Hyp-hOP: Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence : Hypnotherapy Or Pharmacotherapy

• Sponsor: University of New Mexico (Other)
• Overall Status: Completed
• CT.gov ID: NCT01829425
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Enrollment: 165
• Location: 1
• Arms: 2
• Actual Duration (Months): 54.2
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence, Urge	Drug: Anticholinergic medications; Behavioral: Hypnotherapy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 165 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Protocol for Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence An RCT: Hypnotherapy Or Pharmacotherapy
• Actual Study Start Date: Apr 22, 2013
• Actual Primary Completion Date: Oct 27, 2017
• Actual Study Completion Date: Oct 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: 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.; Other Names: Tolterodine (Detrol LA or equivalent generic) Oxybutynin (Ditropan Extended Release or equivalent generic)
Active Comparator: 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.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Percent Change in Urgency Urinary Incontinence Episodes [6 months]

   Differences comparing hypnotherapy to pharmacotherapy percent change in median UUI episodes

2. Percent Change in Urgency Urinary Incontinence Episodes [12 months]

   Percent change in median UUI episodes from baseline to 12 months with comparison made between hypnotherapy & pharmacotherapy

3. 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)

4. Overactive Bladder Questionnaire Short Form Symptom Bother [6 months]

   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)

5. Overactive Bladder Questionnaire Short Form Symptom Bother [12 months]

   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)

6. 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.

7. Overactive Bladder Questionnaire Short Form Quality of Life [6 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-scale score range 0-100.

8. Overactive Bladder Questionnaire Short Form Quality of Life [12 months]

   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.

9. Voids on Bladder Diary [2 months]

   Total Number of voids on 3-day bladder diary.

10. Voids on Bladder Diary [6 months]

    number of voids on 3-day bladder diary

11. Voids on Bladder Diary [12 months]

    number of voids on 3-day bladder diary

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of New Mexico Health Science Center	Albuquerque	New Mexico	United States	87131

Sponsors and Collaborators

• University of New Mexico
• National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Yuko Komesu, MD, University of New Mexcio Health Science Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 16, 2016

More Information

Publications

• Burgio KL, Locher JL, Goode PS, Hardin JM, McDowell BJ, Dombrowski M, Candib D. Behavioral vs drug treatment for urge urinary incontinence in older women: a randomized controlled trial. JAMA. 1998 Dec 16;280(23):1995-2000.
• Coyne K, Revicki D, Hunt T, Corey R, Stewart W, Bentkover J, Kurth H, Abrams P. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res. 2002 Sep;11(6):563-74.
• Coyne KS, Matza LS, Kopp Z, Abrams P. The validation of the patient perception of bladder condition (PPBC): a single-item global measure for patients with overactive bladder. Eur Urol. 2006 Jun;49(6):1079-86. Epub 2006 Jan 24.
• Coyne KS, Zyczynski T, Margolis MK, Elinoff V, Roberts RG. Validation of an overactive bladder awareness tool for use in primary care settings. Adv Ther. 2005 Jul-Aug;22(4):381-94.
• Komesu YM, Ketai LH, Mayer AR, Teshiba TM, Rogers RG. Functional MRI of the Brain in Women with Overactive Bladder: Brain Activation During Urinary Urgency. Female Pelvic Med Reconstr Surg. 2011;17(1):50-54.
• Komesu YM, Sapien RE, Rogers RG, Ketai LH. Hypnotherapy for treatment of overactive bladder: a randomized controlled trial pilot study. Female Pelvic Med Reconstr Surg. 2011 Nov;17(6):308-13. doi: 10.1097/SPV.0b013e31823a08d9.
• Sandvik H, Seim A, Vanvik A, Hunskaar S. A severity index for epidemiological surveys of female urinary incontinence: comparison with 48-hour pad-weighing tests. Neurourol Urodyn. 2000;19(2):137-45.

• Responsible Party: Yuko Komesu, MD, University of New Mexico
• ClinicalTrials.gov Identifier: NCT01829425
• Other Study ID Numbers: 09-314; 1R01AT007171-01A1
• First Posted: Apr 11, 2013
• Last Update Posted: Apr 23, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Yuko Komesu, MD, University of New Mexico: Hypnosis; Mind-Body Therapy; Anticholinergics; Female Urogenital Diseases
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Urge; Tolterodine Tartrate; Oxybutynin; Cholinergic Antagonists

Study Results

Participant Flow

Recruitment Details	Patients recruited March 2013 through October 2016 from the UNMH Urogynecology clinics
Pre-assignment Detail	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

