Effectiveness of Biofeedback-Assisted Pelvic Floor Muscle Training on Sexual Function and Quality of Life in Patient After Hysterectomy
20. august 2026 opdateret af: Rana Hosny Abd Elhamid Ghazy, Kafrelsheikh University
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.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
70
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Rana H Ghazy, B.Sc
- Telefonnummer: 00201024554438
- E-mail: ranahosny1196@gmail.com
Studiesteder
-
-
Kafrelsheikh
-
Kafr ash Shaykh, Kafrelsheikh, Egypten, 33516
- Rekruttering
- Kafrelsheikh University (Faculty of Physical Therapy)
-
Kontakt:
- Rana H Ghazy, B.Sc
- Telefonnummer: 00201024554438
- E-mail: ranahosny1196@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Group A
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.
|
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.
|
|
Aktiv komparator: Group B
Participants will perform undergo standard post hysterectomy core protocol without biofeedback assistance.
|
Participants will perform undergo standard post hysterectomy core protocol without biofeedback assistance.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Female Sexual Function Index (FSFI)
Tidsramme: 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.
|
12 weeks of intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pelvic Floor Muscle Strength
Tidsramme: 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.
|
12 weeks of intervention
|
|
Urinary Incontinence Severity
Tidsramme: 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.
|
12 weeks of intervention
|
|
Pelvic Floor-Related Quality of Life
Tidsramme: 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.
|
12 weeks of intervention
|
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Pelvic Organ Prolapse Severity
Tidsramme: 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.
|
12 weeks of intervention
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2026
Primær færdiggørelse (Anslået)
1. oktober 2026
Studieafslutning (Anslået)
1. oktober 2026
Datoer for studieregistrering
Først indsendt
20. august 2026
Først indsendt, der opfyldte QC-kriterier
20. august 2026
Først opslået (Faktiske)
25. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KFSIRB200-871
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD-delingstidsramme
After the end of study for one year.
IPD-delingsadgangskriterier
The data will be available upon a reasonable request from the corresponding author.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
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