You are invited to participate in a study using Botox to treat severe period pain (dysmenorrhea). Period pain is thought to be due to contractions of the muscle of the womb during menstruation and Botox may prevent these contractions. You have been selected as a possible participant in this study because you are attending the Endo-Gynaecology Clinic as a patient with period pain.
Little is known about how contractions of the womb cause period pain. However, we do know that women who suffer from period pain experience a decrease in their quality of life, including physical activity, work productivity, sexual fulfilment and mood. Therefore, using Botox to ease painful contractions during periods may have a wide range of benefits.
Inclusion Criteria:
Attend the Department of Endogynaecology five times (weeks 0, 2, 8, 16 & 26) plus allow us to conduct telephone follow-up three times (weeks 4, 12, 20). Complete questionnaires before & after injections related to your pain, menstrual pattern, sexual activity, and quality of life. Be examined by a doctor and/or physiotherapist who will perform a digital vaginal examination to help eliminate other possible causes for your period pain. Be willing to be on the oral contraceptive pill for at least one month prior to recruitment to the study and during the 26 weeks of the study. Keep a diary during the 26 weeks of the study noting any health problems, medication use and menstrual patterns. Receive injections anywhere between day four to day twenty eight of the menstrual cycle. Within the last two years to have either laparoscopy negative for endometriosis and ongoing dysmenorrhea OR laparoscopy for stage 1 or 2 histologically-confirmed endometriosis with complete excision of disease and ongoing dysmenorrhea. Normal pap smear. Botox naïve (i.e., has not had previous injection of Botox into the pelvic floor muscles or the myometrium). Regular menstrual cycle (21 – 35 days) with no significant intermenstrual bleeding or post-coital bleeding. 18-55 years and not peri- or post-menopausal. History of dysmenorrhea that alters quality of life, for at least two years.
Exclusion Criteria Known allergy to Botox or its components. Current pregnancy (documented by pregnancy test) or a desire for pregnancy during the study perio. Currently using aminoglycoside antibiotics or agents that interfere with neuromuscular transmission. History of neuromuscular disease (e.g., myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis) or bleeding disorder. Pelvic floor muscle (PFM) spasm documented via palpation and/or resting PFM manometric readings >45 cm H20. Palpable pelvic pathology (nodular endometriosis, uterine fibroids, known adhesions, ovarian enlargement without diagnosis). Current or previous history of gynaecological malignancy (cervix, ovary, endometrium) or its precursors (endometrial hyperplasia/cervical lesion) or abnormal Pap smear. Undiagnosed abnormal vaginal bleeding. Known endometrial inflammation or infection.
If you are interested in helping us with our research by taking part in this study, please call Robyn Walsh at the Endo-Gynaecology Department at the Royal Hospital for Women on (02) 9382 6575 or by email
