Effect of Pelvic Floor Muscle Exercise on Sexual Function

Sexuality Clinical Trial

Official title:

The Effect of Pelvic Floor Muscle Exercise on Sexual Function in Women of Reproductive Age:A Randomized-Controlled Tria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06338371
• Other study ID #: IZTU-TEKBAS-001
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: May 6, 2022

Study information

• Verified date: March 2024
• Source: Izmir Tinaztepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: May 6, 2022
• Est. primary completion date: April 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Pelvic Floor Muscle Weakness
• Sexuality

Intervention

Behavioral:
• Pelvic Floor exercise training
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. Trainings were conducted online on different days. Each training lasted 120 minutes. 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 3 times, in the 1st, 2nd, and 3rd months.

Locations

Country	Name	City	State
Turkey	Izmir Tinaztepe University	Izmir	Buca

Sponsors (1)

Lead Sponsor	Collaborator
Serap Tekbas

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determining Number of Participants	Power calculation was made to determine the size of the sample constituting the training and control groups. In the power analysis performed for the training and control groups in line with the literature data [(SD±6.5) with an a of 5% and a power of 80% (1-ß)], the expected sample size was determined as a total of 68 people, 34 in the training group and 34 in the control group13. However, considering the possible data loss, it was decided to include 40 individuals in each group. Data were collected using Google Forms through social media platforms. Women who volunteered to participate in the study were invited and written consent was taken from the individuals included in the study. 80 women who agreed to participate were included in the study of women who agreed to participate in the study. Sample group n=80	Baseline (Before training)
Primary	Initial scale application	Women's Descriptive Characteristics: The form was prepared by the researcher in line with the literature and consists of 23 questions regarding sociodemographic characteristics, general health status, and obstetric characteristics of women.; Female Sexual Function Index (FSFI): The scale was created by Rosen et al. in 2000 in order to evaluate sexual function. It includes 19 questions and evaluates desire, arousal, lubrication, orgasm, satisfaction, and pain in a multidimensional way. The highest raw score obtainable from the index is 36 and the lowest raw score is 2. An increase in the scores on the total index and the sexual desire, arousal, lubrication, orgasm, and general satisfaction subscales indicate an improvement in all these parameters.	Baseline (Before training)
Primary	Distribution of participants into groups	The sample group was randomly divided into training and control. The study protocol for the trial was created using SPIRIT guidelines and the trial reporting was created according to the CONSORT checklist. In order to avoid selection bias in the study, patients were assigned to the experimental and control groups with the block randomization method. The n=80 samples included in the study were randomly divided into case (n=40) and control (n=40) groups with the help of the "Random Allocation Software" computer program.	Baseline (Before training)
Secondary	Providing pelvic floor exercise for training group	Pelvic Floor Muscle Exercise training was given implemented to the training group Pelvic floor exercise training was given to the control group. A 120-minute training program was created to implement pelvic floor muscle exercises and explain the pelvic muscles. 70 minutes of the training consisted of theoretical information, 30 minutes of watching videos on the application of pelvic floor exercises, and the last 20 minutes of the training consisted of taking and answering questions from the participants on the subject.	Baseline (Before training)
Secondary	Female Sexual Function Index	Female Sexual Function Index (FSFI): The scale was created by Rosen et al. in 2000 in order to evaluate sexual function. It includes 19 questions and evaluates desire, arousal, lubrication, orgasm, satisfaction, and pain in a multidimensional way. The highest raw score obtainable from the index is 36 and the lowest raw score is 2. An increase in the scores on the total index and the sexual desire, arousal, lubrication, orgasm, and general satisfaction subscales indicate an improvement in all these parameters.	1st Month
Secondary	Female Sexual Function Index	Female Sexual Function Index (FSFI): The scale was created by Rosen et al. in 2000 in order to evaluate sexual function. It includes 19 questions and evaluates desire, arousal, lubrication, orgasm, satisfaction, and pain in a multidimensional way. The highest raw score obtainable from the index is 36 and the lowest raw score is 2. An increase in the scores on the total index and the sexual desire, arousal, lubrication, orgasm, and general satisfaction subscales indicate an improvement in all these parameters.	2st Month
Secondary	Female Sexual Function Index	Female Sexual Function Index (FSFI): The scale was created by Rosen et al. in 2000 in order to evaluate sexual function. It includes 19 questions and evaluates desire, arousal, lubrication, orgasm, satisfaction, and pain in a multidimensional way. The highest raw score obtainable from the index is 36 and the lowest raw score is 2. An increase in the scores on the total index and the sexual desire, arousal, lubrication, orgasm, and general satisfaction subscales indicate an improvement in all these parameters.	3st Month

External Links

•   Berman JR, Adhikari SP, Goldstein I. Anatomy and physiology of female sexual function and dysfunction. European urology 2000;38(1),20-29
•   Braekken IH, Majida M, Ellstrom EM, Bø, K. Can pelvic floor muscle training improve sexual function in women with pelvic organ prolapse? A randomized controlled trial. J Sex Med 2015; 14:470-480
•   DeUgarte CM, Berman L, Berman J. Female sexual dysfunction-from diagnosis to treatment. Sexuality, Reproduction and Menopause 2004; 2 (3), 139-145.
•   Kanter G, Rogers RG, Pauls RN, Kammerer-Doak, D, Thakar, RA strong pelvic floor is associated with higher rates of sexual activity in women with pelvic floor disorders. International urogynecology journal 2015; 26(7), 991-996
•   Wright JJ, O'Connor KM. Female sexual dysfunction. Medical Clinics of North America 2015; 99 (3), 607-628