Bladder CancerSPARCNCT07091565
Supporting Sexual Recovery in Women With Bladder Cancer
An observational study of Bladder Cancer and Cystectomy, run by King's College London at 1 site in United Kingdom.
Trial summary
This study looks at how bladder cancer and removing the bladder can affect women's sexual well-being. Bladder cancer can be more serious in women, and treatment like bladder removal can impact how they feel about themselves and their relationships. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer, Cystectomy, Female Sexual Dysfunction
- What is being tested?
- Qualitative interview/Focus group
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2025to Jun 2029
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female bladder cancer patients who have undergone bladder removal.
Patient Inclusion
- All women and other patients with a clitoris, vagina, neo-vagina or neo-clitoris
- Have a diagnosis of BCa-any grade/stage and have had a cystectomy (bladder removal)
- At least 6 months after cystectomy
- >/ 18 years old
- Written informed consent.
HCP Inclusion
- All those working directly within a bladder cancer speciality
- Professional registration
- Written informed consent
Patient Exclusion
- Poor command of the English language to the extent that the researcher judges this to critically undermine the ability to achieve the objectives of the interview.
- A judgement by the researcher or the individual's clinician, based on either clinical appraisal (capacity assessment) or review of the individual's medical notes, that the individual has a cognitive functioning impairment that would interfere with ability to understand and complete the interview.
- Documentation in the accessible medical notes of a psychiatric condition that would hamper participation in interview.
- A judgement by the researcher or the individual's clinician, based on either clinical appraisal or review of the individual's medical notes, that the individual is too ill to participate; or is ill enough that participation would produce an unreasonable burden on that individual.
- Aged <18 years.
HCP Exclusion:
-Those without professional registration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SPARC: Supporting Sexual Recovery in Women With Bladder Cancer
This study looks at how bladder cancer and removing the bladder can affect women's sexual well-being. Bladder cancer can be more serious in women, and treatment like bladder removal can impact how they feel about themselves and their relationships. Women who've gone through this say it's important to talk about and get support for their sexual recovery.
The study has three main parts. First, it reviews what is already known. Next, it involves talking to women with bladder cancer and the doctors and nurses who care for them. Finally, the team will use what they learn to create a toolkit to help healthcare workers support women's sexual recovery.
Women with bladder cancer are helping to design this study. Their input shapes the questions and tools. The final toolkit will include training for doctors and nurses and be shared online and through charities. The aim is to make this part of regular healthcare.
Read the detailed description
Background \& Aims Bladder cancer is one of the top ten cancers in the UK. In women, it can be more aggressive, meaning it can be more harmful. Bladder cancer often needs invasive treatment or procedures such as bladder removal. This can cause problems with a woman's sexual well-being and recovery.
There are different types of bladder cancer, and each requires a different treatment. In high-risk types, a more intensive treatment is required. The patient may need to have their bladder removed. The bladder is replaced with an alternative option for urine drainage such as a bag on the skin. In bladder removal, evidence tells us that there will be an impact on a woman's sexual well-being.
Sexual recovery is an important aspect of personal wellbeing and quality of life after cancer treatment. We have worked with women to develop this proposal and they tell us this is important to them.
This study aims to examine this aspect of well-being in women with bladder cancer and having bladder removal. The study will develop a toolkit alongside women to support sexual recovery in this group of patients.
What will the study involve? The study has been designed in stages to breakdown the individual elements.
Stage 1:
The initial stage involves a detailed examination of the existing literature to understand what needs to be discovered.
Stage 2:
The next stage requires in-depth investigation through interviewing patients individually or in a group. Doctors and nurses will also be interviewed about sexual well-being and bladder cancer. Findings from these interviews will be looked at to identify common themes and to understand how care is given.
Stage 3:
Findings from Stages 1 and 2 will be used to co-design a toolkit. The toolkit will be designed in partnership with patients and clinical experts.
It is anticipated that the toolkit will involve education sessions face to face or online to allow the healthcare provider to give better care. The toolkit will be tested to check it is meeting the needs of patients and that it is acceptable to users.
Public Involvement and Engagement This is a co-design project. This means that patients are involved in the project at every stage. At the start, a project codesign group has been created. This includes five patients with experience of bladder cancer. The group is from different backgrounds and further efforts will be made to include people from under-represented groups. For example, the patient group thought it was important for patients to be offered interviews alone or in groups. This was particularly important for the members from under-represented groups, so the study design was amended.
Considerations Prior to starting, ethical approval will be sought to be sure the study will not cause harm. Patients will be invited to participate by post or email. Participation will be voluntary and can be withdrawn. Recruited patients will be allocated an anonymous identification code and all data will be stored in a safe way. Some participants may feel upset during the study and need extra support. If this happens, they will be referred for specialist help.
Outcomes A toolkit will be designed for healthcare professionals. The toolkit will help healthcare professionals to support women's sexual recovery. The toolkit will be tested to make sure it works. The findings will be shared with patients online and through charity groups. This will be achieved through explanatory animations. Doctors and nurses will be encouraged to complete the training and will be alerted to it at professional meetings and groups. The final aim is to include this toolkit within clinical training and guidelines.
