İS/MAS tedavi Pelvik denervasyon Nöromodülasyon

BoNT-A

Prof. Dr. Mesut Gürdal

Otonom sistem

•  Otonomik (kalp kası, düz kaslar, salgı bezleri..)

•  Bilinç dışı olarak viseral fonksiyonları düzenler

Otonom-sempatik

•  Spinal kord torakolumber T10-L2

•  Hypogastrik sinir

•  Beta 3 adrenerjik düz kas relakse

•  Alfa1a mesane çıkım düz kas kontrakte

Otonom-parasempatik

•  Sakral segment S 2-4

•  Pelvik splanik sinir parasempatik (Ach) muskarinik düz kas kontrakte

Somatik sistem

•  Vücut hareketinin çizgili kas vasıtasıyla

•  Motor ve sensorial

•  Bilinç dahilinde istemli kontrolünü (yürüme, koşmak,yazmak, resim yapmak….)

somatik

•  Sakral 2-4

•  Pudendal sinir

- Eksternal sfinkter çizgili kas kontraksiyonu

•  A delta fiber - mesane dolumunda primer mediatör

•  C fiber -  Aşırı distansiyon -  Soğuk -  Sıcak -  Mesane mukozası kimyasal irritasyon

Ağrı - patofizyolojik

•  Nosiseptif: Somatik/visseral - Sinir uçları sağlam, doku hasarı sonucu

•  Nöropatik Ağrı - Sinir sistemindeki primer lezyon veya fonksiyon bozukluğu

(Sinirler sensitize)

Pelvik Denervasyon

•  Presakral nörektomi •  Laparoscopic uterine nerve ablation – LUNA

•  Pudendal sinir dekompresyonu

Presakral Nörektomi LUNA

! Medikal tedaviye dirençli Endometriozis cerrahisi ile kombine kronik pelvik ağrıda

! Dismenore

Presakral nörektomi

LUNA

METHODS

A literature search was performed using Google, Yahoo, Springerlink and Highwire Press. The following search terms were used: Laparoscopicuterine nerve ablation (LUNA) and Presacral Neurectomy (PSN), complications of LUNA and complication Presacral Neurectomy (PSN) . The 13number of quality citations reviewed was selected for this review. The criteria for selection were:

At least 13 sources should be included in the study especially for evaluation.Method of analysis: Retrospective analysis RCT.Type of operative: Laparoscopic procedureThe institution where the procedure was practiced (preference for those specialized for laparoscopic surgery).

OPERATIVE TECHNIQUE

Procedure Specific for Laparoscopicy Uterine Nerve Ablation and Presacral Neurectomy8

The use of nerve transection procedures has been investigated for the treatment of chronic pelvic pain. They are often carried out during thecourse of other surgical treatment for endometriosis. The most common of these nerve transection procedures are laparoscopic uterine nerveablation (LUNA) and presacral neurectomy (PSN).

Laparoscopic Uterine Nerve Ablation (LUNA) Procedure

The goal is the interruption of uterine nerve fibers traveling down the ligament and relief of uterine pain. During a LUNA procedure, theuterosacral ligaments (USL) are transected near their insertion into the posterior cervix. Laparoscopic uterine nerve ablation involves thedestruction of the uterine nerve fibers that exit the uterus through the uterosacral ligament. Recent anatomical studies by Fujii et al showed thatthe majority of uterosacral nerve fiber bundles were found at a distance of 6.5-33 mm and at a depth of 3-5 mm distal to the site of attachmentof the uterosacral ligaments to the cervix. (9,10) (Fig. 1).

Presacral Neurectomy (PSN)

Laparoscopic electrosurgical PSN through an umbilical approach was developed in 1988. The technique and results have been described in detail.This technique was later adapted for use with a carbon dioxide laser.11,12 The patient is placed in steep Trendelenburg position and rolled to theleft, displacing the sigmoid laterally. A blunt probe also retracts the sigmoid laterally, effectively removing the sigmoid from the operative site.Presacral neurectomy is performed on the anterior aspects of vertebral bodies L5 and S1. The superior hypogastric plexus is the main pathway ofneural transmission from the pelvis.

