Vaginal microflora following the use of a disposable home-use vaginal device and a commercially available ring pessary for pelvic organ prolapse management: a randomized controlled trial.

PURPOSE: To investigate whether ProVate, a novel, disposable, self-inserted vaginal device for pelvic organ prolapse management, clinically affects the vaginal microflora, as compared with a commercially available ring pessary, to assess its microbiological safety. METHODS: This interventional, prospective, multi-center, open-label, randomized, controlled, statistically powered (noninferiority), home-use, crossover study was conducted at seven sites. Participants were randomized into either group A (using ProVate and then a new reusable commercially available ring pessary [control]) or B (using control device and then ProVate) with a 1:1 ratio. Noninferiority of ProVate over the control was evaluated for the primary endpoint, which was based on meeting one of the failure criteria: significant change in Lactobacillus spp., Gardnerella vaginalis, Candida morphotypes, or Staphylococcus aureus levels compared to the baseline (significant change: Nugent score ≥ 7 or > 1 scale unit increase in S. aureus or Candida morphotype), bothersome vaginal infection symptoms, or symptoms requiring treatment for infection. RESULTS: The study included 58 participants (mean age: 64.5 years, 91.4% postmenopausal). There were no significant microfloral changes in terms of the four microorganisms mentioned above, the rate of Nugent score ≥ 7 after use was low and comparable between the two devices, and the rate of patients with a > 1 unit-scale change (increase or decrease) from the baseline to the end-of-use phase in any studied microorganism was comparable between the devices. The failure rate was 15.5% for ProVate and 15.5% for control while using 383 ProVate devices over 1647 days or one control device throughout the study. Two patients had bothersome vaginal complaints and one had overt vaginal infection in the control group, but no such cases were observed in the ProVate group. CONCLUSION: The primary endpoint of possible vaginal microbial changes, bothersome vaginal symptoms, or treatment-requiring vaginal complaints while using ProVate was successfully met. Our findings show that the vaginal microflora is comparable when using either ProVate or commercially available ring pessary (control) with a relatively low rate of vaginal infections. Trial registration details: ClinicalTrials.gov; URL: https://www. CLINICALTRIALS: gov/ct2/show/NCT03345121?term=NCT03345121&draw=2&rank=1 ; No. NCT03345121; Registration date, November 17, 2017; initial enrollment started on August 20, 2017.

A randomized controlled study comparing the objective efficacy and safety of a novel self-inserted disposable vaginal prolapse device and existing ring pessaries.

Introduction: ProVate is a novel, disposable, collapsible self-inserted vaginal device for the nonsurgical management of pelvic organ prolapse (POP). We assessed possible vaginal microflora changes and POP reduction using ProVate and a commercially available ring pessary (control). Methods: We performed post-hoc analysis of data obtained from an interventional, prospective, multicenter, open-label, randomized, controlled, statistically powered (noninferiority), home-use, cross-over study conducted at seven sites. Safety and performance data collected for both devices were analyzed to compare objective POP reduction (employing the Pelvic Organ Prolapse Quantification System [POP-Q]), safety (assessed by the incidence of adverse events [AEs]), and the rates of certain AEs. Results: Eighty-five women with symptomatic POP were screened; 71 were randomized, and 58 completed the study per protocol. Forty-nine (90.7%) ProVate users experienced complete prolapse reduction (stage 0), 3 (5.6%) experienced reductions to POP-Q stage 1, and 2 (3.7%%) experienced reductions to stage 2. Collectively, 52/54 (96.3%) ProVate users experienced prolapse reduction to stage 0 or 1. In all, 47/57 (82.5%) control users experienced complete prolapse reduction, while 5 (8.8%), 4 (7.0%), and 1 (1.8%) experienced reductions to stage 1, 2, and stage 3, respectively. Collectively, 52/57 (91.2%) control users experienced reductions to either stage 0 or 1. In 53/54 (98.1%) ProVate and 55/57 (96.5%) control users, there was at least 1 POP-Q stage prolapse reduction, and in 32 (91.4%) ProVate and 31 (83.8%) control users who had stage ≥3 prolapse, there were at least three POP-Q stage reductions. In total, 26/71 (36.6%) ProVate and 22/64 (34.4%) control users in the safety population experienced AEs. The incidence of device-related AEs was 17/71 (23.9%) for ProVate and 13/64 (20.3%) for the control. Most AEs were minor, mild, and anticipated. Conclusion: Our analysis demonstrated that ProVate and the control are highly effective in reducing POP, and both are associated with comparably low numbers of AEs. However, ProVate has the advantage of being more user-friendly, suitable for home use, and expected to allow women with POP to practice better and easier self-care.

