A Pilot Randomized Controlled Trial of Vaginal Cryotherapy for the Treatment of Pelvic Floor Myofascial Pain.

INTRODUCTION AND HYPOTHESIS: Pelvic floor myofascial pain (PFMP) is a common but underrecognized component of chronic pelvic pain and pelvic floor disorders symptoms with limited, well-studied treatment modalities. Our objective was to determine the effect of vaginal cryotherapy on PFMP with palpation. METHODS: Following a standardized PFMP screening examination, individuals with a pain score ≥4/10 in ≥1 of four muscle groups were invited to participate in a randomized controlled trial comparing patients undergoing vaginal cryotherapy with controls. Participants in both arms could choose to participate in a single in-office treatment; a 2-week, at-home daily treatment; or both. RESULTS: Between March 2019 and September 2021, a total of 163 participants were enrolled and randomized: 80 to cryotherapy, and 83 to the control group. Sixty-three (28 cryotherapy; 35 controls) completed in-office treatment and 56 (32 cryotherapy; 24 controls) completed at-home therapy. In the in-office comparison, mean pain scores decreased significantly in both arms: cryotherapy (5.13 vs 4.10; p=0.02) and controls (5.60 vs 4.72; p<0.01), with a similar magnitude of reduction between arms (p=0.75). In the at-home comparison, mean pain scores decreased significantly in the cryotherapy arm (6.34 vs 4.75; p<0.01), and nonsignificantly in the control arm (5.41 vs 4.66; p=0.07), resulting in a nonsignificant difference between arms (p=0.14). CONCLUSIONS: Pelvic floor myofascial pain with palpation improved following both a single cryotherapy session and 2 weeks of daily cryotherapy. Interestingly, pain scores also improved with room temperature therapy. Whether these findings reflect a therapeutic effect of both cold and room temperature intravaginal therapy or a placebo effect is unclear but should be explored in larger studies.

A pilot trial of movement-based pelvic floor physical therapy to address pelvic floor myofascial pain and lower urinary tract symptoms.

INTRODUCTION AND HYPOTHESIS: Pelvic floor myofascial pain (PFMP) is associated with lower urinary tract symptoms (LUTS). The objective of this study was to test movement-based pelvic floor physical therapy (PT) for patients with PFMP and LUTS. We hypothesized that movement-based PT designed to target PFMP would result in significant improvement in both PFMP and concomitant LUTS. METHODS: This pilot trial enrolled patients with moderate-to-severe PFMP on palpation who were referred to movement-based PT to diagnose and treat pelvic floor dysfunction in the context of body alignment and movement patterns. The primary outcome was change in Urogenital Distress Inventory (UDI) scores after PT. Factors associated with PT attendance were also measured. We aimed to enroll 55 participants to achieve 80% power to detect a difference in 11 points on the UDI scores with an alpha-level of 0.05, accounting for a 10% loss to follow-up. The sample size was increased to 65 owing to a higher-than-expected loss-to-follow-up rate. RESULTS: Sixty-five patients were enrolled and 62 analyzed. Thirty-eight (61.3%) attended PT, and 30 (48.4%) completed a follow-up PT Attendance (PTA) survey. Overall, UDI score and irritative, obstructive, and stress subscales (p<0.0001) improved in participants who attended PT as well as mean myofascial examination scores at each site. CONCLUSIONS: Participants who attended movement-based PT demonstrated an improvement in LUTS. Future studies should extend our findings by: first, confirming whether the myofascial pain-directed elements of PT improved LUTS; second, investigating whether movement-based PT improves prolapse symptoms; and third, including a non-PT control arm to rule out the possible influence of a placebo effect and behavioral modifications on LUTS and PFMP.

