Clinical trial · Interventional
Biofeedback-Assisted Pelvic Floor Rehabilitation for Radiation-Induced Sexual Dysfunction in Cervical Cancer Survivors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Female Sexual Dysfunction (FSD) | — | UNRESOLVED | — |
| Radiation Induced Pelvic Floor Muscle Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation | Behavioral | — | UNRESOLVED |
| Conventional Pelvic Floor Muscle Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation
- description
- Participants will receive supervised biofeedback-assisted pelvic floor muscle rehabilitation three sessions weekly for 8 weeks. Each treatment session will last approximately 45-60 minutes and will include pelvic floor muscle training, electromyographic biofeedback, coordination exercises, diaphragmatic breathing, relaxation training, stretching exercises, and a structured home exercise program.
- interventionNames
- Behavioral: Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation
- type
- ACTIVE_COMPARATOR
- label
- Supervised Conventional Pelvic Floor Muscle Training
- description
- Participants will receive supervised conventional pelvic floor muscle training without electromyographic biofeedback three sessions weekly for 8 weeks. Participants will additionally receive pelvic health education, lifestyle advice, vaginal care recommendations, and a structured home exercise program.
- interventionNames
- Behavioral: Conventional Pelvic Floor Muscle Training
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available