Trial Outcomes & Findings for Pelvic Floor Physical Therapy vs Standard Care in Transgender Women Undergoing Vaginoplasty for Gender Affirmation (NCT NCT05690555)

Last Updated: 2025-07-15

Results Overview

VAS 0-10 is a validated 10 item questionnaire. Responses to each question are scored on a 10-point Likert scale, ranging from 0 (no pain) to 10 (worst pain). A response of 10 is considered to be a worse outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

37 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	Postoperative Pelvic Floor Physical Therapy (PFPT) Pelvic Floor Physical Therapy (PFPT): 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	No Postoperative Pelvic Floor Physical Therapy (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 assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. No Pelvic Floor Physical Therapy (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 assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. 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.	Pre and Postoperative Pelvic Floor Physical Therapy (PFPT) Pelvic Floor Physical Therapy (PFPT): Patients will present to see the physical therapist within 4 weeks preceding surgery and 3 weeks and 6 weeks postoperatively. The following interventions will be performed: Preoperative: Teaching about the pelvic floor and breathing exercises 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
Overall Study STARTED	10	17	10
Overall Study COMPLETED	10	17	10
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pelvic Floor Physical Therapy vs Standard Care in Transgender Women Undergoing Vaginoplasty for Gender Affirmation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Postoperative Pelvic Floor Physical Therapy (PFPT) n=10 Participants Pelvic Floor Physical Therapy (PFPT): 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	No Postoperative Pelvic Floor Physical Therapy (PFPT) n=17 Participants 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 assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. No Pelvic Floor Physical Therapy (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 assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. 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.	Pre and Postoperative Pelvic Floor Physical Therapy (PFPT) n=10 Participants Pelvic Floor Physical Therapy (PFPT): Patients will present to see the physical therapist within 4 weeks preceding surgery and 3 weeks and 6 weeks postoperatively. The following interventions will be performed: Preoperative: Teaching about the pelvic floor and breathing exercises 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	Total n=37 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	17 Participants n=7 Participants	10 Participants n=5 Participants	37 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	33 Years STANDARD_DEVIATION 7 • n=5 Participants	28 Years STANDARD_DEVIATION 14 • n=7 Participants	36 Years STANDARD_DEVIATION 15 • n=5 Participants	32.3 Years STANDARD_DEVIATION 12 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	17 Participants n=7 Participants	10 Participants n=5 Participants	37 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	14 Participants n=7 Participants	9 Participants n=5 Participants	32 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	17 participants n=7 Participants	10 participants n=5 Participants	37 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Postoperative Pelvic Floor Physical Therapy (PFPT) n=10 Participants Pelvic Floor Physical Therapy (PFPT): 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	No Postoperative Pelvic Floor Physical Therapy (PFPT) n=17 Participants 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 assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. No Pelvic Floor Physical Therapy (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 assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. 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.	Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) n=10 Participants Patients who were further randomized to also undergo a preoperative PFPT visit were taught about diaphragmatic breathing at this visit, they were introduced to the postoperative dilator program, underwent an external pelvic floor assessment, and were taught pelvic floor coordination.
Patient Reported Ease of Dilation	6.6 units on a scale Standard Deviation 1.9	7.4 units on a scale Standard Deviation 1.7	8.0 units on a scale Standard Deviation 0.8

POST_HOC outcome

Timeframe: 12 weeks

The Patient Global Impression of Improvement (PGI-I) is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 (very much better) to 7 (very much worse). A score of 7 is considered to be a worse outcome.

Outcome measures

Outcome measures
Measure	Postoperative Pelvic Floor Physical Therapy (PFPT) n=10 Participants Pelvic Floor Physical Therapy (PFPT): 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	No Postoperative Pelvic Floor Physical Therapy (PFPT) n=17 Participants 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 assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. No Pelvic Floor Physical Therapy (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 assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. 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.	Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) n=10 Participants Patients who were further randomized to also undergo a preoperative PFPT visit were taught about diaphragmatic breathing at this visit, they were introduced to the postoperative dilator program, underwent an external pelvic floor assessment, and were taught pelvic floor coordination.
Severity of Pelvic Floor Dysfunction Based on PGI-I	1.4 units on a scale Standard Deviation 0.7	1.65 units on a scale Standard Deviation 1.49	1.9 units on a scale Standard Deviation 1.3

POST_HOC outcome

Timeframe: 12 weeks

Colorectal-Anal Distress Inventory (CRADI-8) provides a symptom inventory (no or yes) and if yes (to measure the degree of bother and distress) caused by the broad array of pelvic floor symptoms, in particular colorectal-anal distress. Responses to the eight questions are scored on a 4-point Likert scale, ranging 1 (not at all) to 4 (quite a bit). The scale scores are found individually by calculating the mean value of their corresponding questions and then multiplying by 25 to obtain a value that ranges from 0 to 100. The reported outcome for this trial is the mean difference in score. A higher CRADI-8 score indicates a greater level of disability. It reflects more significant challenges in daily activities and functioning. A score of 100 is considered to be a worse outcome.