International Urogynaecology Consultation chapter 1 committee 4: patients' perception of disease burden of pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: This manuscript from Chapter 1 of the International Urogynecology Consultation (IUC) on Pelvic Organ Prolapse (POP) reports on the patients' perception of disease burden associated with pelvic organ prolapse. MATERIALS AND METHODS: An international group containing a team of eight urogynaecologists, a physiotherapist and a statistician performed a search of the literature using pre-specified search terms in PubMed and Embase (January 2000 to August 2020). The division of sections within this report includes: (1) perception of POP and the relationship with body image and poor health; (2) a vaginal bulge as it impacts health and wellbeing in women; (3) the impact of POP on sexual life; (4) body image and pelvic floor disorders; (5) POP and mood; (6) appropriate use of treatment goals to better meet patients' expected benefits; (7) using health-related quality of life questionnaires to quantify patients' perception of POP; (8) The financial burden of POP to patients and society. Abstracts were reviewed and publications were eliminated if not relevant or did not include populations with POP or were not relevant to the subject areas as noted by the authors. The manuscripts were next reviewed for suitability using the Specialist Unit for Review Evidence (SURE) checklists for cohort, cross-sectional and case-control epidemiologic studies. RESULTS: The original individual literature searches yielded 2312 references of which 190 were used in the final manuscript. The following perceptions were identified: (1) women were found to have varying perceptions of POP including shame and embarrassment. Some regard POP as consequence of aging and consider there is no effective therapy. (2) POP is perceived as a vaginal bulge and affects lifestyle and emotional wellbeing. The main driver for treatment is absence of bulge sensation. (3) POP is known to affect frequency of sexual intercourse but has less impact on satisfaction. (4) Prolapse-specific body image and genital self-image are important components of a women's emotional, physical and sexual wellbeing. (5) POP is commonly associated with depression and anxiety symptoms which impact HRQoL although are not correlated with objective anatomical findings. (6) Patient-centered treatment goals are useful in facilitating communication, shared decision-making and expectations before and after reconstructive surgery. (7) Disease-specific HRQoL questionnaires are important tools to assess bother and outcome following surgery, and there are now several tools with Level 1 evidence and a Grade A recommendation. (8) The cost of POP to the individual and to society is considerable in terms of productivity. In general, conservative measures tend to be more cost-effective than surgical intervention. CONCLUSIONS: Patients' perception of POP varies in different patients and has a far-reaching impact on their overall state of health and wellbeing. However, recognizing that it is a combination of body image and overall health (which affects mental health) allows clinicians to better tailor expectations for treatment to individual patients. There are HRQoL tools that can be used to quantify these impacts in clinical care and research. The costs to the individual patient (which affects their perception of POP) is an area that is poorly understood and needs more research.

Adult female urinary incontinence guidelines: a systematic review of evaluation guidelines across clinical specialties.

INTRODUCTION AND HYPOTHESIS: To systematically review evaluation guidelines of uncomplicated urinary incontinence (UI) in community-dwelling adult women to assess guidance available to the full range of providers treating UI. METHODS: Systematic literature search of eight bibliographic databases. We included UI evaluation guidelines written for medical providers in English after January 1, 2008. EXCLUSION CRITERIA: guidelines for children, men, institutionalized women, peripartum- and neurologic-related UI. A quantitative scoring system included assessed components and associated recommendation level and clarity. RESULTS: Twenty-two guidelines met the criteria. All guidelines included: history taking, UI characterization, physical examination (PE) performance, urinalysis, and post-void residual volume assessment. At least 75% included medical and surgical history assessment, other disease process exclusion, medication review, impact on quality of life ascertainment, observing stress UI, mental status assessment, performing a pelvic examination, urine culture, bladder diary, and limiting more invasive diagnostics procedures. Fifty to 75% included other important evaluation components (i.e., assessing obstetric history, bowel symptoms, fluid intake, patient expectations/preferences/values, obesity, physical functioning/mobility, other PE [abdominal, rectal, pelvic muscle, and neurologic], urethral hypermobility, and pad testing. Less than 50% of guidelines included discussing patient treatment goals. Guidelines varied in level of detail and clarity, with several instances of unclear or inconsistent recommendations within the same guideline and evaluation components identified only by inference from treatment recommendations. Non-specialty guidelines reported fewer components with a lesser degree of clarity, but this difference was not statistically significant (p = 0.20). CONCLUSIONS: UI evaluation guidelines varied in level of comprehensiveness, detail, and clarity. This variability may lead to inconsistent evaluations in the work-up of UI, contributing to missed opportunities for individualized care.

Pelvic floor myofascial pain severity and pelvic floor disorder symptom bother: is there a correlation?

