| 1. |
- Haraldson, Philip, et al.
(author)
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Botulinum Toxin A as a Treatment for Provoked Vestibulodynia A Randomized Controlled Trial
- 2020
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In: Obstetrics and Gynecology. - : LIPPINCOTT WILLIAMS & WILKINS. - 0029-7844 .- 1873-233X. ; 136:3, s. 524-532
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Journal article (peer-reviewed)abstract
- 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.
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| 2. |
- Haraldson, Philip, et al.
(author)
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Botulinum Toxin A for Provoked Vestibulodynia : 12 Months’ Follow-up of a Randomized Controlled Trial
- 2022
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In: Journal of Sexual Medicine. - : Elsevier B.V.. - 1743-6095 .- 1743-6109. ; 19:11, s. 1670-1679
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Journal article (peer-reviewed)abstract
- Background: Provoked vestibulodynia (PVD) is a common pain disorder afflicting primarily young women, and botulinum toxin A (BTA) has been to a limited extent tested as a treatment. Aim: Evaluate outcome 12 months after injection with BTA as a treatment for PVD. Methods: We conducted a double-blinded, placebo-controlled trial of twice repeated injections of 50 units of BTA or placebo in the bulbocavernosus muscles, 3 months apart, in women with PVD. Treatment outcome after six months’, failed to show any significant difference in pain reduction between the groups, as previously reported. Here, we report treatment outcomes 12 months after the first injections. In addition to injections, participants where instructed to perform pelvic floor exercises during month 6-12. 38 participants/group was calculated to achieve a statistical power of 80% based on an effect size of 20 VAS units (mean score range 56-76±31 SD). Outcomes: Primary outcome was self-reported dyspareunia or pain at tampon use, using a visual analogue scale (VAS) 0-100. Secondary outcomes were vaginal pressure measurements, psychological health, sexual function and distress. Results: From the initial 88 randomized women with PVD, 75 remained at 12 months; 38 in the BTA and 37 in the placebo group. There was no significant difference in primary outcome between the groups. Vaginal pressure in the BTA group had been restored to pre-treatment levels, with no differences between the groups at 12 months. There was an increase in sexual function in the BTA group, with a Female Sexual Function Index of 22.8 (±4.8) compared to the placebo group to 19.7 (±5.0), P=.048. No differences were observed in sexual distress, stress and anxiety. There was an increase in number of women attempting intercourse in the BTA group (74%) compared with placebo (43%), P=.005. Too few patients performed the pelvic floor exercises for this intervention to be analyzed. Clinical Implications: This study highlights BTA as a safe treatment option for patients with PVD. Strengths and limitations: The randomized, double-blinded design and repeated treatments are the major strengths of this study and it is the first study to objectively evaluate muscular effect after BTA injections. The major shortcoming is that few participants performed the pelvic floor exercises, preventing analyses. Conclusion: At 12 months’ follow up, no significant difference in reduction of dyspareunia or pain at tampon use was observed. Women receiving BTA attempted intercourse more often and improved their sexual function compared with women receiving placebo. Haraldson P, Mühlrad H, Heddini U, et al. Botulinum Toxin A for Provoked Vestibulodynia: 12 Months’ Follow-up of a Randomized Controlled Trial. J Sex Med 2022;19:1670–1679.
