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Botulinum Toxin A a...
Botulinum Toxin A as a Treatment for Provoked Vestibulodynia A Randomized Controlled Trial
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- Haraldson, Philip (författare)
- Karolinska Inst, Danderyd Hosp, Div Obstet & Gynecol, Dept Clin Sci, Stockholm, Sweden
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- Muhlrad, Hanna (författare)
- Lund University Dept Econ LUND, SWEDEN
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- Heddini, Ulrika (författare)
- Karolinska Inst, Danderyd Hosp, Div Obstet & Gynecol, Dept Clin Sci, Stockholm, Sweden
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- Nilsson, Kent W. (författare)
- Uppsala universitet,Mälardalens högskola,Hälsa och välfärd,Uppsala Univ, Cty Council Vastmanland Cent Hosp, Clin Res Ctr, Uppsala, Sweden,Centrum för klinisk forskning, Västerås
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- Bohm-Starke, Nina (författare)
- Karolinska Institutet
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(creator_code:org_t)
- LIPPINCOTT WILLIAMS & WILKINS, 2020
- 2020
- Engelska.
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Ingår i: Obstetrics and Gynecology. - : LIPPINCOTT WILLIAMS & WILKINS. - 0029-7844 .- 1873-233X. ; 136:3, s. 524-532
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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http://kipublication...
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Abstract
Ämnesord
Stäng
- OBJECTIVE: To evaluate pain reduction after two injections of 50 units botulinum toxin A compared with placebo for provoked vestibulodynia. METHODS: We conducted a double-blinded, placebo-controlled randomized trial of 50 units botulinum toxin A or placebo injected in the bulbocavernosus muscles twice, 3 months apart, in women with provoked vestibulodynia. Primary outcome was self-reported dyspareunia or pain at tampon use on a visual analog scale (VAS, 0-100). Secondary outcomes were pain at weekly tampon insertion (VAS score), reduction of pelvic floor hypertonicity (measured with a vaginal manometer), adverse events, and sexual function and distress. A sample size of 38 participants for each group was calculated to achieve a statistical power of 80% based on an effect size of 20 VAS units (0-100) (mean score range 56-76 +/- 31 SD). RESULTS: Between May 2016 and June 2018, 124 women with provoked vestibulodynia were assessed, and 88 were randomized to botulinum toxin A (BTA group, n=44) or placebo (placebo group, n=44). Primary outcome showed a lower but statistically nonsignificant pain rating by 7 VAS units (95% CI -15.0 to 0.4) in the BTA group compared with the placebo group. Secondary results showed a significant decrease in pain at weekly tampon insertion by 11 VAS units (95% CI -16.6 to 6.0) with botulinum toxin A injection. The vaginal manometer measured lower maximum contraction strength by 7 mm Hg (95% CI -12.7 to -2.4) and lower 10-second endurance strength by 4 mm Hg (95% CI -7.72 to -1.16) in the BTA group compared with the placebo group. No changes were observed for sexual function and distress, but there was a significant increase in women attempting vaginal intercourse in the BTA group (0.27, 95% CI 0.06-0.48). No severe adverse events were reported. CONCLUSION: Twice-repeated injections of 50 units of botulinum toxin A in women with provoked vestibulodynia did not reduce dyspareunia or pain at tampon use, but secondary outcomes suggested positive effects of the treatment.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Sjukgymnastik (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Physiotherapy (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reproduktionsmedicin och gynekologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Obstetrics, Gynaecology and Reproductive Medicine (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences (hsv//eng)
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- art (ämneskategori)
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