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Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms (Gladiolus)

Primary Purpose

Urinary Incontinence, Stress, Urinary Incontinence, Urge

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Group Behavioral Treatment

About this trial

This is an interventional treatment trial for Urinary Incontinence, Stress

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Female
Aged 55 years or older
Ability to understand, read and write English
Stress, urgency, or mixed urgency and stress urinary incontinence (UI) (by self report)
On the International Consultation on Incontinence Modular Questionnaire - Short Form (ICIQ UI-SF), frequency of leakage at least a 1 ("about once a week or less often") on item #1 and volume of urine loss at least a 2 ("a small amount") on item #2.
Symptoms of three months duration or longer (on history)
Passing score (i.e., categorized as "probably not demented") on the MiniCog Test
Timed "Up and Go" Test (TUG) score of 20 seconds or less
Willing to undergo vaginal/pelvic examination
Signed informed consent form

Exclusion Criteria:

History of renal, bladder, uterine, ovarian, urethral, anal or rectal cancer, radiation therapy to the pelvis for any cancer/malignancy, or any active cancer/malignancy (except skin cancer)
Non-ambulatory (participant confined to bed or wheelchair)
Persistent pelvic pain (defined as daily pelvic pain > 3 months)
History of neurologic or end-stage diseases (e.g. cerebral vascular accident (CVA), Parkinson's disease, multiple sclerosis, epilepsy, spinal cord tumor or trauma, spina bifida, symptomatic herniated disc)
Previous treatment or current participation in a research study for UI, including surgery or formal behavioral treatment (pelvic floor muscle training, biofeedback, pelvic floor electrical stimulation, percutaneous tibial nerve stimulation, sacral neuromodulation, botox or other periurethral injection)
Currently taking urinary incontinence or overactive bladder medications
History of other urinary conditions or procedures that may affect continence status (e.g. urethral diverticula, previous augmentation cystoplasty or artificial urinary sphincter; implanted nerve stimulators for urinary symptoms)
Participation in any drug/device research study.
Pelvic organ prolapse protruding past the introitus (at rest or persisting after strain)
Evidence of urinary tract infection (UTI) by urine dipstick (leukocytes +1 or greater, nitrites +1 or greater, leukocytes alone (w/o nitrites) +2 or greater, or presence of hematuria > +1). Participants may be re-screened after treatment with antibiotics or if hematuria work-up is negative.
History of 2 or more recurrent UTI's within the past year; more than one UTI within past 6 months
Post void residual urine volume 150 cc or more.
Unstable medical condition (as determined by site PI)
-

Sites / Locations

Birmingham VA Medical Cnter
University of Michigan
William Beaumont Hospital
University of Pennsylvania Health System, Urology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group Behavioral Treatment

No Treatment

Arm Description

Participants will attend a group behavioral treatment class and follow-up visits.

Subjects will not attend group behavioral treatment class.

Outcomes

Primary Outcome Measures

Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity.

The primary outcome is the self-reported urinary incontinence severity as measured by the International Consultation on Incontinence questionnaire-short form (ICI-Q). This short and simple questionnaire is used to screen for incontinence (urine leakage) to obtain a brief yet comprehensive summary of the level, impact and perceived cause of symptoms of incontinence. The ICI-Q consists of four questions and numeric scales: 1. How much do you leak urine? (0-5); never - all the time, 2. How much urine do you usually leak? (0-6); none - large amount, 3. Overall, how much does leaking urine interfere with your everyday life? (0-10); not at all - a great deal, 4. When does urine leak? Multiple choices. The ICI-Q score is the sum of questions 1-3 and ranges from 0-21. The higher the score, the greater severity of incontinence. Baseline data is compared to the 3 month data for the primary outcome.

Secondary Outcome Measures

Group Behavioral Treatment Cost-effectiveness

Measure resource use and utilities and compare the difference in incontinence management costs and utilities between treatment and control group.

