Clinical trial NCT06875778: Development & Validation of Pregnancy Specific Pelvic Floor Rehab Protocol
Official title: Development and Validation of Pregnancy Specific Pelvic Floor Rehab Protocol
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pelvic Floor Disorder
Pelvic Floor Muscle Weakness
Pelvic Floor Muscle Training
Pregnancy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This will be a Pretest- Post test Study Design with assignment of Patients in 1 group
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pelvic Floor Distress Inventory (PFDI)
timeFrame: Baseline to 4th Week
measure: Pelvic Floor Impact Questionnaire (PFQI)
timeFrame: Baseline to 4th Week
measure: Pelvic Floor Muscle Strength Assessment through MMT-oxford scale
timeFrame: Baseline to 4th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Mansehra
country: Pakistan
facility: King Abdullah Teaching Hospital
state: KPK
Study officials:
affiliation: Riphah International University
name: Zahra Ejaz
role: PRINCIPAL_INVESTIGATOR
References: