A Randomized Trial Comparing Perioperative Pelvic Floor Physical Therapy to Current Standard of Care in Transgender Women Undergoing Vaginoplasty for Gender Affirmation
Phase: NA
Conditions: Pelvic Floor Disorders
Sponsor: The Cleveland Clinic

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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  
 
Cecile A. Ferrando, MD MPH; Staff, Center for Urogynecology & Pelvic Reconstructive 
Surgery; Subspecialty Care for Women’s Health, Women’s Health Institute, Cleveland 
Clinic, Cleveland OH 
 
Natalie W. Weigand, CNP; Center for Urogynecology & Pelvic Reconstructive Surgery; 
Subspecialty Care for Women’s Health, Women’s Health Institute, Cleveland Clinic, 
Cleveland OH 
 
 
BACKGROUND 
 
In the natal male, the pelvic floor is comprised of bulbospongiosus, ischiocavernosus, 
deep transverse perineal, superficial transverse perineal, pubococcygeus, and obturator 
internus muscles; as well as the perineal body, external anal sphincter, anococcygeal 
ligament, coccyx, ischial tuberosities and the sacrotuberous ligament. Pelvic floor 
dysfunction, including urinary symptoms, bowel symptoms, sexual dysfunction and 
pelvic pain is often thought of a “female-centric” condition, and pelvic floor physical 
therapy (PFPT) is often used as first or second line therapy to treat many of these 
conditions in natal women. However, natal men also experience pelvic floor symptoms 
and while the literature is not as abundant in this patient population, there are data to 
support the use of physical therapy as primary and adjunctive therapy for many 
conditions in men.  
 
In a prospective study by Masterson et al. (1) the authors evaluated 14 men with 
chronic pelvic pain syndrome who underwent a comprehensive PFPT program. 
Treatment included manual therapy (internal and external) of the pelvic floor and 
abdominal musculature to facilitate relaxation of muscles; therapeutic exercises to 
promote range of motion, improve mobility/flexibility and strengthen weak muscles; 
biofeedback to facilitate strengthening and relaxation of pelvic floor musculature; and 
neuromodulation for pelvic floor muscle relaxation and pain relief. A robust treatment 
response was found in 50% of patients while 20% reported a moderate response and 
30% did not have a meaningful change. Longer duration of therapy predicted treatment 
response.  
 
In a review of the literature by Cohen et al (2), the authors found that there was 
evidence supporting the association between the male pelvic floor and 
erectile dysfunction, ejaculatory/orgasmic dysfunction, and chronic 
prostatitis/chronic pelvic pain syndrome, respectively. The authors concluded that pelvic 
floor physical therapy is a necessary tool for the treatment of male 

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sexual dysfunction and pelvic pain. In a systematic review, PFPT was also been shown 
to be beneficial for the treatment of urinary incontinence in men who had undergone 
prostatectomy for prostate cancer (3).  
Transgender women are individuals who were assigned male at birth (are biologically 
male), but identify as female. Vaginoplasty surgery is a gender- affirming genital surgery 
for transgender women seeking surgical transition. The goal of vaginoplasty is to create 
a natural-appearing vulva with a sensate clitoris, a female urethra, and in those patients 
who desire it, a vaginal canal. In constructing the neovaginal canal, a space is created 
between the rectum and the bladder, which requires dissection through the pelvic floor 
musculature. This dissection divides parts of the levator ani complex, which may affect 
pelvic floor function. As such, PFPT may have an important role in the perioperative 
management of transgender women undergoing vaginoplasty.  
The only study published to date examining the effect of PFPT on all patients 
undergoing vaginoplasty was recently published by Jiang et al (4). In this retrospective 
analysis, the authors aimed to describe the incidence of pelvic floor dysfunction in 
transgender women undergoing gender-affirming vaginoplasty as well as to describe 
outcomes from their postoperative PFPT program. Over a two-year period, 77 patients 
were referred to PFPT postoperatively following vaginoplasty and all patients attended 
at least one session. Preoperatively, PFPT assessment identified an incidence of 42% 
for pelvic floor dysfunction and 37% for bowel dysfunction. Of those patients found to 
have dysfunction preoperatively, resolution after the first postoperative pelvic floor PT 
visit was 69% for pelvic floor dysfunction and 73% for bowel dysfunction. In addition, the 
authors found that the incidence of postoperative pelvic floor dysfunction was even 
lower in patients who attended pre- and postoperative PFPT versus postoperative PFPT 
alone.  
There is further evidence that patients undergoing vaginoplasty surgery may have 
preoperative pelvic floor dysfunction symptoms that should be addressed before and 
after surgery. In a retrospective study by Manrique et al (5), patients scheduled to 
undergo male-to-female vaginoplasty were evaluated by a physical therapist for pelvic 
floor dysfunction and patients with pelvic floor symptoms underwent pre- and 
postoperative PFPT. The authors found that of the 40 patients evaluated, 31 (77.5%) 
were found to be symptomatic and that physical therapy significantly reduced severity of 
symptoms and its impact on daily living following surgery.   
 
