Development & Validation of Pregnancy Specific Pelvic Floor Rehab Protocol

NCT ID: NCT06875778

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-11
• Study Completion Date: 2025-07-30

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pelvic Floor Rehab Group

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

Group Type: EXPERIMENTAL

Pelvic Floor Exercises

Intervention Type: OTHER

Low intensity Warm Up Pelvic Floor Exercises and Cool down training

Interventions

Pelvic Floor Exercises

Low intensity Warm Up Pelvic Floor Exercises and Cool down training

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zahra Ejaz

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

King Abdullah Teaching Hospital

Mansehra, KPK, Pakistan

Countries

Pakistan

Other Identifiers

Sanna

Identifier Type: -

Identifier Source: org_study_id