drugset / Trial / NCT02773641
Placebo-controlled RCT of Botulinum Toxin A as a Treatment for Provoked Vestibulodynia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Women with provoked vestibulodynia (PVD) suffer from severe dyspareunia and often present a hyperactivity of the pelvic floor muscles (PFM) which maintain the dyspareunia. The rationale for the study is that for women with PVD who don't succeed to restore the function of the PFM by physiotherapy, Botulinum Toxin A (BTA) could be an optional treatment by decreasing the high muscle tonus and thus possibly reduce the coital pain.
Timeline
- Start
- 2016-05
- Primary completion
- 2019-06
- Completion
- 2019-06
Publications
- Haraldson P, Muhlrad H, Heddini U, Nilsson K, Bohm-Starke N. Botulinum Toxin A for Provoked Vestibulodynia: 12 Months' Follow-up of a Randomized Controlled Trial. J Sex Med. 2022 Nov;19(11):1670-1679. doi: 10.1016/j.jsxm.2022.08.188. Epub 2022 Oct 26.
- Haraldson P, Muhlrad H, Heddini U, Nilsson K, Bohm-Starke N. Botulinum Toxin A as a Treatment for Provoked Vestibulodynia: A Randomized Controlled Trial. Obstet Gynecol. 2020 Sep;136(3):524-532. doi: 10.1097/AOG.0000000000004008.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | 50 unknown | Intramuscular |