A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- --O'Leary Sant Questionnaire (OLS), comprised of Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI), at 12 weeks from baseline MCID: 4 points for ICSI Change in O'Leary Sant Questionnaire Scores >4 points
研究概览
简要总结
The goal of this clinical trial is to compare two different treatment patterns in patients with chronic bladder pain. The main questions the investigators are seeking to answer is if bladder pain improves before and after treatment using a painful bladder scale. The participant will have 5 visits to evaluate your symptoms with questionnaires, at least one procedural visit, and must participate in physical therapy and some kind of behavioral health therapy. This study will assess participant response to a bundled-care approach to chronic bladder pain both pre-and post intervention as well as compared to a group of participants receiving typical care.
详细描述
Objectives:
The goals of this research program are to evaluate the patient-reported outcomes of a multimodal care bundle for patients presenting to a multidisciplinary chronic pelvic pain clinic compared to "usual care" in an Urogynecology clinic.
Primary Aim:
To compare pre and post intervention self-evaluation of pain and function scores in women with chronic pain syndromes with a primary finding of urinary/bladder pain symptoms with or without levator spasm who undergo multi-disciplinary, bundled care compared with usual care in a Urogynecology clinic setting.
Secondary Aims:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient 18 years of age or older
- •diagnosis of Interstitial Cystitis/Painful Bladder Syndrome, scoring 6 points or higher on O'Leary Sant Questionnaire
排除标准
- •Active pelvic or bladder infection within past 2 weeks
- •contraindications to medications or intervention therapeutics
- •inability to speak or read English
- •pelvic floor interventional procedure including bladder instillations 4 weeks prior to study recruitment
- •meets criteria for diagnostic laparoscopy
- •internal referral (to reduce severity bias)
- •Note: patients are not excluded for currently taking any medication on the treatment list.
- •Patients can be treated for UTI during the study period.
研究组 & 干预措施
Multimodal care bundle
Components of multimodal care bundle
- MD Evaluation
- On site pelvic floor physical therapy
- Behavioral health consult with appropriate psychiatric referrals/treatments
- Central sensitization/neurogenic pain:
Amitriptyline 10-50mg Or Gabapentin (doses range from 100mg po tid to 600mg po tid) 5. Urinary symptoms IC/PBS:
Spasm: Overactive bladder medication chosen based on patient characteristics/insurance, dose may be increased as tolerated (Oxybutynin/Trospium/Detrol vs. Mirabegron) 6. Microbiome: Methenamine 7. Vaginal estrogen
At least once within 12 weeks of initial visit: 8. Operative cystoscopy 9. Bladder instillations x 6 weeks (lidocaine, heparin, sodium bicarb, Kenalog, gentamicin) 10. Pudendal/Levator and/or Obturator internus nerve block (120mg Kenalog and 0.25% Marcaine, total 23cc)
干预措施: Multimodal Bundle Drugs (Drug)
Multimodal care bundle
Components of multimodal care bundle
- MD Evaluation
- On site pelvic floor physical therapy
- Behavioral health consult with appropriate psychiatric referrals/treatments
- Central sensitization/neurogenic pain:
Amitriptyline 10-50mg Or Gabapentin (doses range from 100mg po tid to 600mg po tid) 5. Urinary symptoms IC/PBS:
Spasm: Overactive bladder medication chosen based on patient characteristics/insurance, dose may be increased as tolerated (Oxybutynin/Trospium/Detrol vs. Mirabegron) 6. Microbiome: Methenamine 7. Vaginal estrogen
At least once within 12 weeks of initial visit: 8. Operative cystoscopy 9. Bladder instillations x 6 weeks (lidocaine, heparin, sodium bicarb, Kenalog, gentamicin) 10. Pudendal/Levator and/or Obturator internus nerve block (120mg Kenalog and 0.25% Marcaine, total 23cc)
干预措施: Operative Cystoscopy (Procedure)
Multimodal care bundle
Components of multimodal care bundle
- MD Evaluation
- On site pelvic floor physical therapy
- Behavioral health consult with appropriate psychiatric referrals/treatments
- Central sensitization/neurogenic pain:
Amitriptyline 10-50mg Or Gabapentin (doses range from 100mg po tid to 600mg po tid) 5. Urinary symptoms IC/PBS:
Spasm: Overactive bladder medication chosen based on patient characteristics/insurance, dose may be increased as tolerated (Oxybutynin/Trospium/Detrol vs. Mirabegron) 6. Microbiome: Methenamine 7. Vaginal estrogen
At least once within 12 weeks of initial visit: 8. Operative cystoscopy 9. Bladder instillations x 6 weeks (lidocaine, heparin, sodium bicarb, Kenalog, gentamicin) 10. Pudendal/Levator and/or Obturator internus nerve block (120mg Kenalog and 0.25% Marcaine, total 23cc)
干预措施: Behavioral health consultation/therapy (Behavioral)
Multimodal care bundle
