Concurrent Surgery for Prolapse and Stress Urinary Incontinence to Reduce Further Surgery for Incontinence

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age41-83
SponsorShalamar Institute of Health Sciences

About this trial

Urinary incontinence is a common and distressing medical condition which affects 26% of women in developing countries.Globally upto 54% women suffer from pelvic organ prolapse and stress urinary incontinence concomitantly.Women with coexisting stress incontinence have a 40% risk of undergoing subsequent surgery for postoperative stress incontinence and woem with occult incontinence have a 15% risk.Overall,there is sufficient evidence that for women who are symptomatic of stress incontinence and prolapse,concomitant vaginal surgery for both problems is beneficial for reducing postoperative incontinence.However,it must be borne in mind that in woen undergoing vaginal prolapse surgery alone,almost 1/3 may experience cure of incontinence symptoms and despite concomitant continence surgery,stress urinary incontinence persist in approximately 1/3 of women.This study will be conducted to assess whether women with polpase and stress urinary incontinence could benefit from combined surgery in regards of requiring further surgery for stress incontinence.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult females 41-83 years age presenting with concurrent prolapse and stress urinary incontinence willing to participate in the study.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • anti incontinence surgery

    Procedure/Surgery

    anti incontinence surgery with prolapse surgery will be performed simultaneously

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: combined surgery groupActive comparator 1 intervention
Group B: prolapse surgery only groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

symptomatic stress urinary incontinence requiring surgery at six months

Time frame
at six months after surgery

Secondary outcomes

1

quality of life parameters.It will be assessed using ICIQ-UI short form questionnaires

0-12 score will show improved quality of life while 13-21 will show impaired quality

Time frame
1 week,6 week and six month after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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