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OpenTrials
Completed

NCT Number: NCT06875778

Development & 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.

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Key information

Conditions

Pelvic Floor Disorder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pelvic Floor Disorders Pelvic Floor Muscle Training Pelvic Floor Muscle Weakness Pregnancy Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

King Abdullah Teaching Hospital

Mansehra, KPK, 21300, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pelvic floor exercises

Other

Low intensity Warm Up Pelvic Floor Exercises and Cool down training

Primary outcomes

  1. Pelvic Floor Distress Inventory (PFDI)

    Time frame: Baseline to 4th Week

    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.

  2. Pelvic Floor Impact Questionnaire (PFQI)

    Time frame: Baseline to 4th Week

    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.

  3. Pelvic Floor Muscle Strength Assessment through MMT-oxford scale

    Time frame: Baseline to 4th Week

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Development and Validation of Pregnancy Specific Pelvic Floor Rehab Protocol

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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