Novel, disposable, self-inserted, vaginal device for the non-surgical management of pelvic organ prolapse: efficacy, safety, and quality of life.

BACKGROUND: We evaluated a novel disposable, collapsible, ring-shaped vaginal device that is self-inserted within an applicator and removed with a string. The device was developed to overcome the drawbacks of existing ring pessaries for non-surgical pelvic organ prolapse management (POP). METHODS: The primary objective efficacy endpoint of this prospective, interventional, multicenter, self-controlled, and home-use study was the proportion of subjects with improved staging on the Pelvic Organ Prolapse Quantification (POP-Q) scale. Subjective efficacy was assessed using the POP symptoms alleviation score. Safety was evaluated by recording the rate and incidence of adverse events (AEs) in a daily diary, and quality of life (QoL) was evaluated using the modified Pelvic Floor Impact (PFIQ-7) and Pelvic Floor Disability Index (PFDI-20) questionnaires. RESULTS: A total of 94 usage cycles were observed in a group of 52 participants (mean age 60.2 ± 10.5 years, 81.1% postmenopausal) who used the device for 3558 days. Of these, 24 participants completed one usage cycle, 14 completed two usage cycles, and 14 completed three usage cycles with 28-45 days of ProVate use in each usage cycle. All patients experienced greater than two POP-Q stage reductions. The descent was completely reduced to POP-Q stage 0 in 97.8% of participants. The POP symptom alleviation questionnaire showed significant subjective efficacy (P < 0.0001). The modified PFDI-20 and PFIQ-7 scores also improved substantially (P < 0.0001 for both). There were 91 nonserious device-related AEs: 98.9% were mild and 87.9% anticipated, with no vaginal infection, and one case of urinary tract infection. CONCLUSION: The novel device substantially reduces prolapse and provides significant subjective POP symptom relief and QoL improvement, with minimal AEs. The device may enable women to self-manage their prolapse with a small, disposable device that minimizes self-touching and frequent dependency on the clinic. TRIAL REGISTRATION: Clinical. TRIALS: gov , NCT02239133 , posted September 12, 2014 (retrospectively registered).

Significant improvement in the quality of life in women treated with a novel disposable intravaginal device for stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: The aim of the study was to assess the quality of life (QoL) in women with stress urinary incontinence (SUI) while using a novel disposable intravaginal device. METHODS: Fifty women with severe SUI who completed a 7-day control period followed by a 28-day device usage period underwent QoL assessments based on two validated questionnaires, the Incontinence Impact Questionnaire (IIQ-7) and the Urogenital Distress Inventory (UDI-6). RESULTS: Mean total score for the IIQ-7 decreased from 41.8 +/- 24.1 to 4.4 +/- 8.7 at the pre- and poststudy visits, respectively (P < 0.001). The mean total score for the UDI-6 decreased from 48.2 +/- 16.1 to 11.5 +/- 11.9 at the pre- and poststudy visits, respectively (P < 0.001). Statistically significant decreases in most subscale scores were observed by the end of the study for both questionnaires (all P values <0.001). CONCLUSION: The novel disposable intravaginal device significantly improved QoL in women with SUI.

Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence.

OBJECTIVE: The purpose of this study was to evaluate the efficacy and safety of a novel disposable intravaginal device for treatment of stress urinary incontinence (SUI) in women. STUDY DESIGN: Sixty women with severe SUI were recruited from 2 sites in Israel to wear preweighed pads during a 7-day control period followed by a 28-day device usage period in which the device and preweighed pads were worn daily for 8 hours. The primary endpoint was the percentage of women who achieved a > or = 70% reduction in pad weight gain (PWG) from the control period to the last 14 days of device usage. RESULTS: Sixty women who enrolled into the study and used the device for any period of time were included in the intent to treat (ITT) population. Eighty-five percent of them achieved a > or = 70% reduction in PWG (P = .01). Improvements in overall quality of life, subjective perception of incontinence, and satisfaction with the device were observed. CONCLUSION: The intravaginal device is easy to use, well-tolerated, and effective in reducing SUI.