Levator Ani SyndromeNCT01586286
A Study Examining the Use of Vaginal Nifedipine With Pelvic Floor Physical Therapy for Levator Myalgia and Pelvic Pain
A study testing Nifedipine in people with Levator Ani Syndrome, run by Vanderbilt University at 1 site in United States.
Trial summary
The objective of this study is to perform a randomized controlled trial among female patients with a diagnosis of pelvic floor hypertonus (extreme muscle tension) with associated pain, dysfunctional voiding, dyspareunia, and/ or obstructed defecation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Levator Ani Syndrome
- What is being tested?
- Nifedipine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to May 2014
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has levator myalgia upon appropriate pelvic exam that reproduces HPI pain
- Subject has symptoms such as voiding dysfunction, dyspareunia, vaginismus, or obstructed defecation
- Subject is willing and able to give written consent for the study
- Subject is willing to undergo treatment with pelvic physical therapy \& vaginal nifedipine
- Subject is able to speak, read, and write in English
- Subject is at least 18 years of age
Who cannot join
- Subject has previously diagnosed interstitial cystitis
- Subject has an active case of symptomatic HSV, syphilis, or shingles
- Subject has a history of uncontrolled hypertension
- Subject is already taking a calcium channel blocker
- Subject has a history of MI, CHF, or arrhythmia
- Subject has a history of neurologic disease
Show all 15Show fewer
- Subject has a history of congenital or progressive musculoskeletal disease
- Subject has a history of bladder or pelvic cancer and/or pelvic radiation
- Subject is planning to be or currently pregnant
- Subject has known allergy or adverse reaction to nifedipine
- Subject has known allergy or adverse reaction to lanolin, mineral oil, petrolatum
- Subject is undergoing pharmacologic treatment specific to pelvic pain
- Subject is taking oral beta adrenergic antagonist medication
- Subject has an active pelvic or vaginal infection
- Subjects with hypotension on screening physical examination (i.e. confirmed SBP<90 mmHg or DBP<60 mmHg).
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Does Adjunctive Treatment With Vaginal Nifedipine Result in Symptomatic Improvement in Patients With Levator Myalgia and Pelvic Floor Pain Who Are Undergoing Pelvic Floor Physical Therapy?
The objective of this study is to perform a randomized controlled trial among female patients with a diagnosis of pelvic floor hypertonus (extreme muscle tension) with associated pain, dysfunctional voiding, dyspareunia, and/ or obstructed defecation.
Read the detailed description
Given the paucity of information and the magnitude of debilitation that can be associated with chronic pain syndromes, the potential to ameliorate pain and successfully treat these symptoms is an area that merits further exploration. In this study, we hypothesize that the addition of vaginal nifedipine to a physical therapy protocol will result in greater treatment success than treatment with physical therapy alone.
The objective is to perform a randomized controlled trial among female participants with a diagnosis of pelvic floor hypertonus with associated pain, dysfunctional voiding, dyspareunia, and/or obstructed defecation. Group 1 will serve as the control and will undergo pelvic floor physical therapy and placebo (lanolin and mineral oil base). Group 2 will also undergo pelvic floor physical therapy, but will receive compounded vaginal nifedipine.
Specific aims include:
- Comparison of subjective outcome measures, specifically quality of life metrics scales: Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and validated 11-point pain scale.
- Comparison of objective outcome measures, specifically a validated digital assessment of pelvic floor strength: the Oxford scale.
Group 1 will serve as the control and will undergo pelvic floor physical therapy and placebo (lanolin base). Group 2 will also undergo pelvic floor physical therapy, but will receive compounded vaginal nifedipine. We will collect data on these patients to determine if the treatment of vaginal nifedipine with physical therapy provides a more successful treatment for this pelvic floor dysfunction.
- Conditions
- Levator Ani Syndrome
- Being tested
- Nifedipine, Placebo Ointment Base
- Keywords
- Levator Myalgia, Pelvic Pain, Vaginismus, Myofascial pain syndromes
- Medical subject headings
- Levator syndrome, Pelvic Pain, Vaginismus, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NifedipineDrug
Nifedipine - 0.2% concentration in a lanolin base; administered twice per day for 28 days; as a vaginal ointment applied to vulvar and vaginal area
Placebo Ointment BaseDrug
Placebo administered twice per day for 28 days; as a vaginal ointment applied to vulvar and vaginal area
| Study group | Role | What they receive |
|---|---|---|
| Ointment Base | Placebo comparator | Patients in this arm will serve as the control and will undergo pelvic floor physical therapy and receive placebo (lanolin and mineral oil base). Receives: Drug: Placebo Ointment Base |
| Nifedipine Ointment | Active comparator | Patients in this arm will undergo pelvic floor physical therapy, but will receive compounded vaginal nifedipine. Receives: Drug: Nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Quality of Life
The primary outcome will measure quality of life metrics, as reported by the patient herself. We will use the following validated instruments: Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and validated 11-point pain scale. The aim is to measure whether the patient experienced improvement in her symptoms when vaginal nifedipine was administered (in addition to physical therapy).
