Pelvic Floor DisordersNCT06359366
Perineal Massage Combined With Hip Joint Training
A study testing perineal massage combined hip joint training in people with Pelvic Floor Disorders, run by Shenzhen Hospital of Southern Medical University.
Trial summary
The goal of this clinical trial is to learn if perineal massage combined with hip joint training works to improve pelvic function (urinary incontinence, constipation and hip motion) in pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- perineal massage combined hip joint training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2024to 31 Aug 2024
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton pregnant women
- primipara;
- signed informed consent voluntarily
- 36 weeks gestation;
- no pregnancy complication
Who cannot join
- pluripara;
- multiple pregnancies;
- pregnant women with mental or cognitive disabilities;
- scarred uterus;
- pelvic surgery history;
- urinary incontinence before pregnancy history;
- obstipation before pregnancy history
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Perineal Massage Combined With Hip Joint Training on Pelvic Floor Function
The goal of this clinical trial is to learn if perineal massage combined with hip joint training works to improve pelvic function (urinary incontinence, constipation and hip motion) in pregnant women. The main questions it aims to answer are:
Does the perineal massage combined with hip joint training lower the prevalence of participants who have urinary incontinence and constipation? Does the perineal massage combined with hip joint training improve the flexibility of the hip joint? Researchers will compare an intervention (perineal massage combined with hip joint training) to a comparison(regular training and treatment) to see if the intervention (perineal massage combined with hip joint training) works to improve pelvic function.
Read more
Participants will:
receive the intervention (perineal massage combined with hip joint training ) or regular training and treatment fifth a week at 36 weeks gestation before participants receive first-time intervention, they complete Demographic sociological , ICI-Q-LF, Wexner constipation and hip motion questionnaires
Read the detailed description
Women experience varying degrees of damage to the female reproductive and urinary muscle groups during pregnancy and delivery, which can lead to a series of pelvic floor disorders, for example, pelvic organ prolapse (POP), urinary incontinence(UI), chronic constipation (CC) and other syndrome, reducing the quality of life.
This study examined the effect of perineal massage combined with hip joint training on pelvic floor function, especially on UI, CC and hip motion. This is a parallel randomised control trial. The researchers will recruit participants from the obstetrics outpatient ward. Pregnant women attending the maternity clinic who met the inclusion and exclusion criteria will be randomly selected and sign informed consent, then the enrolled population was randomly assigned to each group using sealed envelopes.
The intervention group will receive perineal massage combined with hip joint training; the comparison group will receive regular training.
The primary outcome is the ICI-Q-LF score; Wexner constipation score; and the secondary outcome is hip motion.
- Conditions
- Pelvic Floor Disorders
- Being tested
- perineal massage combined hip joint training
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perineal massage combined hip joint trainingProcedure or surgery
pregnant women take the lithotomy position, disinfect the vulva, and wear sterile gloves. Then thumbs, forefingers, and middle fingers dip massage oil to do a 2 minutes pressurized dilatation massage from inside to outside gently to loosen the fascia. Then rest 30s. All steps need to be repeated 2 to 3 times. When the pregnant women feel a slight sense of acidity and tingling sensation disappears, researchers sterilize the perineal body again. left side pelvic floor receives the same intervention as right. The whole process takes 15-20min, 5 times a week until delivery. Additionally, while using the pelvic floor fascia manipulation, pregnant women are instructed to perform specific movements of internal and external hip rotation, adduction and abduction, upward and downward.
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | perineal massage combined hip joint training Receives: Procedure: perineal massage combined hip joint training |
| comparison arm | No intervention | Routine antenatal examination combined self-exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
pelvic floor function(constipation)
using the Wexner Constipation Scoring System (lowest score, 0; Highest score, 30, contain 8 questions) to assess the outcomes of constipation. total score greater than 15 indicates constipation.the higher the score, the more difficult it is to defecate.
Measured: the outcomes will be assessed at 1.before the first time intervention at 36 gestational age. 2.receive intervention 10 times during two weeks(5 times/week). the results will reported through study completion, an average 3 months.
pelvic floor function (urinary incontinence score)
using the ICI-Q-SF (containing 4 questions) to assess the degree of urinary incontinence. the higher the score, the worse the incontinence.
Measured: the outcomes will be assessed at 1.before the first time intervention at 36 gestational age. 2.receive intervention 10 times during two weeks(5 times/week). the results will reported through study completion, an average 3 months.
