Biofeedback-Assisted Pelvic Floor Muscle Training, Effectiveness, Hysterectomy, Quality of Life, Sexual Function
Conditions
Brief summary
The purpose of this study is to determine the effectiveness of biofeedback-assisted pelvic floor muscle training in improving pelvic floor muscle strength, decreasing urinary incontinence symptoms, reducing genital prolaps and enhancing the quality of life in women after hysterectomy.
Detailed description
Hysterectomy, the surgical removal of the uterus, remains one of the most frequently performed gynecological procedures worldwide, indicated for both malignant and benign conditions. Pelvic floor dysfunction (PFD) is a common complication after hysterectomy, manifesting as urinary incontinence, pelvic organ prolapse, and colorectal symptoms. Conventional pelvic floor rehabilitation focuses on pelvic floor muscle training (PFMT), widely known as Kegel exercises, to strengthen weakened muscles and improve continence.
Interventions
PROCEDUREBiofeedback + standarded post hysterectomy care protocol
Participants will undergo standard post hysterectomy care protocol with electromyographic (EMG)-based biofeedback guidance, using a vaginal sensor to provide real-time visual and/or auditory feedback on pelvic floor muscles contractions.
PROCEDUREStandard post hysterectomy care protocol
Participants will perform undergo standard post hysterectomy core protocol without biofeedback assistance.
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 45-50 years. * Body Mass Index (BMI) within the range of 18.5 to 29.9 kg/m². * History of total or subtotal hysterectomy for benign conditions within the past 6 months. * Abdominal hysterectomy. * Women have menstrual cycle. * Presenting with at least one symptom of pelvic floor dysfunction (e.g., stress urinary incontinence and genital prolapse). * Willing to participate and provide informed consent.
Exclusion criteria
* Hysterectomy performed for malignant conditions. * Prior pelvic floor rehabilitation. * Neurological disorders affecting muscle control. * Pelvic infection or current urinary tract infection (UTI). * Inability to follow instructions or adhere to the program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Female Sexual Function Index (FSFI) | 12 weeks of intervention | Female sexual function will be assessed using the Female Sexual Function Index (FSFI), a validated 19-item questionnaire evaluating six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The total FSFI score ranges from 2 to 36, with higher scores indicating better sexual function. The change in total FSFI score from baseline to the end of the 12-week intervention will be compared between the two study groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Floor Muscle Strength | 12 weeks of intervention | Pelvic floor muscle strength will be assessed using an electromyographic (EMG)-based biofeedback device with an intravaginal sensor. Peak EMG amplitude during maximal voluntary pelvic floor muscle contractions will be recorded as an objective measure of pelvic floor muscle strength. The change from baseline to the end of the 12-week intervention will be compared between the two study groups. |
| Urinary Incontinence Severity | 12 weeks of intervention | Urinary incontinence severity will be assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). The questionnaire evaluates the frequency and severity of urinary leakage and its impact on daily life. Total scores range from 0 to 21, with higher scores indicating greater severity. The change in ICIQ-UI SF score from baseline to the end of the 12-week intervention will be compared between the two study groups. |
| Pelvic Floor-Related Quality of Life | 12 weeks of intervention | Pelvic floor-related quality of life will be assessed using the Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7). The questionnaire assesses the impact of urinary, colorectal, and pelvic organ prolapse symptoms on daily activities and quality of life. Scores range from 0 to 300, with higher scores indicating greater negative impact on quality of life. The change in PFIQ-7 score from baseline to the end of the 12-week intervention will be compared between the two study groups. |
| Pelvic Organ Prolapse Severity | 12 weeks of intervention | Pelvic organ prolapse severity will be assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system. POP-Q measurements will be performed at baseline and after the 12-week intervention to objectively assess changes in pelvic organ support and prolapse stage. Changes in POP-Q measurements and prolapse stage will be compared between the two study groups. |
Countries
Egypt
Contacts
CONTACTRana H Ghazy, B.Sc
Outcome results
None listed