Urinary IncontinenceNCT05624060
Perineal Massage and Pelvic Floor Exercise in the Antenatal Period
A study testing Pelvic Floor Dysfunction Prevention Training, Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise in people with Urinary Incontinence and Fecal Incontinence, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effect of perineal massage and pelvic floor exercise in the antenatal period on sexuality and urinary and fecal incontinence in the postpartum period. This study will be conducted in a pregnant school at a state hospital in Turkey. 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
- Urinary Incontinence, Fecal Incontinence, Sexual Dysfunction
- What is being tested?
- Pelvic Floor Dysfunction Prevention Training, Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 20 Nov 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- being over 18 years old,
- being 32-34th pregnancy weeks,
- being not experiencing any complications in the mother and fetus during pregnancy (gestational diabetes, hypertension, preeclampsia, intrauterine growth retardation, congenital anomaly, etc.),
- having a singleton pregnancy,
- being primiparous
- being volunteer to participate in the study
Who cannot join
- elective cesarean section planning,
- having a history of chronic constipation,
- having a previous history of urinary or anal incontinence,
- having genital infection with lesions (HSV, HPV, Syphilis, Candida Albicans, Chancroid)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Perineal Massage and Pelvic Floor Exercise Applied in the Antenatal Period on Postpartum Sexuality and Incontinence: a Randomized Controlled Study
This study aimed to determine the effect of perineal massage and pelvic floor exercise in the antenatal period on sexuality and urinary and fecal incontinence in the postpartum period. This study will be conducted in a pregnant school at a state hospital in Turkey. An active control group will be formed as the control group. The control group will be given the "Pelvic Floor Dysfunction Prevention Training" booklet prepared by the researchers. Experimental 1 group will receive perineal massage training in addition to the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group. Experimental 2 group will receive pelvic floor exercises in addition to perineal massage training and the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group.
Read the detailed description
The research was conducted as a randomized controlled trial. The simple randomization method will be used for the assignment to groups. The data of the research; will be collected using the Preliminary Evaluation Form, Personal Information Form, Female Sexual Function Index, The International Consultation on Incontinence Questionnaire-ICIQ-SF (Turkish Version), and Fecal Incontinence Severity Index. The research will start at the 34th week of pregnancy and the questionnaires will be administered in the 3rd month after delivery. There will be 3 groups in the research.An active control group will be formed as the control group. The control group will be given the "Pelvic Floor Dysfunction Prevention Training" booklet prepared by the researchers. Experimental 1 group will receive perineal massage training in addition to the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group. Experimental 2 group will receive pelvic floor exercises in addition to perineal massage training and the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group.
- Being tested
- Pelvic Floor Dysfunction Prevention Training, Pelvic Floor Dysfunction Prevention Training and Perineal Massage, Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise
- Medical subject headings
- Urinary Incontinence, Fecal Incontinence, Sexual Dysfunction, Physiological, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Dysfunction Prevention TrainingBehavioural
The "Pelvic Floor Dysfunction Prevention Training" booklet is cover weight control, perineal hygiene, adequate fluid consumption, not smoking and alcohol use, avoidance of spicy, fizzy and fatty foods and beverages, correct posture and frequency of micturition, prevention of constipation and abdominal pressure.
Pelvic Floor Dysfunction Prevention Training and Perineal MassageBehavioural
Women will apply perineal massage for an average of 8-10 minutes at least twice a week, starting from the 34th week of pregnancy until delivery. In addition to perineal massage, the "Pelvic Floor Dysfunction Prevention Training" booklet will be given to participant.
Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor ExerciseBehavioural
Women assigned to this group will apply pelvic floor exercise at least 3 days a week 8-12 times a week, starting from the 34th week of pregnancy until delivery. In addition, women will apply perineal massage for an average of 8-10 minutes at least twice a week, starting from the 34th week of pregnancy until delivery. In addition to perineal massage, the "Pelvic Floor Dysfunction Prevention Training" booklet will be given to participant.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Pelvic Floor Dysfunction Prevention Training Receives: Behavioral: Pelvic Floor Dysfunction Prevention Training |
| Experimental Group 1 | Experimental | Pelvic Floor Dysfunction Prevention Training and Perineal Massage Receives: Behavioral: Pelvic Floor Dysfunction Prevention Training; Behavioral: Pelvic Floor Dysfunction Prevention Training and Perineal Massage |
| Experimental Group 2 | Experimental | Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise Receives: Behavioral: Pelvic Floor Dysfunction Prevention Training; Behavioral: Pelvic Floor Dysfunction Prevention Training and Perineal Massage; Behavioral: Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Index
In the structure of the scale; There are 6 sub-dimensions: desire, arousal, lubrication (lubrication, wetting), orgasm, satisfaction and pain.The highest raw score that can be obtained from the scale is 95 and the lowest raw score is 4.After sub-dimension averages were multiplied by factor loads, the highest score that could be obtained from the scale was calculated as 36 and the lowest score as 2. High score means better function.
Measured: Postpartum 12th weeks
The International Consultation on Incontinence Questionnaire-ICIQ
The International Consultation on Incontinence Questionnaire-ICIQ-SF (Turkish Version) is a scale for evaluating every aspect of urinary incontinence and its impact on quality of life.It consists of 6 questions.The ICIQ Total Score is calculated by the sum of the 3+4+5 questions and scores between 0 and 21. If the score is high and close to 21, it shows that it is overly affected.
Measured: Postpartum 12th weeks
Fecal Incontinence Severity Index-FISI
It is an index developed to diagnose the frequency and type of fecal incontinence.It defines the type of fecal incontinence in four types and its frequency in five categories. The index score is calculated by summing the numbers corresponding to each box and the patient score. In patient-weighted scoring, the highest score that can be obtained from the index is 61 and the lowest score is 0.The cut-off score of the index is 31.7.
Measured: Postpartum 12th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start1 Feb 2023
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Sultan OZKAN SAT, Bitlis Eren University
- Investigators
- Sultan Özkan Şat, Dr, Principal investigator, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624060
- Sponsor's protocol ID
- SULTANOZKANSAT
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2022
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perineal Massage and Pelvic Floor Exercise Applied in the Antenatal Period on Postpartum Sexuality and Incontinence: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05624060
- Acronym / sponsor ID
- SULTANOZKANSAT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 21 Nov 2022 (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 aimed to determine the effect of perineal massage and pelvic floor exercise in the antenatal period on sexuality and urinary and fecal incontinence in the postpartum period. This study will be conducted in a pregnant school at a state hospital in Turkey. An active control group will be formed as the control group. The control group will be given the "Pelvic Floor Dysfunction Prevention Training" booklet prepared by the researchers. Experimental 1 group will receive perineal massage training in addition to the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group. Experimental 2 group will receive pelvic floor exercises in addition to perineal massage training and the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group.
Detailed description
The research was conducted as a randomized controlled trial. The simple randomization method will be used for the assignment to groups. The data of the research; will be collected using the Preliminary Evaluation Form, Personal Information Form, Female Sexual Function Index, The International Consultation on Incontinence Questionnaire-ICIQ-SF (Turkish Version), and Fecal Incontinence Severity Index. The research will start at the 34th week of pregnancy and the questionnaires will be administered in the 3rd month after delivery. There will be 3 groups in the research.An active control group will be formed as the control group. The control group will be given the "Pelvic Floor Dysfunction Prevention Training" booklet prepared by the researchers. Experimental 1 group will receive perineal massage training in addition to the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group. Experimental 2 group will receive pelvic floor exercises in addition to perineal massage training and the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Pelvic Floor Dysfunction Prevention TrainingPelvic Floor Dysfunction Prevention Training |
| Experimental Group 1 | Experimental | Behavioral: Pelvic Floor Dysfunction Prevention Training, Behavioral: Pelvic Floor Dysfunction Prevention Training and Perineal MassagePelvic Floor Dysfunction Prevention Training and Perineal Massage |
| Experimental Group 2 | Experimental | Behavioral: Pelvic Floor Dysfunction Prevention Training, Behavioral: Pelvic Floor Dysfunction Prevention Training and Perineal Massage, Behavioral: Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor ExercisePelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- being over 18 years old,
- being 32-34th pregnancy weeks,
- being not experiencing any complications in the mother and fetus during pregnancy (gestational diabetes, hypertension, preeclampsia, intrauterine growth retardation, congenital anomaly, etc.),
- having a singleton pregnancy,
- being primiparous
Key exclusion criteria (4 listed)
- elective cesarean section planning,
- having a history of chronic constipation,
- having a previous history of urinary or anal incontinence,
- having genital infection with lesions (HSV, HPV, Syphilis, Candida Albicans, Chancroid)
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 Dysfunction Prevention TrainingThe "Pelvic Floor Dysfunction Prevention Training" booklet is cover weight control, perineal hygiene, adequate fluid consumption, not smoking and alcohol use, avoidance of spicy, fizzy and fatty foods and beverages, correct posture and frequency of micturition, prevention of constipation and abdominal pressure. | Behavioural | Control Group, Experimental Group 1, Experimental Group 2 |
| Pelvic Floor Dysfunction Prevention Training and Perineal MassageWomen will apply perineal massage for an average of 8-10 minutes at least twice a week, starting from the 34th week of pregnancy until delivery. In addition to perineal massage, the "Pelvic Floor Dysfunction Prevention Training" booklet will be given to participant. | Behavioural | Experimental Group 1, Experimental Group 2 |
| Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor ExerciseWomen assigned to this group will apply pelvic floor exercise at least 3 days a week 8-12 times a week, starting from the 34th week of pregnancy until delivery. In addition, women will apply perineal massage for an average of 8-10 minutes at least twice a week, starting from the 34th week of pregnancy until delivery. In addition to perineal massage, the "Pelvic Floor Dysfunction Prevention Training" booklet will be given to participant. | Behavioural | Experimental Group 2 |
Primary outcome
Female Sexual Function Index
Time frame: Postpartum 12th weeks
In the structure of the scale; There are 6 sub-dimensions: desire, arousal, lubrication (lubrication, wetting), orgasm, satisfaction and pain.The highest raw score that can be obtained from the scale is 95 and the lowest raw score is 4.After sub-dimension averages were multiplied by factor loads, the highest score that could be obtained from the scale was calculated as 36 and the lowest score as 2. High score means better function.
The International Consultation on Incontinence Questionnaire-ICIQ
Time frame: Postpartum 12th weeks
The International Consultation on Incontinence Questionnaire-ICIQ-SF (Turkish Version) is a scale for evaluating every aspect of urinary incontinence and its impact on quality of life.It consists of 6 questions.The ICIQ Total Score is calculated by the sum of the 3+4+5 questions and scores between 0 and 21. If the score is high and close to 21, it shows that it is overly affected.
Fecal Incontinence Severity Index-FISI
Time frame: Postpartum 12th weeks
It is an index developed to diagnose the frequency and type of fecal incontinence.It defines the type of fecal incontinence in four types and its frequency in five categories. The index score is calculated by summing the numbers corresponding to each box and the patient score. In patient-weighted scoring, the highest score that can be obtained from the index is 61 and the lowest score is 0.The cut-off score of the index is 31.7.
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 17 Jan 2025.
- 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.
Sultan Özkan Şat, Dr principal investigator
Bitlis Eren University
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 Dysfunction Prevention Training, Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise in people with Urinary Incontinence and Fecal Incontinence, run by Bitlis Eren 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 4 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 17 Jan 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?
Female Sexual Function Index (time frame: Postpartum 12th 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 17 Jan 2025.