Trial Outcomes & Findings for Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence : Hypnotherapy Or Pharmacotherapy (NCT NCT01829425)
NCT ID: NCT01829425
Last Updated: 2019-04-23
Results Overview
Percent change in UUI episodes from baseline to 2 months with comparison made between hypnotherapy \& pharmacotherapy
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
165 participants
Primary outcome timeframe
Baseline and 2 month follow-up
Results posted on
2019-04-23
Participant Flow
Patients recruited March 2013 through October 2016 from the UNMH Urogynecology clinics
Patients required to keep 3 day voiding diary to confirm their eligibility for the study prior to randomization. Pts also underwent hypnotic susceptibility testing prior to randomization. Of those consented, 13 did not go on to randomization: 8 were excluded because they did not meet inclusion criteria and 5 were lost to further followup
Participant milestones
| Measure |
Anticholinergic Medications
Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.
Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
|
Hypnotherapy
Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.
Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
74
|
|
Overall Study
COMPLETED
|
72
|
70
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Anticholinergic Medications
Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.
Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
|
Hypnotherapy
Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.
Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence : Hypnotherapy Or Pharmacotherapy
Baseline characteristics by cohort
| Measure |
Hypnotherapy
n=70 Participants
Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.
Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.
|
Anticholinergic Medications
n=72 Participants
Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.
Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 12.77 • n=99 Participants
|
59.5 years
STANDARD_DEVIATION 10.30 • n=107 Participants
|
58.55 years
STANDARD_DEVIATION 11.54 • n=206 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=99 Participants
|
72 participants
n=107 Participants
|
142 participants
n=206 Participants
|
|
Urgency Incontinence episodes on 3 day diary
|
8 episodes
n=99 Participants
|
7 episodes
n=107 Participants
|
7.5 episodes
n=206 Participants
|
|
Overactive bladder short form (OABq-SF) questionnaires
Overactive Bladder Questionnaire Short Form Bother
|
66.88 units on a scale
STANDARD_DEVIATION 21.26 • n=99 Participants
|
66.99 units on a scale
STANDARD_DEVIATION 21.60 • n=107 Participants
|
66.94 units on a scale
STANDARD_DEVIATION 21.43 • n=206 Participants
|
|
Overactive bladder short form (OABq-SF) questionnaires
Overactive Bladder Short Form Quality of Life
|
47.11 units on a scale
STANDARD_DEVIATION 27.40 • n=99 Participants
|
50.38 units on a scale
STANDARD_DEVIATION 25.29 • n=107 Participants
|
48.75 units on a scale
STANDARD_DEVIATION 26.35 • n=206 Participants
|
|
number of voids on bladder diary
|
29.07 episodes
STANDARD_DEVIATION 8.71 • n=99 Participants
|
29.19 episodes
STANDARD_DEVIATION 8.43 • n=107 Participants
|
29.13 episodes
STANDARD_DEVIATION 8.57 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 month follow-upPopulation: Randomized patients with primary outcome (diary information) 2 months. Hypnotherapy: 74 randomized; of those randomized 3 had withdrawn, 1 was lost=70 with primary outcome information for analysis. Medications: 78 randomized-- 4 withdrawn. 2 were missing diary information=72 with primary outcome information for analysis
Percent change in UUI episodes from baseline to 2 months with comparison made between hypnotherapy \& pharmacotherapy
Outcome measures
| Measure |
Hypnotherapy
n=70 Participants
Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.
Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.
|
Anticholinergic Medications
n=72 Participants
Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.
Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
|
|---|---|---|
|
Percent Change in Urgency Urinary Incontinence Episodes
|
73 percentage change in median UUI episodes
Interval 60.0 to 88.9
|
88.6 percentage change in median UUI episodes
Interval 78.6 to 100.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: At 6 months. Hypnotherapy: 74 women randomized-- 4 withdrawn, 2 lost and 1 missing diary information=67 analyzed with diary data. Medication: 78 randomized, 6 had withdrawn and 1 lost=71 analyzed with diary data
Differences comparing hypnotherapy to pharmacotherapy percent change in median UUI episodes
Outcome measures
| Measure |
Hypnotherapy
n=67 Participants
Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.
Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.
|
Anticholinergic Medications
n=71 Participants
Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.
Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
|
|---|---|---|
|
Percent Change in Urgency Urinary Incontinence Episodes
|
85.7 percentage change in median UUI episodes
Interval 75.0 to 100.0
|
83.3 percentage change in median UUI episodes
Interval 64.7 to 100.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Pts with diary data at 12 months. For the Hypnotherapy group, of the 74 women randomized, 4 had withdrawn and 1 was missing diary data. For the medication group, of the 78 women randomized, 7 had withdrawn.
Percent change in median UUI episodes from baseline to 12 months with comparison made between hypnotherapy \& pharmacotherapy
Outcome measures
| Measure |
Hypnotherapy
n=69 Participants
Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.
Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.
|
Anticholinergic Medications
n=71 Participants
Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.
Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
|
|---|---|---|
|
Percent Change in Urgency Urinary Incontinence Episodes
|
85.7 percentage change in median UUI episodes
Interval 66.7 to 94.4
|
80.0 percentage change in median UUI episodes
Interval 54.5 to 100.0
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Randomized patients with primary outcome (diary information) 2 months. Hypnotherapy: 70 had diary information; of those randomized 3 had withdrawn, 1 was lost=70 with primary outcome information for analysis. Medications: 78 randomized-- 4 withdrawn. 2 were missing diary information=72 with primary outcome information for analysis
Overactive Bladder Questionnaire Short Form symptom bother Scale. Sub-Scale range 0-100. Higher numbers are worse (more bother) and lower numbers are better (less bother)
Outcome measures
| Measure |
Hypnotherapy
n=70 Participants
Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.
Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.
|
Anticholinergic Medications
n=72 Participants
Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.
Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
|
|---|---|---|
|
Overactive Bladder Questionnaire Short Form Symptom Bother
|
38.17 scores on a sub-scale
Interval 30.19 to 46.14
|
35.33 scores on a sub-scale
Interval 28.64 to 42.02
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: At 6 months in the hypnotherapy group, 4 had withdrawn and 2 were lost and 1 missing diary. In the medication group, 6 had withdrawn and 1 was missing.
Overactive Bladder Questionnaire Short Form symptom bother. Sub-scale range 0-100. Higher numbers are worse (more bother) and lower numbers are better (less bother)
Outcome measures
| Measure |
Hypnotherapy
n=67 Participants
Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.
Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.
|
Anticholinergic Medications
n=71 Participants
Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.
Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
|
|---|---|---|
|
Overactive Bladder Questionnaire Short Form Symptom Bother
|
34.61 sub-scale scores
Interval 26.26 to 42.96
|
27.93 sub-scale scores
Interval 20.66 to 35.2
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 12 months. Hypnotherapy: 74 randomized, 4 withdrawn \& 1 was missing diary=69 analyzed with diary data. Medication: 78 randomized, 7 had withdrawn=71 analyzed with diary data.
Overactive Bladder Questionnaire Short Form symptom bother. Sub-scale range 0-100. Higher numbers are worse (more bother) and lower numbers are better (less bother)
Outcome measures
| Measure |
Hypnotherapy
n=69 Participants
Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.
Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.
|
Anticholinergic Medications
n=71 Participants
Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.
Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
|
|---|---|---|
|
Overactive Bladder Questionnaire Short Form Symptom Bother
|
32.27 sub-scale scores
Interval 22.89 to 41.66
|
30.74 sub-scale scores
Interval 22.53 to 38.95
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Randomized patients with primary outcome (diary information) 2 months. Hypnotherapy: 74 randomized; 3 withdrawn, 1 lost=70 with primary outcome information used for analysis for secondary outcomes. Medications: 78 randomized-- 4 withdrawn, 2 were missing diary information=72 for analysis of secondary outcome.
Overactive Bladder questionnaire-Short Form Quality of Life. Higher scores are better (better quality of life) and lower scores are worse (poorer quality of life). sub-score range 0-100.
Outcome measures
| Measure |
Hypnotherapy
n=70 Participants
Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.
Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.
|
Anticholinergic Medications
n=72 Participants
Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.
Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
|
|---|---|---|
|
Overactive Bladder Questionnaire Short Form Quality of Life
|
73.96 sub-scale scores
Interval 66.93 to 81.0
|
74.86 sub-scale scores
Interval 68.96 to 80.76
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: At 6 months, in the hypnotherapy group: 4 had withdrawn and 2 were lost and 1 missing diary. In the medication group: 6 had withdrawn and 1 was lost.
Overactive Bladder questionnaire Short Form Quality of Life. Higher scores are better (better quality of life) and lower scores are worse (poorer quality of life). sub-scale score range 0-100.
Outcome measures
| Measure |
Hypnotherapy
n=67 Participants
Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.
Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.
|
Anticholinergic Medications
n=71 Participants
Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.
Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
|
|---|---|---|
|
Overactive Bladder Questionnaire Short Form Quality of Life
|
75.85 sub-scale scores
Interval 68.24 to 83.46
|
80.19 sub-scale scores
Interval 73.63 to 86.75
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: At 12 months in the hypnotherapy group: 4 had withdrawn, 1 missing diary. In the medication group, 7 had withdrawn.
Overactive Bladder questionnaire-Short Form Quality of Life. Higher scores are better (higher quality of life) and lower scores are worse (poorer quality of life). score range 0-100.
Outcome measures
| Measure |
Hypnotherapy
n=69 Participants
Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.
Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.
|
Anticholinergic Medications
n=71 Participants
Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.
Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
|
|---|---|---|
|
Overactive Bladder Questionnaire Short Form Quality of Life
|
75.71 sub-scale scores
Interval 68.07 to 83.35
|
81.57 sub-scale scores
Interval 74.91 to 88.23
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: At 2 months in the hypnotherapy group of the 74 randomized, 3 had withdrawn and 1 was lost. In the medication group, of 78 randomized: 4 had withdrawn and 2 were missing diaries.
