Efficacy of Biofeedback-Assisted Pelvic Floor Muscle Training on Pelvic Radiation-Induced Sexual Dysfunction and Pelvic Floor Dysfunction in Cervical Cancer Survivors : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 30-60 years.
- •Histologically confirmed diagnosis of cervical cancer (any stage at diagnosis) and completion of primary treatment.
- •Completion of pelvic radiotherapy (external beam radiotherapy and/or brachytherapy) ≥3 months prior to enrollment.
- •Presence of radiation-induced sexual dysfunction, defined as a Female Sexual Function Index (FSFI) score ≤26.
- •Self-reported sexual activity within the previous 6 months.
- •Medically stable with no current oncologic indication for active treatment, confirmed by treating oncologist.
- •Ability to understand study procedures and provide written informed consent.
排除标准
- •Evidence of recurrent, persistent, or metastatic cervical cancer.
- •Participation in pelvic floor muscle training or biofeedback-based rehabilitation within the previous 6 months.
- •Presence of severe pelvic organ prolapse (stage III-IV).
- •Active pelvic infection, pelvic inflammatory disease, or untreated vaginal infection.
- •Ongoing significant vaginal bleeding of unknown or pathological origin.
- •Untreated or active urinary tract infection at the time of enrollment.
- •Neurological disorders affecting pelvic floor function (e.g., spinal cord injury, multiple sclerosis).
- •Severe psychiatric illness or uncontrolled mental health disorder affecting participation.
- •Cognitive impairment preventing understanding of instructions or adherence to protocol.
- •Current pregnancy or planning pregnancy during the study period.
- •Participation in another interventional clinical or rehabilitation trial within the last 3 months or during the study period.
研究组 & 干预措施
Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation
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.
干预措施: Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation (Behavioral)
Supervised Conventional Pelvic Floor Muscle Training
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.
干预措施: Conventional Pelvic Floor Muscle Training (Behavioral)
研究者
Marwa Elsayed Mohamed, PhD
Lecturer of Physical Therapy for women Health
Beni-Suef University