Actively Recruiting
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
Led by Beni-Suef University · Updated on 2026-05-20
60
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of biofeedback-assisted pelvic floor muscle training compared to conventional pelvic floor muscle training for treating sexual dysfunction caused by radiation in cervical cancer survivors. This study focuses on women who have undergone pelvic radiotherapy and experience complications such as pain during sex, reduced vaginal lubrication, and pelvic pain. It aims to provide high-quality evidence on whether adding biofeedback enhances pelvic floor rehabilitation outcomes in this specific cancer survivor group. Participants will be randomly assigned to one of two groups for 8 weeks. One group will receive supervised biofeedback-assisted pelvic floor muscle rehabilitation three times a week, including exercises with an intravaginal electromyographic probe providing real-time visual and auditory feedback. Sessions last 45-60 minutes and include muscle training, coordination, breathing, relaxation, stretching, and a home exercise program. The other group will receive supervised conventional pelvic floor muscle training without biofeedback but with similar exercise frequency, lifestyle advice, vaginal care, and a home program. During the study, participants will complete assessments at baseline, after 8 weeks, and at a 3-month follow-up. These include the Female Sexual Function Index to measure sexual function, pelvic floor electromyographic activity to assess muscle performance, and anxiety and depression scales. Researchers will monitor treatment progress and safety throughout. The total participation involves supervised sessions and home exercises over 8 weeks with follow-up evaluations to measure both subjective and objective treatment effects.
CONDITIONS
Brief Title
Biofeedback-Assisted Pelvic Floor Rehabilitation for Radiation-Induced Sexual Dysfunction in Cervical Cancer Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 30 to 60 years
- Histologically confirmed diagnosis of cervical cancer and completion of primary treatment
- Completed pelvic radiotherapy at least 3 months before enrollment
- Radiation-induced sexual dysfunction with a Female Sexual Function Index score of 26.55 or less
- Self-reported sexual activity within the previous 6 months
- Medically stable with no current need for active cancer treatment
- Ability to understand study procedures and provide written informed consent
You will not qualify if you...
- Evidence of recurrent, persistent, or metastatic cervical cancer
- Participation in pelvic floor muscle training or biofeedback rehabilitation within the previous 6 months
- 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 enrollment
- Neurological disorders affecting pelvic floor function (e.g., spinal cord injury, multiple sclerosis)
- Severe psychiatric illness or uncontrolled mental health disorder
- Cognitive impairment preventing understanding or adherence to the protocol
- Current pregnancy or planning pregnancy during the study
- Participation in another interventional clinical or rehabilitation trial within the last 3 months or during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants attend supervised pelvic floor muscle training sessions three times per week for 8 weeks. Sessions last approximately 45-60 minutes and include pelvic floor muscle exercises, with or without electromyographic biofeedback, coordination exercises, diaphragmatic breathing, relaxation training, and stretching. Participants also follow a structured home exercise program five days per week.
3 visits per week for 8 weeks
Duration - 3 months
Participants are assessed for ongoing sexual function, pelvic floor muscle activity, and psychological well-being at 3 months after treatment completion.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Out patient clinic , faculty of Physical Therapy, Beni Sueif university
Banī Suwayf, Egypt
Actively Recruiting
Research Team
M
Marwa Elsayed Mohamed Lecturer, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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