Urinary Incontinence, Urge
Conditions
Keywords
Hypnosis, Mind-Body Therapy, Anticholinergics, Female Urogenital Diseases
Brief summary
This study is randomized controlled trial in which urgency incontinent women (approximately 150-160) will be randomized to hypnotherapy or pharmacotherapy and evaluated at months 2, 6 &12 Hypotheses: Among patients with urgency urinary incontinence (UUI), hypnotherapy will be non-inferior pharmacotherapy in diminishing UUI episodes. Hypnotherapy may be superior or may not differ from pharmacotherapy in diminishing symptoms or quality of life based on validated questionnaires and/or other diary parameters.
Detailed description
Study Objectives Primary: To compare change in Urgency Urinary Incontinence (UUI) episodes at 2 month follow-up on voiding diaries between hypnotherapy and pharmacotherapy groups (to determine whether hypnotherapy is at least as effective and durable in treating UUI as pharmacotherapy) Secondary Analyses: * To determine whether hypnotherapy is at least as effective in treating UUI as pharmacotherapy comparing change in UUI episodes on voiding diary at 6 and 12 month follow-up * To determine whether hypnotherapy differs from pharmacotherapy in treating UUI comparing change in questionnaire results and urinary frequency * enrolled following administration of the Overactive Bladder (OAB) Awareness tool. Participants will keep voiding diaries then be randomized to either pharmacotherapy and conventional behavioral therapy or hypnotherapy and conventional behavioral therapy. Approximately 150-160 women will be randomized. Randomization will occur using a computer-generated randomization scheme in varying permuted block sizes. Study personnel performing data entry will be masked to participants' treatment. Masking participants to treatment is not feasible. Participants will be followed at 2,6 & 12 months. Measurements will be performed before treatment, following completion of treatment visits (approximately 8 weeks), and at 6 and 12 months. Primary analysis will be intention to treat. Exploratory analyses of secondary outcomes will also be performed. Study Visits: UUI participant screening: Study information given. Screening questionnaire given. Visit 1 Enrollment: Formal screening for eligibility, voiding diary reviewed, if eligible, written consent obtained with administration of study questionnaires, demographic and past medical history administration forms, Pelvic Organ Prolapse Quantitation (POP-Q) exam & hypnotic susceptibility testing scheduled. Pariticipants undergo hypnotic susceptibility testing prior to randomization. Participants randomized to treatment and contacted, treatments arranged. Hypnotherapy group: undergo weekly treatments over 8 weeks. Pharmacotherapy group: weekly counseling sessions over 8 week: Following hypnotherapy or medication counseling completion, f/u voiding diaries collected & study questionnaires administered. One of two long acting anti-cholinergic medications offered (Long acting Tolterodine or Extended Release Oxybutynin or equivalent generic substitutes). 6 & 12 month follow-up: Pharmacotherapy subjects receive medications for 1 year and Hypnotherapy subjects encouraged to continue self-hypnosis for 1 year with assistance of audio-recordings, with 1 optional hypnotherapy session between 6-12 months.. Participants informed pharmacotherapy & hypnotherapy sessions are audio-recorded and reviewed ensuring manual of procedures are followed.
Interventions
DRUGAnticholinergic 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.
