Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin A 50u | Experimental | Botulinum toxin A 50 unit injection |
|
| Botulinum toxin A 100u | Experimental | Botulinum toxin A 100 unit injection |
|
| Botulinum toxin A 150u | Experimental | Botulinum toxin A 150 unit injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin A 50u | Drug | Subject will receive injection of 50u Botulinum toxin A with local sedation as an office procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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?" | Baseline, Week 2, Month 3, Month 6, Month 9, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Pain Scale (Dyspareunia) | This is a single question, "How severe was your pelvic pain the last time you had sexual intercourse?" | Baseline, Week 2, Month 3, Month 6, Month 9, Month 12 |
| Patient Global Impression of Severity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mia A. Swartz, MD | EvergreenHealth Urology & Urogynecology Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EvergreenHealth Urology and Urogynecology Care | Kirkland | Washington | 98034 | United States |
There is no plan to share individual participant data.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Botulinum toxin A 100u | Drug | Subject will receive injection of 100u Botulinum toxin A in either the office or while anesthetized. |
|
|
| Botulinum toxin A 150u | Drug | Subject will receive injection of 150u Botulinum toxin A while anesthetized. |
|
|
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.
| 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. | 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. | 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. | Week 2, Month 3, Month 6, Month 9, Month 12 |
| ID | Term |
|---|---|
| D017699 | Pelvic Pain |
| D004414 | Dyspareunia |
| D052065 | Vaginismus |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D014623 | Vaginal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
Not provided
Not provided