Lower Urinary Tract SymptomsLUTS-POGPNCT06956989
Lower Urinary Tract Symptoms in Transmasculine Patients Undergoing Metoidioplasty and Their Acceptability of Pelvic Floor Muscle Training Assessed by a Pelvic, Obstetric and Gynaecological Physiotherapist
An observational study of Lower Urinary Tract Symptoms and Transgenderism, run by Chelsea and Westminster NHS Foundation Trust.
Trial summary
Lower urinary tract symptoms in transmasculine patients undergoing metoidioplasty and their acceptability of pelvic floor muscle training assessed by a Pelvic, Obstetric and Gynaecological Physiotherapist. Read more about this study
- Who is it for?
- Ages 17 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lower Urinary Tract Symptoms, Transgenderism
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study participants will be transmasculine patients undergoing metoidioplasty
Who may be able to join
- Have capacity to consent.
- Diagnosis of gender dysphoria and have lived in a gender role that is congruent to their gender identity for minimum of 12 months.
- Transmasculine patients referred to CCGS for masculinising lower genital reconstructive surgery having received two signatures confirming suitability for reconstructive surgery.
- Undergoing metoidioplasty/phalloplasty.
- Age >17 years old.
- On systemic testosterone therapy for more than 12 months.
Who cannot join
- Age less than 18 years.
- Not undergoing metoidioplasty/phalloplasty.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Lower urinary tract symptoms in transmasculine patients undergoing metoidioplasty and their acceptability of pelvic floor muscle training assessed by a Pelvic, Obstetric and Gynaecological Physiotherapist.
Study Design
Read more
Prospective observational pilot study
Study Participants
Transmasculine patients undergoing metoidioplasty
Planned Sample Size
50
Planned Study Period
2025/26
Objectives
Understand the acceptability of first-line pelvic floor muscle training (PFMT) treatment in transmasculine patients undergoing metoidioplasty
Background incidence of lower urinary tract symptoms (LUTS) in transmasculine patients undergoing surgery
Endpoints
Acceptability of PFMT questionnaire
International Prostate Symptom Score (I-PSS) and International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) questionnaires and uroflowmetry
- Conditions
- Lower Urinary Tract Symptoms, Transgenderism
- Medical subject headings
- Lower Urinary Tract Symptoms, Transsexualism
What is being measured
The primary outcome is the main question the study is designed to answer.
Understand the acceptability of first-line PFMT treatment in transmasculine patients undergoing metoidioplasty
Acceptability of pelvic floor muscle training questionnaire - bespoke unvalidated qualitative questionnaire looking at acceptability of different PFMT techniques on a 0-10 VAS scale. Zero not acceptable, ten very acceptable.
International prostate symptom score. Seven questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaires. Question items: Frequency or urinary incontinence, Amount of leakage, Overall impact of urinary incontinence, Self-diagnostic item. Scoring scale: 0-21. Higher score = worse symptoms.
Uroflowmetry - baseline QMAX vs QMAX post procedure.
Measured: Baseline, 6 weeks, 12 weeks, 6 months post operatively
Background incidence of LUTS in transmasculine patients undergoing surgery
Acceptability of pelvic floor muscle training questionnaire - bespoke unvalidated qualitative questionnaire looking at acceptability of different PFMT techniques on a 0-10 VAS scale. Zero not acceptable, ten very acceptable.
International prostate symptom score. Seven questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaires. Question items: Frequency or urinary incontinence, Amount of leakage, Overall impact of urinary incontinence, Self-diagnostic item. Scoring scale: 0-21. Higher score = worse symptoms.
Uroflowmetry - baseline QMAX vs QMAX post procedure.
Measured: Baseline, 6 weeks, 12 weeks, 6 months post operatively
Secondary outcomes (2)
How well do the I-PSS and ICIQ SF function as measures of LUTS and LUTS specific Quality of Life (QoL) for transmen?
Acceptability of pelvic floor muscle training questionnaire - bespoke unvalidated qualitative questionnaire looking at acceptability of different PFMT techniques on a 0-10 VAS scale. Zero not acceptable, ten very acceptable.
International prostate symptom score. Seven questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaires. Question items: Frequency or urinary incontinence, Amount of leakage, Overall impact of urinary incontinence, Self-diagnostic item. Scoring scale: 0-21. Higher score = worse symptoms.
Uroflowmetry - baseline QMAX vs QMAX post procedure.
Measured: Baseline, 6 weeks, 12 weeks, 6 months post operatively
How do subjective LUTS / objective voiding dysfunction (VD) change after metoidioplasty / vaginectomy / urethral hook up?
