Lower Urinary Tract SymptomsNCT06279455
Pelvic Floor Muscle Exercise During Pregnancy
A study testing Pelvic Floor Muscle Exercise in people with Lower Urinary Tract Symptoms and Sexual Function, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to evaluate the effects of pelvic floor muscle exercises during pregnancy on sexual function, lower urinary tract symptoms and birth process. The research was conducted with pregnant women who applied to the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lower Urinary Tract Symptoms, Sexual Function
- What is being tested?
- Pelvic Floor Muscle Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2022to 30 Oct 2023
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the 18th and 20th weeks of gestation,
- Nulliparous and single pregnancy,
- Sexually active,
- Body mass index before pregnancy <30,
- Urinary incontinence and urinary infection are not diagnosed,
- Not having a psychiatric illness,
- The spouse does not have sexual dysfunction.
Who cannot join
- Pregnant women under 18 weeks and older than 20 weeks,
- Primiparous and multiparous,
- High-risk pregnancy (multiple pregnancy, preeclampsia, gestational diabetes, pregnancy with assisted reproductive techniques),
- Pregnant women who are scheduled for elective cesarean section,
- Those who give birth by cesarean section.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Pelvic Floor Muscle Exercise During Pregnancy on Sexual Function, Lower Urinary Tract Symptoms and Birth Process
This study was conducted to evaluate the effects of pelvic floor muscle exercises during pregnancy on sexual function, lower urinary tract symptoms and birth process. The research was conducted with pregnant women who applied to the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital. Power analysis was performed to determine the number of samples to be included in the study. It was determined that 29 pregnant women should be included in each group (experimental and control). Considering the possibility of data loss, 50 pregnant women were included in each group. As a result of the exclusion of 8 women who withdrew from participating in the study, 5 women due to risky pregnancies (bleeding, preeclampsia and gestational diabetes) and 17 women due to cesarean delivery, the data of 35 pregnant women in the experimental group and 35 pregnant women in the control group were obtained. Pregnant women in the experimental group were gestational aged 18-20. Two sessions of training were given on female reproductive and urinary system anatomy, physiological changes during pregnancy and their effects on sexual life, and pelvic floor muscle exercises, using the "Pelvic Floor Health \& Sexual Life Training Booklet during Pregnancy" and the pelvic floor muscle exercise training video developed by the researcher between the weeks of pregnancy. Pregnant women were asked to perform pelvic floor muscle exercises, 3 sets a day, 3 days a week, for 12 weeks, starting from the 20th week of pregnancy, and record them in the Pelvic Floor Muscle Exercise Follow-up Form created by the researcher. Pregnant women in the control group were not given any training and were routinely monitored in the outpatient clinic. Pregnant women who apply to the outpatient clinic are examined by nurses, with their vital signs taken and anamnesis taken by the physician. Recommendations are made regarding the complaints of pregnant women. Non-stress tests are routinely applied to pregnant women who are at the 36th week of pregnancy and above.
Read the detailed description
Purpose of the research This study was conducted to evaluate the effects of pelvic floor muscle exercises during pregnancy on sexual function, lower urinary tract symptoms and birth process.
Type of Research This research is of randomized controlled prospective type.
Place and Time the Research The research was conducted at the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital, Department of Gynecology and Obstetrics, between December 2022 and October 2023.
Population and Sample of the Research The population of the research consisted of pregnant women who applied to the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital, Department of Gynecology and Obstetrics. G*Power (3.1.9.7) Program was used to determine the sample number of pelvic floor muscle exercise (experimental group) and control groups. The Female Sexual Function Index was taken as the main parameter in the study. As a result of the power analysis performed with α=0.05 and power of 95% (effect size: 0.7), the sample was calculated as 29 pregnant women for each group. Considering that there may be losses during the study period, it was decided to include a total of 100 pregnant women between the ages of 18-40, including the experimental group (n = 50) and the control group (n = 50).
The numbers to be included in the sample were determined using the randomization program (www.randomizer.org).
As a result of the exclusion of 8 women who withdrew from participating in the study, 5 women due to risky pregnancies (bleeding, preeclampsia and gestational diabetes) and 17 women due to cesarean delivery, the data of 35 pregnant women in the experimental group and 35 pregnant women in the control group were obtained.
Research data were collected with "Personal Information Form" (between 18-20th week of pregnancy), "Female Sexual Function Index" (between 18-20th week of pregnancy and 32nd week of pregnancy), "Mid-term Evaluation Form" (26th week of pregnancy), "International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms Long Form (ICIQ-FLUTS LF)" (between 18-20th week of pregnancy and 32nd week of pregnancy), "Birth Process Follow-up Form" (between 3-7th days after birth) and "Pelvic Floor Muscle Exercise Follow-up Form" (20-32 between weeks of pregnancy).
- Conditions
- Lower Urinary Tract Symptoms, Sexual Function
- Being tested
- Pelvic Floor Muscle Exercise
- Keywords
- Lower Urinary Tract Symptoms, Pelvic Floor Muscle Exercise, Pregnancy, Sexual Function, Birth Process
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle ExerciseOther
A 12-week pelvic floor muscle exercise program was applied to pregnant women.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Pregnant women in the control group were not trained and routine follow-up was performed in the outpatient clinic. Female Sexual Function Index (FSFI) and International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms Long Form (ICIQ-FLUTS LF) at 18-20 weeks of gestation, Mid-term Evaluation Form at 26 weeks of gestation and FSFI and ICIQ-FLUTS LF at 32 weeks of gestation were applied to pregnant women in the control group participating in the study. Data on the birth process were collected between 3-7th days after birth with the Birth Process Follow-up Form. |
| Experimental Group | Experimental | Two sessions of training were given using the "Pelvic Floor Health \& Sexual Life in Pregnancy Training Booklet" and the pelvic floor muscle exercise training video developed by the researcher between 18-20 weeks of pregnancy. Before the training, the FSFI and the ICIQ-FLUTS LF were administered to the pregnant women. Pregnant women were asked to perform pelvic floor muscle exercises, 3 sets a day, 3 days a week, for 12 weeks, starting from the 20th week of pregnancy, and record them in the Pelvic Floor Muscle Exercise Follow-up Form created by the researcher. By scanning the literature, 1 set of exercise was determined as 8-12 slow contractions (6-8 seconds) followed by 3-4 fast contractions (1 second). Receives: Other: Pelvic Floor Muscle Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Function
The outcome is sexual function of pregnant women. It will be measured with FSFI.
Measured: 12 weeks
Lower Urinary Tract Symptoms
The outcome is lower urinary tract symptoms of pregnant women. It will be measured with ICIQ-FLUTS LF.
Measured: 12 weeks
Birth Process
The outcome is birth outcomes. It will be evaluated with Birth Process Follow-up Form.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start5 Dec 2022
- Primary completion6 Mar 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pelvic Floor Muscle Exercise Group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Zahide Celebi, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279455
- Sponsor's protocol ID
- E-74555795-050.01.04-392120
- Status last verified
- Apr 2024
- First submitted
- 28 Dec 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Pelvic Floor Muscle Exercise During Pregnancy on Sexual Function, Lower Urinary Tract Symptoms and Birth Process
- ClinicalTrials.gov ID
- NCT06279455
- Acronym / sponsor ID
- E-74555795-050.01.04-392120
- Conditions
- Lower Urinary Tract Symptoms, Sexual Function
- Keywords
- Lower Urinary Tract Symptoms, Pelvic Floor Muscle Exercise, Pregnancy, Sexual Function, Birth Process
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 28 Feb 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.
This study was conducted to evaluate the effects of pelvic floor muscle exercises during pregnancy on sexual function, lower urinary tract symptoms and birth process. The research was conducted with pregnant women who applied to the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital. Power analysis was performed to determine the number of samples to be included in the study. It was determined that 29 pregnant women should be included in each group (experimental and control). Considering the possibility of data loss, 50 pregnant women were included in each group. As a result of the exclusion of 8 women who withdrew from participating in the study, 5 women due to risky pregnancies (bleeding, preeclampsia and gestational diabetes) and 17 women due to cesarean delivery, the data of 35 pregnant women in the experimental group and 35 pregnant women in the control group were obtained. Pregnant women in the experimental group were gestational aged 18-20. Two sessions of training were given on female reproductive and urinary system anatomy, physiological changes during pregnancy and their effects on sexual life, and pelvic floor muscle exercises, using the "Pelvic Floor Health \& Sexual Life Training Booklet during Pregnancy" and the pelvic floor muscle exercise training video developed by the researcher between the weeks of pregnancy. Pregnant women were asked to perform pelvic floor muscle exercises, 3 sets a day, 3 days a week, for 12 weeks, starting from the 20th week of pregnancy, and record them in the Pelvic Floor Muscle Exercise Follow-up Form created by the researcher. Pregnant women in the control group were not given any training and were routinely monitored in the outpatient clinic. Pregnant women who apply to the outpatient clinic are examined by nurses, with their vital signs taken and anamnesis taken by the physician. Recommendations are made regarding the complaints of pregnant women. Non-stress tests are routinely applied to pregnant women who are at the 36th week of pregnancy and above.
Detailed description
Purpose of the research This study was conducted to evaluate the effects of pelvic floor muscle exercises during pregnancy on sexual function, lower urinary tract symptoms and birth process.
Type of Research This research is of randomized controlled prospective type.
Place and Time the Research The research was conducted at the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital, Department of Gynecology and Obstetrics, between December 2022 and October 2023.
Population and Sample of the Research The population of the research consisted of pregnant women who applied to the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital, Department of Gynecology and Obstetrics. G*Power (3.1.9.7) Program was used to determine the sample number of pelvic floor muscle exercise (experimental group) and control groups. The Female Sexual Function Index was taken as the main parameter in the study. As a result of the power analysis performed with α=0.05 and power of 95% (effect size: 0.7), the sample was calculated as 29 pregnant women for each group. Considering that there may be losses during the study period, it was decided to include a total of 100 pregnant women between the ages of 18-40, including the experimental group (n = 50) and the control group (n = 50).
The numbers to be included in the sample were determined using the randomization program (www.randomizer.org).
As a result of the exclusion of 8 women who withdrew from participating in the study, 5 women due to risky pregnancies (bleeding, preeclampsia and gestational diabetes) and 17 women due to cesarean delivery, the data of 35 pregnant women in the experimental group and 35 pregnant women in the control group were obtained.
Research data were collected with "Personal Information Form" (between 18-20th week of pregnancy), "Female Sexual Function Index" (between 18-20th week of pregnancy and 32nd week of pregnancy), "Mid-term Evaluation Form" (26th week of pregnancy), "International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms Long Form (ICIQ-FLUTS LF)" (between 18-20th week of pregnancy and 32nd week of pregnancy), "Birth Process Follow-up Form" (between 3-7th days after birth) and "Pelvic Floor Muscle Exercise Follow-up Form" (20-32 between weeks of pregnancy).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pelvic Floor Muscle Exercise Group
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Pregnant women in the control group were not trained and routine follow-up was performed in the outpatient clinic. Female Sexual Function Index (FSFI) and International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms Long Form (ICIQ-FLUTS LF) at 18-20 weeks of gestation, Mid-term Evaluation Form at 26 weeks of gestation and FSFI and ICIQ-FLUTS LF at 32 weeks of gestation were applied to pregnant women in the control group participating in the study. Data on the birth process were collected between 3-7th days after birth with the Birth Process Follow-up Form. |
| Experimental Group | Experimental | Other: Pelvic Floor Muscle ExerciseTwo sessions of training were given using the "Pelvic Floor Health \& Sexual Life in Pregnancy Training Booklet" and the pelvic floor muscle exercise training video developed by the researcher between 18-20 weeks of pregnancy. Before the training, the FSFI and the ICIQ-FLUTS LF were administered to the pregnant women. Pregnant women were asked to perform pelvic floor muscle exercises, 3 sets a day, 3 days a week, for 12 weeks, starting from the 20th week of pregnancy, and record them in the Pelvic Floor Muscle Exercise Follow-up Form created by the researcher. By scanning the literature, 1 set of exercise was determined as 8-12 slow contractions (6-8 seconds) followed by 3-4 fast contractions (1 second). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Between the 18th and 20th weeks of gestation,
- Nulliparous and single pregnancy,
- Sexually active,
- Body mass index before pregnancy <30,
- Urinary incontinence and urinary infection are not diagnosed,
Key exclusion criteria (5 listed)
- Pregnant women under 18 weeks and older than 20 weeks,
- Primiparous and multiparous,
- High-risk pregnancy (multiple pregnancy, preeclampsia, gestational diabetes, pregnancy with assisted reproductive techniques),
- Pregnant women who are scheduled for elective cesarean section,
- Those who give birth by cesarean section.
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 Muscle ExerciseA 12-week pelvic floor muscle exercise program was applied to pregnant women. | Other | Experimental Group |
Primary outcome
Sexual Function
Time frame: 12 weeks
The outcome is sexual function of pregnant women. It will be measured with FSFI.
Lower Urinary Tract Symptoms
Time frame: 12 weeks
The outcome is lower urinary tract symptoms of pregnant women. It will be measured with ICIQ-FLUTS LF.
Birth Process
Time frame: 18 weeks
The outcome is birth outcomes. It will be evaluated with Birth Process Follow-up Form.
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 Apr 2024.
- Individual participant dataSharing planned: No
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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 Pelvic Floor Muscle Exercise in people with Lower Urinary Tract Symptoms and Sexual Function, run by Istanbul University - Cerrahpasa 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 7 inclusion and 5 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 Apr 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?
Sexual Function (time frame: 12 weeks). 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?
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 Apr 2024.