Sexual Function Questionnaire Total Hip Replacement

NCT02290652 | Withdrawn

• 1 other identifier: 12/SC/0296
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Arthritis

Keywords

Sexual function in Orthopaedic patients

Outcome Measures

Primary Outcomes (1)

• Factors affecting sexual activity related to total hip replacement, as measured by the Arthroplasty & Sexual Function Questionnaire (ASFQ)

  To determine those patient and implant factors that affect sexual activity after hip replacement surgery. The study data will be used to publish an evidence-based patient information booklet that will be a standard reference for patients and healthcare professionals.

  2 years

Secondary Outcomes (1)

• Factors affecting sexual activity related to other joint replacement surgery, as measured by the Arthroplasty & Sexual Function Questionnaire (ASFQ)

  2-5 years

Study Arms (2)

Prospective

Prospective - Factors affecting sexual function pre-THR

Other: Prospective - Factors affecting sexual function pre-THR

Retrospective

Retrospective- Factors affecting sexual function post-THR

Other: Retrospective- Factors affecting sexual function post-THR

Interventions

Prospective - Factors affecting sexual function pre-THR OTHER

A prospective assessment of factors affecting sexual function in patients whom are awaiting a total hip replacement. Patients will carry out a prospective 23 question questionnaire: 'Arthroplasty \& Sexual Function Questionnaire (ASFQ) - Pre-operative' with validated questionnaire Female Sexual Function Index (FSFI), before their operation. Then at 6 months and 12 months post-operatively they will fill out a retrospective 30 question questionnaire: 'Arthroplasty \& Sexual Function Questionnaire (ASFQ) - Post-operative', again with FSFI.

Prospective

Retrospective- Factors affecting sexual function post-THR OTHER

A retrospective assessment of factors affecting sexual function in patients whom have undergone a total hip replacement (THR) in the preceding year. Patients will carry out a retrospective 30 question questionnaire: 'Arthroplasty \& Sexual Function Questionnaire (ASFQ) - Post-operative' with validated questionnaire Female Sexual Function Index (FSFI), at 6 months and/or 12 months (wherever possible). Maximum retrospective collection of data 12 months.

Retrospective

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Female
• Sexually active
• Heterosexual
• years undergoing THR (prospective) or having undergone THR surgery within the last year

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (2)

Spire Southampton Hospital

Southampton, Hampshire, SO16 6UY, United Kingdom

Location

University of Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Joanna C D'Souza, BM BSc(Hons)

  Research Fellow, UHS NHS FT.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 14, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

GB (2)