Painful Bladder SyndromePBSNCT01410461
Identifying Predictors of Treatment Success in Painful Bladder Syndrome
An observational study of Painful Bladder Syndrome, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Study aims to: (1) evaluate the role of morphological and physiological characteristics of the pelvic floor, pain-related psychological and -psychophysical variables in prediction of the success of myofascial physical therapy (MPT) for the treatment of painful bladder syndrome Patients with clinical symptoms of PBS… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Painful Bladder Syndrome
- What is being tested?
- quantitive sensory testing and Ultrasound testing
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2011to Sep 2013
- Phase
- Observational
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinical diagnosis of painful bladder syndrome
Who may be able to join
- age > 18 years old
- urinary frequency of at least 10 per 24 hr including one nighttime voiding
- complaints of bladder pain that has been present for at least 3 months
- pain intensity rated at least four on a VAS from 0 ''no pain at all'' to 10 ''worst imaginable pain'' during the previous month
- pelvic digital exam reveals at least three different TrPs in the levator ani muscles that are verbally confirmed.
Who cannot join
- history of pelvic cancer or radiation
- pelvic or abdominal surgery within 3 months
- urinary tract infection within the last month
- diagnosis of fibromyalgia or irritable bowel disease
- diagnosis of neurologic disorder; diabetes; pregnancy;
- pelvic pain and/ or urgency symptoms presented only during menses.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Zvolon Medical Center
Haifa, 34987
Lior Lowenstein, MD, 97248542612, lowensteinmd@gmail.com
Dalia Kesner, MD, 97248542382, daliake@clalit.org.il
About this study
Official title: Prospective Observational Study That Evaluates Predictor Tests for the Success of Myofascial Pelvic Floor Muscles for the Treatment of PBS
Study aims to: (1) evaluate the role of morphological and physiological characteristics of the pelvic floor, pain-related psychological and -psychophysical variables in prediction of the success of myofascial physical therapy (MPT) for the treatment of painful bladder syndrome Patients with clinical symptoms of PBS will undergo physical examination, sensory testing in the genital area, perineal ultrasound examination for the evaluation of the length of the levator muscles before MPT and following 10 consecutive sessions of MPT.
Improvement in clinical symptoms will be assessed and evaluated for correlations with psychophysical examinations.
Read the detailed description
Background: Chronic pelvic pain syndrome (CPPS) is highly prevalent, yet its etiology and the treatment approach are not clear. Painful bladder syndrome (PBS), a subtype of CPPS, is commonly treated by Myofascial physical therapy (MPT), however its efficiency is limited to portion of patients. The relative contribution of local factors such as pelvic anatomical and physiological function compared with systemic pain- related psychological and psychophysical parameters in the prediction of MPT outcome has not been illumined yet.
Hypothesis and aims: Assuming that MPT has mainly local effect its treatment success can be predicted by local impairment of pelvic anatomical and physiological function assessed pretreatment.
Study aims to: (1) evaluate the role of morphological and physiological characteristics of the pelvic floor, pain-related psychological and -psychophysical variables in prediction of MPT success, (2) to assess the effect of MPT on these parameters.
Methods: PBS patients will be evaluated for symptoms severity prior to MPT by: (1) pelvic physical examination for identification of trigger points, (2) self-report of pelvic pain intensity on visual analogue scale (VAS), (3) filling a questionnaire for urinary urgency symptoms, (4) evaluation of morphological and physiological characters of pelvic muscles floor by ultrasound and Doppler, respectively, (5) assessment of pain-related psychological variables (depression, somatization and pain catastrophizing) by questionnaires, and (6) psychophysical tests of experimental pain perception. Following 3 months treatment of MPT, patients will be reevaluated for the same tests. Treatment success will be determined by 30% reduction in pain and urinary urgency.
Expected results: Patients with shorter levator muscles and reduced blood flow in the pelvic region will benefit from MPT compared to patients with augmented pain sensitivity and higher depression, pain catastrophizing and somatization scores. MPT will elongate levator muscles and increased blood flow to the pelvic region that will be associated with the improvement in PBS symptoms.
Importance: The significance of the proposed study stems from its potential to extend conceptualizing of mechanisms associated with PBS and its treatment success.
