EffectivenessNCT07784465
Effectiveness of Biofeedback-Assisted Pelvic Floor Muscle Training on Sexual Function and Quality of Life in Patient After Hysterectomy
A study testing Biofeedback + standarded post hysterectomy care protocol and Standard post hysterectomy care protocol in people with Effectiveness and Biofeedback-Assisted Pelvic Floor Muscle Training, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 50 years
- Conditions the study is for
- Effectiveness, Biofeedback-Assisted Pelvic Floor Muscle Training, Sexual Function
- What is being tested?
- Biofeedback + standarded post hysterectomy care protocol and Standard post hysterectomy care protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Oct 2026
- 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 45 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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
Kafrelsheikh University (Faculty of Physical Therapy)
Kafr ash Shaykh, Kafrelsheikh, 33516
Rana H Ghazy, B.Sc, 00201024554438, ranahosny1196@gmail.com
About this study
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.
Read the detailed description
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.
- Conditions
- Effectiveness, Biofeedback-Assisted Pelvic Floor Muscle Training, Sexual Function, Quality of Life, Hysterectomy
- Being tested
- Biofeedback + standarded post hysterectomy care protocol, Standard post hysterectomy care protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback + standarded post hysterectomy care protocolProcedure or surgery
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 protocolProcedure or surgery
Participants will perform undergo standard post hysterectomy core protocol without biofeedback assistance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Procedure: Biofeedback + standarded post hysterectomy care protocol |
| Group B | Active comparator | Participants will perform undergo standard post hysterectomy core protocol without biofeedback assistance. Receives: Procedure: Standard post hysterectomy care protocol |
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 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.
Measured: 12 weeks of intervention
Secondary outcomes (4)
Pelvic Floor Muscle Strength
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.
Measured: 12 weeks of intervention
Urinary Incontinence Severity
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.
Measured: 12 weeks of intervention
Pelvic Floor-Related Quality of Life
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.
Measured: 12 weeks of intervention
Pelvic Organ Prolapse Severity
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.
Measured: 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Jan 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EffectivenessStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Hosny Abd Elhamid Ghazy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784465
- Sponsor's protocol ID
- KFSIRB200-871
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Biofeedback-Assisted Pelvic Floor Muscle Training on Sexual Function and Quality of Life in Patient After Hysterectomy
- ClinicalTrials.gov ID
- NCT07784465
- Acronym / sponsor ID
- KFSIRB200-871
- Conditions
- Effectiveness, Biofeedback-Assisted Pelvic Floor Muscle Training, Sexual Function, Quality of Life, Hysterectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 25 Aug 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Biofeedback + standarded post hysterectomy care protocolParticipants 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. |
| Group B | Active comparator | Procedure: Standard post hysterectomy care protocolParticipants will perform undergo standard post hysterectomy core protocol without biofeedback assistance. |
Who may qualify
- Ages
- 45 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 + standarded post hysterectomy care protocolParticipants 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. | Procedure or surgery | Group A |
| Standard post hysterectomy care protocolParticipants will perform undergo standard post hysterectomy core protocol without biofeedback assistance. | Procedure or surgery | Group B |
Primary outcome
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.
4 secondary outcomes
Pelvic Floor Muscle Strength
Time frame: 12 weeks of intervention
Urinary Incontinence Severity
Time frame: 12 weeks of intervention
Pelvic Floor-Related Quality of Life
Time frame: 12 weeks of intervention
Pelvic Organ Prolapse Severity
Time frame: 12 weeks of intervention
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 25 Aug 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Effectiveness
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
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 + standarded post hysterectomy care protocol and Standard post hysterectomy care protocol in people with Effectiveness and Biofeedback-Assisted Pelvic Floor Muscle Training, run by Kafrelsheikh 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 5 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 25 Aug 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 Rana H Ghazy, B.Sc (00201024554438, ranahosny1196@gmail.com), 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: 12 weeks of intervention). 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 25 Aug 2026.