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Open Access Publications from the University of California

Scholarly Works (29 results)

  • Article
  • Peer Reviewed
UC San Francisco Previously Published Works (2017)

Objective

To characterize change in physical performance and differential prevalence of low skeletal muscle mass and strength (sarcopenia) and lower 25-hydroxyvitamin D concentrations among older women who developed urinary incontinence (UI) symptoms.

Methods

This is a secondary analysis of the Health, Aging, and Body Composition Study. Urinary incontinence symptoms were assessed using validated questions. The Short Physical Performance Battery measured physical performance. Sarcopenia, defined by low muscle mass and strength, was determined using validated cutoffs for gait speed, grip strength, and appendicular skeletal muscle mass. All parameters were evaluated at baseline and year 4. Serum 25-hydroxyvitamin D concentrations were assessed at year 2. The primary outcome was change in Short Physical Performance Battery total scores. Sarcopenia and lower serum 25-hydroxyvitamin D concentrations have been independently associated with poor physical performance and UI and were therefore included as secondary outcomes. Univariate and multivariate analyses were used to characterize the associations of change in physical performance from baseline to year 4, incidence of sarcopenia, and lower serum 25-hydroxyvitamin D on the development of UI symptoms.

Results

Of the 1,583 women enrolled, 910 were excluded (730 had baseline UI; 180 with missing data). Six hundred seventy-three women were continent at baseline; 223 (33%) developed UI symptoms at year 4. SPPB total scores significantly declined in women with UI versus continent women (mean difference continent-incident UI 0.32, 95% CI 0.04-0.60, P=.02). Of subscale measures, standing balance showed the greatest decline at 0.20 (0.05-0.36; continent-incident UI, respectively; P=.009). Sarcopenia developed at a higher rate with incident UI (adjusted odds ratio [OR] 1.7, 95% CI 1.0-2.9). Low 25-hydroxyvitamin D was not associated with incident UI (adjusted OR 1.1, 95% CI 0.7-1.6 and 1.1, 95% CI 0.7-1.6 for deficient or insufficient versus sufficient status, respectively).

Conclusion

We observed a significant decline in standing balance among older women who developed UI symptoms. This decline may be associated with coinciding development of sarcopenia.
    Cover page: Characterizing the Functional Decline of Older Women With Incident Urinary Incontinence
    • Article
    • Peer Reviewed
    UC San Diego Previously Published Works (2007)

    OBJECTIVES To describe our experiences with a continuous quality improvement process for the standardization of multicenter urodynamic studies (UDSs) in a multi-institutional network. Multicenter UDSs can have considerable variations in testing procedures, training, equipment, and reviewer biases. METHODS A quality control process was developed that included protocol development, certification of modynamic testers, central review to assess compliance with protocol and quality, protocol modifications, standardization of equipment and signal configuration, development of an electronic signal repository, and the development of UDS Interpretation Guidelines. RESULTS We describe our experience and process in the development and implementation of a standardized UDS protocol in a multicenter surgical trial for stress urinary incontinence. The process included our protocol development, quality control measures, standardization processes, electronic signal repository, and the need for UDS Interpretation Guidelines. A urodynamic testing procedures protocol was implemented successfully by 20 urodynamic testers at nine continence treatment centers. The protocol provides explicit and detailed guidelines for equipment, calibration, patient position, specific annotations, lay language bladder sensation parameters, visual leak point pressure techniques, modifications for prolapse, and data recording. A UDS Interpretation Guidelines document provides specific suggestions for validity and plausibility determination, expected ranges of urodynamic variables, and reasonable agreement of measuring systems. Both documents are available to urodynamic investigators on the Urinary Incontinence Treatment Network website (http://WWW.Llitn.net/resourcesforphysicians.htm). CONCLUSIONS Multicenter UDSs require a continuous quality improvement process and the development of UDS testing procedures and interpretation guidelines. (c) 2007 Elsevier Inc.