Outcome measures

Outcome measures
Measure	Postoperative Pelvic Floor Physical Therapy (PFPT) n=10 Participants Pelvic Floor Physical Therapy (PFPT): 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	No Postoperative Pelvic Floor Physical Therapy (PFPT) n=17 Participants 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 assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. No Pelvic Floor Physical Therapy (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 assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. 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.	Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) n=10 Participants Patients who were further randomized to also undergo a preoperative PFPT visit were taught about diaphragmatic breathing at this visit, they were introduced to the postoperative dilator program, underwent an external pelvic floor assessment, and were taught pelvic floor coordination.
Mean Difference in CRADI-8 Score	-0.6 units on a scale Standard Deviation 3.69	-3.00 units on a scale Standard Deviation 7.37	-1.9 units on a scale Standard Deviation 7.58

POST_HOC outcome

Timeframe: 12 weeks

Urinary Distress Inventory (UDI-6) - The UDI-6 is a 6-item questionnaire. Each item is scored on a scale of 0 to 3, with 0 being "not at all" and 3 being "greatly". The average score is calculated and multiplied by 33 1/3 to give a score on a scale of 0 to 100. A higher score indicates a higher level of disability. The outcome measure reported in this trial is the mean difference in scores pre- and post-intervention. A higher UDI-6 score indicates a greater level of disability. It reflects more significant challenges in daily activities and functioning. A score of 100 is considered to be a worse outcome.

Outcome measures

Outcome measures
Measure	Postoperative Pelvic Floor Physical Therapy (PFPT) n=10 Participants Pelvic Floor Physical Therapy (PFPT): 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	No Postoperative Pelvic Floor Physical Therapy (PFPT) n=17 Participants 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 assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. No Pelvic Floor Physical Therapy (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 assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. 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.	Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) n=10 Participants Patients who were further randomized to also undergo a preoperative PFPT visit were taught about diaphragmatic breathing at this visit, they were introduced to the postoperative dilator program, underwent an external pelvic floor assessment, and were taught pelvic floor coordination.
Mean Difference UDI-6 Score	-1.5 units on a scale Standard Deviation 14.6	-1.41 units on a scale Standard Deviation 7.14	-6.5 units on a scale Standard Deviation 32.02

POST_HOC outcome

Timeframe: 12 weeks

The Pelvic Floor Impact Questionnaire-7 (PFIQ-7) is a seven-question survey that measures the impact of pelvic floor disorders on quality of life, daily activities, and emotional health. The PFIQ-7 is scored on a scale of 0-300. The mean of each of the three scales is calculated, ranging from 0-3. Each mean is multiplied by 100 and then divided by 3. The scale scores are added together to get the total PFIQ-7 score. The reported outcome measure in this trial is the mean difference in this score pre- and post-intervention. A higher PFIQ-7 score indicates a greater level of disability. It reflects more significant challenges in daily activities and functioning. A score of 300 is considered to be a worse outcome.

Outcome measures

Outcome measures
Measure	Postoperative Pelvic Floor Physical Therapy (PFPT) n=10 Participants Pelvic Floor Physical Therapy (PFPT): 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	No Postoperative Pelvic Floor Physical Therapy (PFPT) n=17 Participants 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 assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. No Pelvic Floor Physical Therapy (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 assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. 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.	Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) n=10 Participants Patients who were further randomized to also undergo a preoperative PFPT visit were taught about diaphragmatic breathing at this visit, they were introduced to the postoperative dilator program, underwent an external pelvic floor assessment, and were taught pelvic floor coordination.
Mean Difference PFIQ-7-Bladder Score	6.7 units on a scale Standard Deviation 22.99	-1.64 units on a scale Standard Deviation 10.45	-4.8 units on a scale Standard Deviation 18.4

POST_HOC outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Postoperative Pelvic Floor Physical Therapy (PFPT) n=10 Participants Pelvic Floor Physical Therapy (PFPT): 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	No Postoperative Pelvic Floor Physical Therapy (PFPT) n=17 Participants 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 assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. No Pelvic Floor Physical Therapy (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 assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. 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.	Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) n=10 Participants Patients who were further randomized to also undergo a preoperative PFPT visit were taught about diaphragmatic breathing at this visit, they were introduced to the postoperative dilator program, underwent an external pelvic floor assessment, and were taught pelvic floor coordination.
Mean Difference in PFIQ-7-Rectum Score	6.2 units on a scale Standard Deviation 23.21	-3.17 units on a scale Standard Deviation 11.31	0.5 units on a scale Standard Deviation 3.69

POST_HOC outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Postoperative Pelvic Floor Physical Therapy (PFPT) n=10 Participants Pelvic Floor Physical Therapy (PFPT): 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	No Postoperative Pelvic Floor Physical Therapy (PFPT) n=17 Participants 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 assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. No Pelvic Floor Physical Therapy (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 assessment. Pelvic floor muscle dynamics and coordination assessment. Review of pelvic floor anatomy and function. 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.	Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) n=10 Participants Patients who were further randomized to also undergo a preoperative PFPT visit were taught about diaphragmatic breathing at this visit, they were introduced to the postoperative dilator program, underwent an external pelvic floor assessment, and were taught pelvic floor coordination.
Mean Difference in PFIQ-7-Vagina Score	6.3 units on a scale Standard Deviation 27.65	5.65 units on a scale Standard Deviation 18.18	3.5 units on a scale Standard Deviation 15.0

Adverse Events

Postoperative Pelvic Floor Physical Therapy (PFPT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Postoperative Pelvic Floor Physical Therapy (PFPT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cecile Ferrando, M.D.

Cleveland Clinic

Phone: 216-444-0642

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place