Arm/Group Title	Anticholinergic Medications	Hypnotherapy
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	78	74
COMPLETED	72	70
NOT COMPLETED	6	4

Baseline Characteristics

Arm/Group Title	Hypnotherapy	Anticholinergic Medications	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	70	72	142
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.6 (12.77)	59.5 (10.30)	58.55 (11.54)
Sex: Female, Male (Count of Participants)
Female	70 100%	72 100%	142 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	24 34.3%	15 20.8%	39 27.5%
Not Hispanic or Latino	45 64.3%	55 76.4%	100 70.4%
Unknown or Not Reported	1 1.4%	2 2.8%	3 2.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 2.9%	2 2.8%	4 2.8%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	1 1.4%	0 0%	1 0.7%
Black or African American	3 4.3%	1 1.4%	4 2.8%
White	52 74.3%	61 84.7%	113 79.6%
More than one race	11 15.7%	7 9.7%	18 12.7%
Unknown or Not Reported	1 1.4%	1 1.4%	2 1.4%
Region of Enrollment (participants) [Number]
United States	70 100%	72 100%	142 100%
Urgency Incontinence episodes on 3 day diary (episodes) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [episodes]	8	7	7.5
Overactive bladder short form (OABq-SF) questionnaires (units on a scale) [Mean (Standard Deviation) ]
Overactive Bladder Questionnaire Short Form Bother	66.88 (21.26)	66.99 (21.60)	66.94 (21.43)
Overactive Bladder Short Form Quality of Life	47.11 (27.40)	50.38 (25.29)	48.75 (26.35)
number of voids on bladder diary (episodes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [episodes]	29.07 (8.71)	29.19 (8.43)	29.13 (8.57)

Outcome Measures

1. Primary Outcome

Title	Percent Change in Urgency Urinary Incontinence Episodes
Description	Percent change in UUI episodes from baseline to 2 months with comparison made between hypnotherapy & pharmacotherapy
Time Frame	Baseline and 2 month follow-up

Outcome Measure Data

Analysis Population Description

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/Group Title	Hypnotherapy	Anticholinergic Medications
Arm/Group Description	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.	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.
Measure Participants	70	72
Median (95% Confidence Interval) [percentage change in median UUI episodes]	73	88.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hypnotherapy, Anticholinergic Medications
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The study design will use a non-inferiority design to compare the primary outcome (change in UUI episodes in the hypnotherapy versus pharmacotherapy groups). With respect to the outcome variable of percent reduction in UUI episodes as determined by bladder diaries, we will use a one-sided non- inferiority test at level alpha = 0.25 and a non-inferiority margin of 5%.
Statistical Test of Hypothesis	p-Value	<.025
	Comments
	Method	Exact Mann Whitney
	Comments	Due dispersion, medians were calculated. Exact Mann Whitney test was used for this analysis.
Method of Estimation	Estimation Parameter	Difference in median % change between gr
	Estimated Value	5
	Confidence Interval	(1-Sided) 95%; 5 to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Hypnotherapy - Pharmacotherapy. % difference in median % change in UUI episodes with lower bounds > - 5% would be consistent with non-inferiority

2. Secondary Outcome

Title	Percent Change in Urgency Urinary Incontinence Episodes
Description	Differences comparing hypnotherapy to pharmacotherapy percent change in median UUI episodes
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Hypnotherapy	Anticholinergic Medications
Arm/Group Description	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.	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.
Measure Participants	67	71
Median (95% Confidence Interval) [percentage change in median UUI episodes]	85.7	83.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hypnotherapy, Anticholinergic Medications
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The study design will use a non-inferiority design to compare the primary outcome (change in UUI episodes in the hypnotherapy versus pharmacotherapy groups). With respect to the outcome variable of percent reduction in UUI episodes as determined by bladder diaries, we will use a one-sided non- inferiority test at level alpha = 0.25 and a non-inferiority margin of 5%. If
Statistical Test of Hypothesis	p-Value	<.025
	Comments
	Method	Exact Mann Whitney
	Comments
Method of Estimation	Estimation Parameter	Difference in median % change between gr
	Estimated Value	5
	Confidence Interval	(1-Sided) 95%; 5 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percent Change in Urgency Urinary Incontinence Episodes
Description	Percent change in median UUI episodes from baseline to 12 months with comparison made between hypnotherapy & pharmacotherapy
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Hypnotherapy	Anticholinergic Medications
Arm/Group Description	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.	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.
Measure Participants	69	71
Median (95% Confidence Interval) [percentage change in median UUI episodes]	85.7	80.0

