Kegal Exercises With and Without Postural Correction on Postpartum Pelvic Organ Prolapse in Primiparous Women
Primary Purpose
Pelvic Organ Prolapse
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Kegal exercises with postural correction
Kegal exercises without postural correction
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse
Eligibility Criteria
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
Sites / Locations
- Services HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Kegal exercises with postural correction
Kegal exercises without postural correction
Arm Description
Outcomes
Primary Outcome Measures
Pelvic Floor Impact Questionnaire. (PFIQ-7)
The PFIQ is a patient report designed to assess life impact of pelvic floor disorders on women
Secondary Outcome Measures
Full Information
NCT ID
NCT05851729
First Posted
March 31, 2023
Last Updated
May 9, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05851729
Brief Title
Kegal Exercises With and Without Postural Correction on Postpartum Pelvic Organ Prolapse in Primiparous Women
Official Title
Effects of Kegal Exercises With and Without Postural Correction on Postpartum Pelvic Organ Prolapse in Primiparous Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 3, 2023 (Anticipated)
Study Completion Date
June 3, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Kegal exercises with postural correction
Arm Type
Experimental
Arm Title
Kegal exercises without postural correction
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Kegal exercises with postural correction
Intervention Description
Kegal exercises with postural correction
Intervention Type
Other
Intervention Name(s)
Kegal exercises without postural correction
Intervention Description
Kegal exercises without postural correction
Primary Outcome Measure Information:
Title
Pelvic Floor Impact Questionnaire. (PFIQ-7)
Description
The PFIQ is a patient report designed to assess life impact of pelvic floor disorders on women
Time Frame
1st day
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Misbah Jaffar, MS(WHPT)
Phone
03069680832
Email
mishijaffar1998@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafiza Mehjabeen, MS(WHPT)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Services Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54660
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hafiza Mehjabeen, MSWHPT
Phone
03026577666
Email
hafiza.mehjabeen@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Hafsa Khalid, MS(WHPT)
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36995416
Citation
Sigurdardottir T, Steingrimsdottir T, Geirsson RT, Halldorsson TI, Aspelund T, Bo K. Postpartum pelvic organ prolapse and pelvic floor muscle training: secondary analysis of a randomized controlled trial of primiparous women. Int Urogynecol J. 2023 Jun;34(6):1319-1326. doi: 10.1007/s00192-023-05502-8. Epub 2023 Mar 30.
Results Reference
background
PubMed Identifier
32019378
Citation
Artymuk NV, Khapacheva SY. Device-assisted pelvic floor muscle postpartum exercise programme for the management of pelvic floor dysfunction after delivery. J Matern Fetal Neonatal Med. 2022 Feb;35(3):481-485. doi: 10.1080/14767058.2020.1723541. Epub 2020 Feb 4.
Results Reference
background
Learn more about this trial
Kegal Exercises With and Without Postural Correction on Postpartum Pelvic Organ Prolapse in Primiparous Women
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