A Community Intervention Study of Female Pelvic Floor Condition and Knowledge of Pelvic Floor Exercises

NCT01635894 | Completed

• 2 other identifiers: 1706WellBeing of Women
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of the study were to attempt to answer the following questions; what proportion of women know how to and are able to exercise their pelvic floor and for those who cannot can they be trained and motivated to do so. This was a nested design comprising a prospective cohort study together with a controlled trial intervention after baseline assessment in the cohort study for a defined at-risk group.

Conditions

Behavioural

Keywords

female pelvic floor condition; pelvic floor training; supervised pelvic floor training; practice nurse; nurse specialist

Outcome Measures

Primary Outcomes (1)

• maximal vaginal squeeze pressure (perineometry).

  monthly for 3 months

Secondary Outcomes (1)

• endurance of contraction (perineometry)and digital vaginal palpation (MOS).

  monthly for 3 months

Study Arms (3)

nurse specialist

EXPERIMENTAL

Women were screened for a "weak pelvic floor" (modified Oxford score, MOS, ≤ 2) before being invited into the trial. The women were seen monthly after their initial assessment and training and were followed-up for their final assessment at 3 months.

Behavioral: Training

practice nurse

EXPERIMENTAL

Women were screened for a "weak pelvic floor" (modified Oxford score, MOS, ≤ 2) before being invited into the trial. The women were seen monthly after their initial assessment and training and were followed-up for their final assessment at 3 months.

Behavioral: Training

Control

NO INTERVENTION

Women were screened for a "weak pelvic floor" (modified Oxford score, MOS, ≤ 2) before being invited into the trial. The women were seen monthly after their initial assessment (but no training given) and were followed-up for their final assessment at 3 months.

Interventions

Training BEHAVIORAL

Women in both the practice nurse and specialist nurse groups were given supervised pelvic floor exercise training. After the initial training they were given a daily exercise regimen and seen at monthly intervals for three months. The practice nurses had attended a study day on supervising Pelvic Floor Muscle Training(PFMT)followed by practice sessions with patients overseen by the nurse specialist.

Also known as: Pelvic Floor Muscle Training (PFMT)

nurse specialist; practice nurse

Eligibility Criteria

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

You may qualify if:

• Able to give consent Aged above 18 years modified Oxford score, MOS, ≤ 2

You may not qualify if:

• Unable to give consent

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Related Publications (1)

• Waterfield A, Waterfield M, Campbell J, Freeman R. Can effective supervised pelvic floor muscle training be provided by primary care nurses? A randomized controlled trial. Int Urogynecol J. 2021 Oct;32(10):2717-2725. doi: 10.1007/s00192-021-04692-3. Epub 2021 Feb 23.

  PMID: 33624122 DERIVED

Study Officials

• Robert Freeman, MD

  University Hospital Plymouth NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 10, 2012
• Study Start: April 1, 2002
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: November 5, 2015

Record last verified: 2015-11

Locations

GB (1)