      Cover page: Process for development of multicenter urodynamic studies
      • Article
      • Peer Reviewed
      UC San Diego Previously Published Works (2009)
      The aim of the study was to determine whether successful incontinence pessary fitting or pessary size can be predicted by specific POPQ measurements in women without advanced pelvic organ prolapse. In a multicenter study, women with stress urinary incontinence (SUI) and POPQ stage ≤2 were randomized to three treatment arms: (1) incontinence pessary, (2) behavioral therapy, or (3) both. This study evaluates incontinence pessary size, POPQ measures, and successful fitting in the 266 women assigned to treatment arms 1 and 3. Two hundred thirty-five women (92%) were successfully fitted with an incontinence ring (n = 122) or dish (n = 113). Hysterectomy, genital hiatus (GH), and GH/total vaginal length (TVL) ratios did not predict unsuccessful fitting (p > 0.05). However, mean TVL was greater in women successfully fitted (9.6 vs. 8.8 cm, p < 0.01). Final pessary diameter was not predicted by TVL, point D, or point C (p > 0.05). The vast majority of women with SUI can be successfully fitted with an incontinence pessary, but specific POPQ measures were not helpful in determining incontinence pessary size.
        Cover page: Incontinence pessaries: size, POPQ measures, and successful fitting
        • Article
        • Peer Reviewed
        UC San Diego Previously Published Works (2016)

        Objective

        To longitudinally assess the effect of native tissue vaginal apical prolapse repair with anti-incontinence surgery on quality of life, sexual function, and body image between uterosacral and sacrospinous suspensions.

        Methods

        A planned secondary analysis was performed on 374 women enrolled in a randomized trial of the two types of native tissue repair for apical prolapse. Condition-specific and generic quality of life, sexual function, overall and de novo dyspareunia, and body image were assessed using validated instruments at baseline; 6, 12, and 24 months postoperatively; and changes from baseline were assessed and compared between surgical groups. General linear mixed models were used for comparisons and clinically significant differences were assessed using minimum important differences.

        Results

        Of the women randomized, 82% had outcomes available at 2 years. Overall, clinically and statistically significant improvements in generic and condition-specific quality of life and sexual function were observed after surgery. Dyspareunia rates decreased from 25% to 16% by 24 months with only 3% of all women undergoing treatment. De novo dyspareunia occurred in 5% and 10% by 12 and 24 months, respectively. Body image scores also significantly improved from baseline. There were no clinically meaningful or statistically significant differences between groups for any of these outcomes (all P>.05).

        Conclusion

        Native tissue vaginal prolapse surgery results in statistically and clinically significant improvements in quality of life, sexual function, and body image at 24 months with no significant differences between uterosacral and sacrospinous suspensions. One in 10 women experience de novo dyspareunia but few requested treatment.

        Clinical trial registration

        ClinicalTrials.gov, www.clinicaltrials.gov, NCT00597935.
          • Article
          • Peer Reviewed
          UC San Diego Previously Published Works (2016)

          Purpose

          To determine the best predictor of the mid urethral sling outcome we calculated the AUC of ROC curves of preoperative parameters, including Valsalva leak point pressure, maximum urethral closure pressure, urinary NTx (N-telopeptide of crosslinked type I collagen) and plasma vitamin D values (D2, D3 and D2 plus D3).

          Materials and methods

          This was an ancillary study of TOMUS (Trial of Mid-urethral Slings) and the ValUE (Value of Urodynamics Evaluation) trial in which subjects underwent mid urethral sling surgery for stress urinary incontinence. Valsalva leak point pressure and maximum urethral closure pressure were measured in 427 subjects, whereas NTx, vitamin D2, vitamin D3 and vitamin D2 plus D3 levels were obtained from 150, 116, 115 and 116 subjects respectively. Outcome success was defined using identical outcome (subjective and objective) variables for all subjects. ROC curves with corresponding AUC values were compared.

