Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Patty Brisben Foundation | Other Grant/Funding Number | Patty Brisben Foundation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patty Brisben Foundation For Women's Sexual Health | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate which treatment option for pelvic floor pain allows for improved sexual function.
Pelvic floor pain may be treated with trigger point injections with medications (steroids and local anesthetics) that are FDA approved for injection into muscles. The alternative is a noninvasive treatment option using pelvic rehabilitation which involves vaginal muscle massage. Both treatment options have been used and reported; however, rapidity of improvement and return to normal sexual function have not been assessed. This study assigns patients to either treatment option randomly and the sexual function is assessed based on standardized sexual function questionnaires as well as pain ratings.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic Rehabilitation | Active Comparator | Pelvic Rehabilitation will be conduction on weekly basis for a total of 6 weeks |
|
| Trigger Point Injections | Active Comparator | Trigger point injections will be administered on weekly basis for a total of 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride | Drug | The mixture is injected into the levator muscles, with half the volume on each side of the pelvic musculature. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in rating of pain from baseline until the end of the study according to the Iowa Pain Scale | Patients will be asked to rate their current pain prior to initiation of the treatment at the visits, at the start of the study and after the completion of the study, using the 10 point Iowa Pain scale. | Baseline, Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sexual function between visit 1 and visit 10 | Change in sexual function based on the female sexual function index (19 questions, one final score, maximum score of 36) where the patients fill a questionnaire prior to the first treatment session and after the completion of the treatment at week 10. | Baseline, Week 10 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dani Zoorob, MD | Contact | 5135629080 | zoorobdg@ucmail.uc.edu | |
| Mary South, MD | Contact | 5135629080 | southmm@ucmai.uc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mary South, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Urogynecology, University of Cincinnati Medical Center | Recruiting | Cincinnati | Ohio | 45219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8598948 | Background | 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. | |
| 19222415 | Result | Rao SS, Paulson J, Mata M, Zimmerman B. Clinical trial: effects of botulinum toxin on Levator ani syndrome--a double-blind, placebo-controlled study. Aliment Pharmacol Ther. 2009 May 1;29(9):985-91. doi: 10.1111/j.1365-2036.2009.03964.x. Epub 2009 Feb 13. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 31, 2014 | |
| Unrelease | Yes | |
| Release | Aug 27, 2014 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Pelvic Rehabilitation | Procedure | Pelvic floor massage will be performed on a weekly basis by a licensed physiotherapist specialized in pelvic floor pelvic therapy |
|
|
| 17195176 | Result | Langford CF, Udvari Nagy S, Ghoniem GM. Levator ani trigger point injections: An underutilized treatment for chronic pelvic pain. Neurourol Urodyn. 2007;26(1):59-62. doi: 10.1002/nau.20393. |
| 15089868 | Result | Jarvis SK, Abbott JA, Lenart MB, Steensma A, Vancaillie TG. Pilot study of botulinum toxin type A in the treatment of chronic pelvic pain associated with spasm of the levator ani muscles. Aust N Z J Obstet Gynaecol. 2004 Feb;44(1):46-50. doi: 10.1111/j.1479-828X.2004.00163.x. |
| Reset | Sep 5, 2014 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 31, 2014 | Yes | |||
| Aug 27, 2014 | Sep 5, 2014 |
| ID | Term |
|---|---|
| D004414 | Dyspareunia |
| D052065 | Vaginismus |
| ID | Term |
|---|---|
| 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 |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
Not provided
Not provided