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

NCT06875635 | Completed

• 1 other identifier: Majida zaffar
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Dysfunction

Keywords

pelvic floor training ,; gynecological surgery,; quality of life,; strength of pelvic floor muscle

Outcome Measures

Primary Outcomes (2)

• Pelvic organ distress inventory (PFDI-20)

  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)

  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

Study Arms (3)

Prepost PFMT Group

EXPERIMENTAL

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

Other: Pre and Post op pelvic floor muscle training

Post PFMT Group

EXPERIMENTAL

Only Post-op pelvic floor muscle training for 8 weeks along with Routine medical care

Other: Only post op pelvic floor muscle training

Control

OTHER

Routine medical care was given

Other: Routine medical care

Interventions

Pre and Post op pelvic floor muscle training OTHER

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

Prepost PFMT Group

Only post op pelvic floor muscle training OTHER

post op exercise :breathing exercise, circulatory exercise i.e ankle pump and heel slides, and bed mobility along with pre op protocol

Post PFMT Group

Routine medical care OTHER

Circulatory exercise Breathing exercise Administrating analgesic Nursing care

Control

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: only female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women age:40 -60yrs
• undergoing vaginal or laparoscopic-assisted vaginal surgery for either POP repair (primary or recurrent), and/or hysterectomy

You may not qualify if:

• Emergency Surgery
• Chronic Illness
• Unstable Mental State

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Lady Reading Hospital MTI

Peshawar, KPK, 25000, Pakistan

Location

MeSH Terms

Interventions

Lead

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• Huma Riaz, PhD

  Riphah International University, Islamabad, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The Principal investigator or the researcher will be kept blind about the group allocation and intervention or assessment of patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be comparison between 3 groups.Two intervention group and 1 control group

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 13, 2025
• Study Start: April 25, 2025
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)