Pelvic Floor Dysfunction and Quality of Life in Patient Undergoing Gynecological Surgery

Not Applicable

Recruiting

• Conditions: Pelvic Floor Dysfunction

• Registration Number: NCT06875635
• Lead Sponsor: Riphah International University

Brief Summary

The purpose of the study is to assess the pelvic floor dysfunction and quality of life in patient undergoing gynecological surgery.Common gynecological surgeries done for prolapse, fibroids, and cervical abnormality and also for Gynecological cancer.Early physiotherapy after gynecological surgery improves recovery by managing pain, restoring movement, and strengthening muscles, especially the pelvic floor.Conservative treatments like pelvic floor muscle exercises, biofeedback, and lifestyle changes can help with pelvic symptoms, including urinary incontinence and mild to moderate prolapse.

Detailed Description

This is a randomized control trial to see the effects of pelvic floor training on pelvic floor dysfunction and quality of life in patient undergoing gynecological surgery. Females meeting the inclusion and exclusion criteria will be divided into three groups by convenient sampling technique. A sample size of 48 females with 16 females in each group. Group A will be treated four weeks pre and 8 weeks post op pelvic floor training exercises, group B will be treated only 8 weeks post op pelvic floor training exercises and group C will receive basic post op nursing care. Group A and B will have three treatment sessions per week Assessment will be done at 0 week (1month prior to surgery), 1 day before surgery, 2nd , 4th, 6th and 8th week after surgery. Females will be screened by Pelvic organ distress inventory (PFDI-20) and Pelvic floor impact questionnaire (PFIQ-7).

Study Timeline

• Study First Submitted: 2025-03-09
• Study First Submitted QC: 2025-03-09
• Study First Posted: 2025-03-13
• Study Start: 2025-04-25
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-18
• Last Update Posted: 2025-06-24
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pelvic organ distress inventory (PFDI-20)	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
Pelvic floor impact questionnaire (PFIQ-7)	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

Trial Locations

Locations (1)

Lady Reading Hospital MTI; 🇵🇰 Peshawar, KPK, Pakistan