Pelvic PainPhase 4NCT03199534
A Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction
A Phase 4 study testing Botulinum toxin A 50u, Botulinum toxin A 100u and Botulinum toxin A 150u in people with Pelvic Pain and Dyspareunia, run by EvergreenHealth at 1 site in United States.
Trial summary
This study assesses whether the addition of chemodenervation to an established regimen of pelvic floor physical therapy for painful high tone pelvic floor dysfunction improves patients' objective and subjective outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Pain, Dyspareunia, Pelvic Floor Dysfunction
- What is being tested?
- Botulinum toxin A 50u, Botulinum toxin A 100u and Botulinum toxin A 150u
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2017to 26 Feb 2020
- Phase
- Phase 4
- 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
- Age 18 years or older
- >6 month history of pelvic pain or dyspareunia with high tone pelvic floor dysfunction on exam (pain with palpation of superficial transverse perineii, bulbocavernosus insertion to perineal/central tendon and/or levator ani complex/iliococcygeus)
- Women with male sexual partners
- History of undergoing pelvic floor physical therapy with internal manipulation including trigger point release as directed, with inability to meet goals of therapy despite appropriate pelvic floor physical therapy approach
- Able to read, write, and comprehend English sufficiently to offer informed consent
Who cannot join
- Presence of intact hymen, preventing internal manipulation during pelvic floor physical therapy
- Pregnancy at the time of injection
- Breast feeding at the time of injection
- History of Myasthenia Gravis, Amyotrophic Lateral Sclerosis, Lambert-Eaton syndrome, allergy to Botulinum toxin A, or other contraindication to Botulinum toxin A injection
- History of documented skin disorder of the vulva other than vaginal atrophy or lichen planus
- Prior pelvic radiation
Show all 9Show fewer
- Stage II-IV pelvic organ prolapse
- Has had a pelvic floor Botulinum toxin A injection within the last 12 weeks
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
EvergreenHealth Urology and Urogynecology Care
Kirkland, Washington, 98034
About this study
Official title: A Prospective Cohort Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction
This study assesses whether the addition of chemodenervation to an established regimen of pelvic floor physical therapy for painful high tone pelvic floor dysfunction improves patients' objective and subjective outcomes. Study subjects will select one of three treatment approaches: injection of 50 units Botulinum toxin A with local sedation as an office procedure, injection of 100u BoNTA-cosmetic in either the office or while anesthetized, or injection of 150 units Botulinum toxin A while anesthetized.
Read the detailed description
High-tone pelvic floor dysfunction is often a painful condition that can be associated with a number of female pelvic syndromes including childhood elimination disorders, idiopathic urinary retention, vaginismus, dyspareunia, pelvic pain, constipation, sport injuries, postoperative and bladder pain syndrome/interstitial cystitis. Following appropriate patient education about pelvic floor function, mainstays of therapy for high-tone pelvic floor dysfunction pelvic pain include pharmacotherapeutic agents and pelvic floor physical therapy. The investigators hypothesize that chemodenervation with Botulinum toxin A will offer a safe, efficacious intervention for women with high tone pelvic floor dysfunction that cannot be adequately treated with pelvic floor physical therapy alone.
- Conditions
- Pelvic Pain, Dyspareunia, Pelvic Floor Dysfunction
- Being tested
- Botulinum toxin A 50u, Botulinum toxin A 100u, Botulinum toxin A 150u
- Keywords
- Pelvic Pain, Dyspareunia, Pelvic Floor Dysfunction, Pelvic Floor Physical Therapy, Chemodenervation, Botulinum Toxin A, Vaginismus
- Medical subject headings
- Pelvic Pain, Dyspareunia, Vaginismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin A 50uDrug
Also called BOTOX®, OnabotulinumtoxinA
Subject will receive injection of 50u Botulinum toxin A with local sedation as an office procedure.
Botulinum toxin A 100uDrug
Also called BOTOX®, OnabotulinumtoxinA
Subject will receive injection of 100u Botulinum toxin A in either the office or while anesthetized.
Botulinum toxin A 150uDrug
Also called BOTOX®, OnabotulinumtoxinA
Subject will receive injection of 150u Botulinum toxin A while anesthetized.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin A 50u | Experimental | Botulinum toxin A 50 unit injection Receives: Drug: Botulinum toxin A 50u |
| Botulinum toxin A 100u | Experimental | Botulinum toxin A 100 unit injection Receives: Drug: Botulinum toxin A 100u |
| Botulinum toxin A 150u | Experimental | Botulinum toxin A 150 unit injection Receives: Drug: Botulinum toxin A 150u |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Pain Scale (Non-Menstrual Pelvic Pain) score
This is a single question, "How severe is your pelvic pain at this time?"
Measured: Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
Secondary outcomes (5)
Visual Analog Pain Scale (Dyspareunia)
This is a single question, "How severe was your pelvic pain the last time you had sexual intercourse?"
Measured: Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
Patient Global Impression of Severity
This questionnaire asks subjects to rate the severity of their pelvic pain symptoms. There are 4 choices to answer: 1 - Normal, no pain, 2 - Slightly more pain than normal, 3 - Significantly worse pain than normal, 4 - Severe pain.
Measured: Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
Pelvic Floor Distress Inventory Questionnaire
Subjects' rating on this 20-item questionnaire will be based on their bowel, bladder, and pelvic symptoms.
Measured: Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
Female Sexual Function Index
Subjects' rating on this 19-item questionnaire will be based on their sexual feelings and responses.
