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Clinical Trials/NCT03672461
NCT03672461
Completed
Not Applicable

A Randomized Controlled Trial of a Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women

University of California, San Francisco2 sites in 1 country240 target enrollmentStarted: March 6, 2019Last updated:
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ConditionsStress Incontinence, FemaleStress Incontinence, UrinaryStress IncontinenceUrge IncontinenceUrinary Incontinence, StressUrinary Stress IncontinenceUrgency Urinary

Overview

Phase
Not Applicable
Status
Completed
Enrollment
240
Locations
2
Primary Endpoint
Change From Baseline in Total Urinary Incontinence Episodes
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The investigators will conduct a randomized controlled trial to evaluate the efficacy of a group-based yoga intervention to decrease the frequency and impact of urinary incontinence in ambulatory middle-aged and older women and explore potential mediators of improvement in outcomes. Women aged 45 years and older who report daily or more frequent stress-, urgency-, or mixed-type incontinence, are not already engaged in formal yoga or muscle stretching/strengthening programs, are willing to temporarily forgo other clinical treatments for incontinence, are able to walk to and use the bathroom without assistance, and meet other eligibility criteria will be recruited from multiple locations surrounding the San Francisco Bay area.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
45 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Women aged 45 years or older who report urinary incontinence starting at least 3 months prior to screening
  • •Self-report an average of at least one incontinence episode per day on a validated voiding diary
  • •Self-report urgency-predominant (i.e., at least half of incontinence episodes being urgency-type), stress-predominant (i.e., at least half of episodes being stress-type), or mixed-type (i.e., an equal number of stress- and urgency-type episodes) incontinence on the screening voiding diary
  • •Willing to refrain from initiating medical treatments that may affect their incontinence or voiding pattern during the study intervention period

Exclusion Criteria

  • •Current participation in organized yoga classes or workshops, or any prior organized yoga training directed specifically at improving incontinence
  • •Current participation in organized physical conditioning classes involving muscle strengthening exercises (e.g., Pilates)
  • •Current urinary tract infection or hematuria detected by urinalysis at screening visit (women can re-present after evaluation and treatment through their usual care)
  • •Currently pregnant (by self-report or screening urine pregnancy test), gave birth within the past 3 months, or planning pregnancy during the study period
  • •Report use of medical devices (i.e. pessary) for incontinence within the past month (participants may stop use of device and re-present for study)
  • •Report use of bladder botox, electrostimulation, formal bladder training, or formal pelvic floor exercise training (with certified practitioners) in the past 3 months
  • •Report any history of prior anti-incontinence or urethral surgery (not including urethral dilation), pelvic cancer, or pelvic irradiation
  • •Report other surgery to the pelvis (hysterectomy, oophorectomy, vaginal surgery, bladder surgery, colon surgery) within the past 3 months
  • •Unable to walk 2 blocks on level ground without assistance (functional capacity \< 4 metabolic equivalents)
  • •Unable to get up from a supine to a standing position without assistance (assessed during the screening visit)

Outcomes

Primary Outcomes

Change From Baseline in Total Urinary Incontinence Episodes

Time Frame: Repeated change from baseline to 6 and 12 weeks

Change was calculated as the followup value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points.

Secondary Outcomes

  • Change From Baseline in Patient Perception of Bladder Condition (PPBC)(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in State/Trait Anxiety Inventory (STAI)--Trait(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Specific Reason for Not Being Active(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Global Quality(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Urgency-Type Urinary Incontinence Episodes(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Wake After Sleep Onset (Winsorized)(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specific Impact on Sexual Quality(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Urogenital Distress Inventory-6 Score (UDI)(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Hospital Anxiety & Depression (HADS)--Anxiety Score(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Perceived Stress Scale (PSS) Score(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Impact on Sexual Quality(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Stress-Type Urinary Incontinence Episodes(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Incontinence Impact Questionnaire (IIQ)(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in PROMIS Physical Function Short Form 8B, T-Score(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in One-legged Balance Test (Winsorized)(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specifc Impacts on Activity(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Global Quality(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Chair Stands (in 30 Seconds)(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in 2-Minute Step Test(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Total Sleep Time(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Assessment of Partner Related Impacts (Winsorized)(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Partner Related Reasons for Not Being Active(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Arousal, Orgasm(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Summary Score(Repeated change from baseline to 6 and 12 weeks)
  • Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Desire(Repeated change from baseline to 6 and 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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