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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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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
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.

United Kingdom1 site
  • King's College, London

    London

Other trials in United Kingdom

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.

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 groups in NCT07091565
Study groupRoleWhat they receive
PatientExperienced patients
Receives: Other: Qualitative interview/Focus group
HCPExperienced 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.

  1. 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)
  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.

  1. First posted29 Jul 2025
  2. Study start1 Aug 2025 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

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)
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

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.

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