BEHAVIORALHypnotherapy
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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
(For randomized trial) 1. Non-pregnant English-speaking women 2. 18 yo or older 3. Overactive Bladder (OAB) Awareness scores ≥ 8 4. 3 UUI episodes/week for ≥ 3 months
Exclusion criteria
(For Randomized trial) 1. Women with a history of neurologic diseases such as Multiple Sclerosis, Parkinson's disease, stroke, or dementia 2. History of schizophrenia or untreated bipolar disorder or current drug or alcohol dependence 3. Women who have taken anticholinergic medications for UUI within the last 3 weeks (women who have taken anti-cholinergics for UUI but discontinued them \> than 3 weeks ago may participate in the study) or have a sacral neuromodulator in place to treat UUI or have received Onabotulinum toxin A in the last 12 months to treat UUI 4. Contraindications to anticholinergic medications (untreated narrow angle glaucoma, significant urinary retention or gastric retention) 5. Pregnant women or lactating women, women who plan to become pregnant in the next year, or pre-menopausal women unwilling to use contraception if engaging in sexual relations during the year of study participation (hysterectomy is considered to be a form of contraception) 6. Untreated urinary tract infection 7. Prolapse which extends past the hymen (POP-Q points of ≥ 1+) which may be responsible for UUI symptoms 8. Women who cannot keep the majority of the study therapy appointments or those without reliable contact phone numbers or methods of communication with the study personnel.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Urgency Urinary Incontinence Episodes | Baseline and 2 month follow-up | Percent change in UUI episodes from baseline to 2 months with comparison made between hypnotherapy & pharmacotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Urgency Urinary Incontinence Episodes | 6 months | Differences comparing hypnotherapy to pharmacotherapy percent change in median UUI episodes |
| Overactive Bladder Questionnaire Short Form Symptom Bother | 2 months | 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) |
| Overactive Bladder Questionnaire Short Form Quality of Life | 2 months | 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. |
| Voids on Bladder Diary | 2 months | Total Number of voids on 3-day bladder diary. |
Countries
United States
Participant flow
Recruitment details
Patients recruited March 2013 through October 2016 from the UNMH Urogynecology clinics
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 70 |
| 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. | 72 |
| Total | 142 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Total | Anticholinergic Medications | Hypnotherapy |
|---|---|---|---|
| Age, Continuous | 58.55 years STANDARD_DEVIATION 11.54 | 59.5 years STANDARD_DEVIATION 10.3 | 57.6 years STANDARD_DEVIATION 12.77 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 39 Participants | 15 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 100 Participants | 55 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 1 Participants |
| number of voids on bladder diary | 29.13 episodes STANDARD_DEVIATION 8.57 | 29.19 episodes STANDARD_DEVIATION 8.43 | 29.07 episodes STANDARD_DEVIATION 8.71 |
| Overactive bladder short form (OABq-SF) questionnaires Overactive Bladder Questionnaire Short Form Bother | 66.94 units on a scale STANDARD_DEVIATION 21.43 | 66.99 units on a scale STANDARD_DEVIATION 21.6 | 66.88 units on a scale STANDARD_DEVIATION 21.26 |
| Overactive bladder short form (OABq-SF) questionnaires Overactive Bladder Short Form Quality of Life | 48.75 units on a scale STANDARD_DEVIATION 26.35 | 50.38 units on a scale STANDARD_DEVIATION 25.29 | 47.11 units on a scale STANDARD_DEVIATION 27.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 18 Participants | 7 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 113 Participants | 61 Participants | 52 Participants |
| Region of Enrollment United States | 142 participants | 72 participants | 70 participants |
| Sex: Female, Male Female | 142 Participants | 72 Participants | 70 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Urgency Incontinence episodes on 3 day diary | 7.5 episodes | 7 episodes | 8 episodes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 72 |
| other Total, other adverse events | 12 / 70 | 27 / 72 |
| serious Total, serious adverse events | 1 / 70 | 3 / 72 |
Outcome results
Primary
Percent Change in Urgency Urinary Incontinence Episodes
Percent change in UUI episodes from baseline to 2 months with comparison made between hypnotherapy & pharmacotherapy
Time frame: Baseline and 2 month follow-up
Population: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hypnotherapy | Percent Change in Urgency Urinary Incontinence Episodes | 73 percentage change in median UUI episodes |
| Anticholinergic Medications | Percent Change in Urgency Urinary Incontinence Episodes | 88.6 percentage change in median UUI episodes |
p-value: <0.025Exact Mann Whitney
Secondary
Overactive Bladder Questionnaire Short Form Quality of Life
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.
