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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Biofeedback-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 r
• Поведенческое Conventional Pelvic Floor Muscle Training
  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.

Первичные конечные точки

• Female Sexual Function Index (FSFI) [Срок оценки: Baseline, 8 weeks, and 3-month follow-up]

Вторичные конечные точки (2)

• Pelvic Floor Electromyographic Activity [Срок оценки: Baseline, 8 weeks, and 3-month follow-up]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Baseline, 8 weeks, and 3-month follow-up]

Критерии участия

Критерии включения

• 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 ≤26.55.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Out patient clinic , faculty of Physical Therapy, Beni Sueif university — Banī Suwayf

Идентификаторы

NCT: NCT07597083 · Radiotherapy FSD 2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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