Currently, perioperative PFPT is not standard of care for all patients who undergo 
vaginoplasty surgery. While some practices have implemented these new programs, 
and the above data exist on outcomes associated with perioperative PFPT in 
transgender women undergoing vaginoplasty, no study has compared implementation 
of perioperative PFPT to routine care (no perioperative PFPT). Therefore, the primary 
objective of this study to compare the effectiveness of postoperative PFPT compared to 
no PFPT in transgender women undergoing vaginoplasty surgery for gender affirmation. 
Secondary objectives of the study are 1) to describe the incidence of preoperative pelvic 
floor dysfunction in transgender women undergoing PFPT and 2) to compare the 

v.9.15.2020 
 
effectiveness of postoperative PFPT alone to pre- and postoperative PFPT in these 
patients.  
 
STUDY METHODS 
 
Study Design: Randomized double-blind study  
 
Both subjects and the surgeon performing the surgery as well as the personnel 
administering questionnaires to patients postoperatively will be blind to randomization  
 
Primary Aim 
 
To compare the effectiveness of postoperative PFPT compared to no PFPT in 
transgender women undergoing vaginoplasty. 
 
Primary Outcome: Patient reported ease of dilation at 12 weeks (VAS 0-10) 
 
Secondary Outcome: Severity of pelvic floor dysfunction at 12 weeks 
(questionnaires) 
 
  
 
Secondary Aims 
 
To describe the incidence of preoperative pelvic floor dysfunction in transgender women 
undergoing PFPT. 
 
To compare the effectiveness of postoperative PFPT alone to pre- and postoperative 
PFPT in these patients.  
 
Primary Outcome: Patient reported ease of dilation at 12 weeks (VAS 0-10) 
 
Secondary Outcome: Severity of pelvic floor dysfunction at 12 weeks 
(questionnaires) 
 
Study Population: All transgender women undergoing vaginoplasty surgery through 
the Cleveland Clinic Transgender Surgery & Medicine Program at Cleveland Clinic Main 
Campus.  
 
Inclusion Criteria: 
• Age ≥ 18 years of age 
• Patients scheduled for full-depth vaginoplasty surgery 
 
Exclusion Critiera: 
• Inability to speak or comprehend the English language 
• Patients scheduled for no-depth vaginoplasty surgery 
• Patients who have undergone previous PFPT 

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• Patients who are s/p prostatectomy or treatment for prostate cancer  
 
 
STUDY INTERVENTIONS 
 
Recruitment, Enrollment and Randomization 
 
Patients scheduled to undergo vaginoplasty surgery at Cleveland Clinic Main campus 
will be approached about voluntary participation in this study. This will occur over the 
phone approximately one to three months before their scheduled surgery. Patients who 
agree to participate will be sent a consent form via the mail and will be asked to sign 
consent in person.  Enrollment and randomization will occur following informed consent. 
All patients will be given a copy of their signed and dated consent. 
 
Once enrolled, patients will be randomized into one of two groups: 
 
• Postoperative PFPT  
• No Postoperative PFPT 
 
If patients are randomized into the Postoperative PFPT arm, they will be further 
randomized into the following sub-arms: 
 
• Postoperative PFPT alone 
• Preoperative and Postoperative PFPT  
 
 
Surgery 
 
All patients will undergo vaginoplasty surgery by a single surgeon in a standard fashion. 
The neovaginal cavity will be created using the same technique across all patients. 
Postoperative care will be routine and the same for all patients.  
 
Postoperative Pelvic Floor Physical Therapy 
 
There will be three possible PFPT regimens. All PT regimens will be performed by the 
same two physical therapists, trained in the management of patients who have 
undergone vaginoplasty surgery.  
 
1) No PFPT  
 
Patients will present to see the physical therapist 3 weeks postoperatively. The 
following interventions will be performed: 
 
Subjective assessment of bowel and bladder function. Visual and external 
palpation and assessment of external pelvic floor region. Intravaginal pelvic floor 

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assessment. Pelvic floor muscle dynamics and coordination assessment. Review 
of pelvic floor anatomy and function.  
 
2) Postoperative PFPT Only 
 
Patients will present to see the physical therapist 3 weeks and 6 weeks 
postoperatively. The following interventions will be performed: 
 
3 weeks: 
 
• Subjective assessment of bowel and bladder function 
• Visual and external palpation and assessment of external pelvic floor 
region 
• Intravaginal pelvic floor assessment 
• Pelvic floor muscle dynamics and coordination assessment 
• Instruction of pelvic floor coordination and lengthening 
• Discussion of dilator program and progression 
• Home program with instructions 
 
6 weeks: 
 
• External scar assessment and treatment if tissue healing allows 
• Instruction to patient of scar mobilizations 
• Intravaginal pelvic floor assessment and treatment if indicated 
• Review of pelvic floor lengthening and coordination 
• Review and progression of dilator program if appropriate 
• Assessment of current bowel/bladder symptoms; home program and 
instructions to address these symptoms 
 
 
3) Preoperative PFPT and Postoperative PFPT 
 
Patients will present to see the physical therapist 3 weeks before surgery, 3 
weeks and 6 weeks postoperatively. The following interventions will be 
performed: 
 
Preoperative: 
 
• Diaphragmatic breathing 
• Discuss dilator positioning/introduce dilator program 
• External pelvic floor assessment 
• Teach pelvic floor coordination 
• Assessment of current bowel/bladder symptoms; home program and 
instructions to address these symptoms 
 

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3 weeks: 
 
• Subjective assessment of bowel and bladder function 
• Visual and external palpation and assessment of external pelvic floor 
region 
• Intravaginal pelvic floor assessment 
• Pelvic floor muscle dynamics and coordination assessment 
• Instruction of pelvic floor coordination and lengthening 
• Discussion of dilator program and progression 
• Home program with instructions 
 
 
6 weeks: 
 
• External scar assessment and treatment if tissue healing allows 
• Instruction to patient of scar mobilizations 
• Intravaginal pelvic floor assessment and treatment if indicated 
• Review of pelvic floor lengthening and coordination 
• Review and progression of dilator program if appropriate 
• Assessment of current bowel/bladder symptoms; home program and 
instructions to address these symptoms 
 
 
Study Questionnaires & Exams 
 
All patients will be administered questionnaires preoperatively and 12 weeks 
postoperatively. The following questionnaires will be administered: 
 
Preoperatively: 
• CRAD-8 and UDI-6 
• PFIQ-7 
 
Postoperatively 1 week (at the time of routine dilation teaching): 
• Vaginal length (routine exam) 
 
Postoperatively 12 weeks: 
• CRAD-8 and UDI-6 
• PFIQ-7 
• PGI-I 
• Ease of Passing Dilator (VAS 0-10) 
• Pain with Dilation (VAS 0-10) 
• Largest dilator size used 
• Vaginal length (routine exam) 
 
 

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Cross-Over Treatment 
 
Any patients in the No PFPT arm who are determined to have pelvic floor dysfunction or 
symptoms that may benefit from PFPT referral, will be referred after the 12-week mark. 
Any patient in one of the PFPT arms who is determined to still need PFPT for persistent 
pelvic floor dysfunction or symptoms will be referred for continued care.   
  
DATA COLLECTION & MANAGEMENT 
 
Data Collection: 
 
In addition to the above-mentioned questionnaires and exam findings, the following data 
will be collected from the electronic medical record before surgery and 12 weeks 
postoperatively: 
• MRN 
• Age  
• BMI  
• Length of preoperative hormone therapy  
• Previous orchiectomy 
• Comorbid medical conditions: cardiac, pulmonary, diabetes, autoimmune 
• Chronic pain: lower back pain, fibromyalgia, arthritis, other 
• Intraoperative complications: bleeding, visceral injury, other 
• Postoperative complications: wound issues, hematoma/seroma, infection, 
anatomic urinary stream issues, fistula, other 
• PFPT utilization beyond 6 and 12 weeks postoperatively  
 
Data Management: 
 
Protection of each subject’s personal health information will be a priority in this study. 
One master excel file containing subject personal information including name and 
medical record number will be kept in a password-protected file, on a designated 
protected research drive on a password-protected computer in a locked office at the 
Cleveland Clinic. In that file, each subject will be assigned a subject identification 
number that will be used for the purposes of data collection in order to de-identify 
subjects.  
 
All paper forms used for data collection will be kept in a research cabinet dedicated to 
this project which will be locked at all times, in a locked office at the Cleveland Clinic. All 
forms will contain de-identified information – identification numbers will correspond to 
the subjects listed in the master excel file.  
 
All study data will be transferred and managed electronically using REDCap (Research 
Electronic Data Capture). Each subject will be entered into REDCap using the assigned 
identification number from the master excel file. REDCap is a secure, web-based 
application designed to support data capture for research studies, providing user-
friendly web-based case report forms, real-time data entry validation, audit trials, and a 

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de-identified data export mechanism to common statistical packages. They system was 
developed by a multi-institutional consortium which was initiated at Vanderbilt University 
and includes the Cleveland Clinic. The database is hosted at the Cleveland Clinic 
Research Datacenter in the JJN basement and is managed by the Quantitative Health 
Sciences Department. The system is protected by a login and Secure Sockets Layers 
(SSL) encryption. Data collection is customized for each study as based on a study-
specific data dictionary defined by the research team with guidance from the REDCap 
administrator in Quantitative Health Sciences at the Cleveland Clinic.  
 
POWER ANALYSIS & STATISTICS 
 
There will be 2 arms to this study: No Postoperstive PFPT and Postoperstive PFPT. 
The Postoperstive PFPT arm will be further randomized into two other arms: 
Postoperstive PFPT Only and Preoperative and Postoperative PFPT.  
The primary aim is to compare the effectiveness of postoperative PFPT compared to no 
PFPT in transgender women undergoing vaginoplasty using Ease of Dilation (VAS 0-
10) as the primary outcome. We determined that 17 subjects in each arm were needed 
to detect a difference of 2 (+/-1) points between the two groups (No Postoperstive PFPT 
vs Postoperstive PFPT) with 80% power and a significance level of 0.05. We will 
account for potential subject drop out and loss to follow-up as well as unforeseen 
factors in recruiting and will plan to recruit 20 subjects to each arm, for a total of 40 
subjects. 
.  
 
 
 
 
 
 
 
 
 
 
 
 
 
Continuous descriptive data will be reported as mean and standard deviation (±SD) or 
median with interquartile range (IQR), depending on distribution. Categorical data will 
be reported as frequencies, using percentages. Ease of dilation and pelvic floor 
symptoms will be compared between arms (No PFPT vs Postoperative PFPT). The 
investigators also plan to perform a subgroup analyses, comparing patients who 
40 Subjects 
20 No PT 
Postoperative 
PFPT
20 Postoperative 
PFPT  
Randomization 
10 Postoperative 
PFPT Only 
10 Preoperative 
and Postoperative 
PFPT
Randomization 

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underwent postoperative PFPT only to those who underwent both preoperative and 
postoperative PFPT.   
 
Ease of dilation (mean) and pelvic floor symptoms (mean difference from baseline) will 
be compared as a continuous variables using a student’ t test to compare between the 
two groups. Binary logistic regression will be used to assess the influence of various 
patient factors on the patient reported ease of dilation as well as pelvic floor symptoms 
and results will be reported as odds ratios with 95% confidence intervals.  
 
JMP 14.0 (SAS Institute Inc., Cary, NC) will be used for all statistical analyses. The 
primary investigator (CAF) will perform the statistical analysis. All results yielding 
p < 0.05 will be deemed statistically significant.  
 
All analyses will be conducted using an intention-to-treat principle. The investigators 
anticipate that some non-adherence to the assigned intervention (e.g. crossover to the 
postoperative PFPT arm) may occur if patients are determined to be symptomatic 
requiring PFPT per the surgeon’s discretion, and as these protocol deviations will bias 
the results towards superiority of the intervention, a per-protocol sensitivity analysis has 
also been planned. 
 
 
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):910-915.  
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.  
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.  
4) Jiang DD1, 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):1003-1011.  
5) Manrique OJ, Adabi K, Huang TC, Jorge-Martinez J, Meihofer LE, Brassard P, 
Galan R. 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):661-666.