Upright MRI in the evaluation of the female Genuine Stress Urinary Incontinence

Upright MRI in the evaluation of Genuine Stress Urinary Incontinence: A comparison of pre and post-operative findings in patients undergoing MonarcR trans-obterator sling surgery

Lorne Sullivan annual lectureship and research day June 16, 2015Vancouver General HospitalVancouver, BC, Canada

Dr. Simon TreissmanKamloops, BC

Upright MRI in the evaluation of Genuine Stress Urinary Incontinence: A comparison of pre and post-operative findings in patients undergoing trans-obterator sling surgery

• SP Treissman1, R Brownlee2, R Colistro3

• MJ Treissman4, J Kozic4, L Jonat1, S Faddegon1

• M Querin2, E Goode5

1. Division of Urology, Royal Inland Hospital, Kamloops, BC, Canada

2. Division of Neurosurgery, Royal Inland Hospital, Kamloops, BC, Canada

3. Department of Radiology, Royal Inland Hospital, Kamloops, BC, Canada

4. Department of Obstetrics and Gynaecology, Royal Inland Hospital, Kamloops, BC, Canada

5. School of Nursing, Thompson Rivers University, Kamloops, BC

Upright MRI in the evaluation of Genuine Stress Urinary Incontinence

• Opening discussion

• Genuine Stress Urinary Incontinence (GSUI)• What do we know?• Common bothersome problem in female urology 1

• Major progress in surgical management in 1998 with the introduction of TVTR 2

• Further progress in 2001 with Trans-obterator tapes 3

Albo, M E…et al…The New England Journal of Medicine, 356(21):2143-55 (2007).

1. Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol 2010;116:1096-100

C Falconer ..A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinenceInt Urogynecology J Pelvic Floor Dysfunction. 1998; 9(4): 210 - 32.

3.



• Genuine Stress Urinary Incontinence (GSUI)

What do we not know…. substantial “knowledge gaps”

? Precise mechanism of injury (anatomical / neurological /

Autonomic)

? Pathophysiology (Why at menopause? What kinds of compensation?)

? Positive response to Sling Surgeries



• Genuine Stress Urinary Incontinence (GSUI)• Urology attempts to close the “knowledge gaps”

• Ambulatory / Video Urodynamics 4

• Dynamic MRI 5

• Physiological MRI studies 6

van Waalwijk van Doorn ES, Gommer ED. Curr Opin Obstet Gynecol. Ambulatory urodynamics 1995 Oct;7(5):378-81

Role of static and dynamic MR imaging in surgical pelvic floor dysfunction Boyadzhyan L, Raman SS, Raz S. Radiographics. 2008 Jul-Aug;28(4):949-67. doi: 10.1148/rg.284075139

The comparison of MRI findings with severity score of incontinence after pubovaginal sling surgery Serdar TARHAN, Gökhan TEMELTAŞ , Gülgün YILMAZ OVALI Turk J Med Sci 201; 40 (4): 549 - 556

4.

5.6.


• FonarR upright MRI Melville, NY, USA• Iron frame electromagnetic MRI machine• State of the art MRI• Capable of weight bearing studies

• Cost = $1.5 m• Install = $.5 m

“Has anyone ever tried this……?”- Dr. Richard Brownlee MD the Welcome Back Centre


Abstract: To examine the usefulness of upright MRI in the evaluation of patients with Genuine Stress Urinary Incontinence (GSUI) undergoing MonarcR trans-obterator tape suspension surgery.


Materials and Methods


Materials and Methods: 28 female patients with known GSUI were selected to participate in the study. Prior to MonarcR bladder neck suspension surgery each patient was asked to complete an ICIQ-FLUTS incontinence symptom score. Each patient was then asked to void completely and then undergo urethral catheterization whereby 300 ml of sterile water was instilled into their bladder. Patients were then asked to stand within a FonarR upright MRI scanner (FonarR corporation, Melville, NY). A T2 weighted image at 0.6 Tesla was then obtained while each patient was standing at rest and then undergoing standardized Valsalvas maneuver using a Laborie PeritronR (Laborie medical, Mississauga, Ont.) Valsalvameter at 53 mmHg. Special attention was then given to each midline sagittal image and in particular to the downward movement of the H line (Urogenital Hiatus) against the M line (Pubo-Coccygeal Line). Measurements were taken to determine excursion of the H line against the M line. The MRI procedure was then repeated for each patient at least three months after surgery. The change in H line excursion was then compared to the change in ICIQ-FLUTS score pre and post op using regression analysis and Spearman’s rank correlation test.


• Materials and Methods• Study Design

• Prospective Cohort Study requiring 1.5 – 2 years• Subject number = 50

• Observed Intervention = MonarcR procedure• Observational Methods = FonarR upright MRI / ICIQ-FLUTS

• Administered with Physiological Standardization:• Upright position• Bladder volume = 300 ml• Valsalva pressure = 53 mmHG PeritronR air pressure gauge

• Secure electronic database + “Multivariate” analysis

“No plan of action survives contact with the enemy..” - Helmuth von Moltke the elder


• Inclusion Criteria• Genuine Stress Urinary Incontinence (GSUI) as determined by their

primary care surgeon• Healthy multiparous females • Consented to undergo trans-obterator tape bladder neck suspension

(MonarcR)



• Exclusion Criteria• Must not be pregnant during the study• No OAB, uninhibited bladders, or small peak capacity (< than 200 ml)• Pelvic pathology: mass lesion, endometriosis, recurrent UTI, micro /

leukocyturia• BMI > 40• Unfit for MRI (e.g. pacemaker, intraocular lesion etc..)



• Research / Ethics oversight• Western Institutional Review Board (WIRB, Olympia, Washington, USA)• Quasi-commercial / governmental board of ethics experts

• Sets and enforces ethical standards for US / International human subject studies• Framework for Quarterly Review• Commitment to ethical training


Materials and Methods• Central importance of ICIQ-FLUTS questionnaire (modified)

• International Consultation on Incontinence Questionnaire 7

• 12 question 48 point “statistical instrument”• Content Validity• Internal Consistency• Test / Re-test Reliability

• Responsiveness• Criterion Validity

7. Avery, K Donovan J, Peters T J, Shaw C, Gotoh M, Abrams, P Neurourol Urodyn 2004 23(4) 322 - 330


PeritronR valsalva-meter Laborie medical systems, Mississauga, Ontario

Digital air pressure gauge

Custom 3 m tubing and mouthpiece

Visual / audio biofeedback to target pressure

Target set to 53 mmHg (72 cmH2O) and held a

minimum time of 8 seconds




FonarR upright MRI Melville, NY, USA

• Iron frame electromagnet• Open construction (good for claustrophobics)• Horizontal poles• Generates 0.6 Tesla field strength• Weight bearing anatomical studies



Materials and Methods - flowchart

Recruited by Participating Surgeon

N = 32

Initial Interview and consent

N = 32Each subject

Voids completelyN = 32

Each subject Catheterized300 ml water

N = 30

Each subjectTransferred toUpright MRI

N = 30

3 Step MRI seriesSagittal image

+/- Valsalva Abd. / Pelvic MRI

N = 30

Pre-operative MRI series

ICIQ-FLUTS # 1 Patient data collectedon ExcelR

N = 32


Materials and Methods - flowchart

Post-operative MRI series

Return 3 monthsPost-opN = 27

Pre-MRI Preparation

N = 27

Telephonic DebriefN = 27

2 Step MRI seriesSagittal imagesonly +/- valsalva

N = 27

MRI Image Evaluation

N = 27MRI data added

to ExcelR databaseN = 28

ICIQ-FLUTS # 2


Pre-op resting = 24.1 mm Pre-op valsalva = 36.23 mm“Pre-op excursion” = 12.13 mm


Pre-op image

Resting with Valsalva


Post-op resting = 9.31 mm Post-op valsalva = 14.18 mm “Post-op excursion” = 4.87 mm; 12.13 – 4.87 = “Reduction of Excursion” = 7.26 mm