BACKGROUND: Pelvic floor myofascial pain, which is predominantly identified in the muscles of the levator ani and obturator internus, has been observed in women with chronic pelvic pain and other pelvic floor disorder symptoms, and is hypothesized to contribute to their symptoms. OBJECTIVES: To describe the prevalence of pelvic floor myofascial pain in patients presenting with pelvic floor disorder symptoms and to investigate whether severity of pelvic floor myofascial pain on examination correlates with degree of pelvic floor disorder symptom bother. STUDY DESIGN: All new patients seen at 1 tertiary referral center between 2014 and 2016 were included in this retrospectively assembled cross-sectional study. Pelvic floor myofascial pain was determined by transvaginal palpation of the bilateral obturator internus and levator ani muscles and scored as a discrete number on an 11-point verbal pain rating scale (range, 0-10) at each site. Scores were categorized as none (0), mild (1-3), moderate (4-6), and severe (7-10) for each site. Pelvic floor disorder symptom bother was assessed by the Pelvic Floor Distress Inventory short form scores. The correlation between these 2 measures was calculated using Spearman rank and partial rank correlation coefficients. RESULTS: A total of 912 new patients were evaluated. After exclusion of 79 with an acute urinary tract infection, 833 patients were included in the final analysis. Pelvic floor myofascial pain (pain rated >0 in any muscle group) was identified in 85.0% of patients: 50.4% rated as severe, 25.0% moderate, and 9.6% mild. In unadjusted analyses and those adjusted for postmenopausal status, severity of pelvic floor myofascial pain was significantly correlated with subjective prolapse symptoms such as pelvic pressure and heaviness but not with objective prolapse symptoms (seeing or feeling a vaginal bulge or having to push up on a bulge to start or complete urination) or leading edge. Severity of myofascial pain at several individual pelvic floor sites was also independently correlated with lower urinary tract symptoms, including pain in the lower abdomen (myofascial pain at all sites) and difficulty emptying the bladder (right obturator internus and left levator ani); and with defecatory dysfunction, including sensation of incomplete rectal emptying (pain at all sites combined and the right obturator internus), anal incontinence to flatus (pain at all sites combined), and pain with defecation (pain at all sites combined, and the right obturator internus and left levator ani). CONCLUSION: Pelvic floor myofascial pain was common in patients seeking evaluation for pelvic floor disorder symptoms. Location and severity of pelvic floor myofascial pain was significantly correlated with degree of symptom bother, even after controlling for postmenopausal status. Given the high prevalence of pelvic floor myofascial pain in these patients and correlation between pain severity and degree of symptom bother, a routine assessment for pelvic floor myofascial pain should be considered for all patients presenting for evaluation of pelvic floor symptoms.

Development of a standardized, reproducible screening examination for assessment of pelvic floor myofascial pain.

BACKGROUND: Pelvic floor myofascial pain is common, but physical examination methods to assess pelvic floor muscles are defined poorly. We hypothesized that a simple, transvaginal pelvic floor examination could be developed that would be highly reproducible among providers and would adequately screen for the presence of pelvic floor myofascial pain. OBJECTIVE: The purpose of this study was to develop a simple, reproducible pelvic floor examination to screen for pelvic floor myofascial pain. STUDY DESIGN: A screening examination was developed by Female Pelvic Medicine & Reconstructive Surgery subspecialists and women's health physical therapists at our institution and tested in a simulated patient. We recruited 35 new patients who underwent examinations by blinded, paired, independent examiners. Agreement was calculated with the use of percent agreement and Spearman's rank correlation coefficient. RESULTS: The final examination protocol begins with examination of the following external sites: bilateral sacroiliac joints, medial edge of the anterior superior iliac spine, and cephalad edge of the pubic symphysis (self-reported pain: yes/no). The internal examination follows with palpation of each muscle group in the center of the muscle belly, then along the length of the muscle proceeding counter-clockwise: right obturator internus, right levator ani, left levator ani, left obturator internus (pain on a scale of 0-10). Thirty-five patients were enrolled. Correlation was high at each external (0.80-0.89) and internal point (0.63-0.87; P<.0001). CONCLUSION: Our newly developed, standardized, reproducible examination incorporates assessment of internal and external points to screen for pelvic floor myofascial pain. The examination is straightforward and reproducible and allows for easy use in clinical practice.

Genital hiatus size is associated with and predictive of apical vaginal support loss.