Full Information

NCT ID

NCT02001714

First Posted

November 22, 2013

Last Updated

October 18, 2017

Sponsor

Ananias Diokno

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT02001714

Brief Title

Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms

Acronym

Gladiolus

Official Title

Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

September 2013 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ananias Diokno

Collaborators

National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This three-site randomized controlled trial compares the effectiveness and cost-effectiveness of a group-administered behavioral treatment program to no treatment. Women with stress, urgency, or mixed urinary incontinence will be recruited and screened centrally, evaluated clinically at each of three study sites, and random assigned to one of two treatment arms: 1. Group behavioral treatment or 2. No treatment. Group treatment modalities have the potential to reach a larger population of older women with urinary incontinence, not only in the traditional medical settings, but also in community settings. The investigators hypothesize that group behavioral treatment will be more effective than no treatment. The investigators hypothesize that the group treatment will be cost-effective compared to no treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence, Stress, Urinary Incontinence, Urge

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Masking Description

The randomization schedule will be concealed so that investigators and staff at the sites will not be able to anticipate experimental group assignments. Evaluators at each site will be blind to group assignment throughout all assessments.

Allocation

Randomized

Enrollment

463 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group Behavioral Treatment

Arm Type

Experimental

Arm Description

Participants will attend a group behavioral treatment class and follow-up visits.

Arm Title

No Treatment

Arm Type

No Intervention

Arm Description

Subjects will not attend group behavioral treatment class.

Intervention Type

Behavioral

Intervention Name(s)

Group Behavioral Treatment

Intervention Description

Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class.

Primary Outcome Measure Information:

Title

Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity.

Description

Time Frame

Baseline and 3 months

Secondary Outcome Measure Information:

Title

Group Behavioral Treatment Cost-effectiveness

Description

Measure resource use and utilities and compare the difference in incontinence management costs and utilities between treatment and control group.

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female Aged 55 years or older Ability to understand, read and write English Stress, urgency, or mixed urgency and stress urinary incontinence (UI) (by self report) On the International Consultation on Incontinence Modular Questionnaire - Short Form (ICIQ UI-SF), frequency of leakage at least a 1 ("about once a week or less often") on item #1 and volume of urine loss at least a 2 ("a small amount") on item #2. Symptoms of three months duration or longer (on history) Passing score (i.e., categorized as "probably not demented") on the MiniCog Test Timed "Up and Go" Test (TUG) score of 20 seconds or less Willing to undergo vaginal/pelvic examination Signed informed consent form Exclusion Criteria: History of renal, bladder, uterine, ovarian, urethral, anal or rectal cancer, radiation therapy to the pelvis for any cancer/malignancy, or any active cancer/malignancy (except skin cancer) Non-ambulatory (participant confined to bed or wheelchair) Persistent pelvic pain (defined as daily pelvic pain > 3 months) History of neurologic or end-stage diseases (e.g. cerebral vascular accident (CVA), Parkinson's disease, multiple sclerosis, epilepsy, spinal cord tumor or trauma, spina bifida, symptomatic herniated disc) Previous treatment or current participation in a research study for UI, including surgery or formal behavioral treatment (pelvic floor muscle training, biofeedback, pelvic floor electrical stimulation, percutaneous tibial nerve stimulation, sacral neuromodulation, botox or other periurethral injection) Currently taking urinary incontinence or overactive bladder medications History of other urinary conditions or procedures that may affect continence status (e.g. urethral diverticula, previous augmentation cystoplasty or artificial urinary sphincter; implanted nerve stimulators for urinary symptoms) Participation in any drug/device research study. Pelvic organ prolapse protruding past the introitus (at rest or persisting after strain) Evidence of urinary tract infection (UTI) by urine dipstick (leukocytes +1 or greater, nitrites +1 or greater, leukocytes alone (w/o nitrites) +2 or greater, or presence of hematuria > +1). Participants may be re-screened after treatment with antibiotics or if hematuria work-up is negative. History of 2 or more recurrent UTI's within the past year; more than one UTI within past 6 months Post void residual urine volume 150 cc or more. Unstable medical condition (as determined by site PI) -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ananias C Diokno, MD

Organizational Affiliation

William Beaumont Hospitals

Official's Role

Principal Investigator

Facility Information:

Facility Name

Birmingham VA Medical Cnter

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

William Beaumont Hospital

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

Facility Name

University of Pennsylvania Health System, Urology

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30193294

Citation

Diokno AC, Newman DK, Low LK, Griebling TL, Maddens ME, Goode PS, Raghunathan TE, Subak LL, Sampselle CM, Boura JA, Robinson AE, McIntyre D, Burgio KL. Effect of Group-Administered Behavioral Treatment on Urinary Incontinence in Older Women: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1333-1341. doi: 10.1001/jamainternmed.2018.3766.

Results Reference

derived

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Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms

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