Sexual FunctionNCT07030608
The Effect Of Pelvic Floor Muscle Exercises On Sexual Life In Women With Overactive Bladder
A study testing Exercise in people with Sexual Function and Over Active Bladder, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
This is a randomized controlled experimental study to determine the effect of pelvic floor muscle exercise on sexual life. The study included 64 women admitted to the Erzurum City Hospital, who consented to participate. They were divided into intervention ond control groups (n=32). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Sexual Function, Over Active Bladder
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Mar 2025
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between 18 and 70 years of age
- Speaking Turkish
- Being literate
- Having a diagnosis of Overactive Bladder (OAB)
- Currently receiving pharmacological treatment for OAB
- Being willing to participate in the study voluntarily
Who cannot join
- Presence of perceptual impairments or psychiatric disorders that interfere with communication
- Diagnosis of a neurological disease
- Presence of neuropathy due to Diabetes Mellitus
- Pelvic organ prolapse at Stage 2 or higher
- History of anti-incontinence surgery
- Being pregnant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Biruni Üniversitesi
Istanbul, Zeytinburnu, 34051
About this study
Official title: The Effect of Pelvic Floor Muscle Exercises on Sexual Life in Women With Overactive Bladder
This is a randomized controlled experimental study to determine the effect of pelvic floor muscle exercise on sexual life.
The study included 64 women admitted to the Erzurum City Hospital, who consented to participate. They were divided into intervention ond control groups (n=32). Pelvic Floor Muscle Exercise *PFME* was applied to the intervention group for 6 weeks with the Simplex Device accompanied by biofeedback in accordance with the PFME application procedure. The control group received routine care.
Read the detailed description
This is a randomized controlled experimental study . The research was carried out in the Erzurum City Hospital. This study, which was conducted to examine the effect of pelvic floor muscle exercises *PFME* on sexual life in women with overactive bladder *OAB* , was conducted with 64 women (32 women: control group, 32 women: intervention group) who applied to the Erzurum City Hospital Urology Polyclinic between December 1, 2021 and December 1, 2024.
Research Hypotheses:
H1: Overactive bladder symptoms are positively affected in women with OAB who perform pelvic floor exercises.
H2: Sexual function is positively affected in women with OAB who perform pelvic floor exercises.
H3: Depression symptoms are positively affected in women with OAB who perform pelvic floor exercises.
H4: Sexual quality of life is positively affected in women with OAB who perform pelvic floor exercises.
H5: Pelvic muscle strength increases in women with OAB who undergo pelvic floor muscle training.
H6: The contraction, relaxation, and percentage of maximum voluntary contraction *MVC* % of pelvic floor muscles improve in women with OAB who undergo pelvic floor muscle training.
Implementation:
The intervention group performed a pelvic floor muscle exercise program in addition to the pharmacological treatment routinely provided at the hospital. Pelvic floor muscle exercises-including identifying the correct muscle, contraction, and relaxation-were taught by the researcher using biofeedback via the Simplex device. The training was reinforced through the use of biofeedback techniques, including a game integrated into the Simplex software, as well as verbal cues provided by the researcher .
To ensure proper continuation of the exercises and to help participants remember them, a handbook prepared by the researcher was provided (Pelvic Floor Muscle Exercise Training Handbook for Women with Overactive Bladder). Participants were asked to complete the Pelvic Floor Muscle Exercise Practice Tracking Form after each exercise session.
Additionally, the women were contacted weekly by the researcher via telephone. They were either invited to the hospital for follow-up or visited at home for evaluation and feedback.
Pelvic Floor Muscle Exercise Program
Week 1:
Contract the pelvic floor muscles for 6 seconds, then relax for 6 seconds. Repeat 25 times. Perform 3 sessions per day (total of 75 contractions per day).
Week 2:
Contract for 6 seconds, relax for 6 seconds. Repeat 50 times. Perform 3 sessions per day (total of 150 contractions per day).
Week 3:
Contract for 6 seconds, relax for 6 seconds. Repeat 75 times. Perform 3 sessions per day (total of 225 contractions per day).
Weeks 4-24:
Contract for 6 seconds, relax for 6 seconds. Repeat 100 times. Perform 3 sessions per day (total of 300 contractions per day).
After Week 24:
Contract for 6 seconds, relax for 6 seconds. Repeat 50 times. Perform 3 sessions per day (total of 150 contractions per day).
Alternatively (preferred option):
Contract for 6 seconds, relax for 6 seconds. Repeat 75 times. Perform 2 sessions per day (total of 150 contractions per day).
Women in the control group did not receive any intervention or pelvic floor muscle exercise training.