Post-op image


Results


• Study Population:

• N = 27• MRI series = 57• Average age= 51.5 years Median age = 51.5 years • Youngest subject = 35 years Oldest subject = 82 years• Average weight = 75.5 Kg Average Height = 160.31• Average BMI = 28.13

Results

2 subjects “lost to follow up”1 subject unsuitable due to OAB


2/3 history of previous surgery

Results


Results

No Surgical Complications

Return to OR 0Admission to hospital 0Acute Urinary Retention 0Surgical Site Infection 0UTI 0Erosions 0

2 Study Related ComplicationsSuspected UTI 2


Excursion pre-op with Valsalva of 53 mmHg

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Patient number

Amou

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ursi

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(mm

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Excursion pre

Average = 6.83 mm

Results


Post-op and Pre-op excursion with Valsalva (mm)

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Patient number

Excursion (mm)

Pre-exc

Post-exc

6.84 mm4.41 mm

Results


• Measured reduction in pelvic floor excursion overall (average in mm)

• Prior to surgery = 6.84 mm

• After Surgery = 4.41 mm

• Reduction = 2.43 mm

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Pre-op excursionPost-op excursion

Results

(34%)


• Improvement in average modified ICIQ-FLUTS score overall• Pre-op = 19.96• Post-op = 11.15• Average improvement = 8.81

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ICIQ-FLUTS score

Pre-op ICIQ-FLUTSPost-op ICIQ-FLUTS

Results

(44%)

Problem: Improvement in ICIQ-FLUTS notobviously linked to reduced excursion

The SS improvers were not the same as thePF improvers!


Improvement in ICIQ-FLUTS compared to Reduction in Excursion (Data overlay graph)

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Results


Comparison of pre-op SS to pre-op excursion

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ICIQ-FLUTS SS

PF E

xcur

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Spearman’s Rank Correlation (r) = 0.0723 (p < 0.001)


Degree of Obesity VS SS

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BMI

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TS S

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Spearman’s rank correlation r = 0.117


Correlation pre-op excursion VS SS reduction

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Amount of Pre-operative PF Excursion (mm)

Redu

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ICIQ

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SS Series2

Spearman’s Rank Correlation Co-Efficient (r) = - 0.05094 (p < 0.001)

Results


Correlation of Reduction of SS VS Reduction of PF Excursion

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Spearman's Rank Correlation Co-Efficient (r) = - 0.18206 (p < 0.0001)

Results

Reduction ofPF excursion(mm)

Reduction of SS


Conclusions

(MonarcR) TOT demonstrated to reduce pelvic floor excursion due to standardized Valsalva under physiological conditions by 2.43 mm (on average) = 36% reduction of excursion at 3 months

(MonarcR) TOT demonstrated to improve ICIQ-FLUTS score by 8.81 points / 19.96 (on average) = 44% improvement in psychometrically valid SS

Improvement in ICIQ-FLUTS score is due to (MonarcR) TOT intervention (Spearman's rank coefficient = 0.182)

In this study (MonarcR) TOT was demonstrated to be very safe with 0% complication rate.


Conclusions……. continued

Upright MRI methodology described in this study is a safe and practical way to assesspatients prior to TOT incontinence surgery

Upright MRI methodology may prove to be a very useful investigative tool for a subset ofincontinence patients prior to TOT surgery

Upright MRI methodology may prove to be useful as a screening tool to predict symptom score outcomes prior to TOT surgery


• This study made possible thanks to a grant from American Medical Systems• Developers of the MonarcR trans-obterator tape system

• Interior Health Authority (IHA)• Provided a free Research Ethics Board (REB)

• Laborie Medical Systems• Allowed us to test their new valsalvameter system “PeritronR”• Support and custom made disposables for use in MRI environment

Upright MRI in the evaluation of the female Genuine Stress Urinary Incontinence

Health & Medicine

Transcript of Upright MRI in the evaluation of the female Genuine Stress Urinary Incontinence