Fig. 1: Nerve slice position scheme of LUNA and PSN

While in neurectomy the plexus is exposed and the nerves are either cut or excised to interrupt the neural input, means the interruption of thesympathetic innervation of the uterus at the level of the superior hypogastric plexus (see Fig. 1).Adjacent vital structures which could be injuredinclude the common iliac veins, the ureters, and the sigmoid mesentery. Presacral neurectomy is technically more challenging than LUNA becauseof the presence of large vessels and the ureters near the field of dissection.13,14

40

The Role Laparoscopic Uterine Nerve Ablation (LUNA) and Presacral Neurectomy (PSN) of Pelvic Pain Management

Variations in LUNA Methods

LUNA are the procedure interrupts/ablation of pelvic afferent sensory nerve fibers of the Lee-Frankenkauser nerve plexus. In a 1955 study ofDoyle et al, vaginal transection of the nerves was effective for dysmenorrheal. Wide variations in the practice of LUNA have been shown bycomparing the UK group with the rest of Europe. The latter were more likely to completely transect the uterosacral ligaments (56% vs 36%) at adistance 2 cm or more from its cervical insertion (50% vs 21%) than the UK group. Even the tools for ablation varied between these 2 groups, i.e.laser cutting (3% vs 32%), electrodiathermy (78% vs 75%), scissors cutting (22% vs 15%), and harmonic scalpel for cutting (8% vs 11%).There is widespread clinical uncertainty in the techniques, with insufficient evidence of effectiveness, thereby making it both harder to determinethe optimal time, depth, and site of LUNA procedures, and the opinions regarding its use uncertain and variable.15

Effectiveness Measures of LUNA and PSN

A method structured survey was used to analyze gynecologists "prior beliefs" on the effectiveness for LUNA and PSN on pelvic pain by bothnumeric response (on a l0-point visual analog scale/VAS) and by responses to a questionnaire. The most widely held "prior belief" was that LUNAwould have small beneficial effect on pain.16 The secondary outcome measures will be assessment of sexual function and quality of life. TheSexual Activity Questionnaire (SAQ) will replace the Brief Index of Sexual Satisfaction (BISS) for the assessment sexual function.17 Third measureis health-related quality of life (HRQL) instruments are becoming powerful tools for outcome assessments in randomised trials. Quality of life hasto be defined clearly and patient's perception of normal performance serves a pivotal role in this context. HRQL instruments are administered withquestionnaires assessing a number 1of different domains, i.e. areas of behavior or experience that the instrument is attempting to measure.18

American Society for Reproductive Medicine (ASRM) 2014

- Presakral neurectomy •  Menstrüasyonla birlikte orta hat ağrıların tedavisinde

önerilir - Venöz pleksus kanamaları - Postop. Üriner retansiyon ve konstipasyona neden olabilir -LUNA •  Primer cerrahiye ilave katkısı olmadığı

Pudendal nöralji

•  Teşhis temelde klinik

•  Kronik oturur pozisyonda perineal ağrı

•  Ayağa kalkınca rahatlama

•  Gece ağrı yok

•  Analjeziklere cevap yok

•  16 hasta Transgluteal yaklaşım, 16 kontrol

•  1.yılda başarı cerrahi grup %71.4, kontrol %13.3

•  Kr pudendal nöraljisi olup analjezik ve sinir bloğuna cevap vermeyen hastalarda önerilir

•  72 bayan

•  Anogenital dirençli ağrı

•  Anal incontinans 46 hasta

•  Üriner incontinans 5 hasta (4 urge, 1 stres tip)

(Ortalama 18.5 ay takip sıkışma hissi olan 3 hasta kür, stres tip şikayetlerde azalma)

•  24 bayan, 3 erkek

•  Anogenital bölgede lokalize kronik nöropatik ağrı

•  Preop %64 üriner sıkışma ve sıklık hissi var

•  6 aylı takip edilen 16 hastanın 13 (%81.2) VAS ağrı >%80 azalmış

Lemos N1 , Marques R1 , Sparapani F1 , Plöger-Schor C1 , Schor E1 , Girão 1. Universidade Federal de São Paulo

INTRAPELVIC NERVE ENTRAPMENTS – A NEGLECTED CAUSE OF PERINEAL PAIN AND URINARY SYMPTOMS

kronik pelvik ağrı •  28bayan, 1 erkek •  22 jinekologlar, 4 kişi web sayfasından, 3 ortopedist •  %79.3 (23) hastanın ağrısı en az %50 azalmış

Laparoskopinin sakral ve pudendal sinir

nöromodülasyonlarında,

(hatta spinal kord travmalı hastalarda siyatik sinire )

"

elektrodların doğru yerleştirilmesi ve fiksasyonunda teknik

kolaylıklar sağlaması açısından !!!!

İS/MAS ICS tanımı

•  Mesane dolumu ile bağlantılı suprapubik ağrı, eşlik eden gece gündüz sıklık, üriner enfeksiyon veya diğer belirgin patoloji olmaksızın....

Pelvik denervasyonlar Pudendal dekompresyon

•  İS/MAS kapsamında guideline düzeyinde yeterli bilgi yok

Nöromodülasyon •  Etki mekanizması ?????

•  Spinal veya Supraspinal refleksler ve sensoryal yollarda değişim-düzenleme yaptığı!!!!!

•  78 hasta

•  Test %50 iyileşme olanlara kalıcı implant •  61.5 ay ortalama takip

•  %72 uzun dönem başarı oranı •  %28 çıkarılmış •  %50 revizyon oranı

Minimum 6-year outcomes for interstitial cystitis treated with sacral neuromodulation

Marinkovic SP. Int Urogynecol J. 2011 Apr;22(4):407-12. doi: 10.1007/s00192-010-1235-9. Epub 2010 Sep 17.

•  34 hasta •  0rtalama takip 86 ±9.2 ay

•  Urgenc/frequency skor 21 ±8 , 9 ±6 (p<0.01)

•  VAS 6.5 ±2.9/2.4 ±1.2 (p<0.01)

•  Reoperasyon oranı %27

•  22 hasta •  17 kalıcı implant

•  Semptomların düzelme oranı - Pudendal nerve stimülasyonu (PNS) %59 - Sakral nerve stimülasyonu (SNM) %44

Nöromodülasyon

•  Konservatif tedavilerin yetersiz olduğu dirençli vakalarda major invaziv cerrahiden önce düşünülmelidir.

•  Revizyon oranları %25-50 ve hastalar hayatları boyunca takip edilmelidir.

LE MAS de sakral nöromodülasyon etkili olabilir 3 MAS tedavisinde PNS SNMye göre daha üstündür

1b

Gr

Daha invaziv girişimlerden önce nöromodülasyon düşünülebilir..

B

EAU

30 CHRONIC PELVIC PAIN - UPDATE APRIL 2014

Oxybutynin might be considered for the treatment of BPS. CGabapentin might be considered for oral treatment of BPS. CAdminister intravesical lidocaine plus sodium bicarbonate prior to more invasive methods. AAdminister intravesical pentosanpolysulphate sodium before more invasive treatment alone or combined with oral pentosanpolysulphate sodium.

A

Consider intravesical heparin before more invasive measures alone or in combination treatment. CConsider intravesical hyaluronic acid before more invasive measures. BConsider intravesical chondroitin sulphate before more invasive measures. BConsider intravesical bladder wall and trigonal injection of BTX-A if intravesical instillation therapies have failed.

C

Administer submucosal injection of BTX-A plus hydrodistension if intravesical instillation therapies have failed.

A

Intravesical therapy with BCG is not recommended in BPS. AIntravesical therapy with clorpactin is not recommended in BPS. ABladder distension is not recommended as a treatment of BPS. CConsider transurethral resection (or coagulation or laser) of bladder lesions, but in BPS type 3 C only. BNeuromodulation might be considered before more invasive interventions. BConsider diet avoidance of triggering substances. CAcupuncture is not recommended. CAll ablative organ surgery should be the last resort for experienced and BPS knowledgeable surgeons only.

A

DMSO = dimethyl sulphoxide; BPS = bladder pain syndrome.