Measured: Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
Patient Global Impression of Improvement
This questionnaire asks subjects to rate their current pelvic pain symptoms compared to before treatment. There are 7 choices to answer: 1 - very much better compared to before treatment, 2 - somewhat better compared to before treatment, 3 - slightly better compared to before treatment, 4 - no change compared to before treatment, 5 - slightly worse compared to before treatment, 6 - somewhat worse compared to before treatment, 7 - very much worse compared to before treatment.
Measured: Week 2, Month 3, Month 6, Month 9, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start25 May 2017
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- EvergreenHealth
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- Mia A. Swartz, MD, Principal investigator, EvergreenHealth Urology & Urogynecology Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199534
- Sponsor's protocol ID
- HTPFD
- Status last verified
- Jun 2021
- First submitted
- 13 Jun 2017
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction
- ClinicalTrials.gov ID
- NCT03199534
- Acronym / sponsor ID
- HTPFD
- Conditions
- Pelvic Pain, Dyspareunia, Pelvic Floor Dysfunction
- Keywords
- Pelvic Pain, Dyspareunia, Pelvic Floor Dysfunction, Pelvic Floor Physical Therapy, Chemodenervation, Botulinum Toxin A, Vaginismus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- EvergreenHealthUniversity, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- 25 May 2017 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 27 Jun 2017 (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.
This study assesses whether the addition of chemodenervation to an established regimen of pelvic floor physical therapy for painful high tone pelvic floor dysfunction improves patients' objective and subjective outcomes. Study subjects will select one of three treatment approaches: injection of 50 units Botulinum toxin A with local sedation as an office procedure, injection of 100u BoNTA-cosmetic in either the office or while anesthetized, or injection of 150 units Botulinum toxin A while anesthetized.
Detailed description
High-tone pelvic floor dysfunction is often a painful condition that can be associated with a number of female pelvic syndromes including childhood elimination disorders, idiopathic urinary retention, vaginismus, dyspareunia, pelvic pain, constipation, sport injuries, postoperative and bladder pain syndrome/interstitial cystitis. Following appropriate patient education about pelvic floor function, mainstays of therapy for high-tone pelvic floor dysfunction pelvic pain include pharmacotherapeutic agents and pelvic floor physical therapy. The investigators hypothesize that chemodenervation with Botulinum toxin A will offer a safe, efficacious intervention for women with high tone pelvic floor dysfunction that cannot be adequately treated with pelvic floor physical therapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin A 50u | Experimental | Drug: Botulinum toxin A 50uBotulinum toxin A 50 unit injection |
| Botulinum toxin A 100u | Experimental | Drug: Botulinum toxin A 100uBotulinum toxin A 100 unit injection |
| Botulinum toxin A 150u | Experimental | Drug: Botulinum toxin A 150uBotulinum toxin A 150 unit injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- >6 month history of pelvic pain or dyspareunia with high tone pelvic floor dysfunction on exam (pain with palpation of superficial transverse perineii, bulbocavernosus insertion to perineal/central tendon and/or levator ani complex/iliococcygeus)
- Women with male sexual partners
- History of undergoing pelvic floor physical therapy with internal manipulation including trigger point release as directed, with inability to meet goals of therapy despite appropriate pelvic floor physical therapy approach
- Able to read, write, and comprehend English sufficiently to offer informed consent
Key exclusion criteria (9 listed)
- Presence of intact hymen, preventing internal manipulation during pelvic floor physical therapy
- Pregnancy at the time of injection
- Breast feeding at the time of injection
- History of Myasthenia Gravis, Amyotrophic Lateral Sclerosis, Lambert-Eaton syndrome, allergy to Botulinum toxin A, or other contraindication to Botulinum toxin A injection
- History of documented skin disorder of the vulva other than vaginal atrophy or lichen planus
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 |
|---|---|---|
| Botulinum toxin A 50uAlso: BOTOX®, OnabotulinumtoxinASubject will receive injection of 50u Botulinum toxin A with local sedation as an office procedure. | Drug | Botulinum toxin A 50u |
| Botulinum toxin A 100uAlso: BOTOX®, OnabotulinumtoxinASubject will receive injection of 100u Botulinum toxin A in either the office or while anesthetized. | Drug | Botulinum toxin A 100u |
| Botulinum toxin A 150uAlso: BOTOX®, OnabotulinumtoxinASubject will receive injection of 150u Botulinum toxin A while anesthetized. | Drug | Botulinum toxin A 150u |
Primary outcome
Change in Visual Analog Pain Scale (Non-Menstrual Pelvic Pain) score
Time frame: Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
This is a single question, "How severe is your pelvic pain at this time?"
5 secondary outcomes
Visual Analog Pain Scale (Dyspareunia)
Time frame: Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
Patient Global Impression of Severity
Time frame: Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
Pelvic Floor Distress Inventory Questionnaire
Time frame: Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
Female Sexual Function Index
Time frame: Baseline, Week 2, Month 3, Month 6, Month 9, Month 12
Patient Global Impression of Improvement
Time frame: Week 2, Month 3, Month 6, Month 9, Month 12
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 10 Jun 2021.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
Related trials for Pelvic Pain
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Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
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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.
Mia A. Swartz, MD principal investigator
EvergreenHealth Urology & Urogynecology Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum toxin A 50u, Botulinum toxin A 100u and Botulinum toxin A 150u in people with Pelvic Pain and Dyspareunia, run by EvergreenHealth 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 5 inclusion and 9 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 10 Jun 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Visual Analog Pain Scale (Non-Menstrual Pelvic Pain) score (time frame: Baseline, Week 2, Month 3, Month 6, Month 9, Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2021.