A pilot study to evaluate changes in pelvic floor muscle tone following pelvic organ prolapse surgery using a novel intra-vaginal pressure sensor device.

INTRODUCTION AND HYPOTHESIS: Pelvic floor muscle weakness is a common cause of pelvic organ prolapse and urinary incontinence. Surgical repair of prolapse is commonly undertaken; however, the impact on pelvic floor muscle tone is unknown. The aim of this study was to compare the effect of anterior and posterior colporrhaphy on pelvic floor activation. METHODS: Patients aged under 70 undergoing primary anterior or posterior colporrhaphy were recruited. Intra-vaginal pressure was measured at rest and during pelvic floor contraction using the Femfit® device (an intra-vaginal pressure sensor device [IVPSD]). Peak pressure and mean pressure over 3 s were measured in millimetres of mercury. The pre- and post-operative measurements were compared. The difference between the means was assessed using Cohen's D test, with significance set at p<0.05 RESULTS: A total of 37 patients completed pre- and post-operative analysis, 25 in the anterior colporrhaphy group and 12 in the posterior colporrhaphy group. Anterior colporrhaphy showed no significant change in pelvic floor tone. Change in peak pressure was -1.71mmHg (-5.75 to 2.33; p=0.16) and change in mean pressure was -0.86 mmHg (-4.38 to 2.66; p=0.31). Posterior colporrhaphy showed a significant increase in peak pelvic floor muscle tone of 7.2 mmHg (0.82 to 13.58; p=0.005) and mean pressure of 4.19 mmHg (-0.09 to 8.47; p=0.016). CONCLUSIONS: Posterior colporrhaphy significantly improves pelvic floor muscle tone, whereas anterior colporrhaphy does not. Improved understanding of the impact of pelvic floor surgery may guide future management options for other pelvic floor disorders. Further work is needed to confirm the association of this improvement in pelvic floor disorders.

Using codesign to develop a mobile application for pelvic floor muscle training with an intravaginal device (femfit®).

AIMS: The aim of this project was to use codesign to develop a mobile application (app) for pelvic floor muscle training, with an intravaginal device (femfit®). The objective was to obtain user feedback to guide the design and development of a mobile app, consistent with the Mobile Application Rating Scale (MARS) framework. METHODS: Twenty-six women (22-62 years) provided mobile app feedback using a Design Thinking framework and grounded theory approach. Four focus groups (2 h each) and two sets of one-to-one interviews (1 h each) were held from May 2018 to October 2019. The researchers debriefed the focus groups and interviews, and undertook analysis based on project objectives and key questions. RESULTS: Recurring themes throughout the study aligned with sections of the MARS: (A) engagement (e.g., progress tracking), (B) functionality (e.g., intuitive interface), (C) aesthetics (e.g., smart graphics and colors), (D) information (e.g., clear, concise information). An internal preliminary assessment determined a MARS Quality Mean Score of 4.1 of 5 (engagement: 3.6 of 5; functionality: 4 of 5; aesthetics: 4.3 of 5: information: 4.4 of 5). CONCLUSIONS: The development of the mobile app is on track to meet MARS requirements, and to be a fun, motivating app for women. Future work is required to investigate its efficacy.

Assessing vaginal pressure profiles before and after prolapse surgery using an intravaginal pressure sensor (femfit®).

INTRODUCTION AND HYPOTHESIS: The impact of surgery on pelvic floor muscle (PFM) function remains uncertain. There is a pressure differential along the length of the vagina, influenced by surrounding active and passive tissue structures, giving rise to a pressure profile. The aim of this study is to determine if an intravaginal pressure sensor, femfit®, can measure differences in pressure profiles before and after surgery for pelvic organ prolapse (POP). METHODS: This pilot study includes 22 women undergoing POP surgery. Intravaginal pressure profiles were measured with femfit® pre- and post-surgery and differences tested using paired Student's t-tests. Patients completed validated questionnaires for vaginal, bowel, and urinary incontinence symptoms pre- and post-POP surgery and a femfit® usability questionnaire. RESULTS: Sixteen sets of vaginal pressure data were analysed. The highest pressure generated was identified as the peak PFM pressure, whilst all sensor measurements provided a pressure profile. Intra-abdominal pressure (IAP) was measured by the most distal sensor, 8. On average, the difference between peak PFM pressure and IAP was significantly greater post-surgery (p < 0.01). Urinary and vaginal symptom questionnaire scores were significantly improved after POP surgery. Femfit® usability questionnaires demonstrated high levels of patient acceptability. CONCLUSIONS: Women generate higher peak PFM pressures compared to IAP post-POP surgery, with pressure profiles that are comparable to women without POP. This metric might be useful to assess the outcome of POP surgery and encourage women to maintain this profile via PFM training, potentially reducing POP recurrence risk.