Figure 4: Diagnosis and therapy of BPS

Urine culture

Uroflowmetry

Cystoscopy with hydrodistension

Bladder biopsy

Pelvic floormuscle testing

Assessment

Grade A recommended

Micturition diary

Treatment

Grade B recommended

Not recommended

Standard: Amitriptyline, Pentosanpolysulphate

Intravesical: PPS, DMSO, onabotulinum toxin A plus hydrodistension

Oral: Cimetidine, cyclosporin A

Intravesical: hyaluronic acid, chondroitin sulphate

Bacillus Calmette Guérin

Intravesical Chlorpactin

Hydroxyzine

Electromotive drug administration for intravesical drugs

Neuromodulation, bladder training, physical therapy

Psychological therapy

Data on surgical treatment are largely variable

Phenotyping

ICSI score list

Other comments Coagulation and laser only for Hunner’s lesions

AUA

Signs/Symptoms of Complicated IC/BPS

Confirmed or Uncomplicated IC/BPS

FIRST-LINE TREATMENTS– General Relaxation/ Stress Management– Pain Management– Patient Education– Self-care/Behavioral Modification

SECOND-LINE TREATMENTS– Appropriate manual physical therapy techniques– Oral: amitriptyline, cimetidine, hydroxyzine, PPS– Intravesical: DMSO, Heparin, Lidocaine– Pain Management

THIRD-LINE TREATMENTS– Cystoscopy under anesthesia w/ hydrodistention– Pain Management– Tx of Hunner’s lesions if found

FOURTH-LINE TREATMENTS– Intradetrusor botulinum toxin A– Neuromodulation– Pain Management

FIFTH-LINE TREATMENTS– Cyclosporine A– Pain Management

SIXTH-LINE TREATMENTS– Diversion w/ or w/out cystectomy– Pain Management– Substitution cystoplastyNote: For patients with end-stage structurally small bladders, diversion is indicated at any time clinician and patient believe appropriate.

Dx Urinary Tract Infection

TREAT & REASSESS

BASIC ASSESSMENT– History– Frequency/Volume Chart– Post-void residual– Physical examination

– Urinalysis, culture– Cytology if smoking hx– Symptom questionnaire– Pain evaluation

– Incontinence/OAB– GI signs/symptoms

Microscopic/gross hematuria/sterile pyuria

– Gynecologic signs/symptoms

CONSIDER:– Urine cytology– Imaging– Cystoscopy– Urodynamics– Laparoscopy– Specialist referral (urologic or

non-urologic as appropriate)

IC/BPSAn unpleasant sensation (pain, pressure, discomfort) perceived to be related to

the urinary bladder, associated with lower urinary tract symptoms of more than six weeks duration, in the absence of infection or other identifiable causes

CLINICAL MANAGEMENT PRINCIPLES – Treatments are ordered from most to least conservative;

surgical treatment is appropriate only after other treatment options have been found to be ineffective (except for treatment of Hunner’s lesions if detected)

– Initial treatment level depends on symptom severity, clinician judgment, and patient preferences

– Multiple, simultaneous treatments may be considered if in best interests of patient

– Ineffective treatments should be stopped – Pain management should be considered throughout course of therapy

with goal of maximizing function and minimizing pain and side effects – Diagnosis should be reconsidered if no improvement

within clinically-meaningful time-frame

RESEARCH TRIALSPatient enrollment as appropriate at any point in treatment process

The evidence supporting the use of Neuromodulation, Cyclosporine A, and BTX for IC/BPS is limited by many factors including study quality, small sample sizes, and lack of durable follow up. None of these therapies have been approved by the U.S. Food and Drug Administration for this indication. The panel believes that none of these interventions can be recommended for generalized use for this disorder, but rather should be limited to practitioners with experience managing this syndrome and willingness to provide long term care of these patients post intervention.

Copyright © 2014 American Urological Association Education and Research, Inc.

Signs/Symptoms of Complicated IC/BPS

Confirmed or Uncomplicated IC/BPS

FIRST-LINE TREATMENTS– General Relaxation/ Stress Management– Pain Management– Patient Education– Self-care/Behavioral Modification

SECOND-LINE TREATMENTS– Appropriate manual physical therapy techniques– Oral: amitriptyline, cimetidine, hydroxyzine, PPS– Intravesical: DMSO, Heparin, Lidocaine– Pain Management

THIRD-LINE TREATMENTS– Cystoscopy under anesthesia w/ hydrodistention– Pain Management– Tx of Hunner’s lesions if found

FOURTH-LINE TREATMENTS– Intradetrusor botulinum toxin A– Neuromodulation– Pain Management

FIFTH-LINE TREATMENTS– Cyclosporine A– Pain Management

SIXTH-LINE TREATMENTS– Diversion w/ or w/out cystectomy– Pain Management– Substitution cystoplastyNote: For patients with end-stage structurally small bladders, diversion is indicated at any time clinician and patient believe appropriate.

