, USA TOS (Trans-Obturator Sling) placement a outside-in (ObTape –Coloplast Surgical, Humeleback, Denmark) 124 patients had leakage on valsalva: 29% had low VLPP (Less than 60 cmH2O) 71% had higher VLPP

August 2008 Anast et al, Missouri, USA At a mean of 12 month Low VLPP (29%) High VLPP (71%) Subjective Cure rate 93% 79% Bladder perforation (6 patients) 3% 6% Complication rate 11% 29%

Conclusion TVT-O under local anaesthesia and sedation with the Cough Test in Theatre is very effective and safe surgical treatment of SUI in women with or without ISD. Shortcomings of the Study: Retrospective Small number of the patient in this study Relatively short term follow up period