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Clinical Trials/NCT05719584
NCT05719584
Completed
Not Applicable

Effects of Pelvic Floor Muscle Training With and Without Hypopressive Exercises on Pelvic Organ Prolapse in Postmenopausal Females.

Riphah International University1 site in 1 country36 target enrollmentSeptember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Organ Prolapse
Sponsor
Riphah International University
Enrollment
36
Locations
1
Primary Endpoint
Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
Status
Completed
Last Updated
last year

Overview

Brief Summary

To compare the effects of pelvic floor muscle training with and without hypopressive exercises on pelvic organ prolapse in postmenopausal females

Detailed Description

In this randomized controlled trial multigravida, postmenopausal females with stage 1 and 2 pelvic organ prolapse will be taken (exclusion criteria includes cesarean section females, ovarian cysts ,UTIs and neoplasm). This study will be conducted in Jinnah hospital , Lahore. Sample size of 36 will be taken according to inclusion criteria. Study will be completed in 10 months after approval of synopsis. Non-Probability convenient sampling will be used. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups through lottery method, to either the Pelvic floor muscle training group or group with combined pelvic floor muscle exercise and hypopressive exercise. Treatment period will be 12 weeks 3 days per week. The participants will be advised not to use other forms of treatment during the trial (pharmacologic or non pharmacologic treatment). All subjects will be assessed before and after treatment by POP-Q, pelvic floor impact questionnaire and P-QOL. Data will be analyzed by using SPSS 25 statistical software.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
August 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Multigravida
  • Previous spontaneous vaginal deliveries
  • Diagnosed Stage 1 and 2 pelvic organ prolapse
  • Post-menopausal females

Exclusion Criteria

  • History of cesarean section
  • History of ovarian cysts
  • History of UTIs
  • History of neoplasm
  • Instrumental deliveries

Outcomes

Primary Outcomes

Pelvic Floor Impact Questionnaire-7 (PFIQ-7)

Time Frame: 12th week

It is a short and less comprehensive version of Pelvic Floor Impact Questionnaire (PFIQ). It is a health related questionnaire for women with pelvic floor conditions. consists of 7 questions that need to be answered 3 times each.

pelvic organ prolapse quantification (POP-Q)

Time Frame: 12th week

POP-Q can be seen in Many clinical settings \& published researches and it is used to grade and measure of pelvic organ prolapse during its assessment.

Prolapse Quality of life questionnaire(P-QOL)

Time Frame: 12th week

A simple, valid, reliable questionnaire to assess the severity of symptoms and their impact on the quality of life in women with Pelvic organ prolapse. There are several questions which a participant needs to answer.

Study Sites (1)

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