Urinary Incontinence clinical trials at University of California Health
10 in progress, 7 open to eligible people
Adaptive Design Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair for Persistent or Recurrent Stress Urinary Incontinence Following Surgical Treatment
open to eligible females ages 18 years and up
This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) compared to a placebo in the reduction of stress incontinence episode frequency in adult female patients with post-surgical persistent or recurrent stress urinary incontinence (SUI). Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.
at UC Davis UCLA
An Educational Video to Improve Patient Comprehension of Midurethral Sling
open to eligible females ages 18 years and up
The purpose of this research project is to test the effectiveness of a previsit educational video designed to help women understand the risks and benefits of a midurethral sling for treatment of stress urinary incontinence. A total of 38 participants will be recruited from both the Urogynecology pre-operative clinic of the university of California, Irvine Medical Center and the Urogynecology pre-operative clinic at Kaiser Permanente, Anaheim and Orange County. Participants will be randomized either to watch a 10 minute educational video (intervention group) or read a standard handout describing the midurethral sling (control group). Participants will then complete their pre-operative visit in the usual fashion. Participants will complete a pre- and post- intervention knowledge questionnaire to assess the primary outcome (change in knowledge before and after intervention). Participants will repeat the knowledge questionnaire and complete validated questionnaires for satisfaction with decision scale and decision regret at 2 and 6 weeks post-operative.
at UC Irvine
CAN-Stim Compared to SNS in Treatment of Urinary Urgency Incontinence With Wireless Neuromodulation Technology
open to eligible people ages 18 years and up
This is a prospective, randomized, controlled, multi-center, study in which 150 evaluable subjects will be randomized 1:1 to receive either a Protect CAN-Stim or SNS InterStim® system. Subjects from both groups will immediately start with therapy. The primary endpoint is a ≥ 50% reduction in number of incontinence episodes associated with urgency at the 3-month visit, with additional measurements assessed at 14 days, 1, 6, 9 and 12-months.
at UC Irvine
Intradetrusor Botulinum Toxin A: Are Less Injections Better?
open to eligible females ages 18 years and up
Patients with either overactive bladder (OAB) or urgency urinary incontinence (UUI) with be randomized (like a flip of a coin) to receive 100 units of bladder Botox® at either one injection site or ten injection sites. Efficacy and patient satisfaction will be measured by questionnaires.
at UC Irvine
Sling vs Botox for Mixed Incontinence
open to eligible females ages 21 years and up
The primary aim is to compare the effectiveness of intradetrusor injection of 100 unit injection of Botulinum toxin A to mid-urethral sling for change in MUI symptoms 6 months following treatment.
at UCSD
TReating Incontinence for Underlying Mental and Physical Health
open to eligible females ages 60 years and up
The TRIUMPH study is a randomized, double-blinded, 3-arm, parallel-group trial designed to compare the effects of anticholinergic bladder therapy versus a) beta-3-adrenergic agonist bladder therapy and b) no bladder pharmacotherapy on cognitive, urinary, and other aging-related functional outcomes in ambulatory older women with urgency-predominant urinary incontinence and either normal or mildly impaired cognitive function at baseline.
at UCSF
Artificial Urinary Sphincter Clinical Outcomes
open to eligible males ages 18 years and up
To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.
at UCSF
A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women
Sorry, in progress, not accepting new patients
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.
at UCSF
A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence
Sorry, not yet accepting patients
The burden of urinary incontinence (UI) on American women is immense in human and financial terms, and continues to rise with the growing population of older adults. The goal of this proposal is to improve the care for UI provided to women and, in doing so, decrease the utilization of specialty care while improving patient outcomes. Specific Aim 1 seeks to improve the quality of incontinence care provided to an ethnically diverse population of women through a controlled practice-based intervention involving primary care providers. The intervention involves the implementation of PCOR measures. Four Southern California medical groups will participate in a cluster randomized controlled trial in which 60 offices (15 per site) will be randomized to undergo a practice-based incontinence intervention led by a "clinical champion dyad" comprised of a primary care provider and urologist/urogynecologist, both of whom are members of that specific medical group. The intervention will include physician education, individual performance feedback, electronic decision support, patient education using dedicated advanced practice providers (APPs), and the implementation of an electronic referral service. The quality of patient care, as evidenced by compliance with primary care UI quality indicators the investigators developed and pilot-tested, will be measured across the two randomized arms after implementation of the intervention. Compliance with these quality indicators will be the key means to implement PCOR evidence, while, at the same time, measure quality. In Specific Aim 2, utilization of specialists will be compared before and after the intervention. The investigators hypothesize that improved care at the level of the primary care physician will reduce the number of specialty referrals. Specific Aim 3 will seek to measure the effect of the intervention on patient outcomes. Under the hypothesis that a practice-based intervention will improve disease-specific outcomes, symptom severity, quality of life, and patient knowledge will be measured at baseline using validated questionnaires. After implementation of the intervention, these questionnaires will be given a second time six months later and outcomes will be compared between control and intervention groups. The investigators expect that this intervention will also reduce disparities in care for underrepresented minorities.
at UCLA UCSD
Ancillary Study of the Lessening Incontinence With Low-impact Activity Study
Sorry, in progress, not accepting new patients
The parent trial that supports this ancillary research is 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. 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 are being recruited from multiple locations surrounding the San Francisco Bay area. Following a series of telephone- and then clinic-based screening assessments, including a voiding diary to confirm the frequency and clinical type of incontinence, eligible women are randomized in a 1:1 ratio to participate in either a 3-month yoga program (N~120) or a time-equivalent, non-specific muscle stretching and strengthening control program (N~120). During the 3-month intervention period, participants participate in structured intervention programs (either yoga-specific or muscle stretching-strengthening) consisting of twice weekly, 90-minute group classes led by trained instructors). They are also be instructed to practice their assigned intervention for at least an additional hour per week, with the assistance of participant manuals created by the study team and a set of home yoga or stretching/strengthening exercise props. For this ancillary trial research, the investigators are examining ancillary measures of a) physical performance status, b)perceived stress, depression, and anxiety symptoms, and c) sleep quality, duration, and continuity, already incorporated by the principal investigator into the parent trial. The investigators will examine prospective relationships between these ancillary measures and participant-reported urinary incontinence frequency/severity/impact, examine intervention effects on these ancillary outcomes, and assess the extent to which these ancillary outcomes mediate intervention effects on incontinence frequency/severity/impact.
at UCSF
Our lead scientists for Urinary Incontinence research studies include Jennifer Anger Felicia Lane, MD Jennifer Rothschild, MD Christopher Tarnay, MD Benjamin Breyer, MD Alison Huang, MD, MAS, MPhil Emily Lukacz, MD.
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