Clinical trial NCT03672461: A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women
Official title: A Randomized Controlled Trial of a Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Incontinence, Female
Stress Incontinence, Urinary
Stress Incontinence
Urge Incontinence
Urinary Incontinence, Stress
Urinary Stress Incontinence
Urgency Urinary
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Stanford University
First posted: 2018-09-14
Enrollment: 240
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)
* Report history of interstitial cystitis, bladder or rectal fistula, or congenital defect causing urinary incontinence
* Report incontinence caused by a major neurologic conditions such as multiple sclerosis, spinal cord injury, or Parkinson's disease
* Report use of medications with strong effects on urination (anticholinergic bladder medications, beta-3 agonists, tricyclic antidepressants, mirabegron, loop diuretics) within the past month
* Report starting, stopping, or changing the dose of a medication with the potential to affect anxiety or depression symptoms (i.e., selective serotonin reuptake inhibitors, anxiolytics/sedatives, antipsychotics) within the past 1 month, or plans to start, stop, or change to dose of such a medication during the study period
* Participation in another research study that involves investigational drugs or devices that could potentially confound the results of this study
* Unable to understand study procedures, complete study interviews, or and provide informed consent in English
* Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol, including plans to move, substance abuse, significant psychiatric problems, or dementia

Primary outcomes:
measure: Change From Baseline in Total Urinary Incontinence Episodes
timeFrame: Repeated change from baseline to 6 and 12 weeks
Secondary outcomes:
measure: Change From Baseline in Stress-Type Urinary Incontinence Episodes
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Urgency-Type Urinary Incontinence Episodes
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Incontinence Impact Questionnaire (IIQ)
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Urogenital Distress Inventory-6 Score (UDI)
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Patient Perception of Bladder Condition (PPBC)
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in State/Trait Anxiety Inventory (STAI)--Trait
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Hospital Anxiety & Depression (HADS)--Anxiety Score
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Perceived Stress Scale (PSS) Score
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in PROMIS Physical Function Short Form 8B, T-Score
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in One-legged Balance Test (Winsorized)
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Chair Stands (in 30 Seconds)
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in 2-Minute Step Test
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Wake After Sleep Onset (Winsorized)
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Total Sleep Time
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Impact on Sexual Quality
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Specific Reason for Not Being Active
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Global Quality
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Partner Related Reasons for Not Being Active
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Arousal, Orgasm
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specific Impact on Sexual Quality
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specifc Impacts on Activity
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Summary Score
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Desire
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Global Quality
timeFrame: Repeated change from baseline to 6 and 12 weeks
measure: Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Assessment of Partner Related Impacts (Winsorized)
timeFrame: Repeated change from baseline to 6 and 12 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Alison Huang, MS, MAS, MPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang AJ, Chesney MA, Schembri M, Pawlowsky S, Nicosia F, Subak LL. Rapid Conversion of a Group-Based Yoga Trial for Diverse Older Women to Home-Based Telehealth: Lessons Learned Using Zoom to Deliver Movement-Based Interventions. J Integr Complement Med. 2022 Feb;28(2):188-192. doi: 10.1089/jicm.2021.0268. Epub 2022 Jan 10.