Pelvic Floor DisordersNCT03041246
Manual Fascial Manipulation in Pregnant Women
A study testing Pelvic floor fascial mobilization in people with Pelvic Floor Disorders, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Pregnancy and vaginal delivery are considered as the main risk factors for damage to the pelvic floor. There are various ways to measure the strength of the pelvic floor and to evaluate functional problems. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Pelvic floor fascial mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2018to 1 Jun 2020
- 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-45 years old
- Gestational age 24-30 weeks gestation
- Singleton pregnancy
- Expected second-4ourth delivery
Who cannot join
- First delivery
- Gestational age at more than 30 weeks gestation at enrollment
- Premature contractions
- Cervical insufficiency
- Placenta previa
- Placenta accrete
- Multifetal pregnancy
- Maternal chronic illness including connective tissue disease, neurological illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Manual Fascial Manipulation on the Function of the Pelvic Floor in Pregnant Women
Pregnancy and vaginal delivery are considered as the main risk factors for damage to the pelvic floor. There are various ways to measure the strength of the pelvic floor and to evaluate functional problems. Manual mobilization of the pelvic floor is a well-known treatment modality, however, ample knowledge exists on the efficacy of physiotherapy and exercise for improvement of pelvic floor function and strength. The aim of this study is to analyze the influence of pelvic floor fascial mobilization (PFFM) technique on the function and strength of the pelvic floor muscles as well as parameters presumed to be influenced by the strength of the pelvic floor in pregnant women.
Read the detailed description
Pregnancy and vaginal delivery are considered as the main risk factors for damage to the pelvic floor at various degrees, starting at mild stress incontinence and up to fool fecal incontinence as well as pelvic pains or urination difficulties.
There are various ways to measure the strength of the pelvic floor and to evaluate functional problems. Measured the strength of the pelvic floor muscles by physical examination according to Oxford Grading Scale (scale of 0-5) as well as by using Perineometer device, were equally efficient and well correlated. Other modalities such as the use of surface electro myography (EMG), that presents the level of the muscle electrical activity and expiration volumes and the strength of the pelvic floor muscles were also positively correlated to the strength of the pelvic floor. Recent studies presented dysfunction of pelvic floor during pregnancy as well as in the postpartum period by the use of pelvic floor disability index 20 (PFDI20) questionnaire validated in Hebrew.
Ample knowledge exists on the efficacy of physiotherapy and exercise for improvement of pelvic floor function and strength, however, prolonged and continuous exercise is needed to achieve good results as well as compliance and perseverance. The long-term effect is unwieldly.
Manual mobilization of the pelvic floor is a well-known treatment modality. However the literature regarding the effect of this technique is sparse. A recent series of case reports presented immediate and major improvement of pelvic floor dysfunction after manual mobilization. The peripartum period is critical for the function of the pelvic floor however the yield of manual therapy on function and strength of the pelvic floor was not evaluated in pregnant women. We hypothesize that manual therapy can improve the strength and the function of the pelvic floor within a short time span and this can be objectively measured by common and well used parameters The aim of this study is to analyze the influence of pelvic floor fascial mobilization (PFFM) on the function and strength of the pelvic floor muscles as well as parameters presumed to be influenced by the strength of the pelvic floor in pregnant women
Materials and methods
The study will involve number of phases:
Phase one: Screening and enrollment of patients Women followed at the high risk pregnancy clinic at the Sheba medical center, who carry singleton pregnancy at the ages of 20-45 years old and about to have their 2nd to 4th delivery (primiparous and multiparous women) will be examined for the following parameters: demographic and medical data, focused interview for symptoms of pelvic floor dysfunction including urination and fecal function as well as pelvic floor pain, manual assessment according the Oxford grading scale will be performed, and the strength of the pelvic floor measured by the use of Perineometer (Peritron 'AV' Combined Anal \& Vaginal Perineometer NEW MODEL). Other parameters that will be measured include: mobilization of the pelvic-femoral joint, Forced expiratory volume 1 (FEV1) (a connection was shown between FEV1, intraabdominal pressure and the strength of the pelvic floor, assessment of vocal quality ( analyzed by communication clinician, repeat assessment will be performed after two weeks and after 4 weeks, estimated assessment time - 20 Min) 80 women are expected to be enrolled.