Dx Urinary Tract Infection

TREAT & REASSESS

BASIC ASSESSMENT– History– Frequency/Volume Chart– Post-void residual– Physical examination

– Urinalysis, culture– Cytology if smoking hx– Symptom questionnaire– Pain evaluation

– Incontinence/OAB– GI signs/symptoms

Microscopic/gross hematuria/sterile pyuria

– Gynecologic signs/symptoms

CONSIDER:– Urine cytology– Imaging– Cystoscopy– Urodynamics– Laparoscopy– Specialist referral (urologic or

non-urologic as appropriate)

IC/BPSAn unpleasant sensation (pain, pressure, discomfort) perceived to be related to

the urinary bladder, associated with lower urinary tract symptoms of more than six weeks duration, in the absence of infection or other identifiable causes

CLINICAL MANAGEMENT PRINCIPLES – Treatments are ordered from most to least conservative;

surgical treatment is appropriate only after other treatment options have been found to be ineffective (except for treatment of Hunner’s lesions if detected)

– Initial treatment level depends on symptom severity, clinician judgment, and patient preferences

– Multiple, simultaneous treatments may be considered if in best interests of patient

– Ineffective treatments should be stopped – Pain management should be considered throughout course of therapy

with goal of maximizing function and minimizing pain and side effects – Diagnosis should be reconsidered if no improvement

within clinically-meaningful time-frame

RESEARCH TRIALSPatient enrollment as appropriate at any point in treatment process

The evidence supporting the use of Neuromodulation, Cyclosporine A, and BTX for IC/BPS is limited by many factors including study quality, small sample sizes, and lack of durable follow up. None of these therapies have been approved by the U.S. Food and Drug Administration for this indication. The panel believes that none of these interventions can be recommended for generalized use for this disorder, but rather should be limited to practitioners with experience managing this syndrome and willingness to provide long term care of these patients post intervention.

Copyright © 2014 American Urological Association Education and Research, Inc.

AUA Gr C

Botilunum toksin A

!  Anti-nosiseptive

!  Anti-inflamatuar

!  Kas gevşetici

Nöropatik ağrı regulasyonunda direkt etkili

-TRPV1 -P2X3

•  Nerve Growth Factor (NGF) - Üriner disfonksiyonda ve ağrı - IS/MAS serum ve idrarda artar

•  İnflamatuar sitokinler (ağrıyı indükler) -  Substans-P -  Calsitonin gene-related peptid -  Prostaglandin E2 -  Nitrik oksit

BoTN-A

Botulinum toksin A enjeksiyonu

•  100 -200 IU •  %69-84 ilk 3 ay •  Etki zamanla azalmakta •  TAK gerekirse, bu hastaların tolere edebilmesi için çok iyi

anlatmak gerekir

BoTN-A Enjeksiyon

•  Miktarı - 100-200 U

•  Sayısı - 10-40

•  Yeri -  Trigon -  Trigon + posterior duvar -  Posterior duvar

Tekrarlayan enjeksiyonlarda

•  Kronik enflamasyon ve apoptotik sinyal molekülleri azalmakta

•  Bu azalma semptomatik düzelmeyle paralel

•  Tekrarlayan enjeksiyonlar başarı oranlarını arttırmakta Pinto, R. J. Urol.2013, 189, 548–553. Kuo, H.C. Pain Phys. 2013, 16, E15–E23.