BACKGROUND: Recognition and assessment of apical vaginal support defects remains a significant challenge in the evaluation and management of prolapse. There are several reasons that this is likely: (1) Although the Pelvic Organ Prolapse-Quantification examination is the standard prolapse staging system used in the Female Pelvic Medicine and Reconstructive Surgery field for reporting outcomes, this assessment is not used commonly in clinical care outside the subspecialty; (2) no clinically useful and accepted definition of apical support loss exists, and (3) no consensus or guidelines address the degree of apical support loss at which an apical support procedure should be performed routinely. OBJECTIVE: The purpose of this study was to identify a simple screening measure for significant loss of apical vaginal support. STUDY DESIGN: This was an analysis of women with Pelvic Organ Prolapse-Quantification stage 0-IV prolapse. Women with total vaginal length of ≥7 cm were included to define a population with "normal" vaginal length. Univariable and linear regression analyses were used to identify Pelvic Organ Prolapse-Quantification points that were associated with 3 definitions of apical support loss: the International Consultation on Incontinence, the Pelvic Floor Disorders Network revised eCARE, and a Pelvic Organ Prolapse-Quantification point C cut-point developed by Dietz et al. Linear and logistic regression models were created to assess predictors of overall apical support loss according to these definitions. Receiver operator characteristic curves were generated to determine test characteristics of the predictor variables and the areas under the curves were calculated. RESULTS: Of 469 women, 453 women met the inclusion criterion. The median Pelvic Organ Prolapse-Quantification stage was III, and the median leading edge of prolapse was +2 cm (range, -3 to 12 cm). By stage of prolapse (0-IV), mean genital hiatus size (genital hiatus; mid urethra to posterior fourchette) increased: 2.0 ± 0.5, 3.0 ± 0.5, 4.0 ± 1.0, 5.0 ± 1.0, and 6.5 ± 1.5 cm, respectively (P < .01). Pelvic Organ Prolapse-Quantification points B anterior, B posterior, and genital hiatus had moderate-to-strong associations with overall apical support loss and all definitions of apical support loss. Linear regression models that predict overall apical support loss and logistic regression models predict apical support loss as defined by International Continence Society, eCARE, and the point C; cut-point definitions were fit with points B anterior, B posterior, and genital hiatus; these 3 points explained more than one-half of the model variance. Receiver operator characteristic analysis for all definitions of apical support loss found that genital hiatus >3.75 cm was highly predictive of apical support loss (area under the curve, >0.8 in all models). CONCLUSIONS: Increasing genital hiatus size is associated highly with and predictive of apical vaginal support loss. Specifically, the Pelvic Organ Prolapse-Quantification measurement genital hiatus of ≥3.75 cm is highly predictive of apical support loss by all study definitions. This simple measurement can be used to screen for apical support loss and the need for further evaluation of apical vaginal support before planning a hysterectomy or prolapse surgery.

Body image in the Pelvic Organ Prolapse Questionnaire: development and validation.

OBJECTIVE: The purpose of this study was to develop and validate a prolapse-specific body image questionnaire. STUDY DESIGN: Prolapse-specific body image themes that were identified in our previous work served as a framework for the development of a question pool. After review for face and content validity and reading level, the question pool was reduced to 21 items that represent predominant themes and that form the initial Body Image in Pelvic Organ Prolapse (BIPOP) questionnaire. Women with symptomatic prolapse of Pelvic Organ Prolapse Quantification (POPQ) of more than stage II were enrolled from 2 academic urogynecology practices; they completed questionnaires on pelvic floor symptoms and distress, general body image, depression, self-esteem, and the BIPOP questionnaire, and they underwent the POPQ. We field-tested the BIPOP questionnaire with approximately 200 participants; 10 women completed cognitive interviews, and 100 women repeated the BIPOP questionnaire to assess test-retest reliability. RESULTS: Two hundred eleven participants were enrolled, and 201 women had complete data. Participants had mean age of 60.2 ± 10.5 years, were predominantly white (98%), were partnered (80%), and had median POPQ stage III. Cognitive interviews confirmed comprehension and clarity of questions and acceptability of length and subject matter. Exploratory factor analysis was performed in an iterative process until a parsimonious, 10-item scale with 2 subscales was identified (subscale 1 represented general attractiveness; subscale 2 represented partner-related prolapse reactions). Cronbach's α score for the subscales were 0.90 (partner) and 0.92 (attractiveness). Correlations between related questionnaires and BIPOP subscales were strong and directionally appropriate. Test-retest correlations on both total and subscale measurements were high. CONCLUSION: We developed and validated a prolapse-specific body image measurement that has face and content validity, high internal consistency, strong correlation with general prolapse and body image measures, and strong test-retest reliability.

Most older women recover baseline functional status following pelvic organ prolapse surgery.

