Biofeedback-Assisted Pelvic Floor Rehabilitation for Radiation-Induced Sexual Dysfunction in Cervical Cancer Survivors
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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Marwa Elsayed Mohamed Lecturer, Ph.D
- 電話番号：01141825442
- メール：Marwa.elsayed@pt.bsu.edu.eg
研究場所
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Banī Suwayf、エジプト
- 募集
- Out patient clinic , faculty of Physical Therapy, Beni Sueif university
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
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アクティブコンパレータ：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Female Sexual Function Index (FSFI)
時間枠：Baseline, 8 weeks, and 3-month follow-up
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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.
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Baseline, 8 weeks, and 3-month follow-up
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pelvic Floor Electromyographic Activity
時間枠：Baseline, 8 weeks, and 3-month follow-up
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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.
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Baseline, 8 weeks, and 3-month follow-up
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Hospital Anxiety and Depression Scale (HADS)
時間枠：Baseline, 8 weeks, and 3-month follow-up
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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.
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Baseline, 8 weeks, and 3-month follow-up
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Radiotherapy FSD 2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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