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Currently, perioperative pelvic floor physical therapy (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 was 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 effectiveness of postoperative PFPT alone to pre- and postoperative PFPT in these patients.
This was a randomized double-blind study. Both subjects and the surgeon performing the surgery as well as the personnel administering questionnaires to patients postoperatively were blinded to the randomization.
Recruitment, Enrollment and Randomization
Patients scheduled to undergo vaginoplasty surgery at Cleveland Clinic Main campus were approached about voluntary participation in this study. This occurred over the phone approximately one to three months before their scheduled surgery. Patients who agreed to participate were sent a consent form via the mail and were asked to sign consent in person. Enrollment and randomization occurred following informed consent. All patients were given a copy of their signed and dated consent.
Once enrolled, patients were randomized into one of two groups:
If patients were randomized into the Postoperative PFPT arm, they were further randomized into the following sub-arms:
Surgery:
All patients underwent vaginoplasty surgery by a single surgeon in a standard fashion. The neovaginal cavity was created using the same technique across all patients. Postoperative care was routine and the same for all patients.
Postoperative Pelvic Floor Physical Therapy:
There was three possible PFPT regimens. All PT regimens were performed by the same two physical therapists, trained in the management of patients who have undergone vaginoplasty surgery.
Patients presented to the physical therapist 3 weeks and 6 weeks postoperatively. The following interventions were 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 presented to see the physical therapist 3 weeks before surgery, 3 weeks and 6 weeks postoperatively. The following interventions were 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
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 were administered questionnaires preoperatively and 12 weeks postoperatively. The following questionnaires were administered:
Preoperatively:
Postoperatively 1 week (at the time of routine dilation teaching):
• Vaginal length (routine exam)
Postoperatively 12 weeks:
Cross-Over Treatment:
Any patients in the No PFPT arm who were determined to have pelvic floor dysfunction or symptoms that may have benefitted from PFPT referral, were referred after the 12-week mark. Any patient in one of the PFPT arms who was determined to still need PFPT for persistent pelvic floor dysfunction or symptoms were referred for continued care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) | Experimental | If patients were randomized into the PFPT arm, they were further randomized into the following sub-arms: Preoperative and Postoperative PFPT |
|
| Postoperative Pelvic Floor Physical Therapy (PFPT) | Active Comparator | 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. |
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| No Pelvic Floor Physical Therapy (PFPT) | Active Comparator | Patients were not assigned to physical therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) | Other | Patients will present to see the physical therapist 3 weeks and 6 weeks postoperatively. The following interventions will be performed: 3 weeks:
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Ease of Dilation | 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Transgender women are individuals who were assigned male at birth (are biologically male), but identify as female.
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| Name | Affiliation | Role |
|---|---|---|
| Cecile Ferrando, M.D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2020 |
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| No Pelvic Floor Physical Therapy (PFPT) | Other | 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. |
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| Postoperative PFPT | Other | Preoperative Diaphragmatic breathing Discuss dilator positioning/introduce dilator program External pelvic floor assessment Teach pelvic floor coordination Current bowel/bladder symptoms; home program and instructions 3 weeks 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 Current symptoms; home program and instructions |
|
| FG001 | 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. |
| FG002 | 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:
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
|
| BG001 | 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. |
| BG002 | 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:
|
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Reported Ease of Dilation | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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| Post-Hoc | Severity of Pelvic Floor Dysfunction Based on PGI-I | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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| Post-Hoc | Mean Difference in CRADI-8 Score | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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| Post-Hoc | Mean Difference UDI-6 Score | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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| Post-Hoc | Mean Difference PFIQ-7-Bladder Score | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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| Post-Hoc | Mean Difference in PFIQ-7-Rectum Score | 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 score of 300 is considered to be a worse outcome. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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| Post-Hoc | Mean Difference in PFIQ-7-Vagina Score | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
| 0 | 10 | 0 | 10 | 0 | 10 |
| EG001 | No Postoperative Pelvic Floor Physical Therapy (PFPT) | 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. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cecile Ferrando, M.D. | Cleveland Clinic | 216-444-0642 | ferranc2@ccf.org |
| Nov 21, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 11, 2021 | Nov 21, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
| D052801 | Male Urogenital Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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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.
| OG002 | Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) | 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. |
|
|
| OG001 | 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. |
| OG002 | Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) | 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. |
|
|
| OG001 | 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. |
| OG002 | Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) | 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. |
|
|
| OG001 | 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. |
| OG002 | Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) | 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. |
|
|
| OG001 | 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. |
| OG002 | Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) | 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. |
|
|
| OG001 | 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. |
| OG002 | Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) | 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. |
|
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