Trial Outcomes & Findings for Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence (NCT NCT00909181)
NCT ID: NCT00909181
Last Updated: 2014-07-02
Results Overview
Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
626 participants
Primary outcome timeframe
12 weeks
Results posted on
2014-07-02
Participant Flow
Recruitment in clinical sites (urologists mainly) started in September 2007 and was terminated in February 2010.
Baseline period was 1 week. Patients on OAB drugs had to wash out.
Participant milestones
| Measure |
Oxybutynin Gel 56 mg/Day
|
Oxybutynin Gel 84 mg/Day
|
Placebo Gel
|
|---|---|---|---|
|
Overall Study
STARTED
|
210
|
214
|
202
|
|
Overall Study
COMPLETED
|
171
|
196
|
169
|
|
Overall Study
NOT COMPLETED
|
39
|
18
|
33
|
Reasons for withdrawal
| Measure |
Oxybutynin Gel 56 mg/Day
|
Oxybutynin Gel 84 mg/Day
|
Placebo Gel
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
39
|
18
|
33
|
Baseline Characteristics
Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence
Baseline characteristics by cohort
| Measure |
Oxybutynin Gel 56 mg/Day
n=210 Participants
|
Oxybutynin Gel 84 mg/Day
n=214 Participants
|
Placebo Gel
n=202 Participants
|
Total
n=626 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
120 Participants
n=99 Participants
|
122 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
362 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
90 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
264 Participants
n=7 Participants
|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 12.6 • n=99 Participants
|
59.1 years
STANDARD_DEVIATION 13.3 • n=107 Participants
|
57.8 years
STANDARD_DEVIATION 13.3 • n=206 Participants
|
58.8 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
|
Sex: Female, Male
Female
|
182 Participants
n=99 Participants
|
182 Participants
n=107 Participants
|
178 Participants
n=206 Participants
|
542 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
84 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
210 participants
n=99 Participants
|
214 participants
n=107 Participants
|
202 participants
n=206 Participants
|
626 participants
n=7 Participants
|
|
Number of incontinent episodes at baseline
|
50.1 Episodes
STANDARD_DEVIATION 32.5 • n=99 Participants
|
43.6 Episodes
STANDARD_DEVIATION 27.5 • n=107 Participants
|
45.8 Episodes
STANDARD_DEVIATION 28.9 • n=206 Participants
|
46.5 Episodes
STANDARD_DEVIATION 29.3 • n=7 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: mITT (modified intended to treatment) per protocol Difference between Baseline and after 12 weeks treatment
Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.
Outcome measures
| Measure |
Oxybutynin Gel 56 mg/Day
n=175 Participants
|
Oxybutynin Gel 84 mg/Day
n=191 Participants
|
Placebo Gel
n=166 Participants
|
|---|---|---|---|
|
Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12
|
-24.8 Episodes
Standard Deviation 28.7
|
-21.9 Episodes
Standard Deviation 25.1
|
-20.0 Episodes
Standard Deviation 27.0
|
Adverse Events
Oxybutynin Gel 56 mg/Day
Serious events: 3 serious events
Other events: 98 other events
Deaths: 0 deaths
Oxybutynin Gel 84 mg/Day
Serious events: 4 serious events
Other events: 90 other events
Deaths: 0 deaths
Placebo Gel
Serious events: 2 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oxybutynin Gel 56 mg/Day
n=210 participants at risk
|
Oxybutynin Gel 84 mg/Day
n=214 participants at risk
|
Placebo Gel
n=202 participants at risk
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Abdominal pain
|
0.48%
1/210 • Number of events 1 • Throughout whole study (20 months)
|
0.00%
0/214 • Throughout whole study (20 months)
|
0.00%
0/202 • Throughout whole study (20 months)
|
|
Reproductive system and breast disorders
Abortion missed
|
0.00%
0/210 • Throughout whole study (20 months)
|
0.47%
1/214 • Number of events 1 • Throughout whole study (20 months)
|
0.00%
0/202 • Throughout whole study (20 months)
|
|
Cardiac disorders
Angina pectoris
|
0.48%
1/210 • Number of events 1 • Throughout whole study (20 months)
|
0.00%
0/214 • Throughout whole study (20 months)
|
0.00%
0/202 • Throughout whole study (20 months)
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
0.00%
0/210 • Throughout whole study (20 months)
