Patient reported outcomes following laparoscopic sacrohysteropexy
Research type
Research Study
Full title
Patient reported prolapse, bladder, bowel and sexual outcomes after laparoscopic sacrohysteropexy. A prospective cohort study, in a tertiary urogynaecology unit.
IRAS ID
230548
Contact name
A Vashisht
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Uterine (womb) prolapse is a common condition that often is associated with bladder, bowel and/or sexual dysfunction, it can also impact Quality of Life (QoL). Laparoscopic (key-hole) sacrohysteropexy (LSH) is a uterine sparing, minimally invasive procedure performed to treat uterine prolapse. Published retrospective descriptive studies have shown the procedure to be efficacious and safe. However to date, there have not been any prospective hypothesis driven studies powered to assess treatment success in terms of prolapse. Additionally, there are not any prospectively designed studies published that have assessed bladder, bowel and sexual outcomes after LSH. This is a single-centre, prospective, observational cohort study of women undergoing LSH designed to specifically look at a combination of subjective and objective outcome measures within these domains.
This study will combine patient reported outcome data using validated outcome measures of prolapse, bladder, bowel and sexual function with objective classification of prolapse using International Continence Society Pelvic Organ Prolapse Quantification (POP-Q). Additional objective bladder function will be assessed using urodynamic studies (UDS) and office bladder testing.
Patients will be recruited from the outpatient department of the Urogynaecology Pelvic Floor Unit at University College Hospital (UCH). Patients opting for LSH will be invited to participate and then undergo standard pre-operative clinical assessment as well as the additional clinical examination and investigations as part of the study. They will be asked to fill out validated patient reported outcome questionnaires to assess symptoms and impact on QoL. Patients will then be followed up at three and six months post-operatively.
REC name
Wales REC 5
REC reference
17/WA/0428
Date of REC Opinion
11 Jan 2018
REC opinion
Further Information Favourable Opinion