Interstitial CystitisUPPCRN-RCT#1NCT00434343
Physical Therapy Trial for Pelvic Pain
A study testing Global Therapeutic Massage (GTM) and Myofascial physical therapy (MPT) in people with Interstitial Cystitis and Painful Bladder Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 5 sites in United States.
Trial summary
The purpose of this study is to determine if a randomized trial of physical therapy for pelvic pain is feasible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Cystitis, Painful Bladder Syndrome, Chronic Prostatitis
- What is being tested?
- Global Therapeutic Massage (GTM) and Myofascial physical therapy (MPT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2006to Nov 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female and male patients who have failed to respond to previous therapies for interstitial cystitis/painful bladder syndrome
- male patients who have failed to respond to previous therapies for chronic prostatitis/chronic pelvic pain syndrome
Who cannot join
- neurologic disorder affecting bladder
- bladder cancer, prostate cancer, or urethral cancer
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Loyola University Medical Center
Maywood, Illinois, 60153
William Beaumont Hospital
Royal Oak, Michigan, 48073
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: A Pilot Feasibility Study of Physical Therapy for the Treatment of Urologic Pelvic Pain Syndromes
The purpose of this study is to determine if a randomized trial of physical therapy for pelvic pain is feasible.
Read the detailed description
This is a pilot study wherein eligible participants will be randomly assigned to receive either myofascial tissue manipulation or global therapeutic massage. Those receiving myofascial tissue manipulation will have targeted internal and external connective tissue manipulation focusing on the muscles and connective tissues of the pelvic floor, hip girdle, and abdomen. Those receiving global therapeutic massage will have non-specific somatic treatment with full-body Western massage.
- Conditions
- Interstitial Cystitis, Painful Bladder Syndrome, Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- Being tested
- Global Therapeutic Massage (GTM), Myofascial physical therapy (MPT)
- Keywords
- Interstitial Cystitis, Painful Bladder Syndrome, Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global Therapeutic Massage (GTM)Other
Myofascial physical therapy (MPT)Other
Connective tissue manipulation to all body wall tissues of the abdominal wall, back, buttocks and thighs that clinically were found to contain connective tissue abnormalities and/or myofascial trigger point release to painful myofascial trigger points
| Study group | Role | What they receive |
|---|---|---|
| Global Therapeutic Massage (GTM) | Placebo comparator | Weekly massages consisting of full body Western massage for 1hour. Receives: Other: Global Therapeutic Massage (GTM) |
| Myofascial physical therapy (MPT) | Active comparator | Connective tissue manipulation to all body wall tissues of the abdominal wall, back, buttocks and thighs that clinically were found to contain connective tissue abnormalities and/or myofascial trigger point release to painful myofascial trigger points Receives: Other: Myofascial physical therapy (MPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number consenting to join study out of eligible patients approached
This study will recruit both female and male patients who have failed to respond to previous therapies for either Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) or male patients who have failed to respond to previous therapies for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS).
Measured: 6 months
Number of times therapists adhered to prescribed therapeutic protocol
For each therapy session therapy records are reviewed to determine whether the therapist followed the therapeutic protocol. Each therapy session is scored as adherent or non-adherent and the number of adherent sessions are recorded per participant
Measured: 12 weeks
Secondary outcomes (3)
Number of adverse events reported by the participants
Number of adverse events reported by the participants
Measured: 12 weeks
Global response assessment (GRA) Global response assessment
The global response assessment consists of the following question: "As compared to when you started the study, how would you rate your overall symptoms now?" 1. markedly worse, 2. moderately worse, 3. slightly worse, 4. the same, 5. slightly improved, 6. moderately improved, 7. markedly improved
Measured: 12 weeks
Tolerability of treatment measured by number of treatment sessions participants completed
Treatment session completion was tracked and used to measure tolerability of treatment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startNov 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- John Kusek, PhD, Study director, National Institute of Diabetes & Digestive & Kidney Diseases/National Institutes of HealthLeroy Nyberg, PhD, MD, Study director, National Institute of Diabetes & Digestive & Kidney Diseases/National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434343
- Sponsor's protocol ID
- UPPCRN RCT1 - PT
- Other IDs
- U01DK065209
- Acronym
- UPPCRN-RCT#1
- Status last verified
- Dec 2022
- First submitted
- 12 Feb 2007
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
FitzGerald 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 19535099Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
PubMed 32734597Fitzgerald 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. 2013 Jan;189(1 Suppl):S75-85. doi: 10.1016/j.juro.2012.11.018.
