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A randomized trial comparing perioperative pelvic FLOor physical therapy to current standard of care in transgender Women undergoing vaginoplasty for gendER affirmation: the FLOWER Trial

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Abstract

Introduction and hypothesis

There are sparse data on the use of postoperative pelvic floor physical therapy (PFPT) in patients undergoing vaginoplasty. The primary objective of this study was to compare the impact of PFPT on the ease of vaginal dilation after vaginoplasty in transgender women. We hypothesized that patients undergoing PFPT would report better ease of vaginal dilation following surgery.

Methods

This was a randomized trial of transgender women undergoing vaginoplasty. Patients were randomized to either no PFPT or PFPT 3 and 6 weeks following surgery. Subjects completed the Pelvic Floor Disorders Inventory and the Pelvic Floor Impact Questionnaire at baseline and at 12 weeks. At 12 weeks, subjects underwent vaginal length measurement and completed the Patient Global Impression of Improvement and a visual analogue scale (0–10) for ease of vaginal dilation and pain with dilation. A total of 17 subjects in each arm were needed to detect a significant difference in ease of dilation between the two groups.

Results

Forty-one subjects were enrolled and 12-week data were available for 37 subjects (20 PFPT, 17 no PFPT). Mean age and BMI were 31 ± 13 years and 24.9 (± 4.0) kg/m2. Subjects were on hormone therapy for a median of 39 (20–240) months and 5 (13.5%) patients had undergone previous orchiectomy. At 12 weeks, the median vaginal length was 12.5 (10–16) cm, reported mean ease of dilation was 7.3 (± 1.6), and pain with dilation was 2.4 (± 1.7). There were no differences in these outcomes or in pelvic floor symptoms between the groups.

Conclusions

In this study, routine postoperative PFPT did not improve outcomes in patients undergoing vaginoplasty.

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Data Availability

All data are available upon request.

References

  1. Masterson TA, Masterson JM, Azzinaro J, Manderson L, Swain S, Ramasamy R. Comprehensive pelvic floor physical therapy program for men with idiopathic chronic pelvic pain syndrome: a prospective study. Transl Androl Urol. 2017;6(5):910–5. https://doi.org/10.21037/tau.2017.08.17.

    Article  PubMed  PubMed Central  Google Scholar 

  2. Cohen D, Gonzalez J, Goldstein I. The role of pelvic floor muscles in male sexual dysfunction and pelvic pain. Sex Med Rev. 2016;4(1):53–62. https://doi.org/10.1016/j.sxmr2015.10.001.

    Article  PubMed  Google Scholar 

  3. Straczynska A, Weber-Rajek M, Strojek K, et al. The impact of pelvic floor muscle training on urinary incontinence in men after radical prostatectomy (RP)—a systematic review. Clin Interv Aging. 2019;14:1997–2005. https://doi.org/10.2147/CIA.S228222.

    Article  PubMed  PubMed Central  Google Scholar 

  4. Jiang DD, Gallagher S, Burchill L, Berli J, Dugi D. Implementation of a pelvic floor physical therapy program for transgender women undergoing gender-affirming vaginoplasty. Obstet Gynecol. 2019;133(5):1003–11. https://doi.org/10.1097/AOG.0000000000003236.

    Article  PubMed  Google Scholar 

  5. Manrique OJ, Adabi K, Huang TC, et al. Assessment of pelvic floor anatomy for male-to-female vaginoplasty and the role of physical therapy on functional and patient-reported outcomes. Ann Plast Surg. 2019;82(6):661–6. https://doi.org/10.1097/SAP.0000000000001680.

    Article  PubMed  CAS  Google Scholar 

  6. Barber MD, Chen Z, Lukacz E, et al. Further validation of the short form versions of the pelvic floor distress inventory (PFDI) and pelvic floor impact questionnaire (PFIQ). Neurourol Urodyn. 2011;30(4):541–6. https://doi.org/10.1002/nau.20934.

    Article  PubMed  PubMed Central  Google Scholar 

  7. Coleman E, Radix AE, Bouman WP, et al. Standards of care for the health of transgender and gender diverse people, version 8. Int J Transgender Health. 2022;23(S1):S1-260. https://doi.org/10.1080/26895269.2022.2100644.

    Article  CAS  Google Scholar 

  8. Huber S, Ferrando C, Safer J, et al. Development and validation of urological and appearance domains of the post-affirming surgery form and function individual reporting measure (AFFIRM) for transwomen following genital surgery. J Urol. 2021;206(6):1445–53. https://doi.org/10.1097/JU.0000000000002141.

    Article  PubMed  Google Scholar 

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Authors and Affiliations

Authors

Contributions

C.A. Ferrando: protocol design, data collection, data analysis, manuscript writing; K. Mishra: protocol design, data collection, manuscript writing; F.W. Grimstad: data collection, data analysis, manuscript writing; N.W. Weigand: protocol design, data collection, manuscript writing; C. Pikula: protocol design, data collection, manuscript writing.

Corresponding author

Correspondence to Cecile A. Ferrando.

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Conflicts of interest

C.A. Ferrando receives authorship royalties from UpToDate, Inc. and Elsevier, Inc. The remaining authors have no conflicts of interest.

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Ferrando, C.A., Mishra, K., Grimstad, F.W. et al. A randomized trial comparing perioperative pelvic FLOor physical therapy to current standard of care in transgender Women undergoing vaginoplasty for gendER affirmation: the FLOWER Trial. Int Urogynecol J 34, 2985–2993 (2023). https://doi.org/10.1007/s00192-023-05623-0

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  • DOI: https://doi.org/10.1007/s00192-023-05623-0

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