Cervical CancerNCT07597083
Biofeedback-Assisted Pelvic Floor Rehabilitation for Radiation-Induced Sexual Dysfunction in Cervical Cancer Survivors
A study testing Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation and Conventional Pelvic Floor Muscle Training in people with Cervical Cancer and Female Sexual Dysfunction (FSD), run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Cervical Cancer, Female Sexual Dysfunction (FSD), Radiation Induced Pelvic Floor Muscle Dysfunction
- What is being tested?
- Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation and Conventional Pelvic Floor Muscle Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 19 May 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 interventional clinical or rehabilitation trial within the last 3 months or during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Out patient clinic , faculty of Physical Therapy, Beni Sueif university
Banī Suwayf
About this study
Official title: 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
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.
Read the detailed description
Cervical cancer survivors commonly experience persistent sexual dysfunction and pelvic floor impairments following pelvic radiotherapy, including dyspareunia, reduced vaginal lubrication, vaginal stenosis, decreased genital sensation, pelvic pain, urinary symptoms, and reduced quality of life.
These complications are mainly attributed to radiation-induced fibrosis, vascular changes, and neuromuscular dysfunction affecting pelvic floor muscle performance and coordination, in addition to psychological distress.
Pelvic floor muscle training (PFMT) is an established conservative intervention for improving pelvic floor muscle strength, coordination, and sexual function in women with pelvic floor dysfunction. Electromyographic biofeedback may enhance the effectiveness of PFMT by providing real-time visual and auditory feedback that facilitates motor learning, improves voluntary muscle activation, enhances relaxation capacity, and optimizes contraction-relaxation coordination.
This study is novel as it specifically evaluates electromyographic biofeedback-assisted pelvic floor muscle training in cervical cancer survivors with radiation-induced sexual dysfunction, an area with limited high-quality randomized controlled evidence. Unlike previous studies on general pelvic floor disorders, it uses a cancer-specific population, a standardized supervised active comparator, and integrates both subjective outcomes (Female Sexual Function Index (FSFI)) and objective pelvic floor electromyography measures. The design allows isolation of the specific added benefit of biofeedback over conventional pelvic floor muscle training.
- Conditions
- Cervical Cancer, Female Sexual Dysfunction (FSD), Radiation Induced Pelvic Floor Muscle Dysfunction
- Being tested
- Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation, Conventional Pelvic Floor Muscle Training
- Keywords
- Cervical cancer, sexual dysfunction, electromyographic biofeedback pelvic floor muscle training
- Medical subject headings
- Uterine Cervical Neoplasms, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback-Assisted Pelvic Floor Muscle RehabilitationBehavioural
An intravaginal surface electromyographic probe connected to a pelvic floor biofeedback device will be used during supervised pelvic floor muscle training sessions conducted three times per week for 8 weeks, with each session lasting 45-60 minutes. The protocol will include slow pelvic floor muscle contractions (8-12 repetitions per set, each held for 5-10 seconds with equal relaxation time) and fast contractions (10-15 rapid contractions per set), performed for 2-3 sets per session with short rest intervals (1-2 minutes) between sets according to participant tolerance. Visual and auditory biofeedback will be provided throughout to enhance motor learning, muscle awareness, coordination, contraction quality, and relaxation control. Training intensity, contraction duration, and repetitions will be progressively increased based on individual performance and fatigue response. In addition, participants will perform a structured home exercise program five days per week.
Conventional Pelvic Floor Muscle TrainingBehavioural
Participants will perform supervised pelvic floor muscle exercises including slow sustained contractions and rapid contractions without biofeedback guidance. Exercise frequency, duration, and progression will be matched to the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation | Experimental | 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. Receives: Behavioral: Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation |
| Supervised Conventional Pelvic Floor Muscle Training | Active comparator | 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. Receives: Behavioral: Conventional Pelvic Floor Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Index (FSFI)
Female sexual function will be assessed using the Female Sexual Function Index (FSFI), a validated multidimensional questionnaire evaluating sexual desire, arousal, lubrication, orgasm, satisfaction, and pain domains. Total scores range from 2 to 36, with lower scores indicating greater sexual dysfunction.
Measured: Baseline, 8 weeks, and 3-month follow-up
Secondary outcomes (2)
Pelvic Floor Electromyographic Activity
Resting pelvic floor muscle activity, maximal voluntary contraction amplitude, and average contraction amplitude will be recorded in microvolts (µV) using intravaginal surface electromyography (sEMG). Resting activity will reflect baseline pelvic floor muscle tone during relaxation, while maximal voluntary contraction amplitude and average contraction amplitude will reflect pelvic floor muscle activation strength and recruitment during voluntary contractions. Average values obtained from three maximal voluntary contractions will be used for statistical analysis.
Measured: Baseline, 8 weeks, and 3-month follow-up
Hospital Anxiety and Depression Scale (HADS)
Psychological well-being will be assessed using the Hospital Anxiety and Depression Scale (HADS), a validated self-reported questionnaire consisting of 14 items divided into two subscales assessing anxiety and depression symptoms. Each subscale score ranges from 0 to 21, with higher scores indicating greater psychological distress. Scores of 0-7 are considered normal, 8-10 indicate borderline abnormal symptoms, and 11-21 indicate clinically significant anxiety or depression.
Measured: Baseline, 8 weeks, and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start19 May 2026
- Primary completion15 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the experimental group receiving biofeedback-assisted pelvic floor muscle rehabilitation or the control group receiving supervised conventional pelvic floor muscle training without biofeedback. Both groups will receive supervised treatment sessions three times weekly for 8 weeks with matched treatment duration, exercise intensity, therapist supervision, and home exercise programs. Outcome assessments will be conducted at baseline, post-intervention, and 3-month follow-up by blinded assessors to evaluate the additional therapeutic effect of electromyographic biofeedback on sexual function and pelvic floor outcomes in cervical cancer survivors following radiotherapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Elsayed Mohamed, PhD, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597083
- Sponsor's protocol ID
- Radiotherapy FSD 2026
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07597083
- Acronym / sponsor ID
- Radiotherapy FSD 2026
- Conditions
- Cervical Cancer, Female Sexual Dysfunction (FSD), Radiation Induced Pelvic Floor Muscle Dysfunction
- Keywords
- Cervical cancer, sexual dysfunction, electromyographic biofeedback pelvic floor muscle training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 19 May 2026 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cervical cancer survivors commonly experience persistent sexual dysfunction and pelvic floor impairments following pelvic radiotherapy, including dyspareunia, reduced vaginal lubrication, vaginal stenosis, decreased genital sensation, pelvic pain, urinary symptoms, and reduced quality of life.
These complications are mainly attributed to radiation-induced fibrosis, vascular changes, and neuromuscular dysfunction affecting pelvic floor muscle performance and coordination, in addition to psychological distress.
Pelvic floor muscle training (PFMT) is an established conservative intervention for improving pelvic floor muscle strength, coordination, and sexual function in women with pelvic floor dysfunction. Electromyographic biofeedback may enhance the effectiveness of PFMT by providing real-time visual and auditory feedback that facilitates motor learning, improves voluntary muscle activation, enhances relaxation capacity, and optimizes contraction-relaxation coordination.
This study is novel as it specifically evaluates electromyographic biofeedback-assisted pelvic floor muscle training in cervical cancer survivors with radiation-induced sexual dysfunction, an area with limited high-quality randomized controlled evidence. Unlike previous studies on general pelvic floor disorders, it uses a cancer-specific population, a standardized supervised active comparator, and integrates both subjective outcomes (Female Sexual Function Index (FSFI)) and objective pelvic floor electromyography measures. The design allows isolation of the specific added benefit of biofeedback over conventional pelvic floor muscle training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the experimental group receiving biofeedback-assisted pelvic floor muscle rehabilitation or the control group receiving supervised conventional pelvic floor muscle training without biofeedback. Both groups will receive supervised treatment sessions three times weekly for 8 weeks with matched treatment duration, exercise intensity, therapist supervision, and home exercise programs. Outcome assessments will be conducted at baseline, post-intervention, and 3-month follow-up by blinded assessors to evaluate the additional therapeutic effect of electromyographic biofeedback on sexual function and pelvic floor outcomes in cervical cancer survivors following radiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation | Experimental | Behavioral: Biofeedback-Assisted Pelvic Floor Muscle RehabilitationParticipants 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. |
| Supervised Conventional Pelvic Floor Muscle Training | Active comparator | Behavioral: Conventional Pelvic Floor Muscle TrainingParticipants 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback-Assisted Pelvic Floor Muscle RehabilitationAn intravaginal surface electromyographic probe connected to a pelvic floor biofeedback device will be used during supervised pelvic floor muscle training sessions conducted three times per week for 8 weeks, with each session lasting 45-60 minutes. The protocol will include slow pelvic floor muscle contractions (8-12 repetitions per set, each held for 5-10 seconds with equal relaxation time) and fast contractions (10-15 rapid contractions per set), performed for 2-3 sets per session with short rest intervals (1-2 minutes) between sets according to participant tolerance. Visual and auditory biofeedback will be provided throughout to enhance motor learning, muscle awareness, coordination, contraction quality, and relaxation control. Training intensity, contraction duration, and repetitions will be progressively increased based on individual performance and fatigue response. In addition, participants will perform a structured home exercise program five days per week. | Behavioural | Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation |
| Conventional Pelvic Floor Muscle TrainingParticipants will perform supervised pelvic floor muscle exercises including slow sustained contractions and rapid contractions without biofeedback guidance. Exercise frequency, duration, and progression will be matched to the experimental group. | Behavioural | Supervised Conventional Pelvic Floor Muscle Training |
Primary outcome
Female Sexual Function Index (FSFI)
Time frame: Baseline, 8 weeks, and 3-month follow-up
Female sexual function will be assessed using the Female Sexual Function Index (FSFI), a validated multidimensional questionnaire evaluating sexual desire, arousal, lubrication, orgasm, satisfaction, and pain domains. Total scores range from 2 to 36, with lower scores indicating greater sexual dysfunction.
2 secondary outcomes
Pelvic Floor Electromyographic Activity
Time frame: Baseline, 8 weeks, and 3-month follow-up
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 8 weeks, and 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation and Conventional Pelvic Floor Muscle Training in people with Cervical Cancer and Female Sexual Dysfunction (FSD), run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa Elsayed Mohamed Lecturer, Ph.D (01141825442, Marwa.elsayed@pt.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (FSFI) (time frame: Baseline, 8 weeks, and 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.