- Conditions
- Bladder Cancer, Cystectomy, Female Sexual Dysfunction
- Being tested
- Qualitative interview/Focus group
- Keywords
- Bladder cancer, transitional cell carcinoma, radical cystectomy, anterior exenteration, exenteration, sexual function, women, female, gynaecological organs
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative interview/Focus groupOther
Participants will take part in a 1:1 interview or focus group
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experienced patients Receives: Other: Qualitative interview/Focus group | |
| HCP | Experienced healthcare professionals Receives: Other: Qualitative interview/Focus group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative only
Thematic analysis following an inductive framework approach to elicit codes and themes from the interviews.
Measured: 01/08/25-01/06/26
Secondary outcomes (1)
Intervention development
Emerging codes and themes from the qualitative interviews will inform intervention design and intervention development.
Measured: 06/2026-06/2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's & St Thomas' NHS FT, The Royal Marsden NHS FT, Sheffield Teaching Hospitals NHS FT
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091565
- Sponsor's protocol ID
- 335939
- Acronym
- SPARC
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPARC: Supporting Sexual Recovery in Women With Bladder Cancer
- ClinicalTrials.gov ID
- NCT07091565
- Acronym / sponsor ID
- SPARC / 335939
- Conditions
- Bladder Cancer, Cystectomy, Female Sexual Dysfunction
- Keywords
- Bladder cancer, transitional cell carcinoma, radical cystectomy, anterior exenteration, exenteration, sexual function, women, female
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's & St Thomas' NHS FT, The Royal Marsden NHS FT, Sheffield Teaching Hospitals NHS FT
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 29 Jul 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.
This study looks at how bladder cancer and removing the bladder can affect women's sexual well-being. Bladder cancer can be more serious in women, and treatment like bladder removal can impact how they feel about themselves and their relationships. Women who've gone through this say it's important to talk about and get support for their sexual recovery.
The study has three main parts. First, it reviews what is already known. Next, it involves talking to women with bladder cancer and the doctors and nurses who care for them. Finally, the team will use what they learn to create a toolkit to help healthcare workers support women's sexual recovery.
Women with bladder cancer are helping to design this study. Their input shapes the questions and tools. The final toolkit will include training for doctors and nurses and be shared online and through charities. The aim is to make this part of regular healthcare.
Detailed description
Background \& Aims Bladder cancer is one of the top ten cancers in the UK. In women, it can be more aggressive, meaning it can be more harmful. Bladder cancer often needs invasive treatment or procedures such as bladder removal. This can cause problems with a woman's sexual well-being and recovery.
There are different types of bladder cancer, and each requires a different treatment. In high-risk types, a more intensive treatment is required. The patient may need to have their bladder removed. The bladder is replaced with an alternative option for urine drainage such as a bag on the skin. In bladder removal, evidence tells us that there will be an impact on a woman's sexual well-being.
Sexual recovery is an important aspect of personal wellbeing and quality of life after cancer treatment. We have worked with women to develop this proposal and they tell us this is important to them.
This study aims to examine this aspect of well-being in women with bladder cancer and having bladder removal. The study will develop a toolkit alongside women to support sexual recovery in this group of patients.
What will the study involve? The study has been designed in stages to breakdown the individual elements.
Stage 1:
The initial stage involves a detailed examination of the existing literature to understand what needs to be discovered.
Stage 2:
The next stage requires in-depth investigation through interviewing patients individually or in a group. Doctors and nurses will also be interviewed about sexual well-being and bladder cancer. Findings from these interviews will be looked at to identify common themes and to understand how care is given.
Stage 3:
Findings from Stages 1 and 2 will be used to co-design a toolkit. The toolkit will be designed in partnership with patients and clinical experts.
It is anticipated that the toolkit will involve education sessions face to face or online to allow the healthcare provider to give better care. The toolkit will be tested to check it is meeting the needs of patients and that it is acceptable to users.
Public Involvement and Engagement This is a co-design project. This means that patients are involved in the project at every stage. At the start, a project codesign group has been created. This includes five patients with experience of bladder cancer. The group is from different backgrounds and further efforts will be made to include people from under-represented groups. For example, the patient group thought it was important for patients to be offered interviews alone or in groups. This was particularly important for the members from under-represented groups, so the study design was amended.
Considerations Prior to starting, ethical approval will be sought to be sure the study will not cause harm. Patients will be invited to participate by post or email. Participation will be voluntary and can be withdrawn. Recruited patients will be allocated an anonymous identification code and all data will be stored in a safe way. Some participants may feel upset during the study and need extra support. If this happens, they will be referred for specialist help.
Outcomes A toolkit will be designed for healthcare professionals. The toolkit will help healthcare professionals to support women's sexual recovery. The toolkit will be tested to make sure it works. The findings will be shared with patients online and through charity groups. This will be achieved through explanatory animations. Doctors and nurses will be encouraged to complete the training and will be alerted to it at professional meetings and groups. The final aim is to include this toolkit within clinical training and guidelines.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: Qualitative interview/Focus groupExperienced patients |
| HCP | – | Other: Qualitative interview/Focus groupExperienced healthcare professionals |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female bladder cancer patients who have undergone bladder removal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative interview/Focus groupParticipants will take part in a 1:1 interview or focus group | Other | HCP, Patient |
Primary outcome
Qualitative only
Time frame: 01/08/25-01/06/26
Thematic analysis following an inductive framework approach to elicit codes and themes from the interviews.
1 secondary outcome
Intervention development
Time frame: 06/2026-06/2027
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 3 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Cystectomy, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: enrolling by invitation, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative only (time frame: 01/08/25-01/06/26). 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 3 Aug 2025.