Measured: To be assessed 1 month post-treatment.
Secondary outcomes (1)
Improvement in Hypertonic Pelvic Floor Muscles
The secondary outcome measure will be assessed and reported by the healthcare provider at the above visits. After instructing the patient to voluntarily relax the pelvic floor muscles, the resting tone will be measured using the Oxford scale, which is a validated digital assessment.
Measured: To be assessed at baseline and the following post-treatment intervals: 1, 2, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Why it stopped: No patients were recruited over a 12 month period
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 Levator Ani 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Biller, Vanderbilt University
- Investigators
- Daniel Biller, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586286
- Sponsor's protocol ID
- 111573
- Status last verified
- May 2014
- First submitted
- 20 Apr 2012
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996 Mar;87(3):321-7. doi: 10.1016/0029-7844(95)00458-0.
PubMed 8598948Reiter RC. A profile of women with chronic pelvic pain. Clin Obstet Gynecol. 1990 Mar;33(1):130-6. No abstract available.
PubMed 2178830Butrick CW. Pelvic floor hypertonic disorders: identification and management. Obstet Gynecol Clin North Am. 2009 Sep;36(3):707-22. doi: 10.1016/j.ogc.2009.08.011.
PubMed 19932423Rosenbaum TY, Owens A. The role of pelvic floor physical therapy in the treatment of pelvic and genital pain-related sexual dysfunction (CME). J Sex Med. 2008 Mar;5(3):513-23; quiz 524-5. doi: 10.1111/j.1743-6109.2007.00761.x.
PubMed 18304280Onghena P, Van Houdenhove B. Antidepressant-induced analgesia in chronic non-malignant pain: a meta-analysis of 39 placebo-controlled studies. Pain. 1992 May;49(2):205-219. doi: 10.1016/0304-3959(92)90144-Z.
PubMed 1535121Bornstein J, Tuma R, Farajun Y, Azran A, Zarfati D. Topical nifedipine for the treatment of localized provoked vulvodynia: a placebo-controlled study. J Pain. 2010 Dec;11(12):1403-9. doi: 10.1016/j.jpain.2010.03.016. Epub 2010 May 26.
PubMed 20537958Katsinelos P, Papaziogas B, Koutelidakis I, Paroutoglou G, Dimiropoulos S, Souparis A, Atmatzidis K. Topical 0.5% nifedipine vs. lateral internal sphincterotomy for the treatment of chronic anal fissure: long-term follow-up. Int J Colorectal Dis. 2006 Mar;21(2):179-83. doi: 10.1007/s00384-005-0766-x. Epub 2005 Aug 10.
PubMed 16091912Nelson R. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD003431. doi: 10.1002/14651858.CD003431.pub2.
PubMed 17054170Hundley AF, Wu JM, Visco AG. A comparison of perineometer to brink score for assessment of pelvic floor muscle strength. Am J Obstet Gynecol. 2005 May;192(5):1583-91. doi: 10.1016/j.ajog.2004.11.015.
PubMed 15902162
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Adjunctive Treatment With Vaginal Nifedipine Result in Symptomatic Improvement in Patients With Levator Myalgia and Pelvic Floor Pain Who Are Undergoing Pelvic Floor Physical Therapy?
- ClinicalTrials.gov ID
- NCT01586286
- Acronym / sponsor ID
- 111573
- Conditions
- Levator Ani Syndrome
- Keywords
- Levator Myalgia, Pelvic Pain, Vaginismus, Myofascial pain syndromes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients were recruited over a 12 month period
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 26 Apr 2012 (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 objective of this study is to perform a randomized controlled trial among female patients with a diagnosis of pelvic floor hypertonus (extreme muscle tension) with associated pain, dysfunctional voiding, dyspareunia, and/ or obstructed defecation.
Detailed description
Given the paucity of information and the magnitude of debilitation that can be associated with chronic pain syndromes, the potential to ameliorate pain and successfully treat these symptoms is an area that merits further exploration. In this study, we hypothesize that the addition of vaginal nifedipine to a physical therapy protocol will result in greater treatment success than treatment with physical therapy alone.
The objective is to perform a randomized controlled trial among female participants with a diagnosis of pelvic floor hypertonus with associated pain, dysfunctional voiding, dyspareunia, and/or obstructed defecation. Group 1 will serve as the control and will undergo pelvic floor physical therapy and placebo (lanolin and mineral oil base). Group 2 will also undergo pelvic floor physical therapy, but will receive compounded vaginal nifedipine.
Specific aims include:
- Comparison of subjective outcome measures, specifically quality of life metrics scales: Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and validated 11-point pain scale.
- Comparison of objective outcome measures, specifically a validated digital assessment of pelvic floor strength: the Oxford scale.
