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Urinary IncontinencePRIDENCT00091988

Program to Reduce Incontinence by Diet and Exercise

A study testing Lifestyle & Behavioral Change Program and Structured Education Program in people with Urinary Incontinence, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 4 sites in United States.

Completed

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

Official record
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Trial summary

PRIDE will evaluate the impact of weight loss on urinary incontinence in a randomized, controlled trial. Read more about this study

Who is it for?
Ages 30 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Urinary Incontinence
What is being tested?
Lifestyle & Behavioral Change Program and Structured Education Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
338 participants
Where
4 sitesUnited States
Study dates
Jul 2004to Nov 2007
Phase
Interventional
Are there results?
None posted in the registry

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 30 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • aged ≥ 30 years and not institutionalized
  • body mass index 25 to 50 kg/m2
  • urinary incontinence symptoms for > 3 months by self-report and record > 10 incontinent episodes per week on a 7-day urinary diary
  • able to complete a behavioral run-in consisting of self-monitoring of food and activity
  • report having a primary health care provider
  • able to understand and sign informed consent and complete baseline questionnaires
  • agree to not initiate new treatment for incontinence or weight reduction, including behavioral, pharmacological or surgical therapies, for the duration of the study

Who cannot join

  • current use, or use within the previous month of medical therapy for incontinence
  • currently pregnant or gave birth in the previous 6 months
  • current urinary tract infection (dipstick urinalysis positive for leukocyte esterase, nitrites or blood) or report having > 4 urinary tract infections in the preceding year
  • incontinence of neurologic or functional origin (by history)
  • self-report of prior anti-incontinence or urethral surgery, pelvic cancer or pelvic irradiation
  • self-report of significant medical conditions of the genitourinary tract (genitourinary fistula, interstitial cystitis, symptomatic pelvic organ prolapse)
Show all 11Show fewer
  • report a medical condition that would affect the safety and/or efficacy of a weight management program involving diet and physical activity, including type 2 diabetes requiring medical therapy that may cause hypoglycemia, chronic steroid use or uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure > 100 mm Hg); women with a history of coronary heart disease may participate with written approval from their primary care physician
  • currently engaged in an active weight loss program and/or experienced a 10% or greater weight reduction in the past 3 months
  • report being unable to walk 2 blocks (1/4 mile) without stopping
  • report conditions that, in the judgment of the Clinical Center Principal Investigator, render potential participants unlikely to follow the protocol for 18 months, including illness likely to be terminal within 2 years, plans to move, substance abuse or other significant psychiatric problems, or dementia
  • participating in another research study that involves investigational drugs or can potentially confound the results of PRIDE

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Alabama

    Birmingham, Alabama, 35205

  • University of Arkansas

    Little Rock, Arkansas, 72205

  • Miriam Hospital/Brown University

    Providence, Rhode Island, 02903

  • University of California at San Francisco

    San Francisco, California, 94110

Other trials in United States

About this study

PRIDE will evaluate the impact of weight loss on urinary incontinence in a randomized, controlled trial.

Read the detailed description

Three hundred and thirty overweight and obese women with urinary incontinence, 165 from each of two Clinical Centers, will be randomized to either a 6-month intensive behavioral weight control program or to usual care (no weight reduction intervention) and followed for 18 months. Efficacy of weight reduction as a treatment for urinary incontinence will be examined at 6 months following the intensive weight control program, and the sustained impact of the intervention will be examined at 18 months. To increase the maintenance of weight reduction and facilitate evaluation of the enduring impact of weight loss on urinary incontinence, we propose to study a motivation-based weight maintenance program. At the end of the intensive weight control program, women randomized to the weight loss program will be randomized to either a 12-month skill-based maintenance intervention or to a motivation-based maintenance intervention. The maintenance interventions maximize the potential for sustained weight loss and will allow us to determine if long-term weight reduction will produce continued improvement in urinary incontinence.

Being tested
Lifestyle & Behavioral Change Program, Structured Education Program
Keywords
Urinary Incontinence, Weight Loss, Obesity, Motivation
Medical subject headings
Urinary Incontinence, Weight Loss, Obesity

What participants receive

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

  • Lifestyle & Behavioral Change ProgramBehavioural

    Participants in the weight loss arm will receive an intensive group-based behavioral weight loss program. In the first six months of the intervention, all participants in the weight loss arm will be given skill-based diet and exercise prescriptions for weight loss and will be taught specific cognitive and behavioral skills to assist in the modification of their eating and exercise habits. Participants will meet weekly for 6 months in group sessions led by a nutritionist, exercise physiologist, or behaviorist and will follow a structured protocol. This intervention strategy is modeled on interventions that have been successful in other overweight populations and is similar to the programs implemented in our ongoing studies, such as Look AHEAD. With this intervention, women are expected to lose on average of 7-9% of their initial body weight.

  • Structured Education ProgramBehavioural

    Women randomized to the Structured Education Program will be invited to participate in hour long group educational sessions at months 1, 2, 3, and 4. At months 6, 9 and 15, the groups will meet again for group support sessions. The content of these education and support sessions will include information about weight loss, physical activity, healthy eating habits and general health promotion. The educational sessions will be delivered primarily in a group format, with individual make up sessions provided for participants who miss group sessions.