- Conditions
- Painful Bladder Syndrome
- Being tested
- quantitive sensory testing, Ultrasound testing
- Keywords
- painful bladder, physical therapy, levator ani
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quantitive sensory testingDevice
Also called TSA, Medoc Ramat Yishay, Israel
Mechanical pain threshold: Threshold will be assessed, by using the von Frey filaments. The lowest gram weight capable of inducing pain in two of three trials will be considered as a pain threshold Heat pain threshold (HPT): HPT will be measured using thermal sensory analyzer
Ultrasound testingDevice
Also called Voluson 730 Expert; GE Healthcare
Morphological measures of the pelvic muscles: Using a 3D 4-8MHz abdominal probe ultrasound testing will be performed. The following parameters will be measured: (1) anteroposterior hiatal diameter; (2) lateral hiatal diameter; (3) levator ani thickness and length at 3 o'clock and 9 o'clock; (4) length of the obturator (5) length of the pubococcygeus muscle; (6) obturator thickness.
| Study group | Role | What they receive |
|---|---|---|
| Patients with painful bladder syndrome | Patients with diagnosis of PBS Will be offered to take part in the following study. Receives: Device: quantitive sensory testing; Device: Ultrasound testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of pain level
Following MPT it is expected that patients PBS symptoms will be improved as will be evaluated by VAS.
Measured: 3 months
Secondary outcomes (1)
Elongation of levator ani muscles.
Following MPT treatment it is expected that the levator ani muscles will be elongated as will be measured by perineal US.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Painful Bladder SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Lior Lowenstein, MD, Study chair, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410461
- Sponsor's protocol ID
- RMV-0232-10
- Other IDs
- RMB-0232-10
- Acronym
- PBS
- Status last verified
- Aug 2011
- First submitted
- 4 Aug 2011
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Anderson RU, Sawyer T, Wise D, Morey A, Nathanson BH. Painful myofascial trigger points and pain sites in men with chronic prostatitis/chronic pelvic pain syndrome. J Urol. 2009 Dec;182(6):2753-8. doi: 10.1016/j.juro.2009.08.033. Epub 2009 Oct 17.
PubMed 19837420FitzGerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, Kotarinos R, Fraser L, Cosby A, Fortman C, Neville C, Badillo S, Odabachian L, Sanfield A, O'Dougherty B, Halle-Podell R, Cen L, Chuai S, Landis JR, Mickelberg K, Barrell T, Kusek JW, Nyberg LM; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2009 Aug;182(2):570-80. doi: 10.1016/j.juro.2009.04.022. Epub 2009 Jun 17.
PubMed 19535099
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study That Evaluates Predictor Tests for the Success of Myofascial Pelvic Floor Muscles for the Treatment of PBS
- ClinicalTrials.gov ID
- NCT01410461
- Acronym / sponsor ID
- PBS / RMV-0232-10
- Conditions
- Painful Bladder Syndrome
- Keywords
- painful bladder, physical therapy, levator ani
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 5 Aug 2011 (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.
Study aims to: (1) evaluate the role of morphological and physiological characteristics of the pelvic floor, pain-related psychological and -psychophysical variables in prediction of the success of myofascial physical therapy (MPT) for the treatment of painful bladder syndrome Patients with clinical symptoms of PBS will undergo physical examination, sensory testing in the genital area, perineal ultrasound examination for the evaluation of the length of the levator muscles before MPT and following 10 consecutive sessions of MPT.
Improvement in clinical symptoms will be assessed and evaluated for correlations with psychophysical examinations.
Detailed description
Background: Chronic pelvic pain syndrome (CPPS) is highly prevalent, yet its etiology and the treatment approach are not clear. Painful bladder syndrome (PBS), a subtype of CPPS, is commonly treated by Myofascial physical therapy (MPT), however its efficiency is limited to portion of patients. The relative contribution of local factors such as pelvic anatomical and physiological function compared with systemic pain- related psychological and psychophysical parameters in the prediction of MPT outcome has not been illumined yet.
Hypothesis and aims: Assuming that MPT has mainly local effect its treatment success can be predicted by local impairment of pelvic anatomical and physiological function assessed pretreatment.
Study aims to: (1) evaluate the role of morphological and physiological characteristics of the pelvic floor, pain-related psychological and -psychophysical variables in prediction of MPT success, (2) to assess the effect of MPT on these parameters.
