- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06875635
Pelvic Floor Dysfunction and Quality of Life in Patient Undergoing Gynecological Surgery
Effect of Pelvic Floor Muscle Training on Pelvic Floor Dysfunction and Quality of Life in Patient Undergoing Gynecological Surgery
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
KPK
-
Peshawar, KPK, Pakistan, 25000
- Lady Reading Hospital MTI
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women age:40 -60yrs
- undergoing vaginal or laparoscopic-assisted vaginal surgery for either POP repair (primary or recurrent), and/or hysterectomy
Exclusion Criteria:
- Emergency Surgery
- Chronic Illness
- Unstable Mental State
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Prepost PFMT Group
Routine medical care and pre & post-op - op protocol of pelvic floor muscle training .1 month prior and 8 weeks post op protocol in patient undergoing gynecological surgery
|
pre op exercises: Breathing exercise ,Kegel exercise ,Abdominals exercise include pelvic tilt ,knee rolling with abdominal contraction post op exercise :breathing exercise, circulatory exercise i.e ankle pump and heel slides, and bed mobility along with pre op exercise
|
|
Experimental: Post PFMT Group
Only Post-op pelvic floor muscle training for 8 weeks along with Routine medical care
|
post op exercise :breathing exercise, circulatory exercise i.e ankle pump and heel slides, and bed mobility along with pre op protocol
|
|
Other: Control
Routine medical care was given
|
Circulatory exercise Breathing exercise Administrating analgesic Nursing care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pelvic organ distress inventory (PFDI-20)
Time Frame: From Baseline to 1 day prior to surgery, 2nd,4th,6th and 8th week of intervention
|
Pelvic floor Distress inventory questionnaire is comprised of 3 Sections, including pelvic organ prolapse distress inventory (POPDI-6) from question 1 to 6, urinary distress inventory (UDI-6) from questions 7-12 and colorectal anal distress inventory (CRADI-8) from questions 13-20. The total score ranges from 0 to 300, with higher scores indicating greater distress.the ICC value of the tool is 0.93 |
From Baseline to 1 day prior to surgery, 2nd,4th,6th and 8th week of intervention
|
|
Pelvic floor impact questionnaire (PFIQ-7)
Time Frame: From Baseline to 1 day prior to surgery, 2nd,4th,6th and 8th week of intervention
|
The pelvic floor impact questionnaire is used for quality of life assessment.
it has 3 sections, including Urinary impact questions, Colorectal anal impact questions, and Pelvic organ prolapse impact questionnaire.
The total score ranges from 0-300.
The ICC value of PFIQ is 0.77
|
From Baseline to 1 day prior to surgery, 2nd,4th,6th and 8th week of intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Huma Riaz, PhD, Riphah International University, Islamabad, Pakistan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Majida zaffar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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