Kegal Exercises With and Without Postural Correction on Postpartum Pelvic Organ Prolapse in Primiparous Women

May 9, 2023 updated by: Riphah International University

Effects of Kegal Exercises With and Without Postural Correction on Postpartum Pelvic Organ Prolapse in Primiparous Women

To study the effects of kegal exercises with and without postural correction on pelvic organ prolapse in primiparous women. Although pregnancy is a physiological process, it is associated with risk factors. These risk factors can put women at risk. One of the most common problems is pelvic floor muscle weakness, and this weakness of pelvic floor muscles causes many other problems, such as pelvic organ prolapse. Normal delivery (vaginal delivery) can cause laxity and weakness of ligaments such as the external urethral and pubourethral. Pelvic organs prolapse severely affects the quality of life of patients. Pelvic organ prolapse appears in women after vaginal delivery. Pelvic muscle training is a conservative treatment for many problems, including pelvic organ prolapse. However, the effects of pelvic floor muscle training for pelvic organ prolapse in primiparous women are controversial. This study is aimed at a systematic review of the effects of pelvic floor muscle training on pelvic organ prolapse in primiparous women.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The design of this study will randomize controlled trial. Data will collect from the Settings of Jinnah Hospital Lahore, THQ Hospital Depalpur, and Al-Shifa Hospital Depalpur. The sample size for this study is 30 primiparous women. Participants will be screened for eligibility. Women will be randomly assigned to the training group, which conducts 12 weekly individual sessions. Outcomes will be assessed after the last session. The control group will receive kegal exercise after the initial assessment. Main outcome measures for this study include the symptoms pelvic floor impact questionnaire, the pelvic floor distress inventory questionnaire, and the pelvic organ prolapse quantification examination. The pelvic floor impact questionnaire will assess the lifelong impact of pelvic floor disorders on women.

A pelvic floor distress inventory questionnaire will assess distress caused by PFD (pelvic floor dysfunction).

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54660
        • Recruiting
        • Services Hospital
        • Contact:
        • Principal Investigator:
          • Hafsa Khalid, MS(WHPT)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Primiparous,Age: 20-40,
  • 6th to 8th week after delivery,
  • Singleton baby vaginally fully term,
  • Non instrumented birth of child,
  • Grade 1 prolapse (5)

Exclusion Criteria:

  • Women with Chronic Cough,
  • Constipation,
  • Previous Pelvic surgery,
  • Pelvic malignancy,
  • Genitourinary Infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kegal exercises with postural correction
Other: Kegal exercises with postural correction
Kegal exercises with postural correction
Experimental: Kegal exercises without postural correction
Other: Kegal exercises without postural correction
Kegal exercises without postural correction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic Floor Impact Questionnaire. (PFIQ-7)
Time Frame: 1st day
The PFIQ is a patient report designed to assess life impact of pelvic floor disorders on women
1st day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Hafiza Mehjabeen, MS(WHPT), Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

June 3, 2023

Study Completion (Anticipated)

June 3, 2023

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/23/0517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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