Biofeedback-guided pelvic floor rehab for radiation-related sexual dysfunction after cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares biofeedback-assisted pelvic floor muscle rehabilitation to conventional pelvic floor muscle training in women with radiation-induced sexual dysfunction following cervical cancer treatment. Participants complete an 8-week program with either biofeedback-enabled therapy or standard supervised PFMT, measuring changes in sexual function and pelvic floor performance. The study targets persistent symptoms such as pain, lubrication issues, and reduced genital sensation, rooted in radiation-related tissue changes and neuromuscular factors. Real-time feedback is expected to improve motor learning and coordination of pelvic floor muscles. The trial uses both subjective outcomes (FSFI) and objective pelvic floor measures to evaluate efficacy.

Why it matters

Who can join: the full rules

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) ≥3 months prior to enrollment.
4. Presence of radiation-induced sexual dysfunction, defined as a Female Sexual Function Index (FSFI) score ≤26.55.
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.

Where it's running

• Out patient clinic , faculty of Physical Therapy, Beni Sueif university
  Banī Suwayf, Egypt Recruiting

Study contacts

• Study coordinator: Marwa Elsayed Mohamed Lecturer, Ph.D
• Email: Marwa.elsayed@pt.bsu.edu.eg
• Phone: 01141825442

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.