Trial Outcomes & Findings for Comparison of Combination Therapy vs Single Agent Therapy for Treatment of Urge Incontinence. (NCT NCT02176642)

Results Overview

To compare the change, from baseline, in median number of UUI episodes per day using a 3-day bladder diary between PTNS plus anticholinergic medication versus PTNS plus placebo in women undergoing treatment for UUI. UUI change score will be calculated \[post-treatment UUI/day minus pre-treatment UUI/day\].

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

55 participants

Primary outcome timeframe

Baseline, 6 weeks

Results posted on

2018-01-23

Participant Flow

Potential participants were identified, recruited, and enrolled at the time of their outpatient clinic visits with the Duke Urogynecology clinic. All women who were considering therapy with posterior tibial nerve stimulation were approached for participation in the study.

A total of 104 patients were assessed for eligibility. Forty-nine patients declined or were deemed ineligible. Fifty-five patients consented to participate but 20 dropped out before randomization. Therefore, a total of 35 patients were randomized as noted in the boxes below (18 in the active medication group, 17 in the placebo group).

Participant milestones

Participant milestones
Measure	Oxybutynin Plus PTNS Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks	Placebo Plus PTNS Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks Placebo: Tablet taken by mouth daily for 6 weeks
Overall Study STARTED	18	17
Overall Study COMPLETED	18	16
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Oxybutynin Plus PTNS Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks	Placebo Plus PTNS Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks Placebo: Tablet taken by mouth daily for 6 weeks
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Comparison of Combination Therapy vs Single Agent Therapy for Treatment of Urge Incontinence.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxybutynin Plus PTNS n=18 Participants Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks	Placebo Plus PTNS n=16 Participants Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks Placebo: Tablet taken by mouth daily for 6 weeks	Total n=34 Participants Total of all reporting groups
Age, Continuous	72.7 years STANDARD_DEVIATION 9.8 • n=5 Participants	70.4 years STANDARD_DEVIATION 8.5 • n=7 Participants	71.6 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 weeks

Population: 3 patients in each group did not provide bladder diaries at their 6 week visit, so did not have information available to calculate the primary outcome measure. Median change in UUI episodes/day from baseline to 6 weeks was compared between 2 groups using Wilcoxon Rank Sum test.

To compare the change, from baseline, in median number of UUI episodes per day using a 3-day bladder diary between PTNS plus anticholinergic medication versus PTNS plus placebo in women undergoing treatment for UUI. UUI change score will be calculated \[post-treatment UUI/day minus pre-treatment UUI/day\].

Outcome measures

Outcome measures
Measure	Oxybutynin Plus PTNS n=15 Participants Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks	Placebo Plus PTNS n=13 Participants Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks Placebo: Tablet taken by mouth daily for 6 weeks
Change in Median Number of UUI Episodes Per Day	-0.3 Urge urinary incontinence episodes/day Interval -3.2 to 0.5	0.3 Urge urinary incontinence episodes/day Interval -1.0 to 1.0

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Population: Six participants in the placebo+PNTS group and 3 patients in the oxybutynin+PTNS group did not provide a pad weight at the end of the study, and thus were unable to have the pad weight change score calculated.

To compare the change, from baseline, in 24h pad weight between PTNS plus anticholinergic medication versus PTNS plus placebo. Change in median 24h pad weight from baseline to 6 weeks was compared between the 2 groups using Wilcoxon Rank Sum test.

Outcome measures

Outcome measures
Measure	Oxybutynin Plus PTNS n=15 Participants Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks	Placebo Plus PTNS n=10 Participants Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks Placebo: Tablet taken by mouth daily for 6 weeks
Change in 24hr Pad Weight	-52 grams Interval -201.5 to -15.1	-8 grams Interval -103.5 to 13.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 weeks

Population: 2 patients in the oxybutynin+PTNS group and one patient in the placebo+PTNS group did not complete the 6 week PGI-I questionnaire so they were not included in the analysis.

The Patient Global Impression of Improvement (PGI-I) is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 (Very much better to) 7 (Very much worse).

Outcome measures

Outcome measures
Measure	Oxybutynin Plus PTNS n=16 Participants Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks	Placebo Plus PTNS n=15 Participants Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks Placebo: Tablet taken by mouth daily for 6 weeks
Change in the Patient Global Impression of Improvement (PGI-I)	-1 units on a scale Interval -1.0 to 0.0	-1 units on a scale Interval -1.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 weeks

Population: 3 patients in the oxybutynin+PTNS group did not submit their OABq-SF at the end of the study, so they were unable to be included in the analysis.

Part 1 of the OABq-SF questionnaire asks about the relative bother a patient experiences with regard to overactive bladder symptoms over the previous 4 weeks. This part of the questionnaire has 6 questions, with scores ranging from 6 (least amount of bother) to 36 (most amount of bother). For this secondary outcome, we are measuring the change in score on the OABq-SF Part 1 from baseline to 6 weeks. Median change in scores were compared between the 2 groups using Wilcoxon Rank Sum test.

Outcome measures

Outcome measures
Measure	Oxybutynin Plus PTNS n=15 Participants Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks	Placebo Plus PTNS n=16 Participants Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks Placebo: Tablet taken by mouth daily for 6 weeks
Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 1	-13.3 units on a scale Interval -25.0 to -5.1	-10 units on a scale Interval -23.3 to 6.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 weeks

Population: Four patients in the oxybutynin+PTNS group and 1 patient in the placebo+PTNS did not submit their OABq-SF part 2 at the end of the study, so they were unable to be included in the analysis.

Part 2 of the OABq-SF questionnaire asks about the relative bother a patient experiences with regard to overactive bladder symptoms over the previous 4 weeks. This part of the questionnaire has 13 questions, with scores ranging from 13 (least amount of bother) to 78 (most amount of bother). For this secondary outcome, we are measuring the change in score on the OABq-SF Part 2 from baseline to 6 weeks. Median change in scores were compared between the 2 groups using Wilcoxon Rank Sum test.

Outcome measures

Outcome measures
Measure	Oxybutynin Plus PTNS n=14 Participants Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks	Placebo Plus PTNS n=15 Participants Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks Placebo: Tablet taken by mouth daily for 6 weeks
Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 2	9.2 units on a scale Interval 6.5 to 18.1	0 units on a scale Interval -7.7 to 11.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 weeks

Population: 1 patient in the oxybutynin+PTNS group did not complete the 6 week UDI-6 questionnaire so was not included in the analysis.

The UDI-6 is a 6-question inventory of how frequently and how much bother patients have from overactive bladder symptoms. The scores range from 0 (not at all) to 24 (a great deal of bother). We compared the change in scores from baseline to 6 weeks between the 2 groups using Wilcoxon Rank Sum test.

Outcome measures

Outcome measures
Measure	Oxybutynin Plus PTNS n=17 Participants Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks	Placebo Plus PTNS n=16 Participants Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks Placebo: Tablet taken by mouth daily for 6 weeks
Change in the Urinary Distress Inventory (UDI-6)	-11.1 units on a scale Interval -16.6 to 0.0	5.5 units on a scale Interval -16.6 to 13.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 weeks

Population: 1 patient in the oxybutynin+PTNS group did not complete the 6 week IIQ-7 questionnaire so was not included in the analysis.

The IIQ-7 is a 7-question score assessing how urinary incontinence affects a patient's various activities and feelings. The range of possible scores is from 0 (not at all) to 28 (a great deal). Median change in scores from baseline to 6 weeks were compared between the 2 groups using Wilcoxon Rank Sum test.

Outcome measures

Outcome measures
Measure	Oxybutynin Plus PTNS n=17 Participants Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks	Placebo Plus PTNS n=16 Participants Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks Placebo: Tablet taken by mouth daily for 6 weeks
Change in the Incontinence Impact Questionnaire (IIQ-7)	-9.5 units on a scale Interval -19.0 to 0.0	-2.4 units on a scale Interval -11.9 to 4.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 weeks

Population: Two patients in the placebo+PTN group and 1 patient in the oxybutynin+PTNS group did not complete the 6 week TSQMvII questionnaire so was not included in the analysis.