- Conditions
- Sexual Function, Over Active Bladder
- Being tested
- Exercise
- Keywords
- over active bladder, Pelvic Floor Muscle, sexual function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Pelvic Floor Muscle Exercise Program Week 1: Contract the pelvic floor muscles for 6 seconds, then relax for 6 seconds. Repeat 25 times. Perform 3 sessions per day (total of 75 contractions per day). Week 2: Contract for 6 seconds, relax for 6 seconds. Repeat 50 times. Perform 3 sessions per day (total of 150 contractions per day). Week 3: Contract for 6 seconds, relax for 6 seconds. Repeat 75 times. Perform 3 sessions per day (total of 225 contractions per day). Weeks 4-24: Contract for 6 seconds, relax for 6 seconds. Repeat 100 times. Perform 3 sessions per day (total of 300 contractions per day). After Week 24: Contract for 6 seconds, relax for 6 seconds. Repeat 50 times. Perform 3 sessions per day (total of 150 contractions per day).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Women in the control group did not receive any intervention or pelvic floor muscle exercise training. |
| Intervention | Experimental | The intervention group performed a pelvic floor muscle exercise program in addition to the pharmacological treatment routinely provided at the hospital. Pelvic Floor Muscle Exercise Program Week 1: Contract the pelvic floor muscles for 6 seconds, then relax for 6 seconds. Repeat 25 times. Perform 3 sessions per day (total of 75 contractions per day). Week 2: Contract for 6 seconds, relax for 6 seconds. Repeat 50 times. Perform 3 sessions per day (total of 150 contractions per day). Week 3: Contract for 6 seconds, relax for 6 seconds. Repeat 75 times. Perform 3 sessions per day (total of 225 contractions per day). Weeks 4-24: Contract for 6 seconds, relax for 6 seconds. Repeat 100 times. Perform 3 sessions per day (total of 300 contractions per day). After Week 24: Contract for 6 seconds, relax for 6 seconds. Repeat 50 times. Perform 3 sessions per day (total of 150 contractions per day). Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Over active bladder questionnaire
This questionnaires evaluates urination frequency, sudden feeling of urgency, nocturia, urge type incontinence symptoms. It consists of 8 questions that patients can rate the severity of their complaints as none (0); very little (1); a little (2); quite a bit (3); a lot (4); and very much (5).
Measured: Change from beginning of the study and after 6th week of exercise program
pelvic floor muscle contraction strength
Pelvic floor muscle strength measurement by digital palpation
Measured: Change from beginning of the study and after 6th week of exercise program
pelvic floor muscle contraction strength
Pelvic floor muscle strength measurement by Simplex device
Measured: Change from beginning of the study and after 6th week of exercise program
pelvic floor muscle relaxation strength
Pelvic floor muscle strength measurement by Simplex device
Measured: Change from beginning of the study and after 6th week of exercise program
Female Sexual Function Index Scores ≤ 26.55
The Female Sexual Function Index consists of 19 items that measure six domains of female sexual function:
Desire (2 items)
Arousal (4 items)
Lubrication (4 items)
Orgasm (3 items)
Satisfaction (3 items)
Pain (3 items; includes discomfort during or after vaginal penetration) Each item is scored on a Likert-type scale, typically ranging from 0 or 1 to 5.Total score range: 2.0 to 36.0 Cut-off score: A total FSFI score of ≤26.55 is commonly used to indicate female sexual dysfunction (FSD).
Measured: Change from beginning of the study and after 6th week of exercises program
Center of Epidemiologic Studies Depression Scale
The Center of Epidemiologic Studies Depression Scale is designed to assess the frequency and severity of symptoms associated with depression. The original CES-D contains 20 items.Each item is scored on a 4-point Likert scale:
0 = Rarely or none of the time (<1 day)
- = Some or a little of the time (1-2 days)
- = Occasionally or a moderate amount of time (3-4 days)
- = Most or all of the time (5-7 days)
Total scores range from 0 to 60.
A score of 16 or higher is generally used as a cut-off to indicate significant levels of depressive symptoms, though this is not a diagnostic tool.
Measured: Change from beginning of the study and after 6th week of exercise program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Dec 2021
- Primary completion1 Dec 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual FunctionStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study included 64 women admitted to the Erzurum City Hospital, who consented to participate. They were divided into intervention and controls groups (n=32). PFME (Pelvic Floor Muscle Exercise) was applied to the intervention group for 6 weeks with the Simplex Device accompanied by biofeedback in accordance with the PFME application procedure. The control group received routine care.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezihe KIZILKAYA BEJI, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030608
- Sponsor's protocol ID
- 2021/60-11
- Status last verified
- Jun 2025
- First submitted
- 30 May 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators did not obtain permission from the participants to share their data with other researchers.
Publications
Yilmaz Aladag F, Kizilkaya Beji N. The effect of pelvic floor muscle training on sexual function, depressive symptoms, and pelvic floor muscle performance in women with overactive bladder: a randomized controlled. BMC Womens Health. 2026 Jul 28;26(1):565. doi: 10.1186/s12905-026-04723-5.
