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This randomized controlled trial aims to evaluate the efficacy of biofeedback-assisted pelvic floor muscle training on radiation-induced sexual dysfunction in cervical cancer survivors following pelvic radiotherapy. Participants will be randomly assigned to receive either biofeedback-assisted pelvic floor rehabilitation or supervised conventional pelvic floor muscle training without biofeedback for 8 weeks.
Cervical cancer survivors commonly experience persistent sexual dysfunction and pelvic floor impairments following pelvic radiotherapy, including dyspareunia, reduced vaginal lubrication, vaginal stenosis, decreased genital sensation, pelvic pain, urinary symptoms, and reduced quality of life.
These complications are mainly attributed to radiation-induced fibrosis, vascular changes, and neuromuscular dysfunction affecting pelvic floor muscle performance and coordination, in addition to psychological distress.
Pelvic floor muscle training (PFMT) is an established conservative intervention for improving pelvic floor muscle strength, coordination, and sexual function in women with pelvic floor dysfunction. Electromyographic biofeedback may enhance the effectiveness of PFMT by providing real-time visual and auditory feedback that facilitates motor learning, improves voluntary muscle activation, enhances relaxation capacity, and optimizes contraction-relaxation coordination.
This study is novel as it specifically evaluates electromyographic biofeedback-assisted pelvic floor muscle training in cervical cancer survivors with radiation-induced sexual dysfunction, an area with limited high-quality randomized controlled evidence. Unlike previous studies on general pelvic floor disorders, it uses a cancer-specific population, a standardized supervised active comparator, and integrates both subjective outcomes (Female Sexual Function Index (FSFI)) and objective pelvic floor electromyography measures. The design allows isolation of the specific added benefit of biofeedback over conventional pelvic floor muscle training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation | Experimental | Participants will receive supervised biofeedback-assisted pelvic floor muscle rehabilitation three sessions weekly for 8 weeks. Each treatment session will last approximately 45-60 minutes and will include pelvic floor muscle training, electromyographic biofeedback, coordination exercises, diaphragmatic breathing, relaxation training, stretching exercises, and a structured home exercise program. |
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| Supervised Conventional Pelvic Floor Muscle Training | Active Comparator | Participants will receive supervised conventional pelvic floor muscle training without electromyographic biofeedback three sessions weekly for 8 weeks. Participants will additionally receive pelvic health education, lifestyle advice, vaginal care recommendations, and a structured home exercise program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation | Behavioral | An intravaginal surface electromyographic probe connected to a pelvic floor biofeedback device will be used during supervised pelvic floor muscle training sessions conducted three times per week for 8 weeks, with each session lasting 45-60 minutes. The protocol will include slow pelvic floor muscle contractions (8-12 repetitions per set, each held for 5-10 seconds with equal relaxation time) and fast contractions (10-15 rapid contractions per set), performed for 2-3 sets per session with short rest intervals (1-2 minutes) between sets according to participant tolerance. Visual and auditory biofeedback will be provided throughout to enhance motor learning, muscle awareness, coordination, contraction quality, and relaxation control. Training intensity, contraction duration, and repetitions will be progressively increased based on individual performance and fatigue response. In addition, participants will perform a structured home exercise program five days per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Female Sexual Function Index (FSFI) | Female sexual function will be assessed using the Female Sexual Function Index (FSFI), a validated multidimensional questionnaire evaluating sexual desire, arousal, lubrication, orgasm, satisfaction, and pain domains. Total scores range from 2 to 36, with lower scores indicating greater sexual dysfunction. | Baseline, 8 weeks, and 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Floor Electromyographic Activity | Resting pelvic floor muscle activity, maximal voluntary contraction amplitude, and average contraction amplitude will be recorded in microvolts (µV) using intravaginal surface electromyography (sEMG). Resting activity will reflect baseline pelvic floor muscle tone during relaxation, while maximal voluntary contraction amplitude and average contraction amplitude will reflect pelvic floor muscle activation strength and recruitment during voluntary contractions. Average values obtained from three maximal voluntary contractions will be used for statistical analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marwa Elsayed Mohamed Lecturer, Ph.D | Contact | 01141825442 | Marwa.elsayed@pt.bsu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Out patient clinic , faculty of Physical Therapy, Beni Sueif university | Recruiting | Banī Suwayf | Egypt |
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Participants will be randomly assigned in a 1:1 ratio to either the experimental group receiving biofeedback-assisted pelvic floor muscle rehabilitation or the control group receiving supervised conventional pelvic floor muscle training without biofeedback. Both groups will receive supervised treatment sessions three times weekly for 8 weeks with matched treatment duration, exercise intensity, therapist supervision, and home exercise programs. Outcome assessments will be conducted at baseline, post-intervention, and 3-month follow-up by blinded assessors to evaluate the additional therapeutic effect of electromyographic biofeedback on sexual function and pelvic floor outcomes in cervical cancer survivors following radiotherapy.
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This study will use single-blinding (assessor blinding). Outcome assessors and data analysts will be blinded to group allocation to reduce assessment and analysis bias. Due to the nature of the intervention, participants and treating physiotherapists cannot be blinded, as biofeedback-assisted pelvic floor muscle rehabilitation requires active visual and auditory feedback during treatment sessions, which distinguishes it from conventional pelvic floor muscle training. Group allocation will be concealed from assessors throughout data collection, outcome evaluation, and statistical analysis until completion of the study.
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| Conventional Pelvic Floor Muscle Training | Behavioral | Participants will perform supervised pelvic floor muscle exercises including slow sustained contractions and rapid contractions without biofeedback guidance. Exercise frequency, duration, and progression will be matched to the experimental group. |
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| Baseline, 8 weeks, and 3-month follow-up |
| Hospital Anxiety and Depression Scale (HADS) | Psychological well-being will be assessed using the Hospital Anxiety and Depression Scale (HADS), a validated self-reported questionnaire consisting of 14 items divided into two subscales assessing anxiety and depression symptoms. Each subscale score ranges from 0 to 21, with higher scores indicating greater psychological distress. Scores of 0-7 are considered normal, 8-10 indicate borderline abnormal symptoms, and 11-21 indicate clinically significant anxiety or depression. | Baseline, 8 weeks, and 3-month follow-up |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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