Pelvic floor rehabilitation in women undergoing pelvic floor reconstructive surgery

Not Applicable

• Conditions: Musculoskeletal Diseases; Urological and Genital Diseases; Pelvic organ prolapse

• Registration Number: PACTR201811741131369
• Lead Sponsor: Corlia Brandt

Brief Summary

Participants were a mean age of 59 years with predominantly stage III POP. Baseline outcomes indicated socio-economic, lifestyle and emotional impairment, as well as PF and abdominal muscle dysfunction. PFMT yielded the most significant changes regarding PF function during the first three months, including the LH during Valsalva (median change -3.5mm, 95% CI [-10.3;-1.8]), thickness of the perineal body (median change 1.5mm, 95% CI [0.5;4.1]), and endurance (median change 2sec, 95% CI [1;5]). Only group 2 showed significant changes in abdominal muscle function (Sahrmann and PBU levels, 95% CIs [1;3] and [1;9]) in addition to improved PF function up to six months. Although both intervention groups had some statistically significant muscle changes, no statistically significant differences were found in the magnitude of the changes among the three groups. Only group 2 yielded a statistical significant improvement in their P-QOL scores (95% CI [1.5;28.4]).

Detailed Description

Not available

Study Timeline

• Results First Posted: 2016-12-15
• Study Start: 2018-11-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

•Women over eighteen (18) years of age (Norton et al. 2007:4),
•women scheduled for corrective surgery for POP (including Perineo-colpo-sacro-suspension (sacrocolpopexy), anterior and posterior Prolift or Avaulta, total Prolift or Avaulta, anterior and posterior repair, sacrospinous colpofixation),
•participants that are able to adhere and comply to keep a treatment diary and execute a home exercise programme,
•Caucasian, Asian and Coloured women.

Exclusion Criteria

•Women suffering from neuromusculoskeletal disorders (Jarvis et al. 2005:301),
•Diabetes Mellitus,
•psycho-sexual problems (Norton et al. 2007:6; Laycock et al. 2001:22,31) or
•obesity (body mass index >35);
•pregnant women;
•women older than 75 years;
•women with stage IV POP (exclusion for phase I),
•previous POP surgery where mesh was used, and
•women who have had more than two previous operations for correction of POP;
•women who will not be able to attend frequent follow-up visits over a period of six (6) months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life;Pelvic floor and abdominal muscle function

Secondary Outcome Measures

Name	Time	Method
Exercise adherence, pain