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Neurotoxin

OnabotulinumtoxinA 100 UNT for Pelvic Organ Prolapse

Phase 4

Waitlist Available

Research Sponsored by Walter Reed National Military Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6-12 weeks postoperatively

Awards & highlights

Study Summary

This trial will study whether BOTOX can help treat overactive bladder symptoms during prolapse surgery.

Eligible Conditions

Pelvic Organ Prolapse
Overactive Bladder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6-12 weeks postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6-12 weeks postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6-12 weeks postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline to postoperative weeks 6 to 12 in Overactive Bladder bother short form (OAB-q SF) questionnaire looking for a decrease of 10 points, which is the minimally important difference.

Secondary outcome measures

Change from baseline to postoperative weeks 6 to 12 in Patient Global Impression of Severity Scale (PGI-S).

Change from baseline to postoperative weeks 6 to 12 in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12).

Patient Global Impression of Improvement Scale (PGI-I) at 6 to 12 weeks postoperatively.

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intravesical OnabotulinumtoxinAExperimental Treatment1 Intervention

The treatment group will receive 100 units of BOTOX® reconstituted in 10mL of injectable preservative-free normal saline at the time of cystoscopy. An injection cystoscopy needle will be set to 3mm and used to inject 0.5mL reconstituted OnabotulinumtoxinA at each injection site, approximately 1cm apart along the posterior bladder wall, for a total of 20 injection sites (4 rows of 5 injection sites). This will be the only treatment.

Group II: PlaceboPlacebo Group1 Intervention

Subjects randomized to the placebo group will undergo the same procedure but will only receive 10mL of injectable preservative-free normal saline. This will be the only treatment.

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Who is running the clinical trial?

Walter Reed National Military Medical CenterLead Sponsor

137 Previous Clinical Trials

34,359 Total Patients Enrolled

1 Trials studying Pelvic Organ Prolapse

78 Patients Enrolled for Pelvic Organ Prolapse

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being enrolled for this clinical research?

"Per the clinicaltrials.gov portal, this research is presently searching for participants. The trial was initially posted on September 23rd 2021 and most recently updated on October 5th 2021."

Answered by AI

Are there any precedents for using OnabotulinumtoxinA 100 UNT in clinical trials?

"Currently, 61 clinical trials for OnabotulinumtoxinA 100 UNT are underway – 20 of which have reached the third phase. Most are located in Farmington Hills, Michigan; nonetheless, there exists a total of 759 sites conducting research into this promising therapy."

Answered by AI

What ailments is OnabotulinumtoxinA 100 UNT typically used to address?

"OnabotulinumtoxinA 100 UNT is frequently utilized to treat urinary incontinence. This medication can also be helpful in treating a variety of other conditions, including spinal cord damage, botox injections, and overactive bladder syndrome (OABs)."

Answered by AI

Has OnabotulinumtoxinA 100 UNT obtained the blessing of the federal government?

"There is substantial evidence that OnabotulinumtoxinA 100 UNT poses a low risk of side effects, so it was given an assessment score of 3."

Answered by AI

What is the current enrollment capacity for this trial?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, initially posted on September 23rd 2021, is currently recruiting individuals for participation. The study requires 138 patients and will be conducted at 1 hospitalisation centre."

Answered by AI

Recent research and studies

Journal of UrologyJournal

Efficacy and Safety of Onabotulinumtoxina for Idiopathic Overactive Bladder: A Double-blind, Placebo Controlled, Randomized, Dose Ranging Trial

Dmochowski, Roger, Christopher Chapple, Victor W. Nitti, Michael Chancellor, Karel Everaert, Catherine Thompson, Grace Daniell, Jihao Zhou, and Cornelia Haag-Molkenteller. 2010. “Efficacy and Safety of Onabotulinumtoxina for Idiopathic Overactive Bladder: A Double-blind, Placebo Controlled, Randomized, Dose Ranging Trial”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2010.08.021.

Neurourology and UrodynamicsJournal

Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and Treatment of Urinary Incontinence, Pelvic Organ Prolapse, and Fecal Incontinence

Abrams, P., K.E. Andersson, L. Birder, L. Brubaker, L. Cardozo, C. Chapple, A. Cottenden, et al.. 2010. “Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and Treatment of Urinary Incontinence, Pelvic Organ Prolapse, and Fecal Incontinence”. Neurourology and Urodynamics. Wiley. doi:10.1002/nau.20870.

Female Pelvic Medicine & Reconstructive SurgeryJournal

Overactive Bladder Symptoms After Pelvic Organ Prolapse Repair

Johnson, Justine R., Rachel A. High, Olivia Dziadek, Adriana Ocon, Tristi W. Muir, Jiaqiong Xu, and Danielle D. Antosh. 2019. “Overactive Bladder Symptoms After Pelvic Organ Prolapse Repair”. Female Pelvic Medicine & Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/spv.0000000000000700.

International Urogynecology JournalJournal