Cervical Cancer, Female Sexual Dysfunction (FSD), Radiation Induced Pelvic Floor Muscle Dysfunction
Conditions
Keywords
Cervical cancer, sexual dysfunction, electromyographic biofeedback pelvic floor muscle training
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBiofeedback-Assisted Pelvic Floor Muscle Rehabilitation
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.
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.
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Female participants aged 30-60 years. 2. Histologically confirmed diagnosis of cervical cancer (any stage at diagnosis) and completion of primary treatment. 3. Completion of pelvic radiotherapy (external beam radiotherapy and/or brachytherapy) ≥3 months prior to enrollment. 4. Presence of radiation-induced sexual dysfunction, defined as a Female Sexual Function Index (FSFI) score ≤26.55. 5. Self-reported sexual activity within the previous 6 months. 6. Medically stable with no current oncologic indication for active treatment, confirmed by treating oncologist. 7. Ability to understand study procedures and provide written informed consent.
Exclusion criteria
1. Evidence of recurrent, persistent, or metastatic cervical cancer. 2. Participation in pelvic floor muscle training or biofeedback-based rehabilitation within the previous 6 months. 3. Presence of severe pelvic organ prolapse (stage III-IV). 4. Active pelvic infection, pelvic inflammatory disease, or untreated vaginal infection. 5. Ongoing significant vaginal bleeding of unknown or pathological origin. 6. Untreated or active urinary tract infection at the time of enrollment. 7. Neurological disorders affecting pelvic floor function (e.g., spinal cord injury, multiple sclerosis). 8. Severe psychiatric illness or uncontrolled mental health disorder affecting participation. 9. Cognitive impairment preventing understanding of instructions or adherence to protocol. 10. Current pregnancy or planning pregnancy during the study period. 11. Participation in another interventional clinical or rehabilitation trial within the last 3 months or during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Female Sexual Function Index (FSFI) | Baseline, 8 weeks, and 3-month follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Floor Electromyographic Activity | Baseline, 8 weeks, and 3-month follow-up | 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. |
| Hospital Anxiety and Depression Scale (HADS) | Baseline, 8 weeks, and 3-month follow-up | 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. |
Countries
Egypt
Contacts
CONTACTMarwa Elsayed Mohamed Lecturer, Ph.D
Outcome results
None listed