Clinical trial NCT06338371: Effect of Pelvic Floor Muscle Exercise on Sexual Function
Official title: The Effect of Pelvic Floor Muscle Exercise on Sexual Function in Women of Reproductive Age:A Randomized-Controlled Tria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Muscle Weakness
Sexuality
Keywords: Pelvic floor muscle
exercise
sexual function
reproductive age
Lead sponsor: Izmir Tinaztepe University
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this evaluate the effect of pelvic floor muscle exercises on sexual function in women of reproductive age. A randomized controlled trial was conducted in a sample of women of reproductive age, 77 women were randomly assigned to control (n=39) and training (n=38) groups. A form including questions regarding socio-demographic characteristics and the Female Sexual Function Index was applied to all women included in the study. Pelvic floor exercise training was given to the women in the training group and the Female Sexual Function Index was applied to both groups in the 1st, 2nd, and 3rd months. The differences between those who received and those who did not receive training and the effects of regular pelvic exercise on sexual function were evaluated by month.

Research Hypotheses H1: Sexual function scores of women of reproductive age who regularly perform pelvic floor muscle exercises are higher than those who do not exercise.

H2: Sexual function scores are higher for those who regularly exercise their pelvic floor muscles for at least two months

Detailed description: The research has a prospective, randomized controlled design.

Inclusion criteria of the study:

Women aged between 18-49 who agreed to participate in the study and who had a regular sexual life were included in the study.

Exclusion criteria of the study:

Women who did not have a regular sex life, who had undergone an operation that prevented them from doing pelvic floor exercises, and who exercised regularly because it could strengthen the pelvic muscles and affect the results of the study were excluded from the study. In addition, menopausal women were not included in the study

The purpose of the research was explained and women between the ages of 18-49 were invited to participate from social media platforms. The level of sexual function was determined by implementing FSFI for all individuals included in the sample. The participants were divided into two groups, control and training groups, using the randomization program on the computer. Pelvic floor exercise training was given to one group. The training was given online due to the COVID-19 pandemic. Four groups were formed for the training. Three groups consisted of ten people and one group of eight people. Trainings were conducted online on different days. Each training lasted 120 minutes. 70 minutes of the training consisted of theoretical information, 30 minutes of the training consisted of watching videos about the application of pelvic floor exercises, and the last 20 minutes consisted of taking the questions of the participants on the subject and answering these questions. After training was completed, women in the training group were instructed to perform three sets of 8-12 repetitive pelvic floor muscle contractions per day and to use an exercise diary to record their practice. Women in the training group were also given a booklet and the recording of the training video was shared. the training, a brochure explaining how to perform the pelvic floor muscle exercises, which was included in the training content, was prepared and delivered to the training group on the first day of each week. After the training, FSFI was applied to both groups (who received and did not receive the training) 3 times, in the 1st, 2nd, and 3rd months.

Eligibility criteria: Inclusion Criteria:

* Women aged 18-49
* Women who have not entered menopause
* Women with regular sexual life.

Exclusion Criteria:

* Women in menopause
* Women diagnosed with gynecological cancer
* Women who do not have a regular sexual life

Primary outcomes:
measure: Determining Number of Participants
timeFrame: Baseline (Before training)
measure: Initial scale application
timeFrame: Baseline (Before training)
measure: Distribution of participants into groups
timeFrame: Baseline (Before training)
Secondary outcomes:
measure: Providing pelvic floor exercise for training group
timeFrame: Baseline (Before training)
measure: Female Sexual Function Index
timeFrame: 1st Month
measure: Female Sexual Function Index
timeFrame: 2st Month
measure: Female Sexual Function Index
timeFrame: 3st Month
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Tinaztepe University
state: Buca
Study officials:
affiliation: Head of Midwifery Department
name: Serap Tekbaş
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eftekhar T, Dashti M, Shariat M, Haghollahi F, Raisi F, Ghahghaei-Nezamabadi A. Female Sexual Function During the Menopausal Transition in a Group of Iranian Women. J Family Reprod Health. 2016 Jun;10(2):52-8.