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

18 de maio de 2026 atualizado por: Marwa Elsayed Mohamed, PhD, Beni-Suef University

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

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

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Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: 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 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.
Comparador Ativo: 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.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Female Sexual Function Index (FSFI)
Prazo: 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.
Baseline, 8 weeks, and 3-month follow-up

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Pelvic Floor Electromyographic Activity
Prazo: 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.
Baseline, 8 weeks, and 3-month follow-up
Hospital Anxiety and Depression Scale (HADS)
Prazo: 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.
Baseline, 8 weeks, and 3-month follow-up

Colaboradores e Investigadores

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Patrocinador

Beni-Suef University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

19 de maio de 2026

Conclusão Primária (Estimado)

15 de março de 2027

Conclusão do estudo (Estimado)

31 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

13 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de maio de 2026

Primeira postagem (Real)

19 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • Radiotherapy FSD 2026

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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