Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms

NCT ID: NCT02001714

Last Updated: 2017-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 463 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-12-31

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.

Conditions

Urinary Incontinence, Stress; Urinary Incontinence, Urge

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group Behavioral Treatment

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

Group Type: EXPERIMENTAL

Group Behavioral Treatment

Intervention Type: BEHAVIORAL

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.

No Treatment

Subjects will not attend group behavioral treatment class.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Group Behavioral Treatment

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Female

2. Aged 55 years or older

3. Ability to understand, read and write English

4. Stress, urgency, or mixed urgency and stress urinary incontinence (UI) (by self report)

5. 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.

6. Symptoms of three months duration or longer (on history)

7. Passing score (i.e., categorized as "probably not demented") on the MiniCog Test

8. Timed "Up and Go" Test (TUG) score of 20 seconds or less

9. Willing to undergo vaginal/pelvic examination

10. Signed informed consent form

Exclusion Criteria

1. 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)

2. Non-ambulatory (participant confined to bed or wheelchair)

3. Persistent pelvic pain (defined as daily pelvic pain > 3 months)

4. 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)

5. 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)

6. Currently taking urinary incontinence or overactive bladder medications

7. 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)

8. Participation in any drug/device research study.

9. Pelvic organ prolapse protruding past the introitus (at rest or persisting after strain)

10. 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.

11. History of 2 or more recurrent UTI's within the past year; more than one UTI within past 6 months

12. Post void residual urine volume 150 cc or more.

13. Unstable medical condition (as determined by site PI)

-

• Minimum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Ananias Diokno

OTHER

Sponsor Role: lead

Responsible Party

Ananias Diokno

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ananias C Diokno, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

Birmingham VA Medical Cnter

Birmingham, Alabama, United States

University of Michigan

Ann Arbor, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

University of Pennsylvania Health System, Urology

Philadelphia, Pennsylvania, United States

Countries

United States

References

Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.

Reference Type: DERIVED

PMID: 37811598 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30193294 (View on PubMed)

Other Identifiers

1R01AG043383-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2013-204

Identifier Type: -

Identifier Source: org_study_id