Development & Validation of Pregnancy Specific Pelvic Floor Rehab Protocol

NCT06875778 | Completed

• 1 other identifier: Sanna
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Floor Disorder; Pelvic Floor Muscle Weakness; Pelvic Floor Muscle Training; Pregnancy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Pelvic Floor Rehab Group

EXPERIMENTAL

This Group will receive a developed Pelvic floor exercises protocol for 4 Weeks

Other: Pelvic Floor Exercises

Interventions

Pelvic Floor Exercises OTHER

Low intensity Warm Up Pelvic Floor Exercises and Cool down training

Pelvic Floor Rehab Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Gender must be Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

King Abdullah Teaching Hospital

Mansehra, KPK, 21300, Pakistan

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Zahra Ejaz

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a Pretest- Post test Study Design with assignment of Patients in 1 group

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 13, 2025
• Study Start: February 11, 2024
• Primary Completion: April 1, 2025
• Study Completion: July 30, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)