Clinical trial NCT02290652: Sexual Function Questionnaire Total Hip Replacement
Official title: Development and Validation of a Sexual Function Questionnaire for Female Patients Undergoing Total Hip Replacement
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Arthritis
Keywords: Sexual function in Orthopaedic patients
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All female patients aged over 18 that are listed for a total hip replacement at University Hospital Southampton NHS Foundation Trust and The Spire Hospital Southampton that fulfill the inclusion criteria will be asked to participate.

Brief summary: * Non-commercial trial
* 2 Centres involved: University Hospital Southampton and Spire Southampton
* Expected number of eligible participants available per year: 100, (95% expected to agree to participation)
* The study will recruit prospectively female patients aged 18 - 65 years undergoing THR. A retrospective series of similar patients who have had a hip replacement will also be recruited.
* This is a research project that will run over 2 years. Data from 200 patients will be collected and analysed:

Retrospective 30 question questionnaire: 'Arthroplasty \& Sexual Function Questionnaire (ASFQ) - Post-operative' Version 1.3 11/07/14

Prospective 23 question questionnaire: 'Arthroplasty \& Sexual Function Questionnaire (ASFQ) - Pre-operative' Version 1.3 11/07/14

This project is significant in exploring an area of Orthopaedic medicine that has been little discussed in the literature. Preliminary results of our questionnaires have already revealed patients have a great desire to know how hip replacement will affect sexual function. Components of the questionnaire look at details such as: reasonable time frames for returning to sexual activity, positions that may be undesirable following replacement and which may lead to dislocation, concurrent use of analgesia and psychosexual aspects of total hip replacement surgery. The ultimate objective is to provide patients with detailed information about what to expect after hip replacement surgery.

Detailed description: Prospective

Patients will be recruited from clinics at University Hospital Southampton and Spire Southampton Hospital. If they agree in principle to participate they will be provided with the Patient Information Sheet (PIS) and consent forms. Having completed the consent forms (one for participant to keep and one for the site file) participants are assigned an alphanumeric study number, which will be written at the top of all questionnaires and research paperwork completed. A form detailing demographic information will be filled out on recruitment to provide data for comparative quantitative analysis.

Prior to their operation, whether in hospital or by post (patient preference), they will complete a pre-operative ASFQ and FSFI questionnaire. These will be returned to the research team either in person (if completed by an inpatient) or returned in a pre-stamped addressed envelope. Copies of the National Joint Registry (NJR) data and PROMs will also be made and kept for evaluation alongside the questionnaire data. Patients will then complete the post-operative questionnaires and FSFI validated questionnaire at 6 and 12 months after their surgery. Questionnaires will be distributed to the patients in clinic at 6 months and sent to their home address at 12 months post-operatively (returned with stamped and addressed envelope).

Retrospective

Potential participant will be highlighted from previous inpatient list of patients eligible for participation. These patients will be contacted via telephone by a Good Clinical Practice (GCP) trained member of the research team member and invited to participate in the trial. If keen a PIS will be sent out to the patient's home address. The research team member will then follow-up with a phone-call to gain implied consent and complete an additional form detailing demographic information (the same information as the prospective cohort). The post-operative questionnaire, FSFI questionnaire and consent forms (one for participant to keep and one for the site file) with a stamped address envelope, will then be sent out to the participant to complete. Once documents are completed they will be returned to the research team. Questionnaires will be sent out at 6 and 12 months post-op where possible. Maximum time retrospective recruitment will be 12 months. The patient's NJR and PROMs will also be accessed for evaluation alongside the questionnaire data.

Eligibility criteria: Inclusion Criteria:

* Female
* Sexually active
* Heterosexual
* 18- 65 years undergoing THR (prospective) or having undergone THR surgery within the last year

Exclusion Criteria:

* Sexually inactive pre-operatively and wishing to remain sexually inactive post-operatively
* Unable to comprehend English and with capacity to consent and follow instruction
* Unable to sign and date the ethics committee approved consent documentation

Primary outcomes:
measure: Factors affecting sexual activity related to total hip replacement, as measured by the Arthroplasty & Sexual Function Questionnaire (ASFQ)
timeFrame: 2 years
Secondary outcomes:
measure: Factors affecting sexual activity related to other joint replacement surgery, as measured by the Arthroplasty & Sexual Function Questionnaire (ASFQ)
timeFrame: 2-5 years
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Spire Southampton Hospital
state: Hampshire
city: Southampton
country: United Kingdom
facility: University of Southampton NHS Foundation Trust
state: Hampshire
Study officials:
affiliation: Research Fellow, UHS NHS FT.
name: Joanna C D'Souza, BM BSc(Hons)
role: PRINCIPAL_INVESTIGATOR
References: