Pelvic Floor Muscle WeaknessNCT06338371
Effect of Pelvic Floor Muscle Exercise on Sexual Function
A study testing Pelvic Floor exercise training in people with Pelvic Floor Muscle Weakness and Sexuality, run by Serap Tekbas at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Muscle Weakness, Sexuality
- What is being tested?
- Pelvic Floor exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 6 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-49
- Women who have not entered menopause
- Women with regular sexual life.
Who cannot join
- Women in menopause
- Women diagnosed with gynecological cancer
- Women who do not have a regular sexual life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pelvic Floor Muscle Exercise on Sexual Function in Women of Reproductive Age:A Randomized-Controlled Tria
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
Read the 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.
- Conditions
- Pelvic Floor Muscle Weakness, Sexuality
- Being tested
- Pelvic Floor exercise training
- Keywords
- Pelvic floor muscle, exercise, sexual function, reproductive age
- Medical subject headings
- Sexuality, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Training Content | Experimental | Group receiving training on pelvic floor exercise Receives: Behavioral: Pelvic Floor exercise training |
| Control Group | No intervention | Untrained group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Baseline (Before training)
Secondary outcomes (4)
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.
Measured: Baseline (Before training)
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.
Measured: 1st Month
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.
Measured: 2st Month
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.
Measured: 3st Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Nov 2021
- Primary completion6 Apr 2022
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serap Tekbas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Serap Tekbas, Izmir Tinaztepe University
- Investigators
- Serap Tekbaş, Principal investigator, Head of Midwifery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338371
- Sponsor's protocol ID
- IZTU-TEKBAŞ-001
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27648093Tekbas 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.
PubMed 40958332
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pelvic Floor Muscle Exercise on Sexual Function in Women of Reproductive Age:A Randomized-Controlled Tria
- ClinicalTrials.gov ID
- NCT06338371
- Acronym / sponsor ID
- IZTU-TEKBAŞ-001
- Conditions
- Pelvic Floor Muscle Weakness, Sexuality
- Keywords
- Pelvic floor muscle, exercise, sexual function, reproductive age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Serap TekbasUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Content | Experimental | Behavioral: Pelvic Floor exercise trainingGroup receiving training on pelvic floor exercise |
| Control Group | No intervention | –Untrained group |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 18-49
- Women who have not entered menopause
- Women with regular sexual life.
Key exclusion criteria (3 listed)
- Women in menopause
- Women diagnosed with gynecological cancer
- Women who do not have a regular sexual life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Floor exercise trainingThe 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. | Behavioural | Training Content |
Primary outcome
Determining Number of Participants
Time frame: Baseline (Before training)
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
Initial scale application
Time frame: Baseline (Before training)
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.
Distribution of participants into groups
Time frame: Baseline (Before training)
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.
4 secondary outcomes
Providing pelvic floor exercise for training group
Time frame: Baseline (Before training)
Female Sexual Function Index
Time frame: 1st Month
Female Sexual Function Index
Time frame: 2st Month
Female Sexual Function Index
Time frame: 3st Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Background: PubMed 27648093Eftekhar 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.
- Derived from this study: PubMed 40958332Tekbas 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.
- DeUgarte CM, Berman L, Berman J. Female sexual dysfunction-from diagnosis to treatment. Sexuality, Reproduction and Menopause 2004; 2 (3), 139-145.Link provided by the sponsor.
- Wright JJ, O'Connor KM. Female sexual dysfunction. Medical Clinics of North America 2015; 99 (3), 607-628Link provided by the sponsor.
- 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), 991-996Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Pelvic Floor Muscle Weakness
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Effects of Kegel Ball and Pelvic Floor Exercises on Sexual Function, Unrınary Incontinence and Quality of Life in Women
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Enrolling by invitationObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serap Tekbaş principal investigator
Head of Midwifery Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor exercise training in people with Pelvic Floor Muscle Weakness and Sexuality, run by Serap Tekbas at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining Number of Participants (time frame: Baseline (Before training)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06338371, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.