Pelvic Floor DisorderNCT06875778
Development & Validation of Pregnancy Specific Pelvic Floor Rehab Protocol
A study testing Pelvic Floor Exercises in people with Pelvic Floor Disorder and Pelvic Floor Muscle Weakness, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pelvic Floor Disorder, Pelvic Floor Muscle Weakness, Pelvic Floor Muscle Training
- What is being tested?
- Pelvic Floor Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Feb 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Pelvic Floor Exercises
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor ExercisesOther
Low intensity Warm Up Pelvic Floor Exercises and Cool down training
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Rehab Group | Experimental | This Group will receive a developed Pelvic floor exercises protocol for 4 Weeks Receives: Other: Pelvic Floor Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to 4th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start11 Feb 2024
- Primary completion1 Apr 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisorderStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This will be a Pretest- Post test Study Design with assignment of Patients in 1 group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zahra Ejaz, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875778
- Sponsor's protocol ID
- Sanna
- Status last verified
- Aug 2025
- First submitted
- 20 Feb 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Pregnancy Specific Pelvic Floor Rehab Protocol
- ClinicalTrials.gov ID
- NCT06875778
- Acronym / sponsor ID
- Sanna
- Conditions
- Pelvic Floor Disorder, Pelvic Floor Muscle Weakness, Pelvic Floor Muscle Training, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 11 Feb 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a Pretest- Post test Study Design with assignment of Patients in 1 group
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Rehab Group | Experimental | Other: Pelvic Floor ExercisesThis Group will receive a developed Pelvic floor exercises protocol for 4 Weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Floor ExercisesLow intensity Warm Up Pelvic Floor Exercises and Cool down training | Other | Pelvic Floor Rehab Group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahra Ejaz principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Exercises in people with Pelvic Floor Disorder and Pelvic Floor Muscle Weakness, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Floor Distress Inventory (PFDI) (time frame: Baseline to 4th Week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.