Total Number of voids on 3-day bladder diary.
Outcome measures
| Measure |
Hypnotherapy
n=70 Participants
Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.
Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.
|
Anticholinergic Medications
n=72 Participants
Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.
Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
|
|---|---|---|
|
Voids on Bladder Diary
|
26.4 counts
Interval 24.29 to 31.08
|
25.35 counts
Interval 23.59 to 27.12
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Of the 74 women randomized to hypnotherapy, at 6 months: 4 had withdrawn and 2 were lost and 1 was missing diary information. Of the 78 women randomized to medications, 6 had withdrawn and 1 was lost.
number of voids on 3-day bladder diary
Outcome measures
| Measure |
Hypnotherapy
n=67 Participants
Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.
Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.
|
Anticholinergic Medications
n=71 Participants
Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.
Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
|
|---|---|---|
|
Voids on Bladder Diary
|
25.58 counts
Interval 23.48 to 27.68
|
24.28 counts
Interval 22.69 to 25.87
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: At 12 months, of the 74 randomized to hypnotherapy: 4 had withdrawn and 1 was missing diary information. Of the 78 women randomized to medications, 7 had withdrawn.
number of voids on 3-day bladder diary
Outcome measures
| Measure |
Hypnotherapy
n=69 Participants
Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.
Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.
|
Anticholinergic Medications
n=71 Participants
Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.
Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
|
|---|---|---|
|
Voids on Bladder Diary
|
25.74 counts
Interval 23.69 to 27.79
|
25.37 counts
Interval 23.71 to 27.02
|
Adverse Events
Hypnotherapy
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Anticholinergic Medications
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hypnotherapy
n=70 participants at risk
Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.
Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.
|
Anticholinergic Medications
n=72 participants at risk
Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.
Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
1 in-patient hospitalization
|
0.00%
0/70 • 1 year; from study randomization to study completion
Adverse event collection occurred at all follow-up and by spontaneous participant report
|
1.4%
1/72 • Number of events 1 • 1 year; from study randomization to study completion
Adverse event collection occurred at all follow-up and by spontaneous participant report
|
|
Renal and urinary disorders
1 inpatient hospitalization
|
1.4%
1/70 • Number of events 1 • 1 year; from study randomization to study completion
Adverse event collection occurred at all follow-up and by spontaneous participant report
|
0.00%
0/72 • 1 year; from study randomization to study completion
Adverse event collection occurred at all follow-up and by spontaneous participant report
|
|
Musculoskeletal and connective tissue disorders
1 inpatient hospitalization
|
0.00%
0/70 • 1 year; from study randomization to study completion
Adverse event collection occurred at all follow-up and by spontaneous participant report
|
1.4%
1/72 • Number of events 1 • 1 year; from study randomization to study completion
Adverse event collection occurred at all follow-up and by spontaneous participant report
|
|
Cardiac disorders
1 inpatient hospitalization for observation
|
0.00%
0/70 • 1 year; from study randomization to study completion
Adverse event collection occurred at all follow-up and by spontaneous participant report
|
1.4%
1/72 • Number of events 1 • 1 year; from study randomization to study completion
Adverse event collection occurred at all follow-up and by spontaneous participant report
|
Other adverse events
| Measure |
Hypnotherapy
n=70 participants at risk
Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.
Hypnotherapy: Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.
|
Anticholinergic Medications
n=72 participants at risk
Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.
Anticholinergic medications: The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Falls
|
4.3%
3/70 • Number of events 3 • 1 year; from study randomization to study completion
Adverse event collection occurred at all follow-up and by spontaneous participant report
|
6.9%
5/72 • Number of events 5 • 1 year; from study randomization to study completion
Adverse event collection occurred at all follow-up and by spontaneous participant report
|
|
Infections and infestations
urinary tract infection
|
7.1%
5/70 • Number of events 5 • 1 year; from study randomization to study completion
Adverse event collection occurred at all follow-up and by spontaneous participant report
|
8.3%
6/72 • Number of events 6 • 1 year; from study randomization to study completion
Adverse event collection occurred at all follow-up and by spontaneous participant report
|
|
Musculoskeletal and connective tissue disorders
back pain
|
4.3%
3/70 • Number of events 3 • 1 year; from study randomization to study completion
Adverse event collection occurred at all follow-up and by spontaneous participant report
|
5.6%
4/72 • Number of events 4 • 1 year; from study randomization to study completion
Adverse event collection occurred at all follow-up and by spontaneous participant report
|
|
General disorders
expected adverse events pharmacotherapy
|
1.4%
1/70 • Number of events 1 • 1 year; from study randomization to study completion
Adverse event collection occurred at all follow-up and by spontaneous participant report
|
16.7%
12/72 • Number of events 12 • 1 year; from study randomization to study completion
Adverse event collection occurred at all follow-up and by spontaneous participant report
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place