PubMed 23234638
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of Physical Therapy for the Treatment of Urologic Pelvic Pain Syndromes
- ClinicalTrials.gov ID
- NCT00434343
- Acronym / sponsor ID
- UPPCRN-RCT#1 / UPPCRN RCT1 - PT
- Conditions
- Interstitial Cystitis, Painful Bladder Syndrome, Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- Keywords
- Interstitial Cystitis, Painful Bladder Syndrome, Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- University of Pennsylvania
- Study start
- Nov 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 13 Feb 2007 (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.
The purpose of this study is to determine if a randomized trial of physical therapy for pelvic pain is feasible.
Detailed description
This is a pilot study wherein eligible participants will be randomly assigned to receive either myofascial tissue manipulation or global therapeutic massage. Those receiving myofascial tissue manipulation will have targeted internal and external connective tissue manipulation focusing on the muscles and connective tissues of the pelvic floor, hip girdle, and abdomen. Those receiving global therapeutic massage will have non-specific somatic treatment with full-body Western massage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Global Therapeutic Massage (GTM) | Placebo comparator | Other: Global Therapeutic Massage (GTM)Weekly massages consisting of full body Western massage for 1hour. |
| Myofascial physical therapy (MPT) | Active comparator | Other: Myofascial physical therapy (MPT)Connective tissue manipulation to all body wall tissues of the abdominal wall, back, buttocks and thighs that clinically were found to contain connective tissue abnormalities and/or myofascial trigger point release to painful myofascial trigger points |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- female and male patients who have failed to respond to previous therapies for interstitial cystitis/painful bladder syndrome
- male patients who have failed to respond to previous therapies for chronic prostatitis/chronic pelvic pain syndrome
Key exclusion criteria (2 listed)
- neurologic disorder affecting bladder
- bladder cancer, prostate cancer, or urethral cancer
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 |
|---|---|---|
| Global Therapeutic Massage (GTM) | Other | Global Therapeutic Massage (GTM) |
| Myofascial physical therapy (MPT)Connective tissue manipulation to all body wall tissues of the abdominal wall, back, buttocks and thighs that clinically were found to contain connective tissue abnormalities and/or myofascial trigger point release to painful myofascial trigger points | Other | Myofascial physical therapy (MPT) |
Primary outcome
Number consenting to join study out of eligible patients approached
Time frame: 6 months
This study will recruit both female and male patients who have failed to respond to previous therapies for either Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) or male patients who have failed to respond to previous therapies for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS).
Number of times therapists adhered to prescribed therapeutic protocol
Time frame: 12 weeks
For each therapy session therapy records are reviewed to determine whether the therapist followed the therapeutic protocol. Each therapy session is scored as adherent or non-adherent and the number of adherent sessions are recorded per participant
3 secondary outcomes
Number of adverse events reported by the participants
Time frame: 12 weeks
Global response assessment (GRA) Global response assessment
Time frame: 12 weeks
Tolerability of treatment measured by number of treatment sessions participants completed
Time frame: 12 weeks
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 12 Dec 2022.
- Results publication: 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.
- Derived from this study: PubMed 32734597Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
- Derived from this study: PubMed 23234638Fitzgerald 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. 2013 Jan;189(1 Suppl):S75-85. doi: 10.1016/j.juro.2012.11.018.
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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.
John Kusek, PhD study director
National Institute of Diabetes & Digestive & Kidney Diseases/National Institutes of Health
Leroy Nyberg, PhD, MD study director
National Institute of Diabetes & Digestive & Kidney Diseases/National Institutes of Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global Therapeutic Massage (GTM) and Myofascial physical therapy (MPT) in people with Interstitial Cystitis and Painful Bladder Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 5 sites in United States.
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 2 inclusion and 2 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 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Number consenting to join study out of eligible patients approached (time frame: 6 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 NCT00434343, which also lists 3 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 12 Dec 2022.