Urological and Genital Diseases
Conditions
Interventions
Supervised use of the Leva Pelvic Health System
Sponsors
Axena Health Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women who present to the urogynecology clinic at University of Abuja Teaching Hospital (UATH) or Lagos State University Teaching Hospital (LASUTH) with complaints of PFD symptoms, including: • Urinary incontinence (UI) – the complaint of the involuntary loss of urine with physical exertion (stress UI) and/or with the strong and sudden urge to urinate (urgency UI) • Fecal incontinence (FI) – the complaint of the involuntary loss of solid or liquid stool • Pelvic organ prolapse (POP; not greater than Stage III) – the complaint of pressure or heaviness in the abdomen or pelvis with confirmed prolapse on physical examination (POP-Q) Women will be evaluated by a urogynecologist to confirm the presence of PFD symptoms that are amenable to treatment with pelvic floor muscle training exercises. Additional inclusion criteria are: • Females, 18 years or older • Ambulatory • Have a phone for personal use (may be a shared phone) • Cognitively intact and able to follow verbal instructions • Working knowledge of spoken and written English (due to smartphone application availability in only English at this time)
Exclusion criteria
Exclusion criteria: • Active genital infection • Inability to tolerate insertion of vaginal device (e.g., vaginal agenesis, vaginal stenosis, unremitting pelvic pain, within 12 weeks postpartum) • Current diagnosis of genitourinary, colorectal or anal malignancy • Current vesicovaginal or rectovaginal fistula or cloacal defect • Diagnosis of uncontrolled inflammatory bowel disease • Rectal prolapse (mucosal or full thickness) • Inability to utilize smart phone technology (“app” use) • Chronic Bristol stool types 6 and 7 (chronic diarrhea) • Fecal impaction by exam • Stage 4 pelvic organ prolapse • Pelvic floor surgery within the past 3 months • Currently pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary feasibility endpoints Feasibility will be assessed in the following ways: •Attendance at clinic visits •Adherence to home PFMT program: Digital home program usage (e.g., app metrics) •Patient acceptability of intervention oQualitative data via subjective feedback at each clinic visit and comments submitted via home digital health app, including: ?Facilitators/barriers to clinic visits ?Likes/dislikes regarding (1) in-clinic treatment and (2) digital home program/app usage •Healthcare provider perception of acceptability and implementation oQualitative data via healthcare provider semi-structured interviews ?Factors affecting ease or difficulty of implementation ?Rating/feedback on success and outcomes of the intervention for patients ?Perception of demand by health facility decision-makers ?Factors influencing capital equipment purchases and development/expansion of new service lines | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints • Global rating of patient satisfaction and improvement: This is a standardized 3-question survey that has been validated in women with PFDs and assesses (1) patient satisfaction; (2) global perception of improvement; (3) patient estimated percent improvement • PFD symptom improvement o Change in survey scores from baseline to 12-weeks: ? Australian Pelvic Floor Questionnaire ? International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form (ICIQ-UI SF) • Pelvic floor muscle assessment o Change in PFM strength from baseline to 12-weeks ? Manual muscle test: Modified Oxford scale ? Perineometry: MizCure (Owomed, Korea) o Change in Pelvic Organ Prolapse assessment from baseline to 12-weeks ? Pelvic Organ Prolapse Quantification (POP-Q) | — |
Countries
Nigeria
Contacts
Public ContactJessica McKinney
Vice President of Clinical Affairs and Global Health
Outcome results
None listed