PEssary Plus Physiotherapy for Pelvic Organ Prolapse (PEPPY)

NCT01136889 | Completed

• 4 other identifiers: RG957Wellbeing of WomenMRECNHS GG&C
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

Brief Summary

1. 1.To determine the feasibility of conducting a randomised controlled trial (RCT) of the effectiveness of a PFMT intervention in conjunction with vaginal pessary management versus vaginal pessary management alone for women with pelvic organ prolapse.
2. 2.To develop and test the methods for a main trial.

Conditions

Pelvic Organ Prolapse

Keywords

PFMT; Vaginal pessary; Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Prolapse symptom score (POP-SS)

  7 months

Secondary Outcomes (8)

• Prolapse-related quality of life(single item scored 0 to 10)

  7 months

• Prolapse severity (POP-Q)

  7 months

• Urinary, bowel and sexual symptoms

  7 months

• Lifestyle changes

  7 months

• General Health Status

  7 months

Study Arms (2)

PFMT plus routine pessary management

ACTIVE COMPARATOR

Women allocated to the intervention group will be invited to attend 5 out-patient appointments over a 16 week period with a trained specialist women's health physiotherapist at the study centre. Women will be taught how to contract the muscles, and also how to contract and hold prior to an event that increases intra-abdominal pressure ("the Knack"). Tailored advice will be given on ways of reducing intra-abdominal pressure, e.g. advice on weight loss, chronic cough, heavy lifting and general exercise. A prolapse specific Lifestyle Advice sheet will also be given to the women by the physiotherapist.

Other: PFMT

Lifestyle

ACTIVE COMPARATOR

Women allocated to the control group will be sent a Lifestyle Advice Leaflet only. They will have no planned intervention after their pessary is fitted, other than routine pessary management according to local protocols. The Lifestyle Advice Leaflet gives instructions on seeking advice, where appropriate, about weight loss, constipation, and avoidance of heavy lifting, coughing and high impact exercise, with a view to minimising increases in intra-abdominal pressure which may cause the prolapse to worsen.

Other: PFMT

Interventions

PFMT OTHER

Women who have been successfully fitted with a vaginal pessary will be asked to attend five outpatient appointments over a 16 week period with a trained specialist women's health physiotherapist.

Also known as: Pelvic Floor Muscle Training

Lifestyle; PFMT plus routine pessary management

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women:
• who are new attendees at outpatient gynaecology clinics with a primary complaint of prolapse;
• who have a prolapse of stage I to IV confirmed by their gynaecologist using the POP-Q grading system;
• who have a prolapse of one or more of the following types:
• anterior vaginal wall prolapse (urethrocele, cystocele,paravaginal defect);
• uterine/cervical prolapse;
• vaginal vault (after hysterectomy)prolapse;
• posterior vaginal wall prolapse (enterocele, rectocele, perineal deficiency);
• who require a vaginal pessary for treatment of their prolapse (the process of fitting the pessary will be according to standard practice at the centre thus the protocol for choice of pessary, insertion and follow-up will be determined locally);
• who successfully retain the vaginal pessary for two weeks after fitting;
• who are willing to participate in the study and to comply with their group allocation.

You may not qualify if:

• Women:
• who wish surgical treatment for prolapse and wish to be immediately added to the surgical waiting list;
• who have had previous surgical treatment for prolapse;
• who have had a pessary fitted for treatment of prolapse within the last 12 months;
• who have had previous formal instruction in PFMT;
• who present with contraindications to either pessary or PFMT treatment;
• who are unable to comply with PFMT treatment;
• who have local atrophy (this must be treated first);
• who are less than 6-months postnatal;
• who are pregnant;
• who are unable to give informed consent.

Sponsors & Collaborators

• Glasgow Caledonian University: lead
• NHS Greater Glasgow and Clyde: collaborator

Study Sites (4)

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Location

Falkirk and District Royal Infirmary

Falkirk, United Kingdom

Location

Southern General Hospital

Glasgow, United Kingdom

Location

Victoria Infirmary

Glasgow, United Kingdom

Location

Related Publications (2)

• Bugge C, Adams EJ, Gopinath D, Stewart F, Dembinsky M, Sobiesuo P, Kearney R. Pessaries (mechanical devices) for managing pelvic organ prolapse in women. Cochrane Database Syst Rev. 2020 Nov 18;11(11):CD004010. doi: 10.1002/14651858.CD004010.pub4.

  PMID: 33207004 DERIVED

• Bugge C, Williams B, Hagen S, Logan J, Glazener C, Pringle S, Sinclair L. A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse. Trials. 2013 Oct 25;14:353. doi: 10.1186/1745-6215-14-353.

  PMID: 24160371 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Professor Suzanne Hagen

  NMAHP Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 4, 2010
• Study Start: April 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 19, 2011

Record last verified: 2011-01

Locations

GB (4)