Transperineal ultrasound to estimate the appropriate ring pessary size for women with pelvic organ prolapse

Introduction and hypothesis The objective was to predict the successful ring pessary size based on the levator hiatal area (HA). Methods This is a prospective case–control study. Women with symptomatic pelvic organ prolapse (POP) choosing pessary treatment were included. All women underwent an interview, clinical examination, and 3D/4D transperineal ultrasound (TPUS). The ring pessary size used in each trial and the reason for unsuccessful trials were recorded. In addition, levator hiatal area divided by ring pessary size (HARP ratio) was measured at rest, maximum contraction, and maximum Valsalva. The HARP ratios of successful and unsuccessful trials were compared, receiver operating characteristic curves in the prediction of successful trials were constructed, and the cut-off optimizing sensitivity and specificity was identified. Results A total of 162 women were assessed and 106 were included with 77 successful trials, 49 unsuccessful trials owing to dislodgment or failure to relieve POP symptoms, and 20 unsuccessful trials owing to pain/discomfort. Rest HARP ratio and Valsalva HARP ratio were significantly smaller in the successful trials versus dislodgment/failure to relieve POP symptoms trials (mean rest HARP ratio [SD]: 2.93 [0.59] vs 3.24 [0.67], p = 0.021; median Valsalva HARP ratio (IQR): 4.65 (1.56) vs 5.32 (2.08), p = 0.004). No significant difference was observed between pain/discomfort trials and successful trials. The best cut-off for the prediction of successful trials was Valsalva HARP ratio ≤ 5.00. Conclusions Unsuccessful fitting trials due to dislodgment/failure to relieve POP symptoms are associated with a small ring pessary with respect to the levator HA. A ring pessary that produces a Valsalva HARP ratio > 5.00 has a higher risk of dislodgment/failure to relieve POP symptoms.

Ongoing Research for Managing Stress Urinary Incontinence in Women with a FDA Approved Device, The FemCap™

Background: The previous successful pilot study led the inventor to expand into Sweden and increase the number of participants. We also expanded the research comparing the FemCap to other Pessaries on the market. Pessary treatment is conservative with significant limitations. These limitations include displacement, erosion, ulceration, and urethral obstruction. Stress urinary incontinence (SUI) is prevalent particularly among menopausal women. The first line of SUI treatment is the ring pessary however, a variety of different pessaries have been introduced into the market with hope of achieving better results. Objectives: To provide women with a safer, more effective device to treat SUI. Materials and Methods: The FemCap combines the features of the ring and space- occupying pessaries into one device, which makes it more successful. The Bowl of the Dome of the FemCap covers the cervix and prevents it from prolapsing. The Rim fits snugly into the vaginal fornices that supports the bladder neck. The Brim flares outward pushing against the cystocele and urethrocele anteriorly to restore the anatomy of the urethra and the bladder. We recruited 118 women who had significant SUI and asked them to compare their experience for one week before using the FemCap and one week after. The FemCap was self-inserted and removed by the participants. Results: Only 100 women completed the study 94 were completely dry after one week, while 6 women were not satisfied with the results. No side effects were reported by the participants and pelvic examinations did not show any erosion or ulceration of the vagina. Conclusion: The FemCap is safe and effective in restoring the anatomy of the bladder, and urethra, which could make it ideal for the treatment and prevention of mild to moderate SUI. More studies are warranted to further prove the utility of the FemCap to manage SUI.

Successful Management of Stress Urinary Incontinence in Women by a Contraceptive Device FemCap™ Pilot Study

Background: Women suffer silently from stress urinary incontinence (SUI). SUI is under-reported by women and under-diagnosed and treated by doctors. Treatment with pessaries is conservative and has significant limitations. These limitations include displacement, erosion, ulceration, and urethral obstruction. (SUI) is very prevalent among women of all ages, particularly menopausal women. The first line of SUI treatment is the ring pessary; however, more pessaries of different shapes and sizes have been introduced to achieve better results. Objectives: To provide women with a safer, more effective device to treat SUI. Materials and Methods: The FemCap combines the ring and space-occupying pessary features into one device, making it much more successful. The bowl of the dome of the FemCap covers the cervix and prevents it from prolapsing. The rim fits snugly into the vaginal fornices that support the bladder neck. The brim flares outward, pushing against the cystocele and the urethrocele anteriorly to restore the urethra and the bladder’s anatomy. Forty-one women who had had significant SUI were recruited and asked to compare their experience for one week before using the FemCap and two weeks later. The FemCap was self-inserted and removed by the participants. Results: Thirty-four women out of 41 were completely dry after two weeks of using the FemCap, while four women were partially dry, and three women did not notice any change. The participants reported no side effects, and pelvic examinations did not show any erosion or ulceration of the vagina. Conclusion: The FemCap is safe and effective in restoring the bladder and urethra’s anatomy, which could make it ideal for the treatment and prevention of mild to moderate SUI. More studies are warranted to prove the utility of the FemCap further to manage SUI.

Acceptance of ring pessary in pelvic organ prolapse

Aims: To evaluate the use of pessaries for women with Pelvic Organ Prolapse irrespectivve POP-Q stages. Method: This is retrospective study conducted at Paropakar maternity and Women’s hospital from mid April to mid December 2018 on 114 women with pelvic organ prolapse. Result: Total of 114 women with prolapse evaluated. Age of presentation ranged from 36 to 85 years. Twenty cases (17.6%) underwent prolapsed surgery and 71 cases (62.2%) had ring pessary. Conclusion: Overall acceptance of vaginal ring pessary is very high. It can be used in the majority of women with patient satisfaction and without noteworthy complication.