NCT07597083 Biofeedback-Assisted Pelvic Floor Rehabilitation for Radiation-Induced Sexual Dysfunction in Cervical Cancer Survivors
| NCT ID | NCT07597083 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beni-Suef University |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-05-19 |
| Primary Completion | 2027-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-05-19 with a primary completion date of 2027-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07597083 clinical trial?
This trial is open to female participants only, aged 30 Years or older, up to 60 Years, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07597083 currently recruiting?
Yes, NCT07597083 is actively recruiting participants. Contact the research team at Marwa.elsayed@pt.bsu.edu.eg for enrollment information.
Where is the NCT07597083 trial being conducted?
This trial is being conducted at Banī Suwayf, Egypt.
Who is sponsoring the NCT07597083 clinical trial?
NCT07597083 is sponsored by Beni-Suef University. The trial plans to enroll 60 participants.
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