Pelvic floor symptoms in women receiving peritoneal dialysis
| ISRCTN | ISRCTN99227624 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99227624 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 352200 |
| Protocol serial number | EDGE ID - 176516 |
| Sponsor | University Hospitals of Leicester NHS Trust |
| Funder | Investigator initiated and funded |
- Submission date
- 27/05/2025
- Registration date
- 05/06/2025
- Last edited
- 05/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Peritoneal dialysis is normally carried out at home. This gives the person some flexibility over work, study, and other activities. Because peritoneal dialysis involves the dwelling and exchange of dialysis fluid within the abdomen, the increased pressure may lead to problems in the pelvic floor muscles, such as pelvic floor prolapse. Such problems may be more common in women who have given birth, are or have been overweight.
The pelvic floor is made up of muscles that form a sling from the front to the back to the back of the pelvis. They provide support to the organs within the pelvis and play a role in controlling your bladder, bowel and sexual functions. Pelvic floor prolapse refers to a bulging of bowel, bladder or womb into or outside of the vagina. There have been a few reports of this problem in women who receive peritoneal dialysis. However, we do not know how common it is or how it affects daily living.
The aim of this pilot study is to test questionnaires in women receiving peritoneal dialysis, which ask about pelvic floor symptoms. The information we receive will help us with the design of a larger study.
Who can participate?
Women aged between 18 and 90 years who are receiving peritoneal dialysis
What does the study involve?
The study involves completing questionnaires that ask about the presence of pelvic floor symptoms and how they affect daily life. These will be completed at the start of the study and after 6 months.
What are the possible benefits and risks of participating?
While we do not expect that there will be direct health benefits, symptoms or other health issues may be identified from completing the questionnaires. The doctor will be informed so that treatment or referral for help can be arranged.
The risk is that the study questionnaires may touch on sensitive topics. Psychological support will be provided where there is distress as a result of participating in the study.
Where is the study run from?
University Hospitals of Leicester NHS Trust (UK)
When is the study starting and how long is it expected to run for?
April 2025 to September 2026
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Osasuyi Iyasere, osasuyi.iyasere@nhs.net
Contact information
Public, Scientific, Principal investigator
John Walls renal unit
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
 ORCID ID |
0000-0002-4787-0105 |
|---|---|
| Phone | +44 (0)1162584195 |
| osasuyi.iyasere@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Pilot single-centre prospective cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Exploring pelvic floor symptoms in women receiving peritoneal dialysis – a pilot observational study |
| Study acronym | EXPLORE PD |
| Study objectives | It is feasible to evaluate pelvic floor dysfunction in women receiving peritoneal dialysis (PD) |
| Ethics approval(s) |
Approved 07/04/2025, Health and Social Care Research Ethics Committee A (HSC REC A) (Business Services Organisation Unit 4, Lissue Industrial Estate West Rathdown Walk Moira Road Lisburn BT28 2RF, Lisburn, BT28 2RF, United Kingdom; +44 (0)28 95 361404; RECA@hscni.net), ref: 25/NI/0046 |
| Health condition(s) or problem(s) studied | Pelvic floor symptoms in women on peritoneal dialysis |
| Intervention | Pelvic floor questionnaires that examine the burden and impact of pelvic floor symptoms will be administered to eligible at baseline and after 6 months. Demographic and clinical data will also be captured during the study period. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Study recruitment rate measured as a percentage at baseline |
| Key secondary outcome measure(s) |
1. Pelvic floor symptoms measured using the Pelvic Floor Distress Inventory (PDFI-20) at baseline and 6 months |
| Completion date | 30/09/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Female |
| Target sample size at registration | 35 |
| Key inclusion criteria | 1. Aged between 18 and 90 years 2. Receiving peritoneal dialysis 3. Female 4. Able to provide informed consent |
| Key exclusion criteria | 1. Unable to provide informed consent 2. Any other significant disease or disorder which, in the opinion of the patient’s own clinician, may put the participants at risk because of participation in the study. For example, a severe mental health disorder or recent bereavement |
| Date of first enrolment | 15/05/2025 |
| Date of final enrolment | 30/04/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Osasuyi Iyasere (osasuyi.iyasere@nhs.net) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/05/2025: Study's existence confirmed by Health and Social Care Research Ethics Committee A (HSC REC A).
