Pelvic Floor Muscle Exercise During Pregnancy

NCT06279455 | Completed DMC

• 1 other identifier: E-74555795-050.01.04-392120
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to evaluate the effects of pelvic floor muscle exercises during pregnancy on sexual function, lower urinary tract symptoms and birth process. The research was conducted with pregnant women who applied to the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital. Power analysis was performed to determine the number of samples to be included in the study. It was determined that 29 pregnant women should be included in each group (experimental and control). Considering the possibility of data loss, 50 pregnant women were included in each group. As a result of the exclusion of 8 women who withdrew from participating in the study, 5 women due to risky pregnancies (bleeding, preeclampsia and gestational diabetes) and 17 women due to cesarean delivery, the data of 35 pregnant women in the experimental group and 35 pregnant women in the control group were obtained. Pregnant women in the experimental group were gestational aged 18-20. Two sessions of training were given on female reproductive and urinary system anatomy, physiological changes during pregnancy and their effects on sexual life, and pelvic floor muscle exercises, using the "Pelvic Floor Health \& Sexual Life Training Booklet during Pregnancy" and the pelvic floor muscle exercise training video developed by the researcher between the weeks of pregnancy. Pregnant women were asked to perform pelvic floor muscle exercises, 3 sets a day, 3 days a week, for 12 weeks, starting from the 20th week of pregnancy, and record them in the Pelvic Floor Muscle Exercise Follow-up Form created by the researcher. Pregnant women in the control group were not given any training and were routinely monitored in the outpatient clinic. Pregnant women who apply to the outpatient clinic are examined by nurses, with their vital signs taken and anamnesis taken by the physician. Recommendations are made regarding the complaints of pregnant women. Non-stress tests are routinely applied to pregnant women who are at the 36th week of pregnancy and above.

Conditions

Lower Urinary Tract Symptoms; Sexual Function

Keywords

Lower Urinary Tract Symptoms; Pelvic Floor Muscle Exercise; Pregnancy; Sexual Function; Birth Process

Outcome Measures

Primary Outcomes (3)

• Sexual Function

  The outcome is sexual function of pregnant women. It will be measured with FSFI.

  12 weeks

• Lower Urinary Tract Symptoms

  The outcome is lower urinary tract symptoms of pregnant women. It will be measured with ICIQ-FLUTS LF.

  12 weeks

• Birth Process

  The outcome is birth outcomes. It will be evaluated with Birth Process Follow-up Form.

  18 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Pregnant women in the control group were not trained and routine follow-up was performed in the outpatient clinic. Female Sexual Function Index (FSFI) and International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms Long Form (ICIQ-FLUTS LF) at 18-20 weeks of gestation, Mid-term Evaluation Form at 26 weeks of gestation and FSFI and ICIQ-FLUTS LF at 32 weeks of gestation were applied to pregnant women in the control group participating in the study. Data on the birth process were collected between 3-7th days after birth with the Birth Process Follow-up Form.

Experimental Group

EXPERIMENTAL

Two sessions of training were given using the "Pelvic Floor Health \& Sexual Life in Pregnancy Training Booklet" and the pelvic floor muscle exercise training video developed by the researcher between 18-20 weeks of pregnancy. Before the training, the FSFI and the ICIQ-FLUTS LF were administered to the pregnant women. Pregnant women were asked to perform pelvic floor muscle exercises, 3 sets a day, 3 days a week, for 12 weeks, starting from the 20th week of pregnancy, and record them in the Pelvic Floor Muscle Exercise Follow-up Form created by the researcher. By scanning the literature, 1 set of exercise was determined as 8-12 slow contractions (6-8 seconds) followed by 3-4 fast contractions (1 second).

Other: Pelvic Floor Muscle Exercise

Interventions

Pelvic Floor Muscle Exercise OTHER

A 12-week pelvic floor muscle exercise program was applied to pregnant women.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between the 18th and 20th weeks of gestation,
• Nulliparous and single pregnancy,
• Sexually active,
• Body mass index before pregnancy \<30,
• Urinary incontinence and urinary infection are not diagnosed,
• Not having a psychiatric illness,
• The spouse does not have sexual dysfunction.

You may not qualify if:

• Pregnant women under 18 weeks and older than 20 weeks,
• Primiparous and multiparous,
• High-risk pregnancy (multiple pregnancy, preeclampsia, gestational diabetes, pregnancy with assisted reproductive techniques),
• Pregnant women who are scheduled for elective cesarean section,
• Those who give birth by cesarean section.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.Sc./Research Assistant

Model Details: Pelvic Floor Muscle Exercise Group

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: February 28, 2024
• Study Start: December 5, 2022
• Primary Completion: March 6, 2023
• Study Completion: October 30, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)