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| 3. |
- Haraldson, Philip
(author)
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Provoked vestibulodynia : evaluation of a treatment modality and early life health
- 2021
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Doctoral thesis (other academic/artistic)abstract
- Background: Provoked vestibulodynia (PVD) is a common cause of dyspareunia and have severe negative impact on the quality of life and sexual health in those afflicted. PVD can affect women at a young age without a clear cause and a theory is that birth-related events could contribute to the development of this condition. One important clinical finding is increased tension of the pelvic floor muscles (PFM). Various physiotherapeutic interventions are recommended as first line treatment, but these are not always effective and more options are needed. Objective: The main aim of this thesis was to evaluate the effect of BTA-injections in the bulbocavernosus muscles as a treatment for PVD. Another aim was to investigate if birthrelated events could be a contributing factor to the etiology of PVD. Material and Methods: We conducted a randomized controlled trial (RCT) were we evaluated the effect of bilateral injections of 50 U BTA in the bulbocavernosus muscles in women diagnosed with PVD, compared with placebo. Injections were given twice with three months’ interval. Forty-four women were randomized to BTA and 44 to placebo (in total 88 women). Our primary outcome measure was reduction in dyspareunia or pain at tampon use during the last month. Secondary outcomes were reduction in vaginal pressure as a measure of PFM function, pain at weekly tampon insertion, adverse events and sexual function and distress six months after the first treatment (Study I). A long-term follow-up of the RCT with additional pelvic floor exercises and psychometric evaluation, was conducted at 12 months (Study IV). In an effort to objectively investigate the PFM function in women with PVD, we evaluated a vaginal manometer measuring various vaginal pressures as a proxy for muscle function in women with PVD (n=60), nulliparous women (n=34) and primiparous women (n=34) (Study III). In Study II we conducted a register study were all women born in Sweden between 1973 and 2001 were categorized into those with and without a PVD/vaginismus diagnosis between 2001 and 2016. Here we estimated the association between health during infancy and onset of PVD/vaginismus later in life. Results: In Study I and IV twice repeated injections of 50 U BTA in women with PVD did not reduce dyspareunia or pain at tampon use. Secondary results showed a significant decrease in pain at weekly tampon insertion. The vaginal manometer detected a transient lower maximum contraction and 10-second endurance contraction in the BTA group compared with the placebo group during the time period when the drug was active. No severe adverse events were reported. The group receiving BTA also had an increased number of intercourse attempts compared with placebo at both 6- and 12-months’ follow-up. In study III, all pressure variables showed a similar pattern when comparing the groups. The vaginal resting pressure was lower in primiparous women compared to nulliparous women but not the PVD group. The maximum contraction and endurance pressure was similar for PVD and nulliparous women. Primiparous women exhibited lower pressure in both these variables compared with the other groups. Intra-rater reliability for the VRP variable was moderate and good to excellent intra-rater reliability for MCP and EP. The inter-rater reliability showed excellent reliability for all variables. In Study II adverse health at birth, such as preterm delivery, low birth weight and small for gestational age was found to be associated with developing PVD/vaginismus later in life. In contrast to our hypothesis, we found no evidence to suggest that pain exposure early in life is positively associated with developing PVD/vaginismus later on in life. Conclusions: BTA does have a detectable muscular effect on women with PVD, but the effect on dyspareunia and the optimal dose to reduce this still remains to be determined. After 12 months, increased sexual function and significant increase in number of intercourse attempts were observed in the BTA group. The vaginal manometer was deemed a functional tool to detect differences in vaginal pressures during different states of PFM activity and varying parity with good intra- and inter-rater reliability. Adverse events at birth such preterm delivery, SGA and low birth weight could be contributing factors for developing PVD/vaginismus later in life.
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| 4. |
- Mühlrad, Hanna, et al.
(author)
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Interpregnancy interval and maternal and neonatal morbidity : a nationwide cohort study
- 2022
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In: Scientific Reports. - : Springer Science and Business Media LLC. - 2045-2322. ; 12
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Journal article (peer-reviewed)abstract
- This study aimed to assess the association between interpregnancy interval (IPI)—the time from childbirth to conception of the next pregnancy—and maternal and neonatal morbidity. The World Health Organization (WHO) currently recommends an IPI of at least 24 months after a live birth to reduce adverse birth outcomes. However, assessing the relationship between IPI and perinatal outcome is complicated by confounding factors. We conducted a nationwide population-based cohort study using Swedish registry data, allowing for adjustment of maternal characteristics and health at first birth. The study population consisted of all women with a singleton, live, and vaginal first birth with a second singleton birth within five years during 1997–2017, covering 327,912 women and 655,824 neonates. IPI was grouped into six-month intervals with 24–29 months as the reference. The association between IPI and morbidity was examined using multivariate logistic regression. For women having a vaginal delivery at their first birth, intervals < 24–29 months were associated with decreased maternal morbidity and unaffected neonatal morbidity. Intervals > 24–29 months were associated with increased maternal and neonatal morbidity. Our findings question the relevance of WHO’s recommendation of an IPI of at least 24 months in a high-income country.
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