A randomised controlled cluster trial to evaluate an electronic system for assessing pelvic floor symptomatology in women
| ISRCTN | ISRCTN75596544 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75596544 |
| Protocol serial number | N0059132289 |
| Sponsor | Department of Health |
| Funders | Sheffield Teaching Hospitals NHS Foundation Trust (NHS R&D Support Funding), Urogynaecology research fund |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 13/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Steve Radley
Scientific
Scientific
STH NHS Trust
OGN & Midwifery
G18
Jessop Wing
Sheffield
S10 2SF
United Kingdom
| Phone | +44 (0)114 271 2559 |
|---|---|
| stephen.radley@sth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised controlled cluster trial to evaluate an electronic system for assessing pelvic floor symptomatology in women |
| Study objectives | We aim to evaluate the impact of a new electronic pelvic floor symptoms assessment questionnaire (e-PAQ) on the diagnosis and management of pelvic floor disorders, compared with traditional clinical interviewing. We propose to evaluate this system in a randomised, controlled cluster trial in the areas of pelvic floor medicine in which it is likely to be employed; community continence clinics (physiotherapists and continence nurses) and in secondary care (urologists, gynaecologists and colorectal surgeons). The study will focus on detection rates of symptoms, the patient's perspective of the clinical episode and subsequent referral rates and prescribing patterns. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pelvic floor symptoms |
| Intervention | A randomised controlled cluster trial of a new electronic pelvic floor symptoms assessment questionnaire (e-PAQ), compared with traditional clinical interviewing for the diagnosis and management of pelvic floor disorders |
| Intervention type | Other |
| Primary outcome measure(s) |
Added 28/01/10: |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 1500 |
| Key inclusion criteria | Sheffield patients |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/12/2003 |
| Date of final enrolment | 01/10/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
STH NHS Trust
Sheffield
S10 2SF
United Kingdom
S10 2SF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2006 | Yes | No | |
| Results article | results | 01/10/2008 | Yes | No |
Editorial Notes
13/09/2017: internal review
