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

November 28, 2025 updated by: Riphah International University

Effect of Pelvic Floor Muscle Training on Pelvic Floor Dysfunction and Quality of Life in Patient Undergoing Gynecological Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • KPK
      • Peshawar, KPK, Pakistan, 25000
        • Lady Reading Hospital MTI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: Pre and Post op pelvic floor muscle training
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
Other: Only post op pelvic floor muscle training
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
Other: Routine medical care
Circulatory exercise Breathing exercise Administrating analgesic Nursing care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Huma Riaz, PhD, Riphah International University, Islamabad, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Majida zaffar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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