Development & Validation of Pregnancy Specific Pelvic Floor Rehab Protocol

Development and Validation of Pregnancy Specific Pelvic Floor Rehab Protocol

Pelvic Floor Weakness is very common Facing by women during Pregnancy. PFM weakness is recognized as one of the problems encountered in patients with urinary and fecal incontinence which have very negative impact on Quality of life of Patients. This project aims to design, implement, and validate a pelvic floor rehabilitation protocol specifically for pregnant individuals.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Pelvic Floor Muscle Weakness; Pelvic Floor Muscle Training; Pelvic Floor Disorder
• Intervention / Treatment: Other: Pelvic Floor Exercises

Detailed Description

The review of existing literature undergoes the critical need for a pregnancy-specific pelvic floor rehab protocol to address the unique physiological and functional changes experienced during and after pregnancy. While current pelvic floor rehab approaches provide valuable insights, they often lack specific adaptations for the pregnant population, In First Phase of Study the protocol will be developed .The protocol will focus on preventing and managing pelvic floor dysfunction (PFD), such as urinary incontinence, pelvic organ prolapse, and pelvic pain, which are common during pregnancy. The program will incorporate evidence-based exercises, education, and lifestyle modifications, ensuring it is safe, effective, and adaptable to pregnancy.

In Second Phase it will be validated and Pilot testing will be done.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • KPK
    • Mansehra, KPK, Pakistan, 21300
      • King Abdullah Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• diagnosed pelvic floor dysfunction. Female participants experience pelvic floor symptoms such as incontinence, pelvic pain, or prolapse.

No previous participation in a structured pelvic floor rehabilitation program within the last six months

Exclusion Criteria:

• Pregnant women or those planning to become pregnant during the study period.
• Patients with neurological disorders affecting pelvic floor function (e.g., multiple sclerosis, spinal cord injury).
• Individuals with severe psychiatric conditions that might interfere with participation.
• Recent pelvic surgery within the last three months.
• Any contraindications to physical therapy or specific exercises included in the rehab program.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pelvic Floor Rehab Group; This Group will receive a developed Pelvic floor exercises protocol for 4 Weeks	Other: Pelvic Floor Exercises; Low intensity Warm Up Pelvic Floor Exercises and Cool down training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Floor Distress Inventory (PFDI)	The PFDI-20 questionnaire is designed to evaluate symptoms and quality of life relating to PFDs; it has 20 items and three scales for three different symptoms to assess symptoms of distress from UI (Urinary Distress Inventory-6), POP (Pelvic Organ Prolapse Distress Inventory-6), and defecatory dysfunction (Colo rectal-Anal Distress Inventory-8). By adding three subscales the score ranges from 0-300. The higher the score the greater the perceived impact that pelvic floor dysfunction has on a patient's life.	Baseline to 4th Week
Pelvic Floor Impact Questionnaire (PFQI)	The pelvic floor impact questionnaire was designed to evaluate symptoms and quality of life relating to PFDs; it included scales from the Urinary Impact Questionnaire. (UIQ-7), Pelvic Organ Prolapse Impact Questionnaire (POPIQ), Colorectal - Anal Impact Questionnaire -7(CRAIQ-7). All items use the following format with the response scale ranging from (0 to 3). Add the scores from the 3 scales together to obtain the summary score (range 0-300). Lower scores indicate less effect on QOL.	Baseline to 4th Week
Pelvic Floor Muscle Strength Assessment through MMT-oxford scale	The grading system used to determine the strength of the pelvic floor muscles is the Oxford Scale or Modified Oxford Scale. It is a subjective grading system used to assess the strength and quality of contraction of the pelvic floor muscles. The muscles will be assessed via an external vaginal examination. Score Ranges from 0-5 . higher score indicate better muscle strength.	Baseline to 4th Week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Zahra Ejaz, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2024
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: March 9, 2025
• First Posted (Actual): March 13, 2025

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathologic Processes; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Muscle Weakness; Pelvic Floor Disorders
• Other Study ID Numbers: Sanna

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