INTRODUCTION AND HYPOTHESIS: To evaluate postoperative functional status changes in older women undergoing pelvic organ prolapse (POP) surgery and determine predictors for nonrecovery of baseline status. METHODS: We enrolled women ≥ 65 years in whom POP surgery was planned and measured functional status using the Katz Activities of Daily Living (ADL) and Lawton Instrumental Activities of Daily Living (IADL) scales at baseline, 1 week, 2 weeks, and 3 months postoperatively. We used logistic regression modeling to identify predictors of postoperative nonrecovery of functional status (score < baseline) and calculated score change over time. RESULTS: Sixty-six women were enrolled and 3-month data were complete for 53. Subjects had a mean age of 72 ± 5 years, were all Caucasian, and had predominantly undergone vaginal surgery (70 %). At baseline 31% were ADL-dependent and 12% were IADL-dependent. Both ADL and IADL scores changed significantly over time (p <0.001). At 3 months postoperatively, 19% of women failed to return to baseline ADLs and 25% failed to return to baseline IADLs. At all time points ADL dependence was almost entirely attributable to lack of continence, while IADL dependence was commonly due to the inability to independently perform activities outside the home. Age, number of comorbidities, depression, and baseline functional status were not significant predictors of IADL nonrecovery. In a model controlling for baseline IADL status, age, and BMI, higher baseline Colorectal-Anal Distress Inventory (CRADI) score significantly predicted IADL nonrecovery (AOR 1.13, 95% CI 1.00,1.27, p = 0.04). CONCLUSIONS: Most older women with baseline functional status independence undergoing POP surgery can expect to regain independence by 3 months postoperatively.

Retropubic versus transobturator midurethral slings for stress incontinence.

BACKGROUND: Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. METHODS: We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points. RESULTS: A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life. CONCLUSIONS: The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.)

Long-term efficacy and safety of questionnaire-based initiation of urgency urinary incontinence treatment.

OBJECTIVE: The objective of the study was to determine the longer-term efficacy and safety of initiating treatment for urgency-predominant urinary incontinence (UUI) in women diagnosed using a simple questionnaire rather than an extensive evaluation. STUDY DESIGN: Women completing a 12 week randomized controlled trial of fesoterodine therapy for UUI diagnosed by questionnaire were invited to participate in a 9 month, open-label continuation study. UUI and voiding episodes were collected using voiding diaries. Participant satisfaction was measured by questionnaire. Safety was assessed by the measurement of postvoid residual volume and adverse event monitoring; if necessary, women underwent a specialist evaluation. The longitudinal changes in UUI and voiding episodes were evaluated using linear mixed models adjusting for baseline. RESULTS: Of the 567 women completing the randomized trial, 498 (87.8%) took at least 1 dose of medication during this open-label study. Compared with the baseline visit in the randomized trial, fesoterodine was associated with a reduction in total incontinence episodes per day and urgency incontinence episodes per day at the end of the open-label study (adjusted mean [SE], 4.6 [0.12] to 1.2 [0.13] and 3.9 [0.11] to 0.9 [0.11], respectively, P < .0001 for both). Most women were satisfied with treatment (89%, 92%, and 93% at 3, 6, and 9 months, respectively). Twenty-six women experienced 28 serious adverse events, 1 of which was considered possibly treatment related. Twenty-two women had a specialist evaluation: 5 women's incontinence was misclassified by the 3 Incontinence Questions; none experienced harm because of misclassification. CONCLUSION: Using a simple validated questionnaire to diagnose and initiate treatment for UUI in community-dwelling women is safe and effective, allowing timely treatment by primary care practitioners.

Effect of a preoperative self-catheterization video on anxiety: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The purpose of this study was to determine if a clean intermittent self-catheterization (CISC) instructional video could improve anxiety in women undergoing prolapse and/or incontinence surgery. METHODS: A total of 199 women were randomized to preoperative CISC video or routine counseling prior to prolapse/incontinence surgery. Patient anxiety, satisfaction, and concerns about CISC were evaluated using the State-Trait Anxiety Inventory-State (STAI-S) and study-specific visual analog scale (VAS) questions at four perioperative time points. RESULTS: STAI-S and VAS anxiety measures were similar at baseline between groups; no significant differences were seen by group at any time point. STAI-S scores varied considerably over time, with highest scores at voiding trial failure and lowest scores at postoperative visit. Women in the video group had improved STAI-S scores and reported less worry and more comfort with CISC immediately following video viewing. Women with anxiety/depression had higher STAI-S scores at voiding trial failure and discharge and reported less anxiety reduction following video viewing compared to non-anxious/non-depressed peers. CONCLUSIONS: Women undergoing prolapse/incontinence surgery have significant perioperative anxiety, which is exacerbated by voiding trial failure. Preoperative CISC video viewing decreases anxiety scores immediately following viewing, but this effect is not sustained at voiding trial failure. Women with baseline anxiety/depression exhibit less anxiety score improvement after video viewing and have overall higher anxiety scores perioperatively.