Phase Two Women who will fulfill one or more of the following parameters will be enrolled to the second phase of the study . (n=40)
- Oxford grading scale ≤3/5
- Pelvic floor strength assessed by perineometer≤ 30 cm/h20
- Clinical symptoms of urine, flatus or fecal incontinence
- Pelvic floor, hip joint or pelvic joints pain
Randomization will be performed to one of two groups:
Group A-Control group (n=20) Group B-Study group (n=20) Guidance towards exercise for strengthening of the pelvic floor will be provided for both groups. Study group will be treated manually for the pelvic floor in two sessions two weeks apart. The manual manipulation of the pelvic floor will involve intra vaginal superficial as well as pelvic skin area pressure points. The manipulation will not involve the cervix uterus or rectum. Each session will lasts one hour
Both groups will be assessed by ultrasound for blood flow in the middle cerebral artery, umbilical artery and uterine artery as part of the parameters that may show benefit to the fetus due to pelvic floor mobilization.
Reassessment of all the women and repeat treatment for the study group will be performed after two and four weeks from the primary assessment.
The study will be performed at a high risk pregnancy clinic at the Sheba medical center. Women will be enrolled voluntarily with no financial benefit.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Pelvic floor fascial mobilization
- Keywords
- pelvic floor
- 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.
Pelvic floor fascial mobilizationProcedure or surgery
The manual manipulation of the pelvic floor involves intra vaginal superficial as well as pelvic skin area pressure points.
| Study group | Role | What they receive |
|---|---|---|
| Study group - Treatment with PFFM | Experimental | Manual treatment for the pelvic floor will be provided in two sessions two weeks apart as long as guidance towards exercise for strengthening of the pelvic floor Receives: Procedure: Pelvic floor fascial mobilization |
| Control group - | No intervention | Guidance towards exercise for strengthening of the pelvic floor with no other interventional treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraction strength
Contraction strength assessed by Oxford grading scale
Measured: Change of contraction strength is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )
Contraction pressure
Contraction pressure measured by using Peritron perineometer
Measured: Change of contraction pressure is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )
Secondary outcomes (3)
Symptoms associated with pelvic dysfunction
Assessment of symptoms associated with pelvic dysfunction: urinary incontinence, fecal incontinence, frequency and urgency (by the use of pelvic floor disability index 20 - a questionaire including 20 questions on pelvic floor function)
Measured: Change of pelvic dysfunction is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )
FEV1
Forced expiratory volume 1
Measured: Change of FEV1 is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )
Voice Handicap Index - 10 among Hebrew speakers (VHI-10-HEB) questionaire
Evaluation of the validity of the voice handicap index that includes ten questions concerning voice usage among hebrew speakers
Measured: Change of VHI-10-HEB is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start1 Jul 2018
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- On enrollment, dividing the healthy ( n=40) from the pathological function of the pelvic floor ( n=40). From the second group, randomizing the groups to study group: recieving pelvic floor fascial mobilization (PFFM) treatment (n=20)compared to control group (n=20).
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Aya Mohr-Sasson, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041246
- Sponsor's protocol ID
- 3722-16-SMC
- Status last verified
- Jun 2020
- First submitted
- 24 Jan 2017
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Batista EM, Conde DM, Do Amaral WN, Martinez EZ. Comparison of pelvic floor muscle strength between women undergoing vaginal delivery, cesarean section, and nulliparae using a perineometer and digital palpation. Gynecol Endocrinol. 2011 Nov;27(11):910-4. doi: 10.3109/09513590.2011.569603. Epub 2011 Apr 18.
PubMed 21500994Hallock JL, Handa VL. The Epidemiology of Pelvic Floor Disorders and Childbirth: An Update. Obstet Gynecol Clin North Am. 2016 Mar;43(1):1-13. doi: 10.1016/j.ogc.2015.10.008.
PubMed 26880504Navot S, Kalichman L. Hip and groin pain in a cyclist resolved after performing a pelvic floor fascial mobilization. J Bodyw Mov Ther. 2016 Jul;20(3):604-9. doi: 10.1016/j.jbmt.2016.04.005. Epub 2016 Apr 7.
PubMed 27634085Okido MM, Valeri FL, Martins WP, Ferreira CH, Duarte G, Cavalli RC. Assessment of foetal wellbeing in pregnant women subjected to pelvic floor muscle training: a controlled randomised study. Int Urogynecol J. 2015 Oct;26(10):1475-81. doi: 10.1007/s00192-015-2719-4. Epub 2015 Aug 21.
PubMed 26294205Petricelli CD, Resende AP, Elito Junior J, Araujo Junior E, Alexandre SM, Zanetti MR, Nakamura MU. Distensibility and strength of the pelvic floor muscles of women in the third trimester of pregnancy. Biomed Res Int. 2014;2014:437867. doi: 10.1155/2014/437867. Epub 2014 Apr 28.
PubMed 24877094Talasz H, Kofler M, Kalchschmid E, Pretterklieber M, Lechleitner M. Breathing with the pelvic floor? Correlation of pelvic floor muscle function and expiratory flows in healthy young nulliparous women. Int Urogynecol J. 2010 Apr;21(4):475-81. doi: 10.1007/s00192-009-1060-1. Epub 2009 Dec 8.
PubMed 19997721van Veelen GA, Schweitzer KJ, van der Vaart CH. Ultrasound imaging of the pelvic floor: changes in anatomy during and after first pregnancy. Ultrasound Obstet Gynecol. 2014 Oct;44(4):476-80. doi: 10.1002/uog.13301.
PubMed 24436146Navot S, Carmeli E, Mohr-Sasson A, Hendler I, Kalichman L. Effect of pelvic floor fascial mobilization on pelvic floor dysfunction in multiparous pregnant women - A randomized pilot study. J Bodyw Mov Ther. 2024 Oct;40:437-442. doi: 10.1016/j.jbmt.2024.04.032. Epub 2024 Apr 16.
PubMed 39593622Woodley 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 32378735
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Manual Fascial Manipulation on the Function of the Pelvic Floor in Pregnant Women
- ClinicalTrials.gov ID
- NCT03041246
- Acronym / sponsor ID
- 3722-16-SMC
- Conditions
- Pelvic Floor Disorders
- Keywords
- pelvic floor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 2 Feb 2017 (estimated)
- 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.
Pregnancy and vaginal delivery are considered as the main risk factors for damage to the pelvic floor. There are various ways to measure the strength of the pelvic floor and to evaluate functional problems. Manual mobilization of the pelvic floor is a well-known treatment modality, however, ample knowledge exists on the efficacy of physiotherapy and exercise for improvement of pelvic floor function and strength. The aim of this study is to analyze the influence of pelvic floor fascial mobilization (PFFM) technique on the function and strength of the pelvic floor muscles as well as parameters presumed to be influenced by the strength of the pelvic floor in pregnant women.
Detailed description
Pregnancy and vaginal delivery are considered as the main risk factors for damage to the pelvic floor at various degrees, starting at mild stress incontinence and up to fool fecal incontinence as well as pelvic pains or urination difficulties.
There are various ways to measure the strength of the pelvic floor and to evaluate functional problems. Measured the strength of the pelvic floor muscles by physical examination according to Oxford Grading Scale (scale of 0-5) as well as by using Perineometer device, were equally efficient and well correlated. Other modalities such as the use of surface electro myography (EMG), that presents the level of the muscle electrical activity and expiration volumes and the strength of the pelvic floor muscles were also positively correlated to the strength of the pelvic floor. Recent studies presented dysfunction of pelvic floor during pregnancy as well as in the postpartum period by the use of pelvic floor disability index 20 (PFDI20) questionnaire validated in Hebrew.
Ample knowledge exists on the efficacy of physiotherapy and exercise for improvement of pelvic floor function and strength, however, prolonged and continuous exercise is needed to achieve good results as well as compliance and perseverance. The long-term effect is unwieldly.
Manual mobilization of the pelvic floor is a well-known treatment modality. However the literature regarding the effect of this technique is sparse. A recent series of case reports presented immediate and major improvement of pelvic floor dysfunction after manual mobilization. The peripartum period is critical for the function of the pelvic floor however the yield of manual therapy on function and strength of the pelvic floor was not evaluated in pregnant women. We hypothesize that manual therapy can improve the strength and the function of the pelvic floor within a short time span and this can be objectively measured by common and well used parameters The aim of this study is to analyze the influence of pelvic floor fascial mobilization (PFFM) on the function and strength of the pelvic floor muscles as well as parameters presumed to be influenced by the strength of the pelvic floor in pregnant women
Materials and methods
The study will involve number of phases:
Phase one: Screening and enrollment of patients Women followed at the high risk pregnancy clinic at the Sheba medical center, who carry singleton pregnancy at the ages of 20-45 years old and about to have their 2nd to 4th delivery (primiparous and multiparous women) will be examined for the following parameters: demographic and medical data, focused interview for symptoms of pelvic floor dysfunction including urination and fecal function as well as pelvic floor pain, manual assessment according the Oxford grading scale will be performed, and the strength of the pelvic floor measured by the use of Perineometer (Peritron 'AV' Combined Anal \& Vaginal Perineometer NEW MODEL). Other parameters that will be measured include: mobilization of the pelvic-femoral joint, Forced expiratory volume 1 (FEV1) (a connection was shown between FEV1, intraabdominal pressure and the strength of the pelvic floor, assessment of vocal quality ( analyzed by communication clinician, repeat assessment will be performed after two weeks and after 4 weeks, estimated assessment time - 20 Min) 80 women are expected to be enrolled.
Phase Two Women who will fulfill one or more of the following parameters will be enrolled to the second phase of the study . (n=40)
- Oxford grading scale ≤3/5
- Pelvic floor strength assessed by perineometer≤ 30 cm/h20
- Clinical symptoms of urine, flatus or fecal incontinence
- Pelvic floor, hip joint or pelvic joints pain
Randomization will be performed to one of two groups:
Group A-Control group (n=20) Group B-Study group (n=20) Guidance towards exercise for strengthening of the pelvic floor will be provided for both groups. Study group will be treated manually for the pelvic floor in two sessions two weeks apart. The manual manipulation of the pelvic floor will involve intra vaginal superficial as well as pelvic skin area pressure points. The manipulation will not involve the cervix uterus or rectum. Each session will lasts one hour
Both groups will be assessed by ultrasound for blood flow in the middle cerebral artery, umbilical artery and uterine artery as part of the parameters that may show benefit to the fetus due to pelvic floor mobilization.
Reassessment of all the women and repeat treatment for the study group will be performed after two and four weeks from the primary assessment.
The study will be performed at a high risk pregnancy clinic at the Sheba medical center. Women will be enrolled voluntarily with no financial benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- On enrollment, dividing the healthy ( n=40) from the pathological function of the pelvic floor ( n=40). From the second group, randomizing the groups to study group: recieving pelvic floor fascial mobilization (PFFM) treatment (n=20)compared to control group (n=20).