LE

İntravezikal submukozal BTX-A enjeksiyonu hidrodistansiyonla birlikte sadece hidrodistansiyon yapılanlardan belirgin olarak üstün

1b

Detrussor veya trigon BTX-A enjeksiyonu ile ilgili snırlı data var 3

Öneriler Gr

İntravezikal instilasyon tedavilerinin yetersiz olduğu durumlarda submukozal BTX-A enjeksiyonu ile birlikte hidrodistansiyon

A

İntravezikal instilasyon tedavilerinin yetersiz olduğu durumlarda intravezikal mesane duvarı ve trigonal BTX-A enjeksiyonu düşünülür

C

EAU

30 CHRONIC PELVIC PAIN - UPDATE APRIL 2014

Oxybutynin might be considered for the treatment of BPS. CGabapentin might be considered for oral treatment of BPS. CAdminister intravesical lidocaine plus sodium bicarbonate prior to more invasive methods. AAdminister intravesical pentosanpolysulphate sodium before more invasive treatment alone or combined with oral pentosanpolysulphate sodium.

A

Consider intravesical heparin before more invasive measures alone or in combination treatment. CConsider intravesical hyaluronic acid before more invasive measures. BConsider intravesical chondroitin sulphate before more invasive measures. BConsider intravesical bladder wall and trigonal injection of BTX-A if intravesical instillation therapies have failed.

C

Administer submucosal injection of BTX-A plus hydrodistension if intravesical instillation therapies have failed.

A

Intravesical therapy with BCG is not recommended in BPS. AIntravesical therapy with clorpactin is not recommended in BPS. ABladder distension is not recommended as a treatment of BPS. CConsider transurethral resection (or coagulation or laser) of bladder lesions, but in BPS type 3 C only. BNeuromodulation might be considered before more invasive interventions. BConsider diet avoidance of triggering substances. CAcupuncture is not recommended. CAll ablative organ surgery should be the last resort for experienced and BPS knowledgeable surgeons only.

A

DMSO = dimethyl sulphoxide; BPS = bladder pain syndrome.

Figure 4: Diagnosis and therapy of BPS

Urine culture

Uroflowmetry

Cystoscopy with hydrodistension

Bladder biopsy

Pelvic floormuscle testing

Assessment

Grade A recommended

Micturition diary

Treatment

Grade B recommended

Not recommended

Standard: Amitriptyline, Pentosanpolysulphate

Intravesical: PPS, DMSO, onabotulinum toxin A plus hydrodistension

Oral: Cimetidine, cyclosporin A

Intravesical: hyaluronic acid, chondroitin sulphate

Bacillus Calmette Guérin

Intravesical Chlorpactin

Hydroxyzine

Electromotive drug administration for intravesical drugs

Neuromodulation, bladder training, physical therapy

Psychological therapy

Data on surgical treatment are largely variable

Phenotyping

ICSI score list

Other comments Coagulation and laser only for Hunner’s lesions

AUA

Signs/Symptoms of Complicated IC/BPS

Confirmed or Uncomplicated IC/BPS

FIRST-LINE TREATMENTS– General Relaxation/ Stress Management– Pain Management– Patient Education– Self-care/Behavioral Modification

SECOND-LINE TREATMENTS– Appropriate manual physical therapy techniques– Oral: amitriptyline, cimetidine, hydroxyzine, PPS– Intravesical: DMSO, Heparin, Lidocaine– Pain Management

THIRD-LINE TREATMENTS– Cystoscopy under anesthesia w/ hydrodistention– Pain Management– Tx of Hunner’s lesions if found

FOURTH-LINE TREATMENTS– Intradetrusor botulinum toxin A– Neuromodulation– Pain Management

FIFTH-LINE TREATMENTS– Cyclosporine A– Pain Management

SIXTH-LINE TREATMENTS– Diversion w/ or w/out cystectomy– Pain Management– Substitution cystoplastyNote: For patients with end-stage structurally small bladders, diversion is indicated at any time clinician and patient believe appropriate.

Dx Urinary Tract Infection

TREAT & REASSESS

BASIC ASSESSMENT– History– Frequency/Volume Chart– Post-void residual– Physical examination

– Urinalysis, culture– Cytology if smoking hx– Symptom questionnaire– Pain evaluation

– Incontinence/OAB– GI signs/symptoms

Microscopic/gross hematuria/sterile pyuria

– Gynecologic signs/symptoms

CONSIDER:– Urine cytology– Imaging– Cystoscopy– Urodynamics– Laparoscopy– Specialist referral (urologic or

non-urologic as appropriate)

IC/BPSAn unpleasant sensation (pain, pressure, discomfort) perceived to be related to

the urinary bladder, associated with lower urinary tract symptoms of more than six weeks duration, in the absence of infection or other identifiable causes

