Effectiveness of Biofeedback-Assisted Pelvic Floor Muscle Training on Sexual Function and Quality of Life in Patient After Hysterectomy
20 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
70
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Rana H Ghazy, B.Sc
- Telefonnummer: 00201024554438
- E-post: ranahosny1196@gmail.com
Studieorter
-
-
Kafrelsheikh
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Kafr ash Shaykh, Kafrelsheikh, Egypten, 33516
- Rekrytering
- Kafrelsheikh University (Faculty of Physical Therapy)
-
Kontakt:
- Rana H Ghazy, B.Sc
- Telefonnummer: 00201024554438
- E-post: ranahosny1196@gmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
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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.
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Participants will perform undergo standard post hysterectomy core protocol without biofeedback assistance.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Female Sexual Function Index (FSFI)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pelvic Floor Muscle Strength
Tidsram: 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
Tidsram: 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
|
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Pelvic Floor-Related Quality of Life
Tidsram: 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.
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12 weeks of intervention
|
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Pelvic Organ Prolapse Severity
Tidsram: 12 weeks of intervention
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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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2026
Primärt slutförande (Beräknad)
1 oktober 2026
Avslutad studie (Beräknad)
1 oktober 2026
Studieregistreringsdatum
Först inskickad
20 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
20 augusti 2026
Första postat (Faktisk)
25 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KFSIRB200-871
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Tidsram för IPD-delning
After the end of study for one year.
Kriterier för IPD Sharing Access
The data will be available upon a reasonable request from the corresponding author.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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