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

Sponsor
Beni-Suef University
Study ID
NCT07597083
Status
Recruiting
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Conditions

  • Cervical Cancer
  • Female Sexual Dysfunction (FSD)
  • Radiation Induced Pelvic Floor Muscle Dysfunction

Eligibility Criteria

Sex
FEMALE
Age
30 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation — BEHAVIORAL
    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.
  • Conventional Pelvic Floor Muscle Training — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 19, 2026
Status verified
May 2026
Primary completion
Mar 15, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: 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.

Primary Outcome Measure

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

Central Contacts

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