          Results

          TOMUS and ValUE subjects were significantly different in age, body mass index, UDI (Urogenital Distress Inventory) scores. TOMUS subjects had a lower surgical success rate compared to ValUE subjects (66.3% vs 76.0%, p = 0.03). The AUC values of Valsalva leak point pressure, maximum urethral closure pressure, NTx, and vitamins D2, D3 and D2 plus D3 were 0.542, 0.561, 0.702, 0.627, 0.645 and 0.640, respectively. The AUC of NTx was significantly higher than the AUCs of Valsalva leak point pressure and maximum urethral closure pressure (p = 0.02 and 0.03, respectively).

          Conclusions

          Urinary NTx was the best predictor of the mid urethral sling outcome. This test is not only noninvasive, it is also modifiable. Finding ideal modifiable risk factors prior to mid urethral sling surgery should be subject to future investigations.
            Cover page: Preoperative Urodynamic Parameters (Valsalva Leak Point Pressure and Maximum Urethral Closure Pressure), Urinary Collagen and Plasma Vitamin D Levels as Predictors of Mid Urethral Sling Surgery Outcome
            • Article
            • Peer Reviewed
            UC San Francisco Previously Published Works (2018)

            Purpose

            We sought to determine whether a behavioral weight reduction intervention would improve nonurinary incontinence lower urinary tract storage symptoms at 6 months, including urinary frequency, nocturia and urgency, compared to a structured education program serving as the control group among overweight and obese women with urinary incontinence.

            Materials and methods

            PRIDE (Program to Reduce Incontinence by Diet and Exercise) was a randomized clinical trial performed in 338 overweight or obese women with urinary incontinence. Participants were randomized, including 226 to 6-month behavioral weight loss intervention and 112 to the control group. All participants received a self-help behavioral treatment booklet to improve bladder control. On this secondary data analysis we examined changes in nonurinary incontinence lower urinary tract storage symptoms from baseline to 6 months and the impact of treatment allocation (intervention vs control), weight loss and physical activity.

            Results

            Nonurinary incontinence lower urinary tract storage symptoms were common at baseline, varying from 48% to 62%. In the 2 groups combined women experienced significant improvement in nocturia, urgency and International Prostate Symptom Score at 6 months (all p <0.001). However, lower urinary tract storage symptom outcomes at 6 months did not differ between the intervention and control groups. Similarly no difference was observed in the amount of weight lost (5% or greater vs less than 5%) or physical activity (1,500 kcal or greater expenditure per week compared to less than 1,500 kcal).

            Conclusions

            Lower urinary tract storage symptoms were common among overweight and obese women with urinary incontinence. The prevalence decreased significantly after 6 months independent of treatment group assignment, amount of weight lost or physical activity. These improvements may have been due to self-help behavioral educational materials, trial participation or repeat assessment of symptoms.
              Cover page: A Behavioral Weight Loss Program and Nonurinary Incontinence Lower Urinary Tract Symptoms in Overweight and Obese Women with Urinary Incontinence: A Secondary Data Analysis of PRIDE
              • Article
              • Peer Reviewed
              UC San Diego Previously Published Works (2017)

              Introduction and hypothesis

              We describe the rationale and methods of a study designed to compare vaginal and urinary microbiomes in women with mixed urinary incontinence (MUI) and similarly aged, asymptomatic controls.

              Methods

              This paper delineates the methodology of a supplementary microbiome study nested in an ongoing randomized controlled trial comparing a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone for MUI. Women in the parent study had at least "moderate bother" from urgency and stress urinary incontinence symptoms (SUI) on validated questionnaire and confirmed MUI on bladder diary. Controls had no incontinence symptoms. All participants underwent vaginal and urine collection for DNA analysis and conventional urine culture. Standardized protocols were designed, and a central lab received samples for subsequent polymerase chain reaction (PCR) amplification and sequencing of the bacterial16S ribosomal RNA (rRNA) gene. The composition of bacterial communities will be determined by dual amplicon sequencing of variable regions 1-3 and 4-6 from vaginal and urine specimens to compare the microbiome of patients with controls. Sample-size estimates determined that 126 MUI and 84 control participants were sufficient to detect a 20 % difference in predominant urinary genera, with 80 % power and 0.05 significance level.

              Results

              Specimen collection commenced January 2015 and finished April 2016. DNA was extracted and stored for subsequent evaluation.

              Conclusions

              Methods papers sharing information regarding development of genitourinary microbiome studies, particularly with control populations, are few. We describe the rigorous methodology developed for a novel urogenital microbiome study in women with MUI.
                • Article
                • Peer Reviewed
                UC San Diego Previously Published Works (2020)
                  Cover page: Effect of Vaginal Mesh Hysteropexy Versus Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial
                  • Article
                  • Peer Reviewed
                  UC San Diego Previously Published Works (2017)

                  Background

                  Female urinary microbiota are associated with urgency urinary incontinence and response to medication. The urinary microbiota of women with stress urinary incontinence has not been described.

                  Objective

                  We sought to study the cross-sectional relationships between urinary microbiota features and demographic and clinical characteristics of women undergoing stress urinary incontinence surgery.

                  Study design

                  Preoperative urine specimens were collected from women without urinary tract infection and were available from 197 women (174 voided, 23 catheterized) enrolled in a multicenter prospective randomized trial, the Value of Urodynamic Evaluation study. Demographic and clinical variables were obtained including stress and urgency urinary incontinence symptoms, menopausal status, and hormone use. The bacterial composition of the urine was qualitatively assessed by sequencing the bacterial 16S ribosomal RNA gene. Phylogenetic relatedness and microbial alpha diversity were compared to demographics and symptoms using generalized estimating equation models.

                  Results

                  The majority of 197 urine samples (86%) had detectable bacterial DNA. Bacterial diversity was significantly associated with higher body mass index (P = .02); increased Medical, Epidemiologic, and Social Aspects of Aging urge index score (P = .04); and hormonal status (P < .001). No associations were detected with stress urinary incontinence symptoms. Increased diversity was also associated with a concomitant lower frequency of Lactobacillus in hormone-negative women.

                  Conclusion

                  Women undergoing stress urinary incontinence surgery have detectable urinary microbiota. This cross-sectional analysis revealed that increased diversity of the microbiota was associated with urgency urinary incontinence symptoms, hormonal status, and body mass index. In contrast, the female urinary microbiota were not associated with stress urinary incontinence symptoms.
                    • Article
                    • Peer Reviewed
                    UC San Diego Previously Published Works (2022)

                    Introduction

                    To determine whether percutaneous tibial nerve stimulation (PTNS) is superior to sham stimulation for the treatment of fecal incontinence (FI) in women refractory to first-line treatments.

                    Methods

                    Women aged 18 years or older with ≥3 months of moderate-to-severe FI that persisted after a 4-week run-in phase were randomized 2:1 (PTNS:sham stimulation) to 12 weekly 30-minute sessions in this multicenter, single-masked, controlled superiority trial. The primary outcome was change from baseline FI severity measured by St. Mark score after 12 weeks of treatment (range 0-24; minimal important difference, 3-5 points). The secondary outcomes included electronic bowel diary events and quality of life. The groups were compared using an adjusted general linear mixed model.

                    Results

                    Of 199 women who entered the run-in period, 166 (of 170 eligible) were randomized, (111 in PTNS group and 55 in sham group); the mean (SD) age was 63.6 (11.6) years; baseline St. Mark score was 17.4 (2.7); and recording was 6.6 (5.5) FI episodes per week. There was no difference in improvement from baseline in St. Mark scores in the PTNS group when compared with the sham group (-5.3 vs -3.9 points, adjusted difference [95% confidence interval] -1.3 [-2.8 to 0.2]). The groups did not differ in reduction in weekly FI episodes (-2.1 vs -1.9 episodes, adjusted difference [95% confidence interval] -0.26 [-1.85 to 1.33]). Condition-specific quality of life measures did not indicate a benefit of PTNS over sham stimulation. Serious adverse events occurred in 4% of each group.

                    Discussion

                    Although symptom reduction after 12 weeks of PTNS met a threshold of clinical importance, it did not differ from sham stimulation. These data do not support the use of PTNS as conducted for the treatment of FI in women.
                      Cover page: Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial.
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