d-Mannose for Recurrent Urinary Tract Infection Prevention in Postmenopausal Women Using Vaginal Estrogen: A Randomized Controlled Trial.

IMPORTANCE: Further research is needed to determine whether d-mannose plus vaginal estrogen therapy (VET) is beneficial over VET alone for recurrent urinary tract infection (rUTI) prevention. OBJECTIVE: The aim of this study was to evaluate d-mannose efficacy for rUTI prevention in postmenopausal women using VET. STUDY DESIGN: We conducted a randomized controlled trial comparing d-mannose (2 g/d) with control. Participants were required to have a history of uncomplicated rUTIs and to remain on VET throughout the trial. They were followed up 90 days for incident UTIs. Cumulative UTI incidences were calculated by the Kaplan-Meier method and compared by Cox proportional hazards regression. For the planned interim analysis, P < 0.001 was considered statistically significant. Futility analysis was performed by generating post hoc conditional power for multiple scenarios. RESULTS: We evaluated 545 patients for frequent/recurrent UTIs from March 1, 2018, to January 18, 2020. Of these women, 213 had culture-proven rUTIs, 71 were eligible, 57 enrolled, 44 began their planned 90-day study period, and 32 completed the study. At interim analysis, the overall cumulative UTI incidence was 46.6%; 41.1% in the treatment arm (median time to first UTI, 24 days) and 50.4% in the control arm (median, 21 days); hazard ratio, 0.76; 99.9% confidence interval, 0.15-3.97. d-Mannose was well tolerated with high participant adherence. Futility analysis suggested the study lacked power to detect the planned (25%) or observed (9%) difference as statistically significant; the study was halted before conclusion. CONCLUSIONS: d-Mannose is a well-tolerated nutraceutical, but further research is needed to determine whether d-mannose in combination with VET has a significant, beneficial effect beyond VET alone in postmenopausal women with rUTIs.

Telemedicine: The New "Virtual Reality" of Female Pelvic Medicine and Reconstructive Surgery?

IMPORTANCE: Understanding women's acceptance of telemedicine as a model of care for pelvic floor disorders (PFDs) allows for a more patient-centered approach to widespread implementation in female pelvic medicine and reconstructive surgery. OBJECTIVES: The pandemic sparked rapid and widespread implementation of telemedicine. Our goal was to assess acceptance, satisfaction, and desire for future use of telemedicine among women seeking care for PFDs. STUDY DESIGN: We performed a structured telephone survey of new patients who underwent video visits, and established patients who underwent video or telephone visits, when nonurgent, in-person visits were suspended. Our survey assessed the following domains: satisfaction, future use of telemedicine, level of comfort, perceived utility, and access and comfort with technology. RESULTS: Between April and July 2020, we conducted telemedicine visits with 221 patients, 131 (63% of eligible patients) of whom agreed to participate in our survey (63 (74%) telephone and 68 (56%) video, including 35 established and 33 new patients). Overall, most participants (96.3%) described being "very" or "somewhat satisfied" with telemedicine in addressing their needs and "comfortable" sharing personal information with providers in a telemedicine visit (94.7%). However, video participants (both new and established) were more likely to view telemedicine as valuable (P = 0.02) than telephone participants. Furthermore, established video participants perceived greater quality care of care (P = 0.01) than telephone participants. CONCLUSIONS: Video telemedicine is a well-accepted adjunct model of care with the potential to expand the reach of quality subspecialty care of value to women with PFDs.

Feasibility and Research Insights From a Randomized Controlled Trial for Recurrent Urinary Tract Infection Prevention in Postmenopausal Women Using Vaginal Estrogen Therapy.

