Clinical trial NCT05851729: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Pelvic Floor Impact Questionnaire. (PFIQ-7)
timeFrame: 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Hafiza Mehjabeen, MS(WHPT)
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.