Time frame: 12 months
Population: At 12 months in the hypnotherapy group: 4 had withdrawn, 1 missing diary. In the medication group, 7 had withdrawn.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Hypnotherapy | Overactive Bladder Questionnaire Short Form Quality of Life | 75.71 sub-scale scores |
| Anticholinergic Medications | Overactive Bladder Questionnaire Short Form Quality of Life | 81.57 sub-scale scores |
Secondary
Overactive Bladder Questionnaire Short Form Quality of Life
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Hypnotherapy | Overactive Bladder Questionnaire Short Form Quality of Life | 75.85 sub-scale scores |
| Anticholinergic Medications | Overactive Bladder Questionnaire Short Form Quality of Life | 80.19 sub-scale scores |
Secondary
Overactive Bladder Questionnaire Short Form Quality of Life
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.
Time frame: 2 months
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Hypnotherapy | Overactive Bladder Questionnaire Short Form Quality of Life | 73.96 sub-scale scores |
| Anticholinergic Medications | Overactive Bladder Questionnaire Short Form Quality of Life | 74.86 sub-scale scores |
Secondary
Overactive Bladder Questionnaire Short Form Symptom Bother
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)
Time frame: 2 months
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Hypnotherapy | Overactive Bladder Questionnaire Short Form Symptom Bother | 38.17 scores on a sub-scale |
| Anticholinergic Medications | Overactive Bladder Questionnaire Short Form Symptom Bother | 35.33 scores on a sub-scale |
Secondary
Overactive Bladder Questionnaire Short Form Symptom Bother
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)
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Hypnotherapy | Overactive Bladder Questionnaire Short Form Symptom Bother | 34.61 sub-scale scores |
| Anticholinergic Medications | Overactive Bladder Questionnaire Short Form Symptom Bother | 27.93 sub-scale scores |
Secondary
Overactive Bladder Questionnaire Short Form Symptom Bother
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)
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Hypnotherapy | Overactive Bladder Questionnaire Short Form Symptom Bother | 32.27 sub-scale scores |
| Anticholinergic Medications | Overactive Bladder Questionnaire Short Form Symptom Bother | 30.74 sub-scale scores |
Secondary
Percent Change in Urgency Urinary Incontinence Episodes
Differences comparing hypnotherapy to pharmacotherapy percent change in median UUI episodes
Time frame: 6 months
Population: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hypnotherapy | Percent Change in Urgency Urinary Incontinence Episodes | 85.7 percentage change in median UUI episodes |
| Anticholinergic Medications | Percent Change in Urgency Urinary Incontinence Episodes | 83.3 percentage change in median UUI episodes |
p-value: <0.025Exact Mann Whitney
Secondary
Percent Change in Urgency Urinary Incontinence Episodes
Percent change in median UUI episodes from baseline to 12 months with comparison made between hypnotherapy & pharmacotherapy
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hypnotherapy | Percent Change in Urgency Urinary Incontinence Episodes | 85.7 percentage change in median UUI episodes |
| Anticholinergic Medications | Percent Change in Urgency Urinary Incontinence Episodes | 80.0 percentage change in median UUI episodes |
Secondary
Voids on Bladder Diary
Total Number of voids on 3-day bladder diary.
Time frame: 2 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hypnotherapy | Voids on Bladder Diary | 26.4 counts |
| Anticholinergic Medications | Voids on Bladder Diary | 25.35 counts |
Secondary
Voids on Bladder Diary
number of voids on 3-day bladder diary
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hypnotherapy | Voids on Bladder Diary | 25.74 counts |
| Anticholinergic Medications | Voids on Bladder Diary | 25.37 counts |
Secondary
Voids on Bladder Diary
number of voids on 3-day bladder diary
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hypnotherapy | Voids on Bladder Diary | 25.58 counts |
| Anticholinergic Medications | Voids on Bladder Diary | 24.28 counts |