Methods: PBS patients will be evaluated for symptoms severity prior to MPT by: (1) pelvic physical examination for identification of trigger points, (2) self-report of pelvic pain intensity on visual analogue scale (VAS), (3) filling a questionnaire for urinary urgency symptoms, (4) evaluation of morphological and physiological characters of pelvic muscles floor by ultrasound and Doppler, respectively, (5) assessment of pain-related psychological variables (depression, somatization and pain catastrophizing) by questionnaires, and (6) psychophysical tests of experimental pain perception. Following 3 months treatment of MPT, patients will be reevaluated for the same tests. Treatment success will be determined by 30% reduction in pain and urinary urgency.
Expected results: Patients with shorter levator muscles and reduced blood flow in the pelvic region will benefit from MPT compared to patients with augmented pain sensitivity and higher depression, pain catastrophizing and somatization scores. MPT will elongate levator muscles and increased blood flow to the pelvic region that will be associated with the improvement in PBS symptoms.
Importance: The significance of the proposed study stems from its potential to extend conceptualizing of mechanisms associated with PBS and its treatment success.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with painful bladder syndrome | – | Device: quantitive sensory testing, Device: Ultrasound testingPatients with diagnosis of PBS Will be offered to take part in the following study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical diagnosis of painful bladder syndrome
Key inclusion criteria (5 listed)
- age > 18 years old
- urinary frequency of at least 10 per 24 hr including one nighttime voiding
- complaints of bladder pain that has been present for at least 3 months
- pain intensity rated at least four on a VAS from 0 ''no pain at all'' to 10 ''worst imaginable pain'' during the previous month
- pelvic digital exam reveals at least three different TrPs in the levator ani muscles that are verbally confirmed.
Key exclusion criteria (6 listed)
- history of pelvic cancer or radiation
- pelvic or abdominal surgery within 3 months
- urinary tract infection within the last month
- diagnosis of fibromyalgia or irritable bowel disease
- diagnosis of neurologic disorder; diabetes; pregnancy;
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 |
|---|---|---|
| quantitive sensory testingAlso: TSA, Medoc Ramat Yishay, IsraelMechanical pain threshold: Threshold will be assessed, by using the von Frey filaments. The lowest gram weight capable of inducing pain in two of three trials will be considered as a pain threshold Heat pain threshold (HPT): HPT will be measured using thermal sensory analyzer | Device | Patients with painful bladder syndrome |
| Ultrasound testingAlso: Voluson 730 Expert; GE HealthcareMorphological measures of the pelvic muscles: Using a 3D 4-8MHz abdominal probe ultrasound testing will be performed. The following parameters will be measured: (1) anteroposterior hiatal diameter; (2) lateral hiatal diameter; (3) levator ani thickness and length at 3 o'clock and 9 o'clock; (4) length of the obturator (5) length of the pubococcygeus muscle; (6) obturator thickness. | Device | Patients with painful bladder syndrome |
Primary outcome
Reduction of pain level
Time frame: 3 months
Following MPT it is expected that patients PBS symptoms will be improved as will be evaluated by VAS.
1 secondary outcome
Elongation of levator ani muscles.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2011.
- Background: PubMed 19837420Anderson RU, Sawyer T, Wise D, Morey A, Nathanson BH. Painful myofascial trigger points and pain sites in men with chronic prostatitis/chronic pelvic pain syndrome. J Urol. 2009 Dec;182(6):2753-8. doi: 10.1016/j.juro.2009.08.033. Epub 2009 Oct 17.
- Background: PubMed 19535099FitzGerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, Kotarinos R, Fraser L, Cosby A, Fortman C, Neville C, Badillo S, Odabachian L, Sanfield A, O'Dougherty B, Halle-Podell R, Cen L, Chuai S, Landis JR, Mickelberg K, Barrell T, Kusek JW, Nyberg LM; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2009 Aug;182(2):570-80. doi: 10.1016/j.juro.2009.04.022. Epub 2009 Jun 17.
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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.
Lior Lowenstein, MD study chair
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Painful Bladder Syndrome, run by Rambam Health Care Campus 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 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lior Lowenstein, MD (97248542612, lowensteinmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of pain level (time frame: 3 months). 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 NCT01410461, which also lists 2 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 5 Aug 2011.