Biofeedback-Assisted Pelvic Floor Rehabilitation for Radiation-Induced Sexual Dysfunction in Cervical Cancer Survivors

NCT07597083 | Recruiting

• 1 other identifier: Radiotherapy FSD 2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Female Sexual Dysfunction (FSD); Radiation Induced Pelvic Floor Muscle Dysfunction

Keywords

Cervical cancer; sexual dysfunction; electromyographic biofeedback pelvic floor muscle training

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 8 weeks, and 3-month follow-up

Secondary Outcomes (2)

• Pelvic Floor Electromyographic Activity

  Baseline, 8 weeks, and 3-month follow-up

• Hospital Anxiety and Depression Scale (HADS)

  Baseline, 8 weeks, and 3-month follow-up

Study Arms (2)

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.

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.

Behavioral: Conventional Pelvic Floor Muscle Training

Interventions

Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation BEHAVIORAL

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.

Biofeedback-Assisted Pelvic Floor Muscle Rehabilitation

Conventional Pelvic Floor Muscle Training BEHAVIORAL

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.

Supervised Conventional Pelvic Floor Muscle Training

Eligibility Criteria

• Age: 30 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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.
• Medically stable with no current oncologic indication for active treatment, confirmed by treating oncologist.
• Ability to understand study procedures and provide written informed consent.

You may not qualify 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.
• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Out patient clinic , faculty of Physical Therapy, Beni Sueif university

Banī Suwayf, Egypt

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Marwa Elsayed Mohamed Lecturer, Ph.D

CONTACT

01141825442; Marwa.elsayed@pt.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study will use single-blinding (assessor blinding). Outcome assessors and data analysts will be blinded to group allocation to reduce assessment and analysis bias. Due to the nature of the intervention, participants and treating physiotherapists cannot be blinded, as biofeedback-assisted pelvic floor muscle rehabilitation requires active visual and auditory feedback during treatment sessions, which distinguishes it from conventional pelvic floor muscle training. Group allocation will be concealed from assessors throughout data collection, outcome evaluation, and statistical analysis until completion of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy for women Health

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start: May 19, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

EG (1)