๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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) โฅ3 months prior to enrollment.
4. Presence of radiation-induced sexual dysfunction, defined as a Female Sexual Function Index (FSFI) score โค26.55.
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.
๐
What it tests
- Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation
- Conventional Pelvic Floor Muscle Training
Out patient clinic , faculty of Physical Therapy, Beni Sueif university
Banฤซ Suwayf, Egypt
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.