Trial Outcomes & Findings for A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain (NCT NCT05658874)
NCT ID: NCT05658874
Last Updated: 2026-04-01
Results Overview
This survey assesses IC/BPS symptoms and a change in \> or equal to 4 points is considered clinically significant. A higher score change indicates less pain and urinary symptoms. The minimum possible score is 0. The maximum possible score is 37.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
26 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2026-04-01
Participant Flow
Chronic Pelvic Pain Study, UPMC Magee's Women's Hospital, Recruited from 12/6/2022 to 9/25/2024
Participant milestones
| Measure |
Multimodal Care Bundle
Components of multimodal care bundle
1. MD Evaluation
2. On site pelvic floor physical therapy
3. Behavioral health consult with appropriate psychiatric referrals/treatments
4. 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)
|
Usual Care
IC/PBS treatments as directed by Urogynecology specialist
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
10
|
|
Overall Study
Baseline Visit and Survey Completion
|
15
|
8
|
|
Overall Study
6-week visit and Survey Completion
|
7
|
7
|
|
Overall Study
12-week visit and Survey Completion
|
7
|
6
|
|
Overall Study
6-month visit and Survey Completion
|
4
|
5
|
|
Overall Study
1-year visit and Survey Completion
|
4
|
5
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain
Baseline characteristics by cohort
| Measure |
Multimodal Care Bundle
n=16 Participants
Components of multimodal care bundle
1. MD Evaluation
2. On site pelvic floor physical therapy
3. Behavioral health consult with appropriate psychiatric referrals/treatments
4. 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)
|
Usual Care
n=10 Participants
IC/PBS treatments as directed by Urogynecology specialist
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age Demographics · Ages 18-29 years
|
7 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=10 Participants
|
|
Age, Customized
Age Demographics · Ages 30-42 years
|
6 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=10 Participants
|
|
Age, Customized
Age Demographics · Ages 43-55 years
|
2 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=10 Participants
|
|
Age, Customized
Age Demographics · Ages 56-68 years
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
|
Age, Customized
Age Demographics · Ages 69+ years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
26 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
25 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
26 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Body Mass Index (BMI)
Underweight: BMI < 18.5
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Body Mass Index (BMI)
Healthy weight: BMI 18.5-24.9
|
6 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=10 Participants
|
|
Body Mass Index (BMI)
Overweight: BMI 25-29.9
|
2 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=10 Participants
|
|
Body Mass Index (BMI)
Obese: BMI >30
|
8 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=10 Participants
|
|
Smoking Status
Current Smoker
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Smoking Status
Former Smoker
|
2 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
|
Smoking Status
Never Smoked
|
14 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
24 Participants
n=10 Participants
|
|
Menopausal Status
Premenopausal
|
14 Participants
n=5 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=10 Participants
|
|
Menopausal Status
Postmenopausal, no HRT
|
2 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
|
Menopausal Status
Postmenopausal, HRT
|
0 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
|
Menopausal Status
Uncertain
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksThis survey assesses IC/BPS symptoms and a change in \> or equal to 4 points is considered clinically significant. A higher score change indicates less pain and urinary symptoms. The minimum possible score is 0. The maximum possible score is 37.
Outcome measures
| Measure |
Multimodal Care Bundle
n=7 Participants
Components of multimodal care bundle
1. MD Evaluation
2. On site pelvic floor physical therapy
3. Behavioral health consult with appropriate psychiatric referrals/treatments
4. 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)
|
Usual Care
n=6 Participants
IC/PBS treatments as directed by Urogynecology specialist
|
|---|---|---|
|
--O'Leary Sant Questionnaire (OLS), Comprised of Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI), Change at 12 Weeks From Baseline
|
8.71 O' Leary Sant Score
Standard Deviation 7.11 • Interval 0.0 to 4.0
|
3.50 O' Leary Sant Score
Standard Deviation 7.34 • Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline to 12-monthNumber of encounters with the UPMC healthcare system that include emergency room visits, provider calls, provider visits, procedures, and other treatments based on documentation within their medical record.
Outcome measures
| Measure |
Multimodal Care Bundle
n=16 Participants
Components of multimodal care bundle
1. MD Evaluation
2. On site pelvic floor physical therapy
3. Behavioral health consult with appropriate psychiatric referrals/treatments
4. 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)
|
Usual Care
n=10 Participants
IC/PBS treatments as directed by Urogynecology specialist
|
|---|---|---|
|
Healthcare Encounters Motivated on Pain
Emergency Room Visits
|
2 Encounters
|
5 Encounters
|
|
Healthcare Encounters Motivated on Pain
Provider Calls
|
3 Encounters
|
7 Encounters
|
|
Healthcare Encounters Motivated on Pain
Provider Visits
|
18 Encounters
|
8 Encounters
|
|
Healthcare Encounters Motivated on Pain
Procedures
|
10 Encounters
|
10 Encounters
|
|
Healthcare Encounters Motivated on Pain
Other Treatment (Pelvic Floor PT, bladder instillations, TENS unit for pain relief, etc)
|
31 Encounters
|
70 Encounters
|
Adverse Events
Multimodal Care Bundle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place