CLINICAL MANAGEMENT PRINCIPLES – Treatments are ordered from most to least conservative;

surgical treatment is appropriate only after other treatment options have been found to be ineffective (except for treatment of Hunner’s lesions if detected)

– Initial treatment level depends on symptom severity, clinician judgment, and patient preferences

– Multiple, simultaneous treatments may be considered if in best interests of patient

– Ineffective treatments should be stopped – Pain management should be considered throughout course of therapy

with goal of maximizing function and minimizing pain and side effects – Diagnosis should be reconsidered if no improvement

within clinically-meaningful time-frame

RESEARCH TRIALSPatient enrollment as appropriate at any point in treatment process

The evidence supporting the use of Neuromodulation, Cyclosporine A, and BTX for IC/BPS is limited by many factors including study quality, small sample sizes, and lack of durable follow up. None of these therapies have been approved by the U.S. Food and Drug Administration for this indication. The panel believes that none of these interventions can be recommended for generalized use for this disorder, but rather should be limited to practitioners with experience managing this syndrome and willingness to provide long term care of these patients post intervention.

Copyright © 2014 American Urological Association Education and Research, Inc.

Signs/Symptoms of Complicated IC/BPS

Confirmed or Uncomplicated IC/BPS

FIRST-LINE TREATMENTS– General Relaxation/ Stress Management– Pain Management– Patient Education– Self-care/Behavioral Modification

SECOND-LINE TREATMENTS– Appropriate manual physical therapy techniques– Oral: amitriptyline, cimetidine, hydroxyzine, PPS– Intravesical: DMSO, Heparin, Lidocaine– Pain Management

THIRD-LINE TREATMENTS– Cystoscopy under anesthesia w/ hydrodistention– Pain Management– Tx of Hunner’s lesions if found

FOURTH-LINE TREATMENTS– Intradetrusor botulinum toxin A– Neuromodulation– Pain Management

FIFTH-LINE TREATMENTS– Cyclosporine A– Pain Management

SIXTH-LINE TREATMENTS– Diversion w/ or w/out cystectomy– Pain Management– Substitution cystoplastyNote: For patients with end-stage structurally small bladders, diversion is indicated at any time clinician and patient believe appropriate.

Dx Urinary Tract Infection

TREAT & REASSESS

BASIC ASSESSMENT– History– Frequency/Volume Chart– Post-void residual– Physical examination

– Urinalysis, culture– Cytology if smoking hx– Symptom questionnaire– Pain evaluation

– Incontinence/OAB– GI signs/symptoms

Microscopic/gross hematuria/sterile pyuria

– Gynecologic signs/symptoms

CONSIDER:– Urine cytology– Imaging– Cystoscopy– Urodynamics– Laparoscopy– Specialist referral (urologic or

non-urologic as appropriate)

IC/BPSAn unpleasant sensation (pain, pressure, discomfort) perceived to be related to

the urinary bladder, associated with lower urinary tract symptoms of more than six weeks duration, in the absence of infection or other identifiable causes

CLINICAL MANAGEMENT PRINCIPLES – Treatments are ordered from most to least conservative;

surgical treatment is appropriate only after other treatment options have been found to be ineffective (except for treatment of Hunner’s lesions if detected)

– Initial treatment level depends on symptom severity, clinician judgment, and patient preferences

– Multiple, simultaneous treatments may be considered if in best interests of patient

– Ineffective treatments should be stopped – Pain management should be considered throughout course of therapy

with goal of maximizing function and minimizing pain and side effects – Diagnosis should be reconsidered if no improvement

within clinically-meaningful time-frame

RESEARCH TRIALSPatient enrollment as appropriate at any point in treatment process

The evidence supporting the use of Neuromodulation, Cyclosporine A, and BTX for IC/BPS is limited by many factors including study quality, small sample sizes, and lack of durable follow up. None of these therapies have been approved by the U.S. Food and Drug Administration for this indication. The panel believes that none of these interventions can be recommended for generalized use for this disorder, but rather should be limited to practitioners with experience managing this syndrome and willingness to provide long term care of these patients post intervention.

Copyright © 2014 American Urological Association Education and Research, Inc.

AUA GrC