Secondary outcomes (1)
hip motion
The standard human range of motion scale(hip motion scale). Hip motion was measured under different exercise types.
Measured: the outcomes will be assessed at 1.before the first time intervention at 36 gestational age. 2.receive intervention 10 times during two weeks(5 times/week). the results will reported through study completion, an average 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start10 Apr 2024 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Hospital of Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zonglian Guo, Shenzhen Hospital of Southern Medical University
- Investigators
- wenjuan wang, master, Principal investigator, matron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359366
- Sponsor's protocol ID
- ShenzhenH-guo
- Status last verified
- Apr 2024
- First submitted
- 1 Apr 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol could be share with others
Publications
Jaekel AK, Kirschner-Hermanns R, Knupfer SC. [Diagnostic testing of female urinary incontinence: dos and dont's]. Aktuelle Urol. 2021 Jun;52(3):237-244. doi: 10.1055/a-1492-5287. Epub 2021 May 21. German.
PubMed 34020505Wang X,Li YJ,Deng ML.et al.Analysis of prevalence and risk factors of pelvic floor dysfunction in pregnant women[J].Nursing Research,2012,26(18):1636-1638
Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
PubMed 32378735Walker GJ, Gunasekera P. Pelvic organ prolapse and incontinence in developing countries: review of prevalence and risk factors. Int Urogynecol J. 2011 Feb;22(2):127-35. doi: 10.1007/s00192-010-1215-0. Epub 2010 Jul 9.
PubMed 20617303Cong X. Construction of evidence-based practice plan for postpartum pelvic floor rehabilitation management [D]. Beijing University of Chinese Medicine, 2024.
Glazener C, Elders A, MacArthur C, Lancashire RJ, Herbison P, Hagen S, Dean N, Bain C, Toozs-Hobson P, Richardson K, McDonald A, McPherson G, Wilson D; ProLong Study Group. Childbirth and prolapse: long-term associations with the symptoms and objective measurement of pelvic organ prolapse. BJOG. 2013 Jan;120(2):161-168. doi: 10.1111/1471-0528.12075. Epub 2012 Nov 27.
PubMed 23190018
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perineal Massage Combined With Hip Joint Training on Pelvic Floor Function
- ClinicalTrials.gov ID
- NCT06359366
- Acronym / sponsor ID
- ShenzhenH-guo
- Conditions
- Pelvic Floor Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Shenzhen Hospital of Southern Medical UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 11 Apr 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 clinical trial is to learn if perineal massage combined with hip joint training works to improve pelvic function (urinary incontinence, constipation and hip motion) in pregnant women. The main questions it aims to answer are:
Does the perineal massage combined with hip joint training lower the prevalence of participants who have urinary incontinence and constipation? Does the perineal massage combined with hip joint training improve the flexibility of the hip joint? Researchers will compare an intervention (perineal massage combined with hip joint training) to a comparison(regular training and treatment) to see if the intervention (perineal massage combined with hip joint training) works to improve pelvic function.
Participants will:
receive the intervention (perineal massage combined with hip joint training ) or regular training and treatment fifth a week at 36 weeks gestation before participants receive first-time intervention, they complete Demographic sociological , ICI-Q-LF, Wexner constipation and hip motion questionnaires
Detailed description
Women experience varying degrees of damage to the female reproductive and urinary muscle groups during pregnancy and delivery, which can lead to a series of pelvic floor disorders, for example, pelvic organ prolapse (POP), urinary incontinence(UI), chronic constipation (CC) and other syndrome, reducing the quality of life.
This study examined the effect of perineal massage combined with hip joint training on pelvic floor function, especially on UI, CC and hip motion. This is a parallel randomised control trial. The researchers will recruit participants from the obstetrics outpatient ward. Pregnant women attending the maternity clinic who met the inclusion and exclusion criteria will be randomly selected and sign informed consent, then the enrolled population was randomly assigned to each group using sealed envelopes.
The intervention group will receive perineal massage combined with hip joint training; the comparison group will receive regular training.
The primary outcome is the ICI-Q-LF score; Wexner constipation score; and the secondary outcome is hip motion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Procedure: perineal massage combined hip joint trainingperineal massage combined hip joint training |
| comparison arm | No intervention | –Routine antenatal examination combined self-exercise |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- singleton pregnant women
- primipara;
- signed informed consent voluntarily
- 36 weeks gestation;
- no pregnancy complication
Key exclusion criteria (7 listed)
- pluripara;
- multiple pregnancies;
- pregnant women with mental or cognitive disabilities;
- scarred uterus;
- pelvic surgery history;
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 |
|---|---|---|
| perineal massage combined hip joint trainingpregnant women take the lithotomy position, disinfect the vulva, and wear sterile gloves. Then thumbs, forefingers, and middle fingers dip massage oil to do a 2 minutes pressurized dilatation massage from inside to outside gently to loosen the fascia. Then rest 30s. All steps need to be repeated 2 to 3 times. When the pregnant women feel a slight sense of acidity and tingling sensation disappears, researchers sterilize the perineal body again. left side pelvic floor receives the same intervention as right. The whole process takes 15-20min, 5 times a week until delivery. Additionally, while using the pelvic floor fascia manipulation, pregnant women are instructed to perform specific movements of internal and external hip rotation, adduction and abduction, upward and downward. | Procedure or surgery | intervention arm |
Primary outcome
pelvic floor function(constipation)
Time frame: the outcomes will be assessed at 1.before the first time intervention at 36 gestational age. 2.receive intervention 10 times during two weeks(5 times/week). the results will reported through study completion, an average 3 months.
using the Wexner Constipation Scoring System (lowest score, 0; Highest score, 30, contain 8 questions) to assess the outcomes of constipation. total score greater than 15 indicates constipation.the higher the score, the more difficult it is to defecate.
pelvic floor function (urinary incontinence score)
Time frame: the outcomes will be assessed at 1.before the first time intervention at 36 gestational age. 2.receive intervention 10 times during two weeks(5 times/week). the results will reported through study completion, an average 3 months.
using the ICI-Q-SF (containing 4 questions) to assess the degree of urinary incontinence. the higher the score, the worse the incontinence.
1 secondary outcome
hip motion
Time frame: the outcomes will be assessed at 1.before the first time intervention at 36 gestational age. 2.receive intervention 10 times during two weeks(5 times/week). the results will reported through study completion, an average 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Background: PubMed 34020505Jaekel AK, Kirschner-Hermanns R, Knupfer SC. [Diagnostic testing of female urinary incontinence: dos and dont's]. Aktuelle Urol. 2021 Jun;52(3):237-244. doi: 10.1055/a-1492-5287. Epub 2021 May 21. German.
- BackgroundWang X,Li YJ,Deng ML.et al.Analysis of prevalence and risk factors of pelvic floor dysfunction in pregnant women[J].Nursing Research,2012,26(18):1636-1638
- Background: PubMed 32378735Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
- Background: PubMed 20617303Walker GJ, Gunasekera P. Pelvic organ prolapse and incontinence in developing countries: review of prevalence and risk factors. Int Urogynecol J. 2011 Feb;22(2):127-35. doi: 10.1007/s00192-010-1215-0. Epub 2010 Jul 9.
- BackgroundCong X. Construction of evidence-based practice plan for postpartum pelvic floor rehabilitation management [D]. Beijing University of Chinese Medicine, 2024.
- Background: PubMed 23190018Glazener C, Elders A, MacArthur C, Lancashire RJ, Herbison P, Hagen S, Dean N, Bain C, Toozs-Hobson P, Richardson K, McDonald A, McPherson G, Wilson D; ProLong Study Group. Childbirth and prolapse: long-term associations with the symptoms and objective measurement of pelvic organ prolapse. BJOG. 2013 Jan;120(2):161-168. doi: 10.1111/1471-0528.12075. Epub 2012 Nov 27.
- Individual participant dataSharing planned: Yes. study protocol could be share with others
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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.
wenjuan wang, master principal investigator
matron
Questions about this trial
What is this clinical trial studying?
A study testing perineal massage combined hip joint training in people with Pelvic Floor Disorders, run by Shenzhen Hospital of Southern Medical University.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zonglian guo, master (+8615626450423, zonglianguo@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pelvic floor function(constipation) (time frame: the outcomes will be assessed at 1.before the first time intervention at 36 gestational age. 2.receive intervention 10 times during two weeks(5 times/week). the results will reported through study completion, an average 3 months.). The study lists 2 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 NCT06359366, which also lists 6 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 11 Apr 2024.