Biofeedback-Assisted Pelvic Floor Rehabilitation for Radiation-Induced Sexual Dysfunction in Cervical Cancer Survivors
2026년 5월 18일 업데이트: 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.
연구 개요
상태
모병
상세 설명
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.
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Marwa Elsayed Mohamed Lecturer, Ph.D
- 전화번호: 01141825442
- 이메일: Marwa.elsayed@pt.bsu.edu.eg
연구 장소
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Banī Suwayf, 이집트
- 모병
- Out patient clinic , faculty of Physical Therapy, Beni Sueif university
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Female Sexual Function Index (FSFI)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pelvic Floor Electromyographic Activity
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 19일
기본 완료 (추정된)
2027년 3월 15일
연구 완료 (추정된)
2027년 3월 31일
연구 등록 날짜
최초 제출
2026년 5월 13일
QC 기준을 충족하는 최초 제출
2026년 5월 13일
처음 게시됨 (실제)
2026년 5월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 18일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Radiotherapy FSD 2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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