PubMed 42947098
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pelvic Floor Muscle Exercises on Sexual Life in Women With Overactive Bladder
- ClinicalTrials.gov ID
- NCT07030608
- Acronym / sponsor ID
- 2021/60-11
- Conditions
- Sexual Function, Over Active Bladder
- Keywords
- over active bladder, Pelvic Floor Muscle, sexual function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 22 Jun 2025 (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.
This is a randomized controlled experimental study to determine the effect of pelvic floor muscle exercise on sexual life.
The study included 64 women admitted to the Erzurum City Hospital, who consented to participate. They were divided into intervention ond control groups (n=32). Pelvic Floor Muscle Exercise *PFME* was applied to the intervention group for 6 weeks with the Simplex Device accompanied by biofeedback in accordance with the PFME application procedure. The control group received routine care.
Detailed description
This is a randomized controlled experimental study . The research was carried out in the Erzurum City Hospital. This study, which was conducted to examine the effect of pelvic floor muscle exercises *PFME* on sexual life in women with overactive bladder *OAB* , was conducted with 64 women (32 women: control group, 32 women: intervention group) who applied to the Erzurum City Hospital Urology Polyclinic between December 1, 2021 and December 1, 2024.
Research Hypotheses:
H1: Overactive bladder symptoms are positively affected in women with OAB who perform pelvic floor exercises.
H2: Sexual function is positively affected in women with OAB who perform pelvic floor exercises.
H3: Depression symptoms are positively affected in women with OAB who perform pelvic floor exercises.
H4: Sexual quality of life is positively affected in women with OAB who perform pelvic floor exercises.
H5: Pelvic muscle strength increases in women with OAB who undergo pelvic floor muscle training.
H6: The contraction, relaxation, and percentage of maximum voluntary contraction *MVC* % of pelvic floor muscles improve in women with OAB who undergo pelvic floor muscle training.
Implementation:
The intervention group performed a pelvic floor muscle exercise program in addition to the pharmacological treatment routinely provided at the hospital. Pelvic floor muscle exercises-including identifying the correct muscle, contraction, and relaxation-were taught by the researcher using biofeedback via the Simplex device. The training was reinforced through the use of biofeedback techniques, including a game integrated into the Simplex software, as well as verbal cues provided by the researcher .
To ensure proper continuation of the exercises and to help participants remember them, a handbook prepared by the researcher was provided (Pelvic Floor Muscle Exercise Training Handbook for Women with Overactive Bladder). Participants were asked to complete the Pelvic Floor Muscle Exercise Practice Tracking Form after each exercise session.
Additionally, the women were contacted weekly by the researcher via telephone. They were either invited to the hospital for follow-up or visited at home for evaluation and feedback.
Pelvic Floor Muscle Exercise Program
Week 1:
Contract the pelvic floor muscles for 6 seconds, then relax for 6 seconds. Repeat 25 times. Perform 3 sessions per day (total of 75 contractions per day).
Week 2:
Contract for 6 seconds, relax for 6 seconds. Repeat 50 times. Perform 3 sessions per day (total of 150 contractions per day).
Week 3:
Contract for 6 seconds, relax for 6 seconds. Repeat 75 times. Perform 3 sessions per day (total of 225 contractions per day).
Weeks 4-24:
Contract for 6 seconds, relax for 6 seconds. Repeat 100 times. Perform 3 sessions per day (total of 300 contractions per day).
After Week 24:
Contract for 6 seconds, relax for 6 seconds. Repeat 50 times. Perform 3 sessions per day (total of 150 contractions per day).
Alternatively (preferred option):
Contract for 6 seconds, relax for 6 seconds. Repeat 75 times. Perform 2 sessions per day (total of 150 contractions per day).