| Arm | Type | Receives |
|---|---|---|
| Study group - Treatment with PFFM | Experimental | Procedure: Pelvic floor fascial mobilizationManual treatment for the pelvic floor will be provided in two sessions two weeks apart as long as guidance towards exercise for strengthening of the pelvic floor |
| Control group - | No intervention | –Guidance towards exercise for strengthening of the pelvic floor with no other interventional treatment. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20-45 years old
- Gestational age 24-30 weeks gestation
- Singleton pregnancy
- Expected second-4ourth delivery
Key exclusion criteria (8 listed)
- First delivery
- Gestational age at more than 30 weeks gestation at enrollment
- Premature contractions
- Cervical insufficiency
- Placenta previa
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 fascial mobilizationThe manual manipulation of the pelvic floor involves intra vaginal superficial as well as pelvic skin area pressure points. | Procedure or surgery | Study group - Treatment with PFFM |
Primary outcome
Contraction strength
Time frame: Change of contraction strength is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )
Contraction strength assessed by Oxford grading scale
Contraction pressure
Time frame: Change of contraction pressure is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )
Contraction pressure measured by using Peritron perineometer
3 secondary outcomes
Symptoms associated with pelvic dysfunction
Time frame: Change of pelvic dysfunction is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )
FEV1
Time frame: Change of FEV1 is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )
Voice Handicap Index - 10 among Hebrew speakers (VHI-10-HEB) questionaire
Time frame: Change of VHI-10-HEB is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 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 9 Jun 2020.
- Background: PubMed 21500994Batista EM, Conde DM, Do Amaral WN, Martinez EZ. Comparison of pelvic floor muscle strength between women undergoing vaginal delivery, cesarean section, and nulliparae using a perineometer and digital palpation. Gynecol Endocrinol. 2011 Nov;27(11):910-4. doi: 10.3109/09513590.2011.569603. Epub 2011 Apr 18.
- Background: PubMed 26880504Hallock JL, Handa VL. The Epidemiology of Pelvic Floor Disorders and Childbirth: An Update. Obstet Gynecol Clin North Am. 2016 Mar;43(1):1-13. doi: 10.1016/j.ogc.2015.10.008.
- Background: PubMed 27634085Navot S, Kalichman L. Hip and groin pain in a cyclist resolved after performing a pelvic floor fascial mobilization. J Bodyw Mov Ther. 2016 Jul;20(3):604-9. doi: 10.1016/j.jbmt.2016.04.005. Epub 2016 Apr 7.
- Background: PubMed 26294205Okido MM, Valeri FL, Martins WP, Ferreira CH, Duarte G, Cavalli RC. Assessment of foetal wellbeing in pregnant women subjected to pelvic floor muscle training: a controlled randomised study. Int Urogynecol J. 2015 Oct;26(10):1475-81. doi: 10.1007/s00192-015-2719-4. Epub 2015 Aug 21.
- Background: PubMed 24877094Petricelli CD, Resende AP, Elito Junior J, Araujo Junior E, Alexandre SM, Zanetti MR, Nakamura MU. Distensibility and strength of the pelvic floor muscles of women in the third trimester of pregnancy. Biomed Res Int. 2014;2014:437867. doi: 10.1155/2014/437867. Epub 2014 Apr 28.
- Background: PubMed 19997721Talasz H, Kofler M, Kalchschmid E, Pretterklieber M, Lechleitner M. Breathing with the pelvic floor? Correlation of pelvic floor muscle function and expiratory flows in healthy young nulliparous women. Int Urogynecol J. 2010 Apr;21(4):475-81. doi: 10.1007/s00192-009-1060-1. Epub 2009 Dec 8.
- Background: PubMed 24436146van Veelen GA, Schweitzer KJ, van der Vaart CH. Ultrasound imaging of the pelvic floor: changes in anatomy during and after first pregnancy. Ultrasound Obstet Gynecol. 2014 Oct;44(4):476-80. doi: 10.1002/uog.13301.
- Derived from this study: PubMed 39593622Navot S, Carmeli E, Mohr-Sasson A, Hendler I, Kalichman L. Effect of pelvic floor fascial mobilization on pelvic floor dysfunction in multiparous pregnant women - A randomized pilot study. J Bodyw Mov Ther. 2024 Oct;40:437-442. doi: 10.1016/j.jbmt.2024.04.032. Epub 2024 Apr 16.
- Derived from this study: 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.
- 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 fascial mobilization in people with Pelvic Floor Disorders, run by Sheba Medical Center at 1 site in Israel.
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 4 inclusion and 8 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 9 Jun 2020. 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 Israel. 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?
Contraction strength (time frame: Change of contraction strength is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )). 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 NCT03041246, which also lists 9 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 9 Jun 2020.