Group 1 will serve as the control and will undergo pelvic floor physical therapy and placebo (lanolin base). Group 2 will also undergo pelvic floor physical therapy, but will receive compounded vaginal nifedipine. We will collect data on these patients to determine if the treatment of vaginal nifedipine with physical therapy provides a more successful treatment for this pelvic floor dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ointment Base | Placebo comparator | Drug: Placebo Ointment BasePatients in this arm will serve as the control and will undergo pelvic floor physical therapy and receive placebo (lanolin and mineral oil base). |
| Nifedipine Ointment | Active comparator | Drug: NifedipinePatients in this arm will undergo pelvic floor physical therapy, but will receive compounded vaginal nifedipine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has levator myalgia upon appropriate pelvic exam that reproduces HPI pain
- Subject has symptoms such as voiding dysfunction, dyspareunia, vaginismus, or obstructed defecation
- Subject is willing and able to give written consent for the study
- Subject is willing to undergo treatment with pelvic physical therapy \& vaginal nifedipine
- Subject is able to speak, read, and write in English
Key exclusion criteria (15 listed)
- Subject has previously diagnosed interstitial cystitis
- Subject has an active case of symptomatic HSV, syphilis, or shingles
- Subject has a history of uncontrolled hypertension
- Subject is already taking a calcium channel blocker
- Subject has a history of MI, CHF, or arrhythmia
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 |
|---|---|---|
| NifedipineNifedipine - 0.2% concentration in a lanolin base; administered twice per day for 28 days; as a vaginal ointment applied to vulvar and vaginal area | Drug | Nifedipine Ointment |
| Placebo Ointment BasePlacebo administered twice per day for 28 days; as a vaginal ointment applied to vulvar and vaginal area | Drug | Ointment Base |
Primary outcome
Improvement in Quality of Life
Time frame: To be assessed 1 month post-treatment.
The primary outcome will measure quality of life metrics, as reported by the patient herself. We will use the following validated instruments: Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and validated 11-point pain scale. The aim is to measure whether the patient experienced improvement in her symptoms when vaginal nifedipine was administered (in addition to physical therapy).
1 secondary outcome
Improvement in Hypertonic Pelvic Floor Muscles
Time frame: To be assessed at baseline and the following post-treatment intervals: 1, 2, 3, and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
- Background: PubMed 8598948Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996 Mar;87(3):321-7. doi: 10.1016/0029-7844(95)00458-0.
- Background: PubMed 2178830Reiter RC. A profile of women with chronic pelvic pain. Clin Obstet Gynecol. 1990 Mar;33(1):130-6. No abstract available.
- Background: PubMed 19932423Butrick CW. Pelvic floor hypertonic disorders: identification and management. Obstet Gynecol Clin North Am. 2009 Sep;36(3):707-22. doi: 10.1016/j.ogc.2009.08.011.
- Background: PubMed 18304280Rosenbaum TY, Owens A. The role of pelvic floor physical therapy in the treatment of pelvic and genital pain-related sexual dysfunction (CME). J Sex Med. 2008 Mar;5(3):513-23; quiz 524-5. doi: 10.1111/j.1743-6109.2007.00761.x.
- Background: PubMed 1535121Onghena P, Van Houdenhove B. Antidepressant-induced analgesia in chronic non-malignant pain: a meta-analysis of 39 placebo-controlled studies. Pain. 1992 May;49(2):205-219. doi: 10.1016/0304-3959(92)90144-Z.
- Background: PubMed 20537958Bornstein J, Tuma R, Farajun Y, Azran A, Zarfati D. Topical nifedipine for the treatment of localized provoked vulvodynia: a placebo-controlled study. J Pain. 2010 Dec;11(12):1403-9. doi: 10.1016/j.jpain.2010.03.016. Epub 2010 May 26.
- Background: PubMed 16091912Katsinelos P, Papaziogas B, Koutelidakis I, Paroutoglou G, Dimiropoulos S, Souparis A, Atmatzidis K. Topical 0.5% nifedipine vs. lateral internal sphincterotomy for the treatment of chronic anal fissure: long-term follow-up. Int J Colorectal Dis. 2006 Mar;21(2):179-83. doi: 10.1007/s00384-005-0766-x. Epub 2005 Aug 10.
- Background: PubMed 17054170Nelson R. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD003431. doi: 10.1002/14651858.CD003431.pub2.
- Background: PubMed 15902162Hundley AF, Wu JM, Visco AG. A comparison of perineometer to brink score for assessment of pelvic floor muscle strength. Am J Obstet Gynecol. 2005 May;192(5):1583-91. doi: 10.1016/j.ajog.2004.11.015.
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Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for Treatment of Chronic Pelvic Pain: HOPE Trial
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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.
Daniel Biller, MD principal investigator
Vanderbilt 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 Nifedipine in people with Levator Ani Syndrome, run by Vanderbilt University at 1 site 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 6 inclusion and 15 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: withdrawn, as of the sponsor's last update on 22 May 2014. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Improvement in Quality of Life (time frame: To be assessed 1 month post-treatment.). 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 NCT01586286, 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 22 May 2014.