Acceptability of pelvic floor muscle training questionnaire - bespoke unvalidated qualitative questionnaire looking at acceptability of different PFMT techniques on a 0-10 VAS scale. Zero not acceptable, ten very acceptable.
International prostate symptom score. Seven questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaires. Question items: Frequency or urinary incontinence, Amount of leakage, Overall impact of urinary incontinence, Self-diagnostic item. Scoring scale: 0-21. Higher score = worse symptoms.
Uroflowmetry - baseline QMAX vs QMAX post procedure.
Measured: Baseline, 6 weeks, 12 weeks, 6 months post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956989
- Sponsor's protocol ID
- 336081
- Acronym
- LUTS-POGP
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Urinary Tract Symptoms in Transmasculine Patients Undergoing Metoidioplasty and Their Acceptability of Pelvic Floor Muscle Training Assessed by a Pelvic, Obstetric and Gynaecological Physiotherapist
- ClinicalTrials.gov ID
- NCT06956989
- Acronym / sponsor ID
- LUTS-POGP / 336081
- Conditions
- Lower Urinary Tract Symptoms, Transgenderism
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lower urinary tract symptoms in transmasculine patients undergoing metoidioplasty and their acceptability of pelvic floor muscle training assessed by a Pelvic, Obstetric and Gynaecological Physiotherapist.
Study Design
Prospective observational pilot study
Study Participants
Transmasculine patients undergoing metoidioplasty
Planned Sample Size
50
Planned Study Period
2025/26
Objectives
Understand the acceptability of first-line pelvic floor muscle training (PFMT) treatment in transmasculine patients undergoing metoidioplasty
Background incidence of lower urinary tract symptoms (LUTS) in transmasculine patients undergoing surgery
Endpoints
Acceptability of PFMT questionnaire
International Prostate Symptom Score (I-PSS) and International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) questionnaires and uroflowmetry
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants will be transmasculine patients undergoing metoidioplasty
Key inclusion criteria (6 listed)
- Have capacity to consent.
- Diagnosis of gender dysphoria and have lived in a gender role that is congruent to their gender identity for minimum of 12 months.
- Transmasculine patients referred to CCGS for masculinising lower genital reconstructive surgery having received two signatures confirming suitability for reconstructive surgery.
- Undergoing metoidioplasty/phalloplasty.
- Age >17 years old.
Key exclusion criteria (2 listed)
- Age less than 18 years.
- Not undergoing metoidioplasty/phalloplasty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Understand the acceptability of first-line PFMT treatment in transmasculine patients undergoing metoidioplasty
Time frame: Baseline, 6 weeks, 12 weeks, 6 months post operatively
Acceptability of pelvic floor muscle training questionnaire - bespoke unvalidated qualitative questionnaire looking at acceptability of different PFMT techniques on a 0-10 VAS scale. Zero not acceptable, ten very acceptable. International prostate symptom score. Seven questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaires. Question items: Frequency or urinary incontinence, Amount of leakage, Overall impact of urinary incontinence, Self-diagnostic item. Scoring scale: 0-21. Higher score = worse symptoms. Uroflowmetry - baseline QMAX vs QMAX post procedure.
Background incidence of LUTS in transmasculine patients undergoing surgery
Time frame: Baseline, 6 weeks, 12 weeks, 6 months post operatively
Acceptability of pelvic floor muscle training questionnaire - bespoke unvalidated qualitative questionnaire looking at acceptability of different PFMT techniques on a 0-10 VAS scale. Zero not acceptable, ten very acceptable. International prostate symptom score. Seven questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaires. Question items: Frequency or urinary incontinence, Amount of leakage, Overall impact of urinary incontinence, Self-diagnostic item. Scoring scale: 0-21. Higher score = worse symptoms. Uroflowmetry - baseline QMAX vs QMAX post procedure.
2 secondary outcomes
How well do the I-PSS and ICIQ SF function as measures of LUTS and LUTS specific Quality of Life (QoL) for transmen?
Time frame: Baseline, 6 weeks, 12 weeks, 6 months post operatively
How do subjective LUTS / objective voiding dysfunction (VD) change after metoidioplasty / vaginectomy / urethral hook up?
Time frame: Baseline, 6 weeks, 12 weeks, 6 months post operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms and Transgenderism, run by Chelsea and Westminster NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rufus Cartwright, MA MD(res) PhD MRCOG (0203315800, rufus.cartwright@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understand the acceptability of first-line PFMT treatment in transmasculine patients undergoing metoidioplasty (time frame: Baseline, 6 weeks, 12 weeks, 6 months post operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.