New treatment option for Cervical Cancer
Official title Biofeedback-Assisted Pelvic Floor Rehabilitation for Radiation-Induced Sexual Dysfunction in Cervical Cancer Survivors
ClinicalTrials.gov ID: NCT07597083
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 60, women only
You may be able to join if
- Female participants aged 30-60 years.
- Histologically confirmed diagnosis of cervical cancer (any stage at diagnosis) and completion of primary treatment.
- Completion of pelvic radiotherapy (external beam radiotherapy and/or brachytherapy) ≥3 months prior to enrollment.
- Presence of radiation-induced sexual dysfunction, defined as a Female Sexual Function Index (FSFI) score ≤26.55.
- Self-reported sexual activity within the previous 6 months.
You likely can't join if
- Evidence of recurrent, persistent, or metastatic cervical cancer.
- Participation in pelvic floor muscle training or biofeedback-based rehabilitation within the previous 6 months.
- Presence of 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 the time of enrollment.
See the full eligibility criteria
- Female participants aged 30-60 years.
- Histologically confirmed diagnosis of cervical cancer (any stage at diagnosis) and completion of primary treatment.
- Completion of pelvic radiotherapy (external beam radiotherapy and/or brachytherapy) ≥3 months prior to enrollment.
- Presence of radiation-induced sexual dysfunction, defined as a Female Sexual Function Index (FSFI) score ≤26.55.
- Self-reported sexual activity within the previous 6 months.
- Medically stable with no current oncologic indication for active treatment, confirmed by treating oncologist.
- Ability to understand study procedures and provide written informed consent.
- Evidence of recurrent, persistent, or metastatic cervical cancer.
- Participation in pelvic floor muscle training or biofeedback-based rehabilitation within the previous 6 months.
- Presence of 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 the time of enrollment.
- Neurological disorders affecting pelvic floor function (e.g., spinal cord injury, multiple sclerosis).
- Severe psychiatric illness or uncontrolled mental health disorder affecting participation.
- Cognitive impairment preventing understanding of instructions or adherence to protocol.
- Current pregnancy or planning pregnancy during the study period.
- Participation in another treatment clinical or rehabilitation trial within the last 3 months or during the study period.
The study team makes the final eligibility decision.
Where it's taking place
- Banī Suwayf, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 30 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Banī Suwayf, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.