Clinical trial NCT06279455: Pelvic Floor Muscle Exercise During Pregnancy
Official title: Evaluation of the Effect of Pelvic Floor Muscle Exercise During Pregnancy on Sexual Function, Lower Urinary Tract Symptoms and Birth Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Sexual Function
Keywords: Lower Urinary Tract Symptoms
Pelvic Floor Muscle Exercise
Pregnancy
Sexual Function
Birth Process
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pelvic Floor Muscle Exercise Group
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Purpose of the research 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.

Type of Research This research is of randomized controlled prospective type.

Place and Time the Research The research was conducted at the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital, Department of Gynecology and Obstetrics, between December 2022 and October 2023.

Population and Sample of the Research The population of the research consisted of pregnant women who applied to the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital, Department of Gynecology and Obstetrics. G\*Power (3.1.9.7) Program was used to determine the sample number of pelvic floor muscle exercise (experimental group) and control groups. The Female Sexual Function Index was taken as the main parameter in the study. As a result of the power analysis performed with α=0.05 and power of 95% (effect size: 0.7), the sample was calculated as 29 pregnant women for each group. Considering that there may be losses during the study period, it was decided to include a total of 100 pregnant women between the ages of 18-40, including the experimental group (n = 50) and the control group (n = 50).

The numbers to be included in the sample were determined using the randomization program (www.randomizer.org).

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.

Research data were collected with "Personal Information Form" (between 18-20th week of pregnancy), "Female Sexual Function Index" (between 18-20th week of pregnancy and 32nd week of pregnancy), "Mid-term Evaluation Form" (26th week of pregnancy), "International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms Long Form (ICIQ-FLUTS LF)" (between 18-20th week of pregnancy and 32nd week of pregnancy), "Birth Process Follow-up Form" (between 3-7th days after birth) and "Pelvic Floor Muscle Exercise Follow-up Form" (20-32 between weeks of pregnancy).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Sexual Function
timeFrame: 12 weeks
measure: Lower Urinary Tract Symptoms
timeFrame: 12 weeks
measure: Birth Process
timeFrame: 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References: