NCT07784465

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Completed
Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

August 20, 2026

Last Update Submit

August 20, 2026

Conditions

EffectivenessBiofeedback-Assisted Pelvic Floor Muscle TrainingSexual FunctionQuality of LifeHysterectomy

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 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

Secondary Outcomes (4)

  • Pelvic Floor Muscle Strength

    12 weeks of intervention

  • Urinary Incontinence Severity

    12 weeks of intervention

  • Pelvic Floor-Related Quality of Life

    12 weeks of intervention

  • Pelvic Organ Prolapse Severity

    12 weeks of intervention

Study Arms (2)

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.

Procedure: Biofeedback + standarded post hysterectomy care protocol

Group B

ACTIVE COMPARATOR

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

Procedure: Standard post hysterectomy care protocol

Interventions

Biofeedback + standarded post hysterectomy care protocolPROCEDURE

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.

Group A
Standard post hysterectomy care protocolPROCEDURE

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

Group B

Eligibility Criteria

Age45 Years - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsWomen undergoing hysterectomy
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University (Faculty of Physical Therapy)

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

RECRUITING

MeSH Terms

Interventions

Biofeedback, Psychology

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Central Study Contacts

Rana H Ghazy, B.Sc

CONTACT

00201024554438ranahosny1196@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
B.Sc. in Physical Therapy, Faculty of Physical Therapy, Kafrelsheikh University, Kafrelsheikh Cairo, Egypt

Study Record Dates

First Submitted

August 20, 2026

First Posted

August 25, 2026

Study Start

January 1, 2026

Primary Completion

October 1, 2026

Study Completion

October 1, 2026

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations

EG(1)