Components of multimodal care bundle
- MD Evaluation
- On site pelvic floor physical therapy
- Behavioral health consult with appropriate psychiatric referrals/treatments
- Central sensitization/neurogenic pain:
Amitriptyline 10-50mg Or Gabapentin (doses range from 100mg po tid to 600mg po tid) 5. Urinary symptoms IC/PBS:
Spasm: Overactive bladder medication chosen based on patient characteristics/insurance, dose may be increased as tolerated (Oxybutynin/Trospium/Detrol vs. Mirabegron) 6. Microbiome: Methenamine 7. Vaginal estrogen
At least once within 12 weeks of initial visit: 8. Operative cystoscopy 9. Bladder instillations x 6 weeks (lidocaine, heparin, sodium bicarb, Kenalog, gentamicin) 10. Pudendal/Levator and/or Obturator internus nerve block (120mg Kenalog and 0.25% Marcaine, total 23cc)
干预措施: Pelvic floor physical therapy (Other)
Multimodal care bundle
Components of multimodal care bundle
- MD Evaluation
- On site pelvic floor physical therapy
- Behavioral health consult with appropriate psychiatric referrals/treatments
- Central sensitization/neurogenic pain:
Amitriptyline 10-50mg Or Gabapentin (doses range from 100mg po tid to 600mg po tid) 5. Urinary symptoms IC/PBS:
Spasm: Overactive bladder medication chosen based on patient characteristics/insurance, dose may be increased as tolerated (Oxybutynin/Trospium/Detrol vs. Mirabegron) 6. Microbiome: Methenamine 7. Vaginal estrogen
At least once within 12 weeks of initial visit: 8. Operative cystoscopy 9. Bladder instillations x 6 weeks (lidocaine, heparin, sodium bicarb, Kenalog, gentamicin) 10. Pudendal/Levator and/or Obturator internus nerve block (120mg Kenalog and 0.25% Marcaine, total 23cc)
干预措施: Bladder Instillation (Drug)
Multimodal care bundle
Components of multimodal care bundle
- MD Evaluation
- On site pelvic floor physical therapy
- Behavioral health consult with appropriate psychiatric referrals/treatments
- Central sensitization/neurogenic pain:
Amitriptyline 10-50mg Or Gabapentin (doses range from 100mg po tid to 600mg po tid) 5. Urinary symptoms IC/PBS:
Spasm: Overactive bladder medication chosen based on patient characteristics/insurance, dose may be increased as tolerated (Oxybutynin/Trospium/Detrol vs. Mirabegron) 6. Microbiome: Methenamine 7. Vaginal estrogen
At least once within 12 weeks of initial visit: 8. Operative cystoscopy 9. Bladder instillations x 6 weeks (lidocaine, heparin, sodium bicarb, Kenalog, gentamicin) 10. Pudendal/Levator and/or Obturator internus nerve block (120mg Kenalog and 0.25% Marcaine, total 23cc)
干预措施: Vaginal estrogen (Drug)
Multimodal care bundle
Components of multimodal care bundle
- MD Evaluation
- On site pelvic floor physical therapy
- Behavioral health consult with appropriate psychiatric referrals/treatments
- Central sensitization/neurogenic pain:
Amitriptyline 10-50mg Or Gabapentin (doses range from 100mg po tid to 600mg po tid) 5. Urinary symptoms IC/PBS:
Spasm: Overactive bladder medication chosen based on patient characteristics/insurance, dose may be increased as tolerated (Oxybutynin/Trospium/Detrol vs. Mirabegron) 6. Microbiome: Methenamine 7. Vaginal estrogen
At least once within 12 weeks of initial visit: 8. Operative cystoscopy 9. Bladder instillations x 6 weeks (lidocaine, heparin, sodium bicarb, Kenalog, gentamicin) 10. Pudendal/Levator and/or Obturator internus nerve block (120mg Kenalog and 0.25% Marcaine, total 23cc)
干预措施: Methenamine (Drug)
Multimodal care bundle
Components of multimodal care bundle
- MD Evaluation
- On site pelvic floor physical therapy
- Behavioral health consult with appropriate psychiatric referrals/treatments
- Central sensitization/neurogenic pain:
Amitriptyline 10-50mg Or Gabapentin (doses range from 100mg po tid to 600mg po tid) 5. Urinary symptoms IC/PBS:
Spasm: Overactive bladder medication chosen based on patient characteristics/insurance, dose may be increased as tolerated (Oxybutynin/Trospium/Detrol vs. Mirabegron) 6. Microbiome: Methenamine 7. Vaginal estrogen
At least once within 12 weeks of initial visit: 8. Operative cystoscopy 9. Bladder instillations x 6 weeks (lidocaine, heparin, sodium bicarb, Kenalog, gentamicin) 10. Pudendal/Levator and/or Obturator internus nerve block (120mg Kenalog and 0.25% Marcaine, total 23cc)
干预措施: Amitriptyline/Gabapentin (Drug)
Usual care
IC/PBS treatments as directed by Urogynecology specialist
干预措施: Usual Urogynecologic care (Other)
结局指标
主要结局
--O'Leary Sant Questionnaire (OLS), comprised of Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI), at 12 weeks from baseline MCID: 4 points for ICSI Change in O'Leary Sant Questionnaire Scores >4 points
时间窗: 12 weeks
Validated Questionnaire for evaluating Interstitial Cystitis. Scale range ICSI 0-20, ICPI 0-16, total 0-36. Higher score=worse pain. Improvement of 1-2 point is consider clinically significant.
次要结局
- Healthcare encounters(1 year)
研究者
Jocelyn Fitzgerald
Assistant Professor
University of Pittsburgh