Urinary Incontinence, UrgeHyp-hOPNCT01829425

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

A study testing Anticholinergic medications and Hypnotherapy in people with Urinary Incontinence, Urge, run by University of New Mexico at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Urinary Incontinence, Urge
What is being tested?: Anticholinergic medications and Hypnotherapy
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 165 participants
Where: 1 siteUnited States
Study dates: 22 Apr 2013to 27 Oct 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Non-pregnant English-speaking women
18 yo or older
Overactive Bladder (OAB) Awareness scores ≥ 8
3 UUI episodes/week for ≥ 3 months

Who cannot join

Women with a history of neurologic diseases such as Multiple Sclerosis, Parkinson's disease, stroke, or dementia
History of schizophrenia or untreated bipolar disorder or current drug or alcohol dependence
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
Contraindications to anticholinergic medications (untreated narrow angle glaucoma, significant urinary retention or gastric retention)
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)
Untreated urinary tract infection
Prolapse which extends past the hymen (POP-Q points of ≥ 1+) which may be responsible for UUI symptoms
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of New Mexico Health Science Center
Albuquerque, New Mexico, 87131

Other trials in United States

About this study

Official title: Protocol for Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence An RCT: Hypnotherapy Or Pharmacotherapy

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.

Read the 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.

Conditions: Urinary Incontinence, Urge
Being tested: Anticholinergic medications, Hypnotherapy
Keywords: Hypnosis, Mind-Body Therapy, Anticholinergics, Female Urogenital Diseases
Medical subject headings: Urinary Incontinence, Urge, Female Urogenital Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anticholinergic medicationsDrug
Also called Tolterodine (Detrol LA or equivalent generic), Oxybutynin (Ditropan Extended Release or equivalent generic)
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.
HypnotherapyBehavioural
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.

Study groups in NCT01829425
Study group	Role	What they receive
Anticholinergic medications	Active comparator	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. Receives: Drug: Anticholinergic medications
Hypnotherapy	Active comparator	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. Receives: Behavioral: Hypnotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (11)

Percent Change in Urgency Urinary Incontinence Episodes
Differences comparing hypnotherapy to pharmacotherapy percent change in median UUI episodes
Measured: 6 months
Percent Change in Urgency Urinary Incontinence Episodes
Percent change in median UUI episodes from baseline to 12 months with comparison made between hypnotherapy \& pharmacotherapy
Measured: 12 months
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)
Measured: 2 months
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)
Measured: 6 months
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)
Measured: 12 months
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.
Measured: 2 months
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.
Measured: 6 months
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.
Measured: 12 months
Voids on Bladder Diary
Total Number of voids on 3-day bladder diary.
Measured: 2 months
Voids on Bladder Diary
number of voids on 3-day bladder diary
Measured: 6 months
Voids on Bladder Diary
number of voids on 3-day bladder diary
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Apr 201327 Oct 2017

First posted11 Apr 2013 (estimated)
Study start22 Apr 2013
Primary completion27 Oct 2017
Study completion27 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Urinary Incontinence, UrgeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01829425
Sponsor's protocol ID: 09-314
Other IDs: 1R01AT007171-01A1
Acronym: Hyp-hOP
Status last verified: Apr 2019
First submitted: 8 Apr 2013
Last updated: 23 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: The information will be shared with other researchers upon their request. Our IRB required that we re-consent participants in order to make their data available to others. We can only share the information available on participants who signed these additional consents.

Publications

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. doi: 10.1097/SPV.0b013e3182065507.
PubMed 21399722
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.
PubMed 22453228
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. doi: 10.1023/a:1016370925601.
PubMed 12206577
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. doi: 10.1002/(sici)1520-6777(2000)19:23.0.co;2-g.
PubMed 10679830
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. doi: 10.1016/j.eururo.2006.01.007. Epub 2006 Jan 24.
PubMed 16460875
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. doi: 10.1007/BF02850085.
PubMed 16418145
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. doi: 10.1001/jama.280.23.1995.
PubMed 9863850
Ketai LH, Komesu YM, Schrader RM, Rogers RG, Sapien RE, Dodd AB, Mayer AR. Mind-body (hypnotherapy) treatment of women with urgency urinary incontinence: changes in brain attentional networks. Am J Obstet Gynecol. 2021 May;224(5):498.e1-498.e10. doi: 10.1016/j.ajog.2020.10.041. Epub 2020 Oct 26.
PubMed 33122028
Komesu YM, Schrader RM, Rogers RG, Sapien RE, Mayer AR, Ketai LH. Hypnotherapy or medications: a randomized noninferiority trial in urgency urinary incontinent women. Am J Obstet Gynecol. 2020 Feb;222(2):159.e1-159.e16. doi: 10.1016/j.ajog.2019.08.025. Epub 2019 Aug 23.
PubMed 31449805

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Active, not recruiting
INTIBIA Pivotal Study
Urinary Incontinence, Urge, Urinary Bladder, Overactive
Recruiting
Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
Urge Urinary Incontinence
Recruiting
A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
Overactive Bladder, Urge Incontinence

