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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05851729
• Other study ID #: REC/RCR&AHS/23/0517
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 3, 2023

Study information

• Verified date: May 2023
• Source: Riphah International University
• Contact: Misbah Jaffar, MS(WHPT)
• Phone: 03069680832
• Email: mishijaffar1998[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 3, 2023
• Est. primary completion date: June 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• Kegal exercises with postural correction
Kegal exercises with postural correction
• Kegal exercises without postural correction
Kegal exercises without postural correction

Locations

Country	Name	City	State
Pakistan	Services Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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

Outcome

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