|
0.47%
1/214 • Number of events 1 • Throughout whole study (20 months)
|
0.00%
0/202 • Throughout whole study (20 months)
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/210 • Throughout whole study (20 months)
|
0.47%
1/214 • Number of events 1 • Throughout whole study (20 months)
|
0.00%
0/202 • Throughout whole study (20 months)
|
|
Hepatobiliary disorders
Hepatic neoplasm malignant
|
0.48%
1/210 • Number of events 1 • Throughout whole study (20 months)
|
0.00%
0/214 • Throughout whole study (20 months)
|
0.00%
0/202 • Throughout whole study (20 months)
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/210 • Throughout whole study (20 months)
|
0.47%
1/214 • Number of events 1 • Throughout whole study (20 months)
|
0.00%
0/202 • Throughout whole study (20 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/210 • Throughout whole study (20 months)
|
0.47%
1/214 • Number of events 1 • Throughout whole study (20 months)
|
0.99%
2/202 • Number of events 2 • Throughout whole study (20 months)
|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
0.00%
0/210 • Throughout whole study (20 months)
|
0.00%
0/214 • Throughout whole study (20 months)
|
0.50%
1/202 • Number of events 1 • Throughout whole study (20 months)
|
Other adverse events
| Measure |
Oxybutynin Gel 56 mg/Day
n=210 participants at risk
|
Oxybutynin Gel 84 mg/Day
n=214 participants at risk
|
Placebo Gel
n=202 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoe
|
2.4%
5/210 • Throughout whole study (20 months)
|
0.93%
2/214 • Throughout whole study (20 months)
|
0.50%
1/202 • Throughout whole study (20 months)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
2.9%
6/210 • Throughout whole study (20 months)
|
2.8%
6/214 • Throughout whole study (20 months)
|
5.0%
10/202 • Throughout whole study (20 months)
|
|
Infections and infestations
Urinary tract infection
|
4.3%
9/210 • Throughout whole study (20 months)
|
2.8%
6/214 • Throughout whole study (20 months)
|
2.0%
4/202 • Throughout whole study (20 months)
|
|
Gastrointestinal disorders
Dry mouth
|
11.0%
23/210 • Throughout whole study (20 months)
|
12.1%
26/214 • Throughout whole study (20 months)
|
5.0%
10/202 • Throughout whole study (20 months)
|
|
Gastrointestinal disorders
Constipation
|
1.4%
3/210 • Throughout whole study (20 months)
|
3.7%
8/214 • Throughout whole study (20 months)
|
2.5%
5/202 • Throughout whole study (20 months)
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
5/210 • Throughout whole study (20 months)
|
2.3%
5/214 • Throughout whole study (20 months)
|
0.00%
0/202 • Throughout whole study (20 months)
|
|
Infections and infestations
Sinusitis
|
2.4%
5/210 • Throughout whole study (20 months)
|
1.4%
3/214 • Throughout whole study (20 months)
|
0.99%
2/202 • Throughout whole study (20 months)
|
|
Skin and subcutaneous tissue disorders
Application site reaction
|
2.4%
5/210 • Throughout whole study (20 months)
|
1.4%
3/214 • Throughout whole study (20 months)
|
0.00%
0/202 • Throughout whole study (20 months)
|
|
Nervous system disorders
Headache
|
2.9%
6/210 • Throughout whole study (20 months)
|
2.8%
6/214 • Throughout whole study (20 months)
|
4.0%
8/202 • Throughout whole study (20 months)
|
|
Nervous system disorders
Dizziness
|
2.9%
6/210 • Throughout whole study (20 months)
|
0.93%
2/214 • Throughout whole study (20 months)
|
2.0%
4/202 • Throughout whole study (20 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
5/210 • Throughout whole study (20 months)
|
0.93%
2/214 • Throughout whole study (20 months)
|
2.5%
5/202 • Throughout whole study (20 months)
|
|
General disorders
Application site erythema
|
3.8%
8/210 • Throughout whole study (20 months)
|
3.7%
8/214 • Throughout whole study (20 months)
|
0.99%
2/202 • Throughout whole study (20 months)
|
|
General disorders
Application site rash
|
4.3%
9/210 • Throughout whole study (20 months)
|
3.3%
7/214 • Throughout whole study (20 months)
|
0.50%
1/202 • Throughout whole study (20 months)
|
|
General disorders
Application site pruritus
|
1.4%
3/210 • Throughout whole study (20 months)
|
2.8%
6/214 • Throughout whole study (20 months)
|
0.50%
1/202 • Throughout whole study (20 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60