To compare treatment satisfaction between PTNS plus anticholinergic medication versus PTNS plus placebo using the Treatment Satisfaction Questionnaire for Medication, version two (TSQMvII). Patients completed the questionnaire at baseline and again at 6 weeks. The TSQMvII satisfaction domains at each timepjoint were transformed into a score from 0 (extremely dissatisfied) to 100 (extremely satisfied). Median change in scores from baseline to 6 weeks were compared between the 2 groups using Wilcoxon Rank Sum Test.

Outcome measures

Outcome measures
Measure	Oxybutynin Plus PTNS n=17 Participants Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks	Placebo Plus PTNS n=14 Participants Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks Placebo: Tablet taken by mouth daily for 6 weeks
Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Global Satisfaction Domain	83.3 units on a scale Interval 50.0 to 100.0	70.8 units on a scale Interval 50.0 to 83.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 weeks

Population: Two patients in the placebo+PTN group did not complete the 6 week TSQMvII questionnaire so was not included in the analysis.

To compare bother from medication side effects between PTNS plus anticholinergic medication versus PTNS plus placebo using the Treatment Satisfaction Questionnaire for Medication, version two (TSQMvII). The questionnaire was completed at baseline and at 6 weeks. The TSQMvII side effects domain at each time point was transformed into a score from 0 (extremely dissatisfied) to 150 (extremely satisfied). Median change in scores from baseline to 6 weeks were compared between the 2 groups using Wilcoxon Rank Sum Test.

Outcome measures

Outcome measures
Measure	Oxybutynin Plus PTNS n=18 Participants Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks	Placebo Plus PTNS n=14 Participants Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks Placebo: Tablet taken by mouth daily for 6 weeks
Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Side Effects Domain	0 units on a scale Interval 0.0 to 41.7	0 units on a scale Interval 0.0 to 50.0

Adverse Events

Oxybutynin Plus PTNS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Plus PTNS

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Oxybutynin Plus PTNS n=18 participants at risk Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks	Placebo Plus PTNS n=16 participants at risk Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks Placebo: Tablet taken by mouth daily for 6 weeks
Skin and subcutaneous tissue disorders Skin Rash	0.00% 0/18 • Baseline to 6 weeks We systematically assessed for adverse events related to either PTNS or medication/placebo on a weekly basis. Any adverse events related to PTNS were documented on the patients weekly treatment note for the clinic encounter. Any adverse events related to study medication or placebo were documented via the TSQMvII questionnaire that subjects completed on a weekly basis during treatment.	6.2% 1/16 • Number of events 1 • Baseline to 6 weeks We systematically assessed for adverse events related to either PTNS or medication/placebo on a weekly basis. Any adverse events related to PTNS were documented on the patients weekly treatment note for the clinic encounter. Any adverse events related to study medication or placebo were documented via the TSQMvII questionnaire that subjects completed on a weekly basis during treatment.
Eye disorders Glaucoma	0.00% 0/18 • Baseline to 6 weeks We systematically assessed for adverse events related to either PTNS or medication/placebo on a weekly basis. Any adverse events related to PTNS were documented on the patients weekly treatment note for the clinic encounter. Any adverse events related to study medication or placebo were documented via the TSQMvII questionnaire that subjects completed on a weekly basis during treatment.	6.2% 1/16 • Number of events 1 • Baseline to 6 weeks We systematically assessed for adverse events related to either PTNS or medication/placebo on a weekly basis. Any adverse events related to PTNS were documented on the patients weekly treatment note for the clinic encounter. Any adverse events related to study medication or placebo were documented via the TSQMvII questionnaire that subjects completed on a weekly basis during treatment.
Cardiac disorders Possible cardiac symptons	0.00% 0/18 • Baseline to 6 weeks We systematically assessed for adverse events related to either PTNS or medication/placebo on a weekly basis. Any adverse events related to PTNS were documented on the patients weekly treatment note for the clinic encounter. Any adverse events related to study medication or placebo were documented via the TSQMvII questionnaire that subjects completed on a weekly basis during treatment.	6.2% 1/16 • Number of events 1 • Baseline to 6 weeks We systematically assessed for adverse events related to either PTNS or medication/placebo on a weekly basis. Any adverse events related to PTNS were documented on the patients weekly treatment note for the clinic encounter. Any adverse events related to study medication or placebo were documented via the TSQMvII questionnaire that subjects completed on a weekly basis during treatment.

Additional Information

Nazema Siddiqui MD

Duke University

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place