Women in the control group did not receive any intervention or pelvic floor muscle exercise training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study included 64 women admitted to the Erzurum City Hospital, who consented to participate. They were divided into intervention and controls groups (n=32). PFME (Pelvic Floor Muscle Exercise) was applied to the intervention group for 6 weeks with the Simplex Device accompanied by biofeedback in accordance with the PFME application procedure. The control group received routine care.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Women in the control group did not receive any intervention or pelvic floor muscle exercise training. |
| Intervention | Experimental | Behavioral: ExerciseThe intervention group performed a pelvic floor muscle exercise program in addition to the pharmacological treatment routinely provided at the hospital. Pelvic Floor Muscle Exercise Program Week 1: Contract the pelvic floor muscles for 6 seconds, then relax for 6 seconds. Repeat 25 times. Perform 3 sessions per day (total of 75 contractions per day). Week 2: Contract for 6 seconds, relax for 6 seconds. Repeat 50 times. Perform 3 sessions per day (total of 150 contractions per day). Week 3: Contract for 6 seconds, relax for 6 seconds. Repeat 75 times. Perform 3 sessions per day (total of 225 contractions per day). Weeks 4-24: Contract for 6 seconds, relax for 6 seconds. Repeat 100 times. Perform 3 sessions per day (total of 300 contractions per day). After Week 24: Contract for 6 seconds, relax for 6 seconds. Repeat 50 times. Perform 3 sessions per day (total of 150 contractions per day). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being between 18 and 70 years of age
- Speaking Turkish
- Being literate
- Having a diagnosis of Overactive Bladder (OAB)
- Currently receiving pharmacological treatment for OAB
Key exclusion criteria (6 listed)
- Presence of perceptual impairments or psychiatric disorders that interfere with communication
- Diagnosis of a neurological disease
- Presence of neuropathy due to Diabetes Mellitus
- Pelvic organ prolapse at Stage 2 or higher
- History of anti-incontinence surgery
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 |
|---|---|---|
| ExercisePelvic Floor Muscle Exercise Program Week 1: Contract the pelvic floor muscles for 6 seconds, then relax for 6 seconds. Repeat 25 times. Perform 3 sessions per day (total of 75 contractions per day). Week 2: Contract for 6 seconds, relax for 6 seconds. Repeat 50 times. Perform 3 sessions per day (total of 150 contractions per day). Week 3: Contract for 6 seconds, relax for 6 seconds. Repeat 75 times. Perform 3 sessions per day (total of 225 contractions per day). Weeks 4-24: Contract for 6 seconds, relax for 6 seconds. Repeat 100 times. Perform 3 sessions per day (total of 300 contractions per day). After Week 24: Contract for 6 seconds, relax for 6 seconds. Repeat 50 times. Perform 3 sessions per day (total of 150 contractions per day). | Behavioural | Intervention |
Primary outcome
Over active bladder questionnaire
Time frame: Change from beginning of the study and after 6th week of exercise program
This questionnaires evaluates urination frequency, sudden feeling of urgency, nocturia, urge type incontinence symptoms. It consists of 8 questions that patients can rate the severity of their complaints as none (0); very little (1); a little (2); quite a bit (3); a lot (4); and very much (5).
pelvic floor muscle contraction strength
Time frame: Change from beginning of the study and after 6th week of exercise program
Pelvic floor muscle strength measurement by digital palpation
pelvic floor muscle contraction strength
Time frame: Change from beginning of the study and after 6th week of exercise program
Pelvic floor muscle strength measurement by Simplex device
pelvic floor muscle relaxation strength
Time frame: Change from beginning of the study and after 6th week of exercise program
Pelvic floor muscle strength measurement by Simplex device
Female Sexual Function Index Scores ≤ 26.55
Time frame: Change from beginning of the study and after 6th week of exercises program
The Female Sexual Function Index consists of 19 items that measure six domains of female sexual function: Desire (2 items) Arousal (4 items) Lubrication (4 items) Orgasm (3 items) Satisfaction (3 items) Pain (3 items; includes discomfort during or after vaginal penetration) Each item is scored on a Likert-type scale, typically ranging from 0 or 1 to 5.Total score range: 2.0 to 36.0 Cut-off score: A total FSFI score of ≤26.55 is commonly used to indicate female sexual dysfunction (FSD).
Center of Epidemiologic Studies Depression Scale
Time frame: Change from beginning of the study and after 6th week of exercise program.
The Center of Epidemiologic Studies Depression Scale is designed to assess the frequency and severity of symptoms associated with depression. The original CES-D contains 20 items.Each item is scored on a 4-point Likert scale: 0 = Rarely or none of the time (<1 day) 1. = Some or a little of the time (1-2 days) 2. = Occasionally or a moderate amount of time (3-4 days) 3. = Most or all of the time (5-7 days) Total scores range from 0 to 60. A score of 16 or higher is generally used as a cut-off to indicate significant levels of depressive symptoms, though this is not a diagnostic tool.
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 3 Aug 2025.
- Derived from this study: PubMed 42947098Yilmaz Aladag F, Kizilkaya Beji N. The effect of pelvic floor muscle training on sexual function, depressive symptoms, and pelvic floor muscle performance in women with overactive bladder: a randomized controlled. BMC Womens Health. 2026 Jul 28;26(1):565. doi: 10.1186/s12905-026-04723-5.
- Individual participant dataSharing planned: No. The investigators did not obtain permission from the participants to share their data with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Sexual Function and Over Active Bladder, run by Biruni University 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 6 inclusion and 6 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 3 Aug 2025. 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?
Over active bladder questionnaire (time frame: Change from beginning of the study and after 6th week of exercise program). The study lists 6 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 NCT07030608, which also lists 1 linked publication.
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 3 Aug 2025.