Effect of Pelvic Floor Muscle Exercise on Sexual Function

NCT06338371 | Completed

• 1 other identifier: IZTU-TEKBAŞ-001
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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

Conditions

Pelvic Floor Muscle Weakness; Sexuality

Keywords

Pelvic floor muscle; exercise; sexual function; reproductive age

Outcome Measures

Primary Outcomes (3)

• 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 \[(SD±6.5) with an α of 5% and a power of 80% (1-ß)\], 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)

• 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)

• 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 Outcomes (4)

• Providing pelvic floor exercise for training group

  Baseline (Before training)

• Female Sexual Function Index

  1st Month

• Female Sexual Function Index

  2st Month

• Female Sexual Function Index

  3st Month

Study Arms (2)

Training Content

EXPERIMENTAL

Group receiving training on pelvic floor exercise

Behavioral: Pelvic Floor exercise training

Control Group

NO INTERVENTION

Untrained group

Interventions

Pelvic Floor exercise training BEHAVIORAL

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.

Training Content

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: A study was planned in which the sample group consisted only of women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Serap Tekbas: lead

Study Sites (1)

Izmir Tinaztepe University

Izmir, Buca, 35400, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 27648093 BACKGROUND

• Tekbas S. The effect of pelvic floor muscle exercise on sexual function in women of reproductive age: A randomized controlled trial. Medicine (Baltimore). 2025 Sep 12;104(37):e44324. doi: 10.1097/MD.0000000000044324.

  PMID: 40958332 DERIVED

Related Links

• DeUgarte CM, Berman L, Berman J. Female sexual dysfunction-from diagnosis to treatment. Sexuality, Reproduction and Menopause 2004; 2 (3), 139-145.
• Wright JJ, O'Connor KM. Female sexual dysfunction. Medical Clinics of North America 2015; 99 (3), 607-628
• 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

MeSH Terms

Conditions

Sexuality; Motor Activity

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Serap Tekbaş

  Head of Midwifery Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 29, 2024
• Study Start: November 1, 2021
• Primary Completion: April 6, 2022
• Study Completion: May 6, 2022
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)