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NCT Number: NCT07784465

Effectiveness of Biofeedback-Assisted Pelvic Floor Muscle Training on Sexual Function and Quality of Life in Patient After Hysterectomy

The purpose of this study is to determine the effectiveness of biofeedback-assisted pelvic floor muscle training in improving pelvic floor muscle strength, decreasing urinary incontinence symptoms, reducing genital prolaps and enhancing the quality of life in women after hysterectomy.

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Key information

Conditions

Effectiveness Biofeedback-Assisted Pelvic Floor Muscle Training Hysterectomy Quality of Life Sexual Function

Age range

45 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University (Faculty of Physical Therapy)

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location status: Recruiting

Location contact

Rana H Ghazy, B.Sc

CONTACT

[email protected]

00201024554438

About this study

Hysterectomy, the surgical removal of the uterus, remains one of the most frequently performed gynecological procedures worldwide, indicated for both malignant and benign conditions.

Pelvic floor dysfunction (PFD) is a common complication after hysterectomy, manifesting as urinary incontinence, pelvic organ prolapse, and colorectal symptoms.

Conventional pelvic floor rehabilitation focuses on pelvic floor muscle training (PFMT), widely known as Kegel exercises, to strengthen weakened muscles and improve continence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 45-50 years.
  • Body Mass Index (BMI) within the range of 18.5 to 29.9 kg/m².
  • History of total or subtotal hysterectomy for benign conditions within the past 6 months.
  • Abdominal hysterectomy.
  • Women have menstrual cycle.
  • Presenting with at least one symptom of pelvic floor dysfunction (e.g., stress urinary incontinence and genital prolapse).
  • Willing to participate and provide informed consent.

Exclusion criteria

  • Hysterectomy performed for malignant conditions.
  • Prior pelvic floor rehabilitation.
  • Neurological disorders affecting muscle control.
  • Pelvic infection or current urinary tract infection (UTI).
  • Inability to follow instructions or adhere to the program.

Treatment and study plan

Biofeedback + standarded post hysterectomy care protocol

Procedure

Participants will undergo standard post hysterectomy care protocol with electromyographic (EMG)-based biofeedback guidance, using a vaginal sensor to provide real-time visual and/or auditory feedback on pelvic floor muscles contractions.

Standard post hysterectomy care protocol

Procedure

Participants will perform undergo standard post hysterectomy core protocol without biofeedback assistance.

Primary outcomes

  1. Female Sexual Function Index (FSFI)

    Time frame: 12 weeks of intervention

    Female sexual function will be assessed using the Female Sexual Function Index (FSFI), a validated 19-item questionnaire evaluating six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The total FSFI score ranges from 2 to 36, with higher scores indicating better sexual function. The change in total FSFI score from baseline to the end of the 12-week intervention will be compared between the two study groups.

Secondary outcomes

  1. Pelvic Floor Muscle Strength

    Time frame: 12 weeks of intervention

    Pelvic floor muscle strength will be assessed using an electromyographic (EMG)-based biofeedback device with an intravaginal sensor. Peak EMG amplitude during maximal voluntary pelvic floor muscle contractions will be recorded as an objective measure of pelvic floor muscle strength. The change from baseline to the end of the 12-week intervention will be compared between the two study groups.

  2. Urinary Incontinence Severity

    Time frame: 12 weeks of intervention

    Urinary incontinence severity will be assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). The questionnaire evaluates the frequency and severity of urinary leakage and its impact on daily life. Total scores range from 0 to 21, with higher scores indicating greater severity. The change in ICIQ-UI SF score from baseline to the end of the 12-week intervention will be compared between the two study groups.

  3. Pelvic Floor-Related Quality of Life

    Time frame: 12 weeks of intervention

    Pelvic floor-related quality of life will be assessed using the Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7). The questionnaire assesses the impact of urinary, colorectal, and pelvic organ prolapse symptoms on daily activities and quality of life. Scores range from 0 to 300, with higher scores indicating greater negative impact on quality of life. The change in PFIQ-7 score from baseline to the end of the 12-week intervention will be compared between the two study groups.

  4. Pelvic Organ Prolapse Severity

    Time frame: 12 weeks of intervention

    Pelvic organ prolapse severity will be assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system. POP-Q measurements will be performed at baseline and after the 12-week intervention to objectively assess changes in pelvic organ support and prolapse stage. Changes in POP-Q measurements and prolapse stage will be compared between the two study groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Rana H Ghazy, B.Sc

CONTACT

[email protected]

00201024554438

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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