Study groups in NCT00091988
Study groupRoleWhat they receive
Lifestyle & Behavioral Change ProgramExperimentalNot described
Receives: Behavioral: Lifestyle & Behavioral Change Program
Structured Education ProgramActive comparatorNot described
Receives: Behavioral: Structured Education Program

What is being measured

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

  1. Change in the number of incontinent episodes

    Change in the number of incontinence episodes reported in a 7-day voiding diary from baseline to 6 months

    Measured: 6 months

Secondary outcomes (3)

  1. Change in body weight at 6 months

    Change from baseline in body weight measured in kg

    Measured: 6 months

  2. Change in body weight at 12 months

    Change from baseline in body weight measured in kg

    Measured: 12 months

  3. Change in body weight at 18 months

    Change from baseline in body weight measured in kg

    Measured: 18 months

Timeline

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

  1. First posted22 Sep 2004 (estimated)
  2. Study startJul 2004
  3. Primary completionNov 2007
  4. Study completionNov 2007

Resources

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
Outcomes assessor
Enrolment
338 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00091988
Sponsor's protocol ID
U01DK067860
Other IDs
U01DK067860
Acronym
PRIDE
Status last verified
Apr 2020
First submitted
21 Sep 2004
Last updated
16 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/pride/?query=pride

Publications

  • Myers DL, Sung VW, Richter HE, Creasman J, Subak LL. Prolapse symptoms in overweight and obese women before and after weight loss. Female Pelvic Med Reconstr Surg. 2012 Jan-Feb;18(1):55-9. doi: 10.1097/SPV.0b013e31824171f9.

    PubMed 22453270

  • Pinto AM, Subak LL, Nakagawa S, Vittinghoff E, Wing RR, Kusek JW, Herman WH, West DS, Kuppermann M. The effect of weight loss on changes in health-related quality of life among overweight and obese women with urinary incontinence. Qual Life Res. 2012 Dec;21(10):1685-94. doi: 10.1007/s11136-011-0086-2. Epub 2011 Dec 10.

    PubMed 22161726

  • Pinto AM, Kuppermann M, Nakagawa S, Vittinghoff E, Wing RR, Kusek JW, Herman WH, Subak LL. Comparison and correlates of three preference-based health-related quality-of-life measures among overweight and obese women with urinary incontinence. Qual Life Res. 2011 Dec;20(10):1655-62. doi: 10.1007/s11136-011-9896-5. Epub 2011 Apr 3.

    PubMed 21461953

  • West DS, Gorin AA, Subak LL, Foster G, Bragg C, Hecht J, Schembri M, Wing RR; Program to Reduce Incontinence by Diet and Exercise (PRIDE) Research Group. A motivation-focused weight loss maintenance program is an effective alternative to a skill-based approach. Int J Obes (Lond). 2011 Feb;35(2):259-69. doi: 10.1038/ijo.2010.138. Epub 2010 Aug 3.

    PubMed 20680012

  • Wing RR, Creasman JM, West DS, Richter HE, Myers D, Burgio KL, Franklin F, Gorin AA, Vittinghoff E, Macer J, Kusek JW, Subak LL; Program to Reduce Incontinence by Diet and Exercise (PRIDE). Improving urinary incontinence in overweight and obese women through modest weight loss. Obstet Gynecol. 2010 Aug;116(2 Pt 1):284-292. doi: 10.1097/AOG.0b013e3181e8fb60.

    PubMed 20664387

  • Wing RR, West DS, Grady D, Creasman JM, Richter HE, Myers D, Burgio KL, Franklin F, Gorin AA, Vittinghoff E, Macer J, Kusek JW, Subak LL; Program to Reduce Incontinence by Diet and Exercise Group. Effect of weight loss on urinary incontinence in overweight and obese women: results at 12 and 18 months. J Urol. 2010 Sep;184(3):1005-10. doi: 10.1016/j.juro.2010.05.031.

    PubMed 20643425

  • Huang AJ, Subak LL, Wing R, West DS, Hernandez AL, Macer J, Grady D; Program to Reduce Incontinence by Diet and Exercise Investigators. An intensive behavioral weight loss intervention and hot flushes in women. Arch Intern Med. 2010 Jul 12;170(13):1161-7. doi: 10.1001/archinternmed.2010.162.

    PubMed 20625026

  • Subak LL, Wing R, West DS, Franklin F, Vittinghoff E, Creasman JM, Richter HE, Myers D, Burgio KL, Gorin AA, Macer J, Kusek JW, Grady D; PRIDE Investigators. Weight loss to treat urinary incontinence in overweight and obese women. N Engl J Med. 2009 Jan 29;360(5):481-90. doi: 10.1056/NEJMoa0806375.

    PubMed 19179316

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle & Behavioral Change Program and Structured Education Program in people with Urinary Incontinence, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 4 sites 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 7 inclusion and 11 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 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in the number of incontinent episodes (time frame: 6 months). 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 NCT00091988, which also lists 8 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 16 Apr 2020.

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