Trial Outcomes & Findings for Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease (NCT NCT03149809)

NCT ID: NCT03149809

Last Updated: 2024-09-24

Results Overview

The ICIQ-OAB questionnaire is a 4-question assessment of OAB symptoms and the degree to which they bother the respondent (urgency, frequency, nocturia, UI).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 77 participants
• Primary outcome timeframe: ICIQ-OAB Symptom score at 12 weeks
• Results posted on: 2024-09-24

Participant Flow

Participant milestones

Measure	Behavioral Therapy Pelvic floor muscle exercise-based behavioral therapy Pelvic floor muscle exercise-based behavioral therapy: Multicomponent intervention including fluid management, constipation management and behavioral techniques incorporating pelvic floor muscle-exercise based urge suppression and self-monitoring to reduce overactive bladder symptoms	Drug Therapy Daily solifenacin drug therapy solifenacin: Antimuscarinic bladder relaxant, antagonizes bladder muscarinic receptors
Overall Study STARTED	36	41
Overall Study COMPLETED	36	37
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease

Baseline characteristics by cohort

Measure	Behavioral Therapy n=36 Participants Pelvic floor muscle exercise-based behavioral therapy Pelvic floor muscle exercise-based behavioral therapy: Multicomponent intervention including fluid management, constipation management and behavioral techniques incorporating pelvic floor muscle-exercise based urge suppression and self-monitoring to reduce overactive bladder symptoms	Drug Therapy n=41 Participants Daily solifenacin drug therapy solifenacin: Antimuscarinic bladder relaxant, antagonizes bladder muscarinic receptors	Total n=77 Participants Total of all reporting groups
Age, Continuous	69.4 years STANDARD_DEVIATION 9.3 • n=5 Participants	72.9 years STANDARD_DEVIATION 8.4 • n=7 Participants	71.3 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	36 Participants n=7 Participants	65 Participants n=5 Participants
Race/Ethnicity, Customized White	32 Participants n=5 Participants	37 Participants n=7 Participants	69 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Montreal Cognitive Assessment	24.8 units on a scale STANDARD_DEVIATION 3.3 • n=5 Participants	23.9 units on a scale STANDARD_DEVIATION 3.1 • n=7 Participants	24.3 units on a scale STANDARD_DEVIATION 3.2 • n=5 Participants
ICIQ-OAB Symptom Score	8.5 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants	9.1 units on a scale STANDARD_DEVIATION 1.7 • n=7 Participants	8.8 units on a scale STANDARD_DEVIATION 1.5 • n=5 Participants
ICIQ-OAB QoL	72.5 units on a scale STANDARD_DEVIATION 22.8 • n=5 Participants	69.8 units on a scale STANDARD_DEVIATION 27.3 • n=7 Participants	71.2 units on a scale STANDARD_DEVIATION 25.0 • n=5 Participants
Bladder-diary derived daily incontinence	1.29 incontinence episodes per day STANDARD_DEVIATION 1.90 • n=5 Participants	0.97 incontinence episodes per day STANDARD_DEVIATION 1.71 • n=7 Participants	1.12 incontinence episodes per day STANDARD_DEVIATION 1.80 • n=5 Participants

PRIMARY outcome

Timeframe: ICIQ-OAB Symptom score at 12 weeks

Population: Multiple imputation methods used to account for missing data.

The ICIQ-OAB questionnaire is a 4-question assessment of OAB symptoms and the degree to which they bother the respondent (urgency, frequency, nocturia, UI).

Outcome measures

Measure	Behavioral Therapy n=36 Participants Pelvic floor muscle exercise-based behavioral therapy Pelvic floor muscle exercise-based behavioral therapy: Multicomponent intervention including fluid management, constipation management and behavioral techniques incorporating pelvic floor muscle-exercise based urge suppression and self-monitoring to reduce overactive bladder symptoms	Drug Therapy n=41 Participants Daily solifenacin drug therapy solifenacin: Antimuscarinic bladder relaxant, antagonizes bladder muscarinic receptors
ICIQ-OAB Questionnaire	5.5 score on a scale Standard Deviation 2.0	5.8 score on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: Incontinence episodes per day at 12 weeks

7-day bladder diary includes daily participant-reported incontinence episodes

Outcome measures

Measure	Behavioral Therapy n=21 Participants Pelvic floor muscle exercise-based behavioral therapy Pelvic floor muscle exercise-based behavioral therapy: Multicomponent intervention including fluid management, constipation management and behavioral techniques incorporating pelvic floor muscle-exercise based urge suppression and self-monitoring to reduce overactive bladder symptoms	Drug Therapy n=27 Participants Daily solifenacin drug therapy solifenacin: Antimuscarinic bladder relaxant, antagonizes bladder muscarinic receptors
Bladder Diary	0.45 Incontinence episodes per day Standard Deviation 1.19	0.86 Incontinence episodes per day Standard Deviation 1.48

SECONDARY outcome

Timeframe: ICIQ-OAB QOL score at 12 weeks

Assessment of quality of life related to the impact of overactive bladder symptoms on daily activities, range 25-160 with higher scores indicating worse quality of life related to overactive bladder

Outcome measures

Measure	Behavioral Therapy n=36 Participants Pelvic floor muscle exercise-based behavioral therapy Pelvic floor muscle exercise-based behavioral therapy: Multicomponent intervention including fluid management, constipation management and behavioral techniques incorporating pelvic floor muscle-exercise based urge suppression and self-monitoring to reduce overactive bladder symptoms	Drug Therapy n=41 Participants Daily solifenacin drug therapy solifenacin: Antimuscarinic bladder relaxant, antagonizes bladder muscarinic receptors
ICIQ-OAB QOL	56.6 units on a scale Standard Deviation 22.2	56.8 units on a scale Standard Deviation 26.6

Adverse Events

Behavioral Therapy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Drug Therapy

Serious events: 6 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Behavioral Therapy n=36 participants at risk Pelvic floor muscle exercise-based behavioral therapy Pelvic floor muscle exercise-based behavioral therapy: Multicomponent intervention including fluid management, constipation management and behavioral techniques incorporating pelvic floor muscle-exercise based urge suppression and self-monitoring to reduce overactive bladder symptoms	Drug Therapy n=41 participants at risk Daily solifenacin drug therapy solifenacin: Antimuscarinic bladder relaxant, antagonizes bladder muscarinic receptors
Musculoskeletal and connective tissue disorders Fall	0.00% 0/36 • 12 weeks	4.9% 2/41 • Number of events 2 • 12 weeks
Blood and lymphatic system disorders Edema	0.00% 0/36 • 12 weeks	4.9% 2/41 • Number of events 2 • 12 weeks
Respiratory, thoracic and mediastinal disorders Pneumonia	2.8% 1/36 • Number of events 1 • 12 weeks	0.00% 0/41 • 12 weeks
Skin and subcutaneous tissue disorders Foot sore	0.00% 0/36 • 12 weeks	4.9% 2/41 • Number of events 2 • 12 weeks

Other adverse events

Measure	Behavioral Therapy n=36 participants at risk Pelvic floor muscle exercise-based behavioral therapy Pelvic floor muscle exercise-based behavioral therapy: Multicomponent intervention including fluid management, constipation management and behavioral techniques incorporating pelvic floor muscle-exercise based urge suppression and self-monitoring to reduce overactive bladder symptoms	Drug Therapy n=41 participants at risk Daily solifenacin drug therapy solifenacin: Antimuscarinic bladder relaxant, antagonizes bladder muscarinic receptors
Musculoskeletal and connective tissue disorders Fall	0.00% 0/36 • 12 weeks	9.8% 4/41 • Number of events 4 • 12 weeks

Additional Information

E. Camille Vaughan, MD, MS

Atlanta VA Health Care System

Phone: 404 315 4100

Email: elizabeth.vaughan2@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place