OBJECTIVE: The aim of the study was to inform feasibility parameters (eligibility, enrollment, and retention) for a recurrent urinary tract infection (rUTI) prevention randomized controlled trial (RCT). METHODS: We assessed feasibility parameters of an RCT of postmenopausal women with uncomplicated rUTIs using vaginal estrogen. Participants were randomized to either d-mannose or a control arm. All participants were required to be using vaginal estrogen and to have a negative urine culture before 90-day trial participation. An RCT exit survey and separate survey for UTI patients (N = 196) were added to inform feasibility parameters and patient preferences for rUTI prevention and study participation after slower enrollment than anticipated. RESULTS: At the time of interim and subsequent futility analyses, 545 patients had been evaluated for frequent/recurrent UTIs from March 1, 2018, to January 18, 2020. Of these, 213 (39.1%) had culture-proven rUTIs and 71 (33.3% of those with culture-proven rUTIs) were eligible for the RCT. Reasons for ineligibility included complicated UTIs, premenopausal/perimenopausal status, or existing UTI prevention regimen. Of the 71 eligible participants, 57 (80.3%) enrolled, and 44 began their planned 90-day study period (77.2%; 80.0% after excluding 2 participants awaiting negative urine cultures at the time of analysis). The study was halted before conclusion. Study retention (76.0%-83.7%) was slightly lower than expected. Urinary tract infection survey patients demonstrated significant interest in rUTI research participation. CONCLUSIONS: We learned several important lessons that can benefit future research. Many patients with frequent/recurrent UTIs are interested in research, but rigorous eligibility criteria and referral urine culture documentation made recruitment challenging.

Pelvic Floor Mobility measured by Transperineal Ultrasound Imaging in Women with and without Urgency and Frequency Predominant Lower Urinary Tract Symptoms.

Background: Women with urgency/frequency predominant lower urinary tract symptoms (UF-LUTS) may have elevated pelvic floor muscle (PFM) position at rest and limited mobility with PFM contraction and bearing down, but this has not been quantified. Objectives: To compare PFM position and mobility using transperineal ultrasound (TPUS) at rest, maximal PFM contraction (perineal elevation), and bearing down (perineal descent) in women with and without UF-LUTS. We hypothesized that women with UF-LUTS would demonstrate elevated resting position and decreased excursion of pelvic landmarks during contraction and bearing down as compared to women without UF-LUTS. Study Design: Case-control study. Methods: Women with UF-LUTS were matched 1:1 on age, body mass index and vaginal parity to women without UF-LUTS. TPUS videos were obtained during 3 conditions: rest, PFM contraction, and bearing down. Levator plate angle (LPA) and puborectalis length (PR length), were measured for each condition. Paired t-tests or Wilcoxon signed rank tests compared LPA and PR length between cases and controls. Results: 21 case-control pairs (42 women): Women with UF-LUTS demonstrated greater LPA at rest (66.8 ± 13.2 degrees vs 54.9 ± 9.8 degrees; P=0.006), and less PR lengthening from rest to bearing down (0.2 ± 3.1 mm vs 2.1 ± 2.9 mm; P=.03). Conclusion: Women with UF-LUTS demonstrated more elevated (cranioventral) position of the PFM at rest and less PR muscle lengthening with bearing down. These findings highlight the importance of a comprehensive PFM examination and possible treatment for women with UF-LUTS to include PFM position and mobility.

Body image perceptions in women with pelvic organ prolapse: a qualitative study.

OBJECTIVE: To describe perceptions of prolapse-specific body image in women with symptomatic prolapse. STUDY DESIGN: Women with symptomatic pelvic organ prolapse quantification stage ≥ II prolapse participated in semistructured focus groups or self-report questionnaire. Transcripts were independently reviewed and body image themes were identified and confirmed by consensus. RESULTS: Twenty-five women participated in focus groups and 27 in online questionnaires. Transcript analysis revealed 3 central themes and 25 body-image related subthemes. Women living with prolapse were more likely to feel self-conscious, isolated, "different," less feminine, and less attractive. Women often changed sexual intimacy practices because of embarrassment or discomfort, and many avoided intimacy all together. Prolapse greatly affected women's personal and professional activities causing some women to adjust routines or stop activities. Women reported loss of interest in activities, distraction while performing daily/work-related tasks, and embarrassment when asking for help with activities. CONCLUSION: Themes identified in this qualitative study demonstrate the profound effect of prolapse on a woman's body image.

