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

• Sponsor: Riphah International University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05851729
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Other: Kegal exercises with postural correction; Other: Kegal exercises without postural correction	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Kegal Exercises With and Without Postural Correction on Postpartum Pelvic Organ Prolapse in Primiparous Women
• Actual Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Jun 3, 2023
• Anticipated Study Completion Date: Jun 3, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pelvic Floor Impact Questionnaire. (PFIQ-7) [1st day]

   The PFIQ is a patient report designed to assess life impact of pelvic floor disorders on women

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Services Hospital	Lahore	Punjab	Pakistan	54660

Sponsors and Collaborators

• Riphah International University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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 Mar 30. doi: 10.1007/s00192-023-05502-8. Online ahead of print.

• Responsible Party: Riphah International University
• ClinicalTrials.gov Identifier: NCT05851729
• Other Study ID Numbers: REC/RCR&AHS/23/0517
• First Posted: May 10, 2023
• Last Update Posted: May 10, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of May 10, 2023