All Urinary Incontinence, Urge trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Protocol for Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence An RCT: Hypnotherapy Or Pharmacotherapy
ClinicalTrials.gov ID: NCT01829425
Acronym / sponsor ID: Hyp-hOP / 09-314
Conditions: Urinary Incontinence, Urge
Keywords: Hypnosis, Mind-Body Therapy, Anticholinergics, Female Urogenital Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 165 participants (actual)
Lead sponsor: University of New MexicoUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: 22 Apr 2013 (actual)
Primary completion: 27 Oct 2017 (actual)
Study completion: 27 Oct 2017 (actual)
First posted: 11 Apr 2013 (estimated)
Results: Posted 1 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Participants informed pharmacotherapy \& hypnotherapy sessions are audio-recorded and reviewed ensuring manual of procedures are followed.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Anticholinergic medications	Active comparator	Drug: Anticholinergic medicationsEither 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.
Hypnotherapy	Active comparator	Behavioral: HypnotherapySubjects 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Non-pregnant English-speaking women
18 yo or older
Overactive Bladder (OAB) Awareness scores ≥ 8
3 UUI episodes/week for ≥ 3 months

Key exclusion criteria (8 listed)

Women with a history of neurologic diseases such as Multiple Sclerosis, Parkinson's disease, stroke, or dementia
History of schizophrenia or untreated bipolar disorder or current drug or alcohol dependence
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
Contraindications to anticholinergic medications (untreated narrow angle glaucoma, significant urinary retention or gastric retention)
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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Anticholinergic medicationsAlso: Tolterodine (Detrol LA or equivalent generic), Oxybutynin (Ditropan Extended Release or equivalent generic)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.	Drug	Anticholinergic medications
HypnotherapyHypnotherapy 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.	Behavioural	Hypnotherapy

Primary outcome

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

11 secondary outcomes

Percent Change in Urgency Urinary Incontinence Episodes
Time frame: 6 months
Percent Change in Urgency Urinary Incontinence Episodes
Time frame: 12 months
Overactive Bladder Questionnaire Short Form Symptom Bother
Time frame: 2 months
Overactive Bladder Questionnaire Short Form Symptom Bother
Time frame: 6 months
Overactive Bladder Questionnaire Short Form Symptom Bother
Time frame: 12 months
Overactive Bladder Questionnaire Short Form Quality of Life
Time frame: 2 months
Overactive Bladder Questionnaire Short Form Quality of Life
Time frame: 6 months
Overactive Bladder Questionnaire Short Form Quality of Life
Time frame: 12 months
Voids on Bladder Diary
Time frame: 2 months
Voids on Bladder Diary
Time frame: 6 months
Voids on Bladder Diary
Time frame: 12 months

Results and safety

Results posted to the registry on 1 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anticholinergic Medications	78	72
Hypnotherapy	74	70

Primary outcome: Percent Change in Urgency Urinary Incontinence Episodes

Time frame: Baseline and 2 month follow-up. Median (95% Confidence Interval). Unit: percentage change in median UUI episodes

Measure	Hypnotherapy n = 70	Anticholinergic Medications n = 72
Value	73 (60 to 88.9)	88.6 (78.6 to 100)

Hypnotherapy vs Anticholinergic Medications: Difference in median % change between gr: 5, p <.025, Exact Mann Whitney

Population analysed: 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

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year; from study randomization to study completion. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hypnotherapy	1 of 70 (1.4%)	12 of 70 (17.1%)	0 of 70
Anticholinergic Medications	3 of 72 (4.2%)	27 of 72 (37.5%)	0 of 72

Limitations and caveats (from the sponsor): Women willing to participate x1 yr in RCT may not represent the general population. Population limited to 1 U.S. southwestern institution

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21399722Komesu 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. doi: 10.1097/SPV.0b013e3182065507.
Background: PubMed 22453228Komesu 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.
Background: PubMed 12206577Coyne 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. doi: 10.1023/a:1016370925601.
Background: PubMed 10679830Sandvik 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. doi: 10.1002/(sici)1520-6777(2000)19:23.0.co;2-g.
Background: PubMed 16460875Coyne 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. doi: 10.1016/j.eururo.2006.01.007. Epub 2006 Jan 24.
Background: PubMed 16418145Coyne 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. doi: 10.1007/BF02850085.
Background: PubMed 9863850Burgio 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. doi: 10.1001/jama.280.23.1995.
Derived from this study: PubMed 33122028Ketai LH, Komesu YM, Schrader RM, Rogers RG, Sapien RE, Dodd AB, Mayer AR. Mind-body (hypnotherapy) treatment of women with urgency urinary incontinence: changes in brain attentional networks. Am J Obstet Gynecol. 2021 May;224(5):498.e1-498.e10. doi: 10.1016/j.ajog.2020.10.041. Epub 2020 Oct 26.
Derived from this study: PubMed 31449805Komesu YM, Schrader RM, Rogers RG, Sapien RE, Mayer AR, Ketai LH. Hypnotherapy or medications: a randomized noninferiority trial in urgency urinary incontinent women. Am J Obstet Gynecol. 2020 Feb;222(2):159.e1-159.e16. doi: 10.1016/j.ajog.2019.08.025. Epub 2019 Aug 23.
Individual participant dataSharing planned: Yes. The information will be shared with other researchers upon their request. Our IRB required that we re-consent participants in order to make their data available to others. We can only share the information available on participants who signed these additional consents.

Related trials for Urinary Incontinence, Urge

RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Active, not recruiting
INTIBIA Pivotal Study
Urinary Incontinence, Urge, Urinary Bladder, Overactive
Recruiting
Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
Urge Urinary Incontinence
Recruiting
A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
Overactive Bladder, Urge Incontinence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yuko Komesu, MD principal investigator

University of New Mexcio Health Science Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Anticholinergic medications and Hypnotherapy in people with Urinary Incontinence, Urge, run by University of New Mexico at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Urgency Urinary Incontinence Episodes (time frame: Baseline and 2 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01829425, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.