4. Secondary Outcome

Title	Overactive Bladder Questionnaire Short Form Symptom Bother
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Hypnotherapy	Anticholinergic Medications
Arm/Group Description	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.	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.
Measure Participants	70	72
Least Squares Mean (95% Confidence Interval) [scores on a sub-scale]	38.17	35.33

5. Secondary Outcome

Title	Overactive Bladder Questionnaire Short Form Symptom Bother
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Hypnotherapy	Anticholinergic Medications
Arm/Group Description	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.	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.
Measure Participants	67	71
Least Squares Mean (95% Confidence Interval) [sub-scale scores]	34.61	27.93

6. Secondary Outcome

Title	Overactive Bladder Questionnaire Short Form Symptom Bother
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Hypnotherapy	Anticholinergic Medications
Arm/Group Description	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.	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.
Measure Participants	69	71
Least Squares Mean (95% Confidence Interval) [sub-scale scores]	32.27	30.74

7. Secondary Outcome

Title	Overactive Bladder Questionnaire Short Form Quality of Life
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Hypnotherapy	Anticholinergic Medications
Arm/Group Description	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.	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.
Measure Participants	70	72
Least Squares Mean (95% Confidence Interval) [sub-scale scores]	73.96	74.86

8. Secondary Outcome

Title	Overactive Bladder Questionnaire Short Form Quality of Life
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Hypnotherapy	Anticholinergic Medications
Arm/Group Description	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.	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.
Measure Participants	67	71
Least Squares Mean (95% Confidence Interval) [sub-scale scores]	75.85	80.19

9. Secondary Outcome

Title	Overactive Bladder Questionnaire Short Form Quality of Life
Description	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

Outcome Measure Data

Analysis Population Description

At 12 months in the hypnotherapy group: 4 had withdrawn, 1 missing diary. In the medication group, 7 had withdrawn.

Arm/Group Title	Hypnotherapy	Anticholinergic Medications
Arm/Group Description	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.	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.
Measure Participants	69	71
Least Squares Mean (95% Confidence Interval) [sub-scale scores]	75.71	81.57

10. Secondary Outcome

Title	Voids on Bladder Diary
Description	Total Number of voids on 3-day bladder diary.
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Hypnotherapy	Anticholinergic Medications
Arm/Group Description	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.	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.
Measure Participants	70	72
Mean (95% Confidence Interval) [counts]	26.4	25.35

11. Secondary Outcome

Title	Voids on Bladder Diary
Description	number of voids on 3-day bladder diary
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Hypnotherapy	Anticholinergic Medications
Arm/Group Description	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.	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.
Measure Participants	67	71
Mean (95% Confidence Interval) [counts]	25.58	24.28

12. Secondary Outcome

Title	Voids on Bladder Diary
Description	number of voids on 3-day bladder diary
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Hypnotherapy	Anticholinergic Medications
Arm/Group Description	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.	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.
Measure Participants	69	71
Mean (95% Confidence Interval) [counts]	25.74	25.37

Adverse Events

Time Frame	1 year; from study randomization to study completion
Adverse Event Reporting Description	Adverse event collection occurred at all follow-up and by spontaneous participant report
Arm/Group Title	Hypnotherapy		Anticholinergic Medications
Arm/Group Description	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.		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.
All Cause Mortality
	Hypnotherapy		Anticholinergic Medications
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/72 (0%)
Serious Adverse Events
	Hypnotherapy		Anticholinergic Medications
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/70 (1.4%)		3/72 (4.2%)
Cardiac disorders
1 inpatient hospitalization for observation	0/70 (0%)	0	1/72 (1.4%)	1
Musculoskeletal and connective tissue disorders
1 inpatient hospitalization	0/70 (0%)	0	1/72 (1.4%)	1
1 in-patient hospitalization	0/70 (0%)	0	1/72 (1.4%)	1
Renal and urinary disorders
1 inpatient hospitalization	1/70 (1.4%)	1	0/72 (0%)	0
Other (Not Including Serious) Adverse Events
	Hypnotherapy		Anticholinergic Medications
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/70 (17.1%)		27/72 (37.5%)
General disorders
expected adverse events pharmacotherapy	1/70 (1.4%)	1	12/72 (16.7%)	12
Infections and infestations
urinary tract infection	5/70 (7.1%)	5	6/72 (8.3%)	6
Musculoskeletal and connective tissue disorders
Falls	3/70 (4.3%)	3	5/72 (6.9%)	5
back pain	3/70 (4.3%)	3	4/72 (5.6%)	4

Limitations/Caveats

Women willing to participate x1 yr in RCT may not represent the general population. Population limited to 1 U.S. southwestern institution

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.