Hip and Pelvic Floor Muscle Strength in Women with and without Urgency and Frequency Predominant Lower Urinary Tract Symptoms.

BACKGROUND: Urgency and frequency are common lower urinary tract symptoms (UF-LUTS) in women. There is limited evidence to guide physical therapist-led treatment. OBJECTIVES: To compare hip and pelvic floor muscle strength between women with and without UF-LUTS. We hypothesized women with UF-LUTS would demonstrate 1) diminished hip external rotator and abductor strength and 2) equivalent pelvic floor strength and diminished endurance compared to controls. STUDY DESIGN: A matched case-control study. METHODS: Women with UF-LUTS (cases) and controls were matched on age, body mass index (BMI), vaginal parity. Examiner measured participants' 1) hip external rotator and abductor strength via dynamometry (maximum voluntary effort against fixed resistance) and 2) pelvic floor muscle strength (peak squeeze pressure) and endurance (squeeze pressure over a 10 second hold) via vaginal manometry. Values compared between cases and controls with paired-sample t-tests (hip) or Wilcoxon signed rank tests (pelvic floor). RESULTS: 21 pairs (42 women): Hip external rotation (67.0 ± 19.0 N vs 83.6 ± 21.5 N; P=0.005) and hip abduction strength (163.1 ± 48.1 N vs 190.1 ± 53.1 N; P=0.04) were significantly lower in cases than controls. There was no significant difference in pelvic floor strength (36.8 ± 19.9 cmH20 vs 41.8 ± 21.0 cmH20; P=0.40) or endurance (234.0 ± 149.6 cmH20*seconds vs 273.4 ± 149.1 cmH20*seconds; P=0.24). CONCLUSION: Women with UF-LUTS had weaker hip external rotator and abductor muscles, but similar pelvic floor strength and endurance compared to controls. Hip strength may be important to assess in patients with UF-LUTS, further research is needed.

Prophylactic bilateral oophorectomy or removal of remaining ovary at the time of hysterectomy in the United States, 1979-2004.

OBJECTIVE: The purpose of this study was to describe national rates and trends of prophylactic bilateral oophorectomy or remaining oophorectomy (BO/RO) at hysterectomy in women without specific gynecologic disease. STUDY DESIGN: Data from the National Hospital Discharge Survey were analyzed for 1979-2004. Hysterectomies were divided into 2 groups: (1) hysterectomy with BO/RO and (2) hysterectomy alone (> or =1 ovary remaining). Age-adjusted rates (AARs) were calculated with 2000 US census data. RESULTS: Approximately 3,686,000 hysterectomies with BO/RO were performed from 1979-2004. AARs of hysterectomy with BO/RO decreased during this period; the AARs in women > or =50 years old increased. The number of hysterectomies alone was 5,461,100, and AARs of hysterectomy alone decreased significantly from 2.9 per 1000 women in from 1979-1981 to 1.1 per 1000 women in 2001 (P < .001). The proportion of women who underwent hysterectomy with BO/RO increased from 29% in 1979 to 45% in 2004. CONCLUSION: Although AARs of prophylactic BO/RO decreased from 1979-2004, the actual proportion of BO/RO at hysterectomy increased.

Body image in women before and after reconstructive surgery for pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: This study seeks to determine the impact of prolapse surgery on body image in women with pelvic organ prolapse. METHODS: Case-control study of 76 sexually active women with greater than or equal to stage II prolapse planning reconstructive surgery and 67 women with lesser than or equal to stage I prolapse. Questionnaires/examinations were completed at baseline and 6 months postoperatively for cases and at baseline for controls: Body Exposure During Sexual Activity Questionnaire (BESAQ), Body Image Quality of Life Inventory (BIQLI), Pelvic Floor Distress Inventory (PFDI)/Pelvic Floor Impact Questionnaire (PFIQ), and Pelvic Organ Prolapse-Incontinence Sexual Function Questionnaire-12 (PISQ-12), and the Pelvic Organ Prolapse Quantification (POPQ) examination. RESULTS: Baseline and 6-month data were available for 64 case women with mean age of 60 +/- 8 years, mean body mass index of 28 +/- 5 kg/m(2), 96% Caucasian, and 83% postmenopausal. Baseline POPQ stage distribution was: stage II 14%, stage III 78%, and stage IV 8%. BESAQ, BIQLI, PFDI/PFIQ, and PISQ-12 postoperative scores significantly improved compared to preoperatively (all p