Pelvic organ prolapse Pelvic floor dysfunction Pelvic floor Pelvic organ prolapse Pelvic floor muscle training Electromagnetic stimulation Transperineal ultrasound Quality of life
Conditions
Interventions
Participants assigned to this arm will receive high intensity focused electromagnetic therapy applied to the pelvic floor combined with standardized pelvic floor muscle training according to the study
Experimental Device,Sham Comparator Device
High intensity focused electromagnetic therapy plus pelvic floor muscle training,Sham electromagnetic therapy plus pelvic floor muscle training
Sponsors
Faculty of Medicine Ramathibodi Hospital, Mahidol University
BTL Medical Technologies (in-kind HIFEM device support),GE Medical Systems (Thailand) Ltd. (in-kind ultrasound equipment support)
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1.Women 18 years old with symptomatic anterior compartment POP Q Stage I and II POP Q Stage I and II as defined by the Pelvic Organ Prolapse Quantification system, diagnosed by clinical examination and symptoms defined by Thai ICIQ VS Question no. 6 presence of vaginal bulge 2.Able and willing to provide written informed consent. 3.Recruited from the Female Pelvic Medicine and Reconstructive Surgery outpatient clinic, Department of Obstetrics and Gynaecology, Ramathibodi Hospital.
Exclusion criteria
Exclusion criteria: 1.POP-Q Stage III or greater (as defined by the POP-Q system) 2.Prior POP surgery <1 year 3.Current pessary use with inability or unwillingness to discontinue use for the entire study period (from baseline through the 12-week follow-up) 4.Contraindications to HIFEM (pacemaker, metallic implants, pregnancy, infection, epilepsy) 5.Inability to perform pelvic floor muscle training (PFMT) as instructed 6.Malignancy 7.Inability to undergo TPUS/perineometry 8.Postpartum women (<6 months after delivery) 9.Previous treatment with high-intensity focused electromagnetic (HIFEM) therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Pelvic Floor Disability Index twenty total score Baseline and twelve weeks post intervention Pelvic Floor Distress Inventory twenty total score Thai validated questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in pelvic floor ultrasound parameters Baseline and twelve weeks post intervention Transperineal ultrasound assessment of anteroposterior diameter laterolateral diameter bladder neck descent and anterior compartment descent,Change in pelvic floor muscle strength Baseline and twelve weeks post intervention Perineometry assessment of pelvic floor muscle contraction strength,Change in quality of life scores Baseline and twelve weeks post intervention International Consultation on Incontinence Questionnaire Vaginal Symptoms and Prolapse Quality of Life questionnaires Thai validated versions | — |
Countries
Thailand
Contacts
Public ContactPhatcha Tontapanit
Ramathibodi Hospital Mahidol University
Outcome results
None listed