Biofeedback-Assisted Pelvic Floor Rehabilitation for Radiation-Induced Sexual Dysfunction in Cervical Cancer Survivors

Beni-Suef University

Status: Enrolling

Conditions: Radiation Induced Pelvic Floor Muscle Dysfunction; Female Sexual Dysfunction (FSD); Cervical Cancer

Treatments: Behavioral: Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation; Behavioral: Conventional Pelvic Floor Muscle Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07597083

Radiotherapy FSD 2026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation

Experimental group

Description:

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.

Treatment:

Behavioral: Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation

Supervised Conventional Pelvic Floor Muscle Training

Active Comparator group

Description:

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.